Perspective Therapeutics, Inc.
For the period ended Sep 30, 2026. Filed Nov 9, 2026.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2026 · Filed Nov 9, 2026
CATX$0.86+1.9%Stored close · as of Nov 9, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2026-06-30; filed 2026-08-10.
0001193125-26-342512
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-09-30; filed 2026-11-09.
0001193125-26-453712
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 137 previous paragraphs and 133 current paragraphs.
92 unchanged; 32 reworded; 9 added; 13 removed; 0 previous and 0 current paragraphs rearranged.
Tables are not compared: 2 previous and 2 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (9)
Current report
In October and November 2026, updated interim results from the VMT-α-NET program were presented at the European Society for Medical Oncology Congress 2026 (ESMO) and the 2026 North American Neuroendocrine Tumors Society (NANETS) Multidisciplinary NET Medical Symposium. The presentations provided initial cohort-level safety data in Cohorts 1, 2 and 3 of the study, as well as updated efficacy results from both patients in Cohort 1 (up to four treatments with 2.5 mCi of [²¹²Pb]VMT-α-NET) and initial results from all 46 patients in Cohort 2 (up to four treatments with 5.0 mCi) and all 20 patients in Cohort 3 (up to four treatments with 6.0 mCi), as of September 10, 2026. Fifteen (or 33%) of the Cohort 2 patients experienced an initial response; 14 of those responses were confirmed. One of the Cohort 2 patients experienced an initial response 72 weeks after their first treatment, remained in study, and was expected to receive subsequent tumor assessment. A further 13 patients with stable disease in Cohort 2 remained in study as of September 10, 2026. Higher responses were observed in Cohort 3 relative to Cohort 2 at early assessments. Ten (or 50%) of the Cohort 3 patients experienced an initial response. Six of those responses were confirmed as of September 10, 2026. All four patients with responses pending confirmation remained in study and were expected to receive subsequent tumor assessment. A further eight patients with stable disease in Cohort 3 remained in study as of September 10, 2026. Disease control rate was 89% and 95% in Cohorts 2 and 3, respectively, and progression-free survival was 72% at 18 months across all three cohorts among patients who received at least one treatment. Among gastroenteropancreatic neuroendocrine tumor (GEP-NET) patients in Cohorts 1-3 whose target lesions all express SSTR2, progression-free survival was 75% at 18 months; disease control was observed in 35 (92%) of 38 Cohort 2 patients and all 17 (100%) patients in Cohort 3; and responses were seen in 14 (37%) of 38 Cohort 2 patients and in eight (47%) of 17 Cohort 3 patients. No dose-limiting toxicities (DLTs), Grade 4 or 5 treatment-emergent adverse events (AEs), or AE-related treatment discontinuations were reported. A low incidence of high-grade treatment-emergent AEs (20 out of 68 patients, or 29%) was observed, all of which were Grade 3. No dysphagia and no myelodysplastic syndrome were reported. Two patients (3%) experienced Grade 3 renal events, both acute kidney injuries, during ongoing study follow-up. One patient experienced the event approximately two years after their final treatment; the investigator assessed the event to be possibly related and the event is ongoing. For the second patient, the investigator assessed the event to be unlikely related to VMT-α-NET treatment, and the event has resolved. In addition, a creatinine level elevation to above 2 mg/dL was reported in one patient. This event occurred after the patient discontinued VMT-α-NET treatm…
Excerpt shortened here; the source contains the full paragraph.
Current report
In September 2026, we announced that data have been accepted for presentation at the 38th EORTC-NCI-AACR Symposium 2026 on Molecular Targets and Cancer Therapeutics taking place November 18 to 20, 2026 in Barcelona, Spain.
Current report
We are targeting an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) during the first quarter of 2027.
Current report
In November 2026, [212 Pb]VMT01 data were presented at the Society for Immunotherapy of Cancer 41st Annual Meeting and Pre-Conference Programs. The update covered 20 patients who received at least one monotherapy treatment as of September 18, 2026, 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 as of the data cut-off date had objective partial responses, one of whom remained in partial response and in study approximately 40 weeks after their first treatment. Disease control rate was 75%, including two patients with long-lasting disease stabilization. One of the eight patients recently received treatment and was not yet eligible for their first tumor assessment. VMT01 was generally well tolerated in this preliminary analysis. Among the 20 patients who received VMT01 as a monotherapy, there were no reported DLTs, adverse event-related treatment discontinuations or serious treatment-emergent adverse events related to VMT01 treatment during the treatment-emergent AE window. Grade 3 or higher treatment-emergent adverse events occurred in five of these patients (25%), with none considered treatment-related.
Current report
As of October 30, 2026, 12 patients have been treated in a monotherapy cohort allowing up to a cumulative 9 mCi (333 MBq), administered in three treatments of 3.0 mCi every eight weeks. Five patients have been treated since the cohort reopened for enrollment in the third quarter of 2026; by mid 2027, they are expected to reach at least 24 weeks of follow-up. This cohort remains open for enrollment.
Current report
In September 2026, we announced a clinical trial collaboration agreement with Merck, known as MSD outside of the United States and Canada. The agreement supports the potential evaluation of our targeted alpha-particle therapy [212 Pb]PSV359 in combination with Keytruda® (pembrolizumab), Merck’s anti-PD-1 therapy. This combination would be evaluated under an amendment to our ongoing Phase 1/2a study of [212 Pb]PSV359 in patients with certain types of non-small cell lung cancer and colorectal cancer that express FAP-α (clinicaltrials.gov identifier NCT06710756). We are sponsoring the study, and Merck is providing pembrolizumab at no cost.
Current report
In October 2026, we announced that the FDA granted Fast Track Designation for the development of PSV359 for adult patients with locally advanced unresectable and/or metastatic FAP-positive solitary fibrous tumors.
Current report
continue to build out our manufacturing capabilities;
Current report
continue to build out our manufacturing capabilities;
Removed paragraphs (13)
Previous report
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 [212 Pb]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.
Previous report
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.
Previous report
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.
Previous report
As of July 31, 2026, a total of 76 NETs patients across four cohorts and one meningioma patient had been treated with [212 Pb]VMT-α-NET. Updated data on NETs patients enrolled in the trial will be presented at the ESMO 2026 conference on October 23, 2026.
Previous report
We continue to advance [212 Pb]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.
Previous report
As of February 28, 2026, a total of 10 patients had received VMT01 treatment following the re-opening of the [212 Pb]VMT01 3.0 mCi monotherapy cohort and the opening of the cohort in which patients are receiving [212 Pb]VMT01 at 3.0 mCi in combination with nivolumab. Six patients had received VMT01 at 3.0 mCi in combination with nivolumab. 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 were fully enrolled.
Previous report
Updated data was presented at ASCO with a DCO date of March 25, 2026. One new response was observed early in the 3.0 mCi monotherapy cohort, in addition to a previously reported response, for a total of two responders out of the seven treated patients. Six out of the seven patients (86%) in the 3.0 mCi monotherapy cohort experienced stable disease or partial response, four patients completed all three treatments with 24 weeks or more of follow-up after their first treatment, and two remained on treatment and in study. Patients continued to demonstrate that [212 Pb]VMT01 was well tolerated with no DLTs, no discontinuations due to AEs, and no grade 4 or 5 treatment emergent AEs. Eight (30%) patients out of a total of 27 patients treated experienced grade 3 treatment emergent AEs.
Previous report
By late 2026, six patients in the cohort receiving [212 Pb]VMT01 at 3.0 mCi in combination with nivolumab are expected to reach at least 24 weeks of follow-up.
Previous report
continue to build our manufacturing capabilities, including potential expansion of our manufacturing footprint;
Previous report
We have plans for facilities and manufacturing beyond our current footprint.
Previous report
The exercise price and the number of shares of Common Stock issuable upon exercise of each 2026 Pre-funded Warrant are subject to appropriate adjustment in the event of certain stock dividends and distributions, stock splits, stock combinations, reclassifications or similar events affecting the Common Stock as well as upon any distribution of assets, including cash, stock or other property, to our stockholders. The 2026 Pre-funded Warrants will not expire and are exercisable in cash or by means of a cashless exercise. A holder of the 2026 Pre-funded Warrants may not exercise such 2026 Pre-funded Warrants if the aggregate number of shares of Common Stock beneficially owned by such holder, together with its affiliates, would be more than 4.99% or 9.99%, as elected by such holder, of the issued and outstanding shares of Common Stock following such exercise, as such percentage ownership is determined in accordance with the terms of the 2026 Pre-funded Warrants. A holder of the 2026 Pre-funded Warrants may increase or decrease this percentage not in excess of 19.99% by providing at least 61 days’ prior notice to us.
Previous report
The exercise price and the number of shares of Common Stock issuable upon exercise of each 2026 Pre-funded Warrant are subject to appropriate adjustment in the event of certain stock dividends and distributions, stock splits, stock combinations, reclassifications or similar events affecting the Common Stock as well as upon any distribution of assets, including cash, stock or other property, to our stockholders. The 2026 Pre-funded Warrants will not expire and are exercisable in cash or by means of a cashless exercise. A holder of the 2026 Pre-funded Warrants may not exercise such 2026 Pre-funded Warrants if the aggregate number of shares of Common Stock beneficially owned by such holder, together with its affiliates, would be more than 4.99% or 9.99%, as elected by such holder, of the issued and outstanding shares of Common Stock following such exercise, as such percentage ownership is determined in accordance with the terms of the 2026 Pre-funded Warrants. A holder of the 2026 Pre-funded Warrants may increase or decrease this percentage not in excess of 19.99% by providing at least 61 days’ prior notice to us.
Previous report
continue to build our manufacturing capabilities, including potential expansion of our manufacturing footprint;
Reworded paragraphs (32)
Previous wording
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 224 Ra/212 Pb 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.
Current wording
We are 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). We are expanding our regional finished drug product candidate supply network, enabled by our proprietary 224 Ra/212 Pb 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.
Previous wording
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.
Current wording
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.
Previous wording
In late June 2025, we announced the opening of Cohort 3 in which patients are receiving up to four fixed administered doses of [212 Pb]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.
Current wording
In late June 2025, we announced the opening of Cohort 3 in which patients are receiving up to four fixed administered doses of [212 Pb]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 was completed, and this cohort was fully enrolled with 20 patients.
Previous wording
In May 2026, we announced that the first patient was treated with [212 Pb]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.
Current wording
In May 2026, we announced that the first patient was treated with [212 Pb]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. As of October 30, 2026, we have recruited 20 patients into Cohort 4, which is now closed for recruitment. The meningioma cohort remains open for recruitment with two patients treated as of October 30, 2026.
Previous wording
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 212 Pb 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.
Current wording
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 212 Pb 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. Our intent is to test the safety and tolerability of [212 Pb]VMT01 in patients who have been heavily pretreated and are experiencing progression or recurrence of disease as monotherapy as well as in combination with first-line immunotherapies.
Previous wording
In preclinical experiments [212 Pb]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 [212 Pb]VMT01 for the diagnosis and treatment of patients with unresectable or metastatic melanoma and who have demonstrated MC1R tumor expression.
Current wording
In preclinical experiments, [212 Pb]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 FDA granted Fast Track Designation for the development of [212 Pb]VMT01 for the diagnosis and treatment of patients with unresectable or metastatic melanoma and who have demonstrated MC1R tumor expression.
Previous wording
In March 2024, we entered into a clinical trial collaboration with Bristol Myers Squibb to evaluate the safety and tolerability of [212 Pb]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 [212 Pb]VMT01 in patients with histologically confirmed melanoma and positive MC1R imaging scans in our ongoing Phase 1/2a clinical study of [212 Pb]VMT01.
Current wording
In March 2024, we entered into a clinical trial collaboration with Bristol Myers Squibb (BMS) to evaluate the safety and tolerability of [212 Pb]VMT01 in combination with BMS’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 [212 Pb]VMT01 in patients with histologically confirmed melanoma and positive MC1R imaging scans in our ongoing Phase 1/2a clinical study of [212 Pb]VMT01. In September 2026, BMS notified us that it was terminating the clinical trial collaboration agreement with us due to economic factors. We are in discussions with BMS to ensure an orderly wind-down under the collaboration agreement.
Previous wording
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 [212 Pb]VMT01, while seven patients were enrolled in Cohort 2 and received 5 mCi of [212 Pb]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.
Current wording
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 [212 Pb]VMT01, while seven patients were enrolled in Cohort 2 and received 5 mCi of [212 Pb]VMT01. Patients in each cohort received a median of five prior lines of systemic therapy, including a median of three prior lines of immunotherapy. No DLTs were observed among any patients, and no 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.
Previous wording
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 was also opened for enrollment. The first patients in the combination and monotherapy cohorts received their first treatments in March and April 2025, respectively. As of July 31, 2025, a total of five patients had received their initial monotherapy treatments of VMT01 at 1.5 mCi per dose, once every eight weeks for up to three doses. Additionally, two patients had received VMT01 1.5 mCi with nivolumab. Both cohorts were fully enrolled.
Current wording
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 allowed 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 was also opened for enrollment. The first patients in the combination and monotherapy cohorts received their first treatments in March and April 2025, respectively. As of July 31, 2025, a total of five patients had received their initial monotherapy treatments of VMT01 at 1.5 mCi per dose, once every eight weeks for up to three doses. Additionally, two patients had received VMT01 1.5 mCi with nivolumab. Both cohorts were fully enrolled.
Previous wording
In September 2025, we announced that the first patient received [212 Pb]VMT01 at 3.0 mCi in combination with nivolumab, as part of a new cohort. Additionally, the [212 Pb]VMT01 3.0 mCi monotherapy cohort reopened for enrollment. The SMC recommended evaluating [212 Pb]VMT01 at a higher dose based on its review of five patients dosed with [212 Pb]VMT01 at 1.5 mCi in the monotherapy cohort and two patients dosed with [212 Pb]VMT01 at 1.5 mCi together with nivolumab.
Current wording
In June 2026, the SMC recommended evaluating [212 Pb]VMT01 at a higher dose based on its review of the five patients dosed with [212 Pb]VMT01 at 1.5 mCi in the monotherapy cohort and the two patients dosed with [212 Pb]VMT01 at 1.5 mCi together with nivolumab. In September 2025, we announced that the first patient received [212 Pb]VMT01 at 3.0 mCi in combination with nivolumab, as part of a new cohort. Additionally, the [212 Pb]VMT01 3.0 mCi monotherapy cohort reopened for enrollment.
Previous wording
In October 2024, we announced first-in-human SPECT/CT images of [203 Pb]PSV359 from an independent investigator revealed strong tumor uptake, fast clearance through the renal system, low accumulation in normal organs, and long tumor retention in three patients with FAP-α expressing cancers.
Current wording
In October 2024, we announced first-in-human SPECT/CT images of [203 Pb]PSV359 from an independent investigator that revealed strong tumor uptake, fast clearance through the renal system, low accumulation in normal organs, and long tumor retention in three patients with FAP-α-expressing cancers.
Previous wording
Preclinical results for PSV359 were presented during the Society of Nuclear Medicine and Molecular Imaging 2024 Annual Meeting and the 37th Annual Congress of the European Association of Nuclear Medicine meetings in June and October 2024, respectively. Researchers presented a novel cyclic peptide targeting human FAP-α, which was discovered by us via phage display methods. FAP-α is a protein abundantly expressed in certain cancer cells as well as cancer-associated fibroblasts in tumor lesions and involved in promoting disease progression. The peptide was conjugated to a lead (Pb)-specific chelator via a molecular linker to form a novel construct, PSV359. The purpose of this study was to evaluate the in vitro and in vivo performance of [203/212 Pb]PSV359 in preclinical xenograft models. Overall, strong anti-tumor clinical activity of [212 Pb]PSV359 was found in both HT1080-human FAP-α (FAP-α on cancer cells) and U87MG (FAP-α in stromal tissues) xenograft models.
Current wording
Preclinical results for PSV359 were presented during the Society of Nuclear Medicine and Molecular Imaging 2024 Annual Meeting and the 37th Annual Congress of the European Association of Nuclear Medicine in June and October 2024, respectively. Researchers presented a novel cyclic peptide targeting human FAP-α, which was discovered by us via phage display methods. FAP-α is a protein abundantly expressed in certain cancer cells as well as cancer-associated fibroblasts in tumor lesions and involved in promoting disease progression. The peptide was conjugated to a lead (Pb)-specific chelator via a molecular linker to form a novel construct, PSV359. The purpose of this study was to evaluate the in vitro and in vivo performance of [203/212 Pb]PSV359 in preclinical xenograft models. Overall, strong anti-tumor clinical activity of [212 Pb]PSV359 was found in both HT1080-human FAP-α (FAP-α on cancer cells) and U87MG (FAP-α in stromal tissues) xenograft models.
Previous wording
We filed an IND application for PSV359 in December 2024, and we received a “study may proceed” letter (i.e., approval to conduct the trial) from the FDA in the first quarter of 2025. In April 2025, we announced the first patient was treated with [212 Pb]PSV359. Data from Cohort 1 (2.5 mCi) and Cohort 2 (5.0 mCi) was presented at ASCO with a DCO date of December 24, 2025, which demonstrated that [212 Pb]PSV359 was well tolerated with no DLTs and treatment emergent AEs at grades 1 and 2 only.
Current wording
We filed an IND application for PSV359 in December 2024, and we received a “study may proceed” letter (i.e., approval to conduct the trial) from the FDA in the first quarter of 2025. In April 2025, we announced the first patient was treated with [212 Pb]PSV359. Data from Cohort 1 (2.5 mCi) and Cohort 2 (5.0 mCi) were presented at ASCO with a data cutoff date of December 24, 2025. The data demonstrated that [212 Pb]PSV359 was well tolerated with no DLTs and treatment-emergent AEs at grades 1 and 2 only. Cohort 1 and Cohort 2 were fully enrolled.
Previous wording
Cohort 3 was cleared to open following the SMC’s review of safety data from Cohort 2. Patients in Cohort 3 are receiving up to four fixed administered doses of PSV359 at 6.0 mCi every eight weeks. The first patient was treated in May 2026. Cohort 3 fully enrolled eight patients during the second quarter of 2026 and is closed.
Current wording
Cohort 3 was cleared to open following the SMC’s review of safety data from Cohort 2. Patients in Cohort 3 are receiving up to four fixed administered doses of PSV359 at 6.0 mCi every eight weeks. The first patient was treated in May 2026. Cohort 3 was fully enrolled with eight patients during the second quarter of 2026 and is closed.
Previous wording
Our discovery team is preparing multiple additional novel constructs for potential first-in-human (FIH) imaging as a de-risking step for potential therapeutic benefit, including our pre-targeting platform license from Stony Brook University. If and when these constructs meet our criteria for further development, we plan to proceed with pre-IND filing activities.
Current wording
Our discovery team is preparing multiple additional novel constructs for potential first-in-human imaging as a de-risking step for potential therapeutic benefit. If and when these constructs meet our criteria for further development, we plan to proceed with pre-IND filing activities.
Previous wording
In May 2026, we presented an FIH image for PSV594, designed to target and deliver 212 Pb to tumor sites expressing the cholecystokinin 2 receptor (CCK2R), which is expressed across a range of hard-to-treat cancers. The targeting moiety may also be radiolabeled with 203 Pb or 68 Ga to detect CCK2R expression in-vivo. Preclinical data and FIH biodistribution observations support continued pre-IND development of PSV594.
Current wording
In May 2026, we presented a first-in-human image for PSV594, designed to target and deliver 212 Pb to tumor sites expressing the cholecystokinin 2 receptor (CCK2R), which is expressed across a range of hard-to-treat cancers. The targeting moiety may also be radiolabeled with 203 Pb or 68 Ga to detect CCK2R expression in vivo. Preclinical data and first-in-human biodistribution observations support continued pre-IND development of PSV594.
Previous wording
We continue to strengthen our intellectual property portfolio in support of our platform technologies, product candidates and other programs. Our patent covering CCK2R-targeted radiopharmaceutical compounds was issued in the U.S. in June 2026. Our FAP-α-targeted radiopharmaceutical compounds were patented in China in July 2026. We believe these developments further enhance the geographic scope and depth of protection for our core radiopharmaceutical technologies and manufacturing platforms.
Current wording
We continue to strengthen our intellectual property portfolio in support of our platform technologies, product candidates and other programs. During the three months ended September 30, 2026, patents covering our radionuclide-generation technology were granted in Europe and Australia. We also continued to expand the scope of our patent portfolio through additional international and divisional patent filings covering our radionuclide-generation platform and FAP-α-targeted radiopharmaceutical compounds. We believe these developments further enhance the geographic scope and depth of protection for our core radiopharmaceutical technologies and manufacturing platforms.
Previous wording
As of June 30, 2026, we had cash, cash equivalents and short-term investments of $236.9 million. We believe our cash, cash equivalents and short-term investments will be sufficient to fund our current planned clinical milestones and operational investments for at least the next 12 months from the date the condensed consolidated financial statements in this report were issued and into late 2027. Management anticipates a significant increase in expenses, particularly in research and development, as it works to implement its strategy to advance our clinical assets in their clinical trials, expand our manufacturing capabilities and progress our preclinical assets towards clinical trials.
Current wording
As of September 30, 2026, we had cash, cash equivalents and short-term investments of $201.7 million. We believe our cash, cash equivalents and short-term investments will be sufficient to fund our current planned clinical milestones and operational investments for at least the next 12 months from the date the condensed consolidated financial statements in this report were issued and into 2028. Management expects that expenses, particularly in research and development, may continue to increase as we work to implement our strategy to advance our clinical assets in their clinical trials, expand our manufacturing capabilities and progress our preclinical assets towards clinical trials.
Previous wording
In 2024, we purchased buildings located in the metropolitan areas of Houston, TX, Chicago, IL, and Los Angeles, CA, which we intend to use for the manufacture of our product candidates upon completion of modifications and installation of equipment.
Current wording
In 2024, we purchased buildings located in the metropolitan areas of Houston, TX, Chicago, IL, and Los Angeles, CA, with the intent to use those facilities for the manufacture of our product candidates upon completion of modifications and installation of equipment.
Previous wording
Also in 2024, we acquired the assets and associated lease of Lantheus’ radiopharmaceutical manufacturing facility in Somerset, NJ. Soon after the acquisition, we began the onboarding and operationalization processes and, in October 2024, we achieved the first shipment and patient dosing from our Somerset facility. With three manufacturing suites that can meet CGMP requirements, the Somerset facility is expected to have the capacity to meet future clinical trial demand at major cancer treatment centers throughout the Northeastern U.S. An existing production suite in Somerset has been upgraded to support Phase 3 activities, with installation completed and commissioning targeted for the end of 2026. A fourth production suite has also been installed and completed, and we expect it to be operational in 2026.
Current wording
Also in 2024, we acquired the assets and associated lease of Lantheus’ radiopharmaceutical manufacturing facility in Somerset, NJ. Soon after the acquisition, we began the onboarding and operationalization processes and, in October 2024, we achieved the first shipment and patient dosing from our Somerset facility. With four manufacturing suites, the Somerset facility is expected to have the capacity to meet future clinical trial demand at major cancer treatment centers throughout the Northeastern U.S. We have completed the installation of equipment and implementation of processes at our Somerset facility to support Phase 3 activities.
Previous wording
In 2025 and 2026, we entered into agreements with a general contractor pursuant to which we committed to pay approximately $53.3 million. The agreements are for the general contractor to make building modifications at our facilities in the metropolitan areas of Chicago, IL, and Los Angeles, CA, and to prepare for the installation of some of the Comecer manufacturing equipment and associated clean rooms at those sites. We anticipate incurring additional spending with this general contractor, and actual costs may differ. We expect to complete construction at the Chicago-area site in early 2027 and at the Los Angeles-area site by the end of 2027.
Current wording
In 2025 and 2026, we entered into agreements with a general contractor pursuant to which we committed to pay approximately $54.5 million. The agreements are for the general contractor to make building modifications at our facilities in the metropolitan areas of Chicago, IL, and Los Angeles, CA, and to prepare for the installation of Comecer manufacturing equipment and associated clean rooms at those sites. We anticipate incurring additional spending with this general contractor, and actual costs may differ. We expect to complete construction at the Chicago-area site in early 2027.
Previous wording
Management’s discussion and analysis of our financial condition and results of operations are based upon our condensed consolidated financial statements, which have been prepared in accordance with generally accepted accounting principles in the United States. The preparation of these condensed consolidated financial statements requires management to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses, and related disclosure of contingent liabilities. On an ongoing basis, management evaluates critical accounting estimates and judgments. Management bases its estimates on historical experience and on various other assumptions that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. The accounting policies and related risks described in Part II, Item 7 and Note 2, Summary of Significant Accounting Policies, to the consolidated financial statements included in Part II, Item 8 of the 2025 Form 10-K are those that depend most heavily on these judgments and estimates.
Current wording
Management’s discussion and analysis of our financial condition and results of operations are based upon our condensed consolidated financial statements, which have been prepared in accordance with generally accepted accounting principles in the United States. The preparation of these condensed consolidated financial statements requires management to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses, and related disclosures of contingent liabilities. On an ongoing basis, management evaluates critical accounting estimates and judgments. Management bases its estimates on historical experience and on various other assumptions that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. The accounting policies and related risks described in Part II, Item 7 and Note 2, Summary of Significant Accounting Policies, to the consolidated financial statements included in Part II, Item 8 of the 2025 Form 10-K are those that depend most heavily on these judgments and estimates.
Previous wording
Research and development expenses were $21.5 million for the three months ended June 30, 2026, compared to $16.6 million for the three months ended June 30, 2025, an increase of $4.9 million. Research and development expenses were $42.9 million for the six months ended June 30, 2026, compared to $31.0 million for the six months ended June 30, 2025, an increase of $12.0 million. The increase in research and development expenses was primarily related to higher personnel costs, including share-based compensation, due to additional headcount to support our ongoing clinical trials, including chemistry, manufacturing, and control work related to our clinical product candidates, as well as increased spending on contract development and manufacturing organizations, clinical site activities, drug programs and delivery, pipeline studies and consulting.
Current wording
Research and development expenses were $26.1 million for the three months ended September 30, 2026, compared to $20.3 million for the three months ended September 30, 2025, an increase of $5.8 million. The increase in research and development expenses was primarily related to higher personnel costs, including share-based compensation, due to additional headcount to support our ongoing clinical trials, including chemistry, manufacturing and controls work related to our clinical product candidates, as well as increased spending on consulting, contract development and manufacturing organizations, pipeline studies, and clinical site activities partially offset by a decrease in costs related to drug candidate production including isotopes and delivery costs. Research and development expenses were $69.0 million for the nine months ended September 30, 2026, compared to $51.3 million for the nine months ended September 30, 2025, an increase of $17.7 million. The increase in research and development expenses was primarily related to higher personnel costs, including share-based compensation, due to additional headcount to support our ongoing clinical trials, including chemistry, manufacturing and controls work related to our clinical product candidates, as well as increased spending on contract development and manufacturing organizations, pipeline studies, consulting, drug candidate production including isotopes and delivery costs, depreciation, and clinical site activities.
Previous wording
Management believes that research and development expenses will continue to increase as we continue to invest in the development of novel radiopharmaceutical drugs and product candidates and expand our manufacturing capabilities. We are investing in equipment and modifications for the three buildings we acquired in 2024 located in the Houston, TX, Chicago, IL, and Los Angeles, CA, metropolitan areas. Upon completion, we intend to use the buildings to manufacture our product candidates.
Current wording
Management believes that research and development expenses may continue to increase as we continue to invest in the development of novel radiopharmaceutical drugs and product candidates and expand our manufacturing capabilities. We are currently investing in equipment and modifications for two of the buildings we acquired in 2024 located in the Chicago, IL and Los Angeles, CA, metropolitan areas with the intent to use the buildings to manufacture our product candidates.
Previous wording
We are also actively strengthening our current manufacturing capabilities to support the clinical supply of radiopharmaceuticals through the expansion of clinical production lines at our locations in Coralville, IA, and Somerset, NJ. In Coralville, we built a second production suite that became operational in 2025. The Somerset facility, with its three manufacturing suites that can meet CGMP requirements, is expected to have the capacity to meet future clinical trial demand at major cancer treatment centers throughout the Northeastern U.S. An existing production suite in Somerset has been upgraded to support Phase 3 activities, with installation completed and commissioning targeted for the end of 2026. A fourth production suite has also been installed and completed, and we expect it to be operational in 2026.
Current wording
We are actively strengthening our manufacturing capabilities to support the clinical supply of radiopharmaceuticals through the expansion of clinical production lines at our locations in Coralville, IA, and Somerset, NJ. In Coralville, we built a second production suite that became operational in 2025. With four manufacturing suites, the Somerset facility is expected to have the capacity to meet future clinical trial demand at major cancer treatment centers throughout the Northeastern U.S. We have completed the installation of equipment and processes at our Somerset facility to support Phase 3 activities.
Previous wording
Management believes that the cost of certain raw materials used in the production of our novel radiopharmaceutical drugs and product candidates may increase in the coming years, including as a result of increased demand for materials required for the production of radiopharmaceuticals. We are also currently evaluating how potential U.S. and international trade policies, including tariffs, might impact our costs for supplies, equipment and materials used in the development and production of our TAT drug product candidates. We currently source much of the raw materials that are used to produce our product candidates in the U.S. Some equipment and other materials that will be used at our manufacturing sites is sourced from outside the U.S. Based on our analysis of recently announced tariffs, we do not expect to experience any material incremental tariff-related cost impacts in 2026. We will continue to monitor policy developments related to tariffs and the implementation dates of new tariffs, as well as potential opportunities to source materials and equipment from alternative suppliers, as we continue to evaluate the potential impacts of tariffs.
Current wording
Management believes that the cost of certain raw materials used in the production of our novel radiopharmaceutical drugs and product candidates may increase in the coming years, including as a result of increased demand for materials required for the production of radiopharmaceuticals. We are also currently evaluating how potential U.S. and international trade policies, including tariffs, might impact our costs for supplies, equipment and materials used in the development and production of our TAT drug product candidates. We currently source much of the raw materials that are used to produce our product candidates in the U.S. Some equipment and other materials that will be used at our manufacturing sites are sourced from outside the U.S. Based on our analysis of recently announced tariffs, we do not expect to experience any material incremental tariff-related cost impacts in 2026. We will continue to monitor policy developments related to tariffs and the implementation dates of new tariffs, as well as potential opportunities to source materials and equipment from alternative suppliers, as we continue to evaluate the potential impacts of tariffs.
Previous wording
General and administrative expenses were $7.8 million for the three months ended June 30, 2026, compared to $7.7 million for the three months ended June 30, 2025, an increase of $0.1 million. The increase in general and administrative expenses was primarily related to higher personnel costs, including share-based compensation, partially offset by decreased fees for professional services and fees related to operating as a public company. General and administrative expenses were $14.8 million for the six months ended June 30, 2026, compared to $15.6 million for the six months ended June 30, 2025, a decrease of $0.8 million. The decrease in general and administrative expenses was primarily due to decreased fees for professional and consulting services and fees related to operating as a public company, partially offset by increased personnel costs.
Current wording
General and administrative expenses were $8.3 million for the three months ended September 30, 2026, compared to $7.7 million for the three months ended September 30, 2025, an increase of $0.6 million. The increase in general and administrative expenses was primarily related to higher share-based compensation partially offset by decreased personnel costs including salaries and benefits. General and administrative expenses were $23.0 million for the nine months ended September 30, 2026, compared to $23.3 million for the nine months ended September 30, 2025, a decrease of $0.3 million. The decrease in general and administrative expenses was primarily due to decreased fees for professional and consulting services and fees related to operating as a public company and personnel costs including salaries and benefits, partially offset by increased share-based compensation.
Previous wording
Operating Activities: The increase of $10.6 million in net cash used in operating activities for the six months ended June 30, 2026, compared to the same period in 2025 was primarily due to an increase of $13.3 million in net loss, partially offset by an increase of $2.4 million in non-cash activities and $0.3 million due to changes in operating assets and liabilities.
Current wording
Operating Activities: The increase of $25.6 million in net cash used in operating activities for the nine months ended September 30, 2026, compared to the same period in 2025 was primarily due to an increase of $19.8 million in net loss and $9.7 million due to changes in operating assets and liabilities, partially offset by an increase of $3.8 million in non-cash activities.
Previous wording
Investing Activities: The increase of $93.2 million in net cash used in investing activities for the six months ended June 30, 2026, as compared to the same period in 2025 was primarily due to an increase of $118.9 million in purchases of short-term investments and a $15.4 million increase in additions to property and equipment, partially offset by an increase of $41.0 million in maturities of short-term investments.
Current wording
Investing Activities: The increase of $83.5 million in net cash used in investing activities for the nine months ended September 30, 2026, as compared to the same period in 2025 was primarily due to an increase of $120.8 million in purchases of short-term investments and a $17.9 million increase in additions to property and equipment, partially offset by an increase of $55.2 million in maturities of short-term investments.
Previous wording
Financing Activities: Net cash provided by financing activities of $164.5 million and $10.1 million for the six months ended June 30, 2026 and 2025, respectively, were primarily related to the proceeds received from the sale of Common Stock and pre-funded warrants pursuant to the 2026 Offering (defined below) and the 2024 ATM Agreement (defined below), respectively.
Current wording
Financing Activities: Net cash provided by financing activities of $164.7 million and $10.3 million for the nine months ended September 30, 2026 and 2025, respectively, were primarily related to the proceeds received from the sale of Common Stock and pre-funded warrants pursuant to the 2026 Offering (defined below) and the 2024 ATM Agreement (defined below), respectively.
Previous wording
At June 30, 2026, we had cash, cash equivalents and short-term investments of $236.9 million. We believe our cash, cash equivalents and short-term investments will be sufficient to fund our current planned clinical milestones and operational investments into late 2027. Management anticipates a significant increase in expenses, particularly in research and development, as it works to implement its strategy to advance our clinical assets in their clinical trials, expand our manufacturing capabilities and progress our preclinical assets towards clinical trials.
Current wording
As of September 30, 2026, we had cash, cash equivalents and short-term investments of $201.7 million. We believe our cash, cash equivalents and short-term investments will be sufficient to fund our current planned clinical milestones and operational investments into 2028. Management expects that expenses, particularly in research and development, may continue to increase as we work to implement our strategy to advance our clinical assets in their clinical trials, expand our manufacturing capabilities and progress our preclinical assets towards clinical trials.
Previous wording
We presented our other commitments and contingencies in the 2025 Form 10-K. There have been no material changes outside of the ordinary course of business in those obligations during the six months ended June 30, 2026, other than those disclosed in Note 10, Commitments and Contingencies, to the condensed consolidated financial statements in this Form 10-Q.
Current wording
We presented our other commitments and contingencies in the 2025 Form 10-K. There have been no material changes outside of the ordinary course of business in those obligations during the nine months ended September 30, 2026, other than those disclosed in Note 10, Commitments and Contingencies, to the condensed consolidated financial statements in this Form 10-Q.