Continued progress enrolling in its VMT-α-NET and VMT01 clinical trials Disclosed a new internally discovered molecule that targets fibroblast activation protein-α Announced the in-licensing of a technology that enables the use of antibodies to direct radiolabeled ligands to tumor sites Raised $177.2 million in gross proceeds through various financing transactions and raised an additional $49.5 million subsequent to March 31st under our ATM Agreement. SEATTLE, May 15, 2024 (GLOBE NEWSWIRE) -- Perspective Therapeutics, Inc. ("Perspective" or "the Company") (NYSE:CATX), a radiopharmaceutical company that is pioneering advanced treatment applications for cancers throughout the body, today announced first quarter financial results for the period ended March 31, 2024. "I am proud of the progress we are making with our clinical-stage proprietary radiopharmaceuticals," said Thijs Spoor, Perspective Therapeutics' CEO. "At the same time, our discovery team continues to generate additional novel molecular entities for future clinical development, in keeping with our goal of developing potential innovative precision medicines based on alpha-emitting isotopes and peptide optimization. In the coming months, we look forward to providing multiple updates on our progress in building a fully integrated radiopharmaceuticals company." Program HighlightsVMT-α-NET Company-sponsored Phase 1/2a trial of [212Pb]VMT-α-NETPerspective is conducting a multi-center open-label dose escalation, dose expansion 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 peptide receptor radionuclide therapies ("PRRT"). The Company received Fast Track Designation for this program from the U.S. Food and Drug Administration ("FDA") based on preclinical data for the indication of SSTR2-positive NETs regardless of prior treatment response. As of May 15, 2024, the Company initiated dosing of nine patients in Cohorts 1 and 2 of its Phase 1/2a study of [212Pb]VMT-α-NET in patients with unresectable or metastatic SSTR2-expressing NETs. A total of seven patients received activities of 185 MBq (5mCi) of [212Pb]VMT-α-NET in Cohort 2.This program has been selected by the FDA to participate in the Chemistry, Manufacturing, and Controls ("CMC") Development and Readiness Pilot ("CDRP") program. FDA's CDRP Program was initiated in 2022 to facilitate alignment of CMC development of novel products under investigational new drug ("IND") applications with expedited clinical development timeframes based upon the anticipated clinical benefits of earlier patient access.1 Updated results from Cohorts 1 and 2 of the Phase 1/2a trial are expected in the second half of 2024. Concurrently, the Company is evaluating appropriate scientific forums to present these updates. Next steps will be determined based on recommendations from the Safety Monitoring Committee ("SMC") for the study and in consultation with the FDA. Data informing the SMC's recommendation and FDA consultation is expected to be submitted to an upcoming scientific forum. 1 Chemistry, Manufacturing, and Controls Development and Readiness Pilot Program; Program Announcement. https://www.federalregister.gov/documents/2023/09/11/2023-19502/chemistry-manufacturing-and-controls-development-and-readiness-pilot-program-program-announcement. Accessed May 7, 2024. Investigator-initiated clinical research of [212Pb]VMT-α-NETPerspective is collaborating with a number of thought leaders to further elucidate the clinical profile of [212Pb]VMT-α-NET through investigator-initiated studies in the U.S. as well as overseas. Investigator Led Study in IndiaThe investigator enrolled adult patients with histologically confirmed NETs and metastatic medullary thyroid carcinomas. The Company was informed by the investigator that updated results from 12 patients have been accepted for presentation at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) meeting taking place during June 8-11, 2024 in Toronto. The most recent scientific conference presentation by the investigator was during the 36th Annual Congress of the European Association of Nuclear Medicine (EANM) in September 2023. Ten patients whose disease progressed after at least one prior line of standard of care therapy received [212Pb]VMT-α-NET therapy, with initial responses observed in seven of nine evaluable patients; responses were observed across both PRRT-naïve and PRRT-refractory disease; no significant renal or hepatic function adverse events were observed to date; most adverse events were mild and usually resolved within one week of [212Pb]VMT-α-NET administration; and two patients experienced serious adverse events that were deemed unrelated to [212Pb]VMT-α-NET treatment. PRRT refractory patients at the University of IowaThis is a single site Phase 1 trial evaluating the safety of [212Pb]VMT-α-NET in patients with unresectable or metastatic SSTR2-expressing NETs (clinicaltrials.gov identifier NCT06148636). Patients being enrolled in the study have either progressed or relapsed after previous therapies, including currently approved PRRT. The Company was informed by the investigator that preliminary data readout is expected in the second half of 2024. VMT01Perspective designed VMT01 to target and deliver 212Pb to tumor sites expressing melanocortin 1 receptor ("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. As of May 15, 2024, the Company continues to dose patients in Cohort 1 and in Cohort 2 of the Phase 1/2a clinical study of [212Pb]VMT01 in patients with progressive MC1R-positive metastatic melanoma. As of March 31, 2024, [212Pb]VMT01 was well tolerated with no unexpected adverse events. Updated results from Cohorts 1 and 2 of the Phase 1/2a study are expected in the second half of 2024. Concurrently, the Company is evaluating appropriate scientific forums to present these updates. In March 2024, the Company entered a clinical trial collaboration agreement with Bristol Myers Squibb (NYSE:BMY) to evaluate the safety and tolerability of Perspective's [212Pb]VMT01 in combination with Bristol Myers Squibb's nivolumab in patients with histologically confirmed melanoma and positive MC1R imaging scans. The combination arm of the study will be an amendment to the Company's ongoing Phase 1/2a study of [212Pb]VMT01 in patients with metastatic melanoma which the Company anticipates submitting in the second quarter of 2024. If the study may proceed with the amendment, the first combination cohort would open shortly thereafter. Highlights from the March Investor Event Perspective hosted an investor event on March 18, 2024. The replay and slides may be accessed on the Events page of the Company's website. During the investor event, the Company disclosed a novel pre-IND stage asset as well as further details on a new enabling technology platform that broadens the scope of targets addressable by radiopharmaceuticals, in addition to the status of ongoing clinical programs at the beginning of March. New target: PSV359 is an internally discovered molecule that targets fibroblast activation protein-α, or FAP-α, associated with a variety of solid tumors. Preclinical imaging and therapy as well as human imaging results suggest the Company's proprietary targeting ligand has differential levels of target engagement in tumors and healthy tissues that may result in a desirable therapeutic index.During the investor event, the Company presented data which included analysis of a first-in-human imaging study, under the direction of Dr. Dharmender Malik of Fortis Memorial Research Institute, evaluating the suitability of [203Pb]PSV359 for SPECT/CT imaging of patients with lung adenocarcinoma, NETs and chondroblast osteosarcoma.Perspective is working to file an IND in late 2024 for this new asset. If the study may proceed, the U.S. Phase I study would commence in 2025. New platform: Pre-targeting is technology enabling the use of antibodies to direct radiolabeled ligands to tumor sites. Antibodies can bind with high specificity to a wider variety of cancer-specific proteins preferentially expressed on the surface of tumor cells. However, the amount of time required for an adequate amount of antibodies to bind to the cancer-specific proteins may not align with the properties of the desired isotope. By attaching an additional chemical entity to an antibody that would bind to a radioligand, the resultant modified antibodies may be administered separately from and in advance of the radioligand as appropriate.Further details on our license to this technology are in the "Other Business Highlights" section below. Status of other pre-IND assets PSV40X: The Company has a license agreement with Mayo Clinic for the rights to Mayo's prostate-specific membrane antigen ("PSMA") Alpha-PET DoubLET platform technology for the treatment of PSMA-expressing cancers, with an initial focus on prostate. This radiopharmaceutical platform provides detailed PET imaging-based diagnosis and dosimetry using long-lived copper-64 (64Cu) for imaging and alpha-particle targeted therapies using 212Pb. Preclinical studies are ongoing to assess whether this new molecular entity meets the hurdle for progressing into the clinic with potential to achieve best-in-class profile. Other Business Highlights  In January 2024, the Company entered into strategic agreements with Lantheus Holdings, Inc. and its affiliates ("Lantheus") (NASDAQ:LNTH). Under the agreements, Lantheus has the option to negotiate for an exclusive license to Perspective's [212Pb]VMT-α-NET. Lantheus also has the option to co-fund and negotiate for an exclusive license for certain early-stage therapeutic candidates targeting prostate cancer using Perspective's lead platform technology. In February 2024, the Company announced it entered into an exclusive license agreement with Stony Brook University for the rights to its Cuburbit[7]uril-admantane ("CB7-Adma") pre-targeting platform for the diagnosis and treatment of cancer. The exclusive license with Stony Brook University covers the global intellectual property rights for the CB7-Adma pre-targeting platform. The Company has applied for the Phase I tranche of a 2.5-year Fastrack Small Business Innovation Research grant (Phase I $400,000; total $2.4 million) from the National Institutes of Health National Cancer Institute to support the development of the pre-targeting program. In March 2024, the Company closed the acquisition of a state-of-the-art radiopharmaceutical manufacturing facility and associated equipment and systems for the production of its 203Pb- and 212Pb-labeled radiopharmaceuticals in Somerset, New Jersey. Perspective is currently fitting out and adapting the site in accordance with relevant licensing requirements for handling the Company's materials. Filing is expected in the second half of 2024. In April 2024, the Company closed the divestiture of its brachytherapy business, including its radioactive Cesium-131 seed assets and related business infrastructure, to GT Medical Technologies, Inc. Under the terms of the agreement, Perspective owns 0.5% of outstanding capital stock of GT Medical Technologies, on a fully diluted basis. Perspective is entitled to certain cash royalties on net sales of Cesium-131 seeds and GT Medical's GammaTile therapy utilizing Cesium-131 over the next four years. The Company disclosed pro forma annual financials for continuing operations in an 8-K dated April 22, 2024. First Quarter 2024 Financial Summary  In January 2024, the Company announced the closing of a $69.0 million public offering and a $20.8 million private offering. The public offering included the issuance of 156,399,542 shares of common stock at $0.37 per share and pre-funded warrants of 30,086,944 shares at a price of $0.369 per pre-funded warrant. Each pre-funded warrant has an exercise price of $0.001 per share. Concurrent with the public offering, the Company closed a private placement of 56,342,355 shares of common stock to Lantheus at a price of $0.37 per share. In March 2024, the Company announced a private placement of $87.4 million in which it sold 92,009,981 shares of its common stock at a price of $0.95 per share, representing the closing price per share of the Company's common stock on the NYSE American as of March 1, 2024. The Company has previously presented its results in two segments: Drug Operations and Brachytherapy. Due to the divestiture of its entire brachytherapy segment to GT Medical, the assets and operations of the brachytherapy segment have been classified as discontinued operations in the Company's financials. The comments below pertain to our continuing operations unless otherwise noted. Grant revenue for the three months ended March ...