IsoRay Inc - Entwickler von isotopbasierten Medizinprodukten (Seite 5)

[Edelweiss70]

Publication One
Title: Influence of the Molar Activity of 203/212Pb-PSC-PEG2-TOC on Somatostatin Receptor Type 2-Binding and Cell Uptake

Summary: This study in Pharmaceuticals (November 2023, 16(11), 1605) notes that the molar activity (AM) can play a crucial role in tumor uptake, especially in receptor-mediated uptake, such as in neuroendocrine tumors. In this work, the influence of the AM-to-cell uptake of 203/212Pb-PSC-TOC was investigated in multiple different cell lines to develop a more detailed understanding of the tracer in preparation for clinical use. This study provides independent confirmatory evidence of the stability of the 212Bi daughter radionuclide in formulation upon the decay of 212Pb, generating >95% radiochemical purity in their study.

Key Highlights:

The quality control showed a radiochemical yield greater than 95% in most cases for 203/212Pb-PSC-TOC, confirming stability of the 212Bi in the Perspective chelator.
Higher AM, correlated positively with cell uptake. A moderate AM of 15–40 MBq/nmol showed the highest cell uptake.
No uptake limitation was found in the first 24 to 48 hours. However, authors suggest that further escalation experiments with higher AM should be performed.
Author Affiliations: University Hospital Carl Gustav Carus, Technical University Dresden, Dresden, Germany; The University of Iowa, Iowa City, Iowa, USA.

Publication Two
Title: Structural Modifications Toward Improved Lead-203/Lead-212 Peptide-Based Image-Guided Alpha-Particle Radiopharmaceutical Therapies for Neuroendocrine Tumors

Summary: This study in the European Journal of Nuclear Medicine and Molecular Imaging (in press as of November 2023) aims to improve the performance of somatostatin receptor subtype 2 (SSTR2)-targeted radionuclide imaging and therapy through structural modifications to Tyr3-octreotide (TOC)-based radiopharmaceuticals. The findings suggest that PSC-PEG2-TOC (i.e., VMT-a-NET) is a promising candidate for Pb-based targeted therapy for SSTR2 positive tumors.

Key Highlights:

The data demonstrated that the modified radiopeptide drug conjugate (RPDC), [203Pb]PSC-PEG2-TOC, significantly improved tumor-targeting properties, including receptor binding, tumor accumulation and retention, and exhibited faster renal clearance as compared to [203Pb]-DOTATOC.
Treatment resulted in a dose-dependent therapeutic effect with minimal signs of toxicity in a tumor xenograft mouse model.
Fractionated administrations of 3.7 MBq [212Pb]PSC-PEG2-TOC over three doses further improved antitumor effectiveness, resulting in 80% survival (70% complete response) over 120 days in the mouse model.
Author Affiliations: Korea Military Academy, Seoul, Republic of Korea; Perspective Therapeutics, Coralville, Iowa, USA; The University of Iowa, Iowa City, Iowa, USA.



Publication Three
Title: Optimized Methods for the Production of High-Purity 203Pb Using Electroplated Thallium Targets

Summary: This study published in the Journal of Nuclear Medicine (November 2023, 64 (11) 1791-1797) aims to optimize the production and separation of high specific activity 203Pb using electroplated Thallium targets suitable for cyclotron irradiation. This work contributes to the broader body of knowledge to satisfy the growing interest in clinical applications for theranostic match pair (203Pb/212Pb).

Key Highlights:

The data confirmed the development of an efficient electroplating method for routine 203Pb production.
The data demonstrated that 203Pb production was fast and could be achieved in under 1.5 hours, the method employed a simple separation process that resulted in high recovery yields of approximately 95%, and high purity.
The study showed that the novel electroplating method is compatible with a 24 MeV incident beam and high current without using a degrader.
Results corroborated evidence published in a recent article by our colleagues at the University of Alberta (Nelson et al., Nuclear Medicine and Biology 116–117 (2023) 108314) that the production of 203Pb is relatively straightforward and scalable.
Author Affiliations: University of Alabama at Birmingham, Alabama, USA; Perspective Therapeutics, Coralville, Iowa, USA; The University of Iowa, Iowa City, Iowa, USA.

Publication Four

Title: Pre-clinical Evaluation of Biomarkers for Early Detection of Nephrotoxicity Following Alpha-Particle Radioligand Therapy

Summary:
This publication in the European Journal of Nuclear Medicine and Molecular Imaging 2023 (in press as of November 2023) highlights findings from a pre-clinical study evaluating biomarkers for early detection of nephrotoxicity following alpha-particle radioligand therapy (α-RLT). The results suggest that increased biomarker urinal neutrophil gelatinase-associated lipocalin (NGAL) secretion could be an additional diagnostic tool to improve our understanding of the potential for subclinical acute kidney injury (AKI) arising from radionuclide therapies and have the potential to guide more effective therapies with a lower risk of chronic kidney disease (CKD).

Key Highlights:

Early secretion of urinary biomarker NGAL may be a valuable tool for early detection of kidney injury in response to radioligand therapies and has the potential to assist in optimizing therapies.
Identification and feasibility of the use of urinary epidermal growth factor as a biomarker response readout that may provide evidence of early tubular damage in response to radioligand therapies.
Author Affiliations: Nationwide Children's Hospital, Columbus, Ohio, USA; The University of Iowa, Iowa City, Iowa, USA; Korea Military Academy, Seoul, Republic of Korea; and The Ohio State University College of Veterinary Medicine, Columbus, Ohio, USA.

so jetzt ist alles komplett ,habe eben nicht gesehen das die Meldung noch weiter ging

[Edelweiss70]

Antwort auf Beitrag Nr.: 74.816.756 von Edelweiss70 am 16.11.23 15:31:59

SEATTLE, Nov. 27, 2023 (GLOBE NEWSWIRE) --

Perspective, Therapeutics, Inc. (NYSE AMERICAN: CATX), today announced the publication of four preclinical studies in support of the Company’s discovery pipeline. The studies were published in the European Journal of Nuclear Medicine and Molecular Imaging, Journal of Nuclear Medicine, and Pharmaceuticals.

“The results from these preclinical studies are compelling and continue to support our ongoing clinical efforts to advance our novel lead-based targeted alpha-particle therapies. Overall, these data demonstrate a dose-dependent therapeutic benefit of our treatment candidate [212Pb]VMT-α-NET in mouse models, and also demonstrate the high radiolabeling yields and high radiochemical purity and stability that are achievable using our radiopharmaceutical production process,” commented Michael Schultz, PhD, Chief Science Officer of Perspective Therapeutics. “Additionally, our collaborative investigations with our academic research partners are enhancing our understanding of biomarkers (e.g., NGal) that can be used in optimizing the therapeutic window for not only our alpha-particle therapies, but all tumor targeted radiopharmaceutical therapies. The use of these biomarkers has the potential to improve our ability to monitor patient safety and optimize the effectiveness of treatment. We are grateful to all our collaborators and look forward to generating and contributing additional data to our community in 2024.”

[Edelweiss70]

Antwort auf Beitrag Nr.: 74.807.612 von Edelweiss70 am 15.11.23 09:06:18

Perspective Therapeutics Completes Initial Dose Escalation Cohort for Second Novel Targeted Alpha Therapy
November 16, 2023
SEATTLE, Nov. 16, 2023 (GLOBE NEWSWIRE) -- Perspective Therapeutics, Inc. (NYSE AMERICAN: CATX), today announced the completion of cohort 1 dosing in the Phase 1/2a clinical trial of [212Pb]VMT-α-NET in patients with unresectable or metastatic somatostatin receptor type 2 (SSTR2)-expressing neuroendocrine tumors (NETs). This milestone follows the recent completion of the first dose escalation cohort for Perspective's melanoma therapeutic [212Pb]VMT01.

"We are pleased with the progress of our Company-sponsored clinical evaluation of [212Pb]VMT-α-NET in patients with difficult-to-treat SSTR2-expressing NETs. The rapid recruitment into this study reflects the demand for potent alpha-particle therapies that exists in this patient population," commented Markus Puhlmann, Chief Medical Officer of Perspective Therapeutics. "We are grateful to our collaborator, Nikolaos Trikalinos, MD, Medical Oncologist at Washington University in St. Louis, who serves as the referring medical oncologist for the study and ensures that patients can access our potentially life-changing therapeutic. With both of our investigational therapies, [212Pb]VMT-α-NET and [212Pb]VMT01, now having completed their first cohorts, we look forward to generating data at higher doses early in 2024."

The Company currently has two active clinical trial sites for the trial and anticipates that two additional sites will become operational in December, coinciding with the launch of cohort 2. Overall, the Company remains on track to launch an additional 14 clinical trial sites throughout the U.S. including the Mayo Clinic, the University of Iowa and more.

About The Study
This is a multi-center open-label clinical trial (clinicaltrials.gov identifier NCT05636618) of [212Pb]VMT-α-NET, a targeted alpha-particle therapy, for patients with advanced SSTR2-positive neuroendocrine tumors. The first part of this Phase 1/2a trial is a dose-escalation study designed to determine the Maximum Tolerated Dose ("MTD") or Maximum Feasible Dose ("MFD") following a single administration of [212Pb]VMT-α-NET. Patients who have not received prior peptide receptor radionuclide therapy will be scheduled to receive up to 4 administrations of [212Pb]VMT-α-NET approximately 8 weeks apart. The first patient cohort will receive 111 MBq (3mCi) per dose. The second cohort will receive administered activities of 185 MBq (5mCi), with cohorts 3 and 4 receiving 370 MBq (10 mCi) and 555 MBq (15 mCi), respectively, if the MTD or MFD is not reached during escalation. According to the Modified Toxicity Probability Interval 2 (mTPI-2) study design, intermediate de-escalation doses are also possible to allow selection of the optimal activity dose to take forward into the dose expansion part of the study.

The second part of the trial is a dose expansion phase based on the identified MTD/MFD. Patients with positive uptake on FDA-approved SSTR2 PET/CT will receive a fixed dose of [212Pb]VMT-α-NET IV administered at the recommended Phase 2 dose and schedule determined in the Phase I dose escalation.

About Neuroendocrine Tumors
Neuroendocrine tumors form in cells that interact with the nervous system or in glands that produce hormones. They can originate in various parts of the body, most often in the gut or the lungs and can be benign or malignant. Neuroendocrine tumors are typically classified as pancreatic neuroendocrine tumors or non-pancreatic neuroendocrine tumors. According to cancer.net, it is estimated that more than 12,000 people in the United States are diagnosed with a NET each year. Importantly, neuroendocrine tumors are associated with a relatively long duration of survival compared to other tumors and as a result, there are approximately 175,000 people living with this diagnosis.

About VMT-α-NET
VMT-α-NET is a clinical stage targeted alpha particle therapy (TAT) radiopharmaceutical being developed for the treatment and diagnosis of somatostatin receptor subtype 2 (SSTR2) expressing neuroendocrine tumors, which are a rare and difficult-to-treat type of cancer. VMT-α-NET incorporates Perspective Therapeutics' proprietary lead-specific chelator (PSC) to bind 203Pb for SPECT imaging, and 212Pb for alpha particle therapy.

About Perspective Therapeutics, Inc.
Perspective Therapeutics, Inc., is a diversified medical technology and radiopharmaceutical company that is pioneering advanced treatment applications for cancers throughout the body. The Company has a proprietary technology that utilizes the alpha emitting isotope Lead-212 to deliver powerful radiation specifically to cancer cells via specialized targeting peptides. The Company is also developing complementary imaging diagnostics that incorporate the same targeting peptides which provide the opportunity to personalize treatment and optimize patient outcomes. This "theranostic" approach enables the ability to see the specific tumor and then treat it to potentially improve efficacy and minimize toxicity associated with many other types of cancer treatments.

The Company's melanoma (VMT01) and neuroendocrine tumor (VMT-α-NET) programs have entered Phase 1/2a imaging and therapy trials for the treatment of metastatic melanoma and neuroendocrine tumors at several leading academic institutions in the United States. The Company has also developed a proprietary Lead-212 generator to secure key isotopes for clinical trial and commercial operations.

In addition to its targeted alpha therapy programs, Perspective is the sole producer of Cesium-131 brachytherapy seeds which is commercially available in the United States for the treatment of prostate cancer and other solid tumors.

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 potential for [212Pb]VMT-α-NET to be a life-changing therapeutic for patients with difficult-to-treat SSTR2-expressing NETs, the Company's expectations regarding the addition of clinical trial sites; the Company's clinical development plans and the expected timing thereof; the expected timing for availability and release of data; expectations regarding the potential market opportunities for the Company's product candidates; the potential functionality, capabilities, and benefits of the Company's product candidates and the potential application of these product candidates for other disease indications; the Company's expectations, beliefs, intentions, and strategies regarding the future; 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, including, without limitation: the potential that regulatory authorities may not grant or may delay approval for the Company's product candidates; uncertainties and delays relating to the design, enrollment, completion, and results of clinical trials; unanticipated costs and expenses; the Company's ability to continue as a going concern; early clinical trials may not be indicative of the results in later clinical trials; clinical trial results may not support regulatory approval or further development in a specified indication or at all; actions or advice of regulatory authorities may affect the design, initiation, timing, continuation and/or progress of clinical trials or result in the need for additional clinical trials; the Company's ability to obtain and maintain regulatory approval for the Company's product candidates; delays, interruptions or failures in the manufacture and supply of the Company's product candidates; the size and growth potential of the markets for the Company's product candidates, and the Company's ability to service those markets; the Company's cash and cash equivalents may not be sufficient to support its operating plan for as long as anticipated; the Company's expectations, projections and estimates regarding expenses, future revenue, capital requirements, and the availability of and the need for additional financing; the Company's ability to obtain additional funding to support its clinical development programs; the availability or potential availability of alternative products or treatments for conditions targeted by the Company that could affect the availability or commercial potential of its product candidates; the ability of the Company to manage growth and successfully integrate its businesses; the Company's ability to maintain its key employees; whether there is sufficient training and use of the Company's products and product candidates; the market acceptance and recognition of the Company's products and product candidates; the Company's ability to maintain and enforce its intellectual property rights; the Company's ability to maintain its therapeutic isotope supply agreement with the Department of Energy; the Company's ability to continue to comply with the procedures and regulatory requirements mandated by the FDA for additional trials, Phase 1 and 2 approvals, Fast Track approvals, and 510(k) approval and reimbursement codes; and any changes in applicable laws and regulations. Other factors that may cause the Company's actual results to differ materially from those expressed or implied in the forward-looking statements in this press release are described under the heading "Risk Factors" in the Company's most recent Transition Report on Form 10-KT and the Company's most recent Quarterly Report on Form 10-Q, each 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
Investor Relations Contact:
LifeSci Advisors
Chuck Padala
E: [e-mail]
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[Edelweiss70]

Seatle Newswire
IR Perspective Therapeutics
14.11.23



Perspective Therapeutics Reports Third Quarter Fiscal 2023 Results and Recent Business Highlights

SEATTLE, Nov. 14, 2023 (GLOBE NEWSWIRE) -- Perspective Therapeutics, Inc. (NYSE AMERICAN: CATX), today announced third quarter financial results for the period ended September 30, 2023 and provided recent business highlights..

“Our commitment to advancing targeted alpha-particle therapies against neuroendocrine tumors remains steadfast as we have completed dosing of the first patient in the Phase 1/2a clinical trial of [212Pb]VMT-α-NET,” said Thijs Spoor, Perspective Therapeutics' CEO. “In addition, we completed recruitment for the first patient cohort in the Company-sponsored Phase 1/2a dose escalation/dose expansion clinical trial evaluating [212Pb]VMT01 for the treatment of histologically confirmed melanoma. We are nearing completion of the imaging portion of the clinical trial evaluating the suitability of [203Pb]VMT01 for SPECT/CT imaging.”

“We are pleased with our execution this quarter and continue to see positive momentum in the number of patients being treated with Cesium-131 each month, marking a return to growth as compared to the same period in the prior year,” stated Andrew Bright, Perspective Therapeutics’ Executive Vice President of Brachytherapy. “The rebound in the number of patients treated was driven by engagement with current customers, as well as new customers adopting Cesium-131 in their brachytherapy programs. Additionally, increased utilization of Cesium-131 is evident in our core prostate business, as well as in other disease areas, notably lung and brain brachytherapy.”

VMT-α-NET Recent Highlights

Company-sponsored Phase 1/2a clinical trial of [212Pb]VMT-α-NET

Dosed first patient in the Phase 1/2a clinical trial of [212Pb]VMT-α-NET for unresectable or metastatic SSTR2-expressing neuroendocrine tumors (NETs) at Washington University in St. Louis.

The Company currently has two active sites for the clinical trial and anticipates that two additional clinical trial sites will become operational in December.

The Company remains on track to launch an additional 14 clinical trial sites.
Investigator-Initiated clinical trials of [212Pb]VMT-α-NET

Presented early clinical findings at the 36th Annual Congress of the European Association of Nuclear Medicine (EANM) for the Phase 2a clinical trial of [212Pb]VMT-α-NET in pre- and post-Lutathera gastroenteropancreatic (GEP)-NET patients, being conducted at Fortis Healthcare, India. Dr. Dharmender Malik of Fortis Memorial Research Institute presented data on [212Pb]VMT-α-NET therapy in 10 patients who had failed prior treatment, including standard care. Initial data readout demonstrated high objective response rate for 7 of 9 evaluable patients, spanning peptide receptor radionuclide therapy (PRRT)-naïve and PRRT-refractory cases. Two additional patients were enrolled in the third quarter for a total of 9 GEP-NET patients and 2 medullary thyroid cancer (MTC) patients. All ongoing patients are expected to complete their 4th treatment cycle by the end of February 2024. Updated clinical results are expected to be presented at an upcoming scientific meeting in 2024.

Two patients were screened in the Phase 1/2a clinical trial for post-Lutathera GEP-NET patients at the University of Iowa. A third patient is scheduled for screening mid-November. If eligible, all three patients will receive treatment in December for the completion of the first cohort. The end of fourth cycle of treatment is expected in June 2024.

End-of-life compassionate use program for patients with advanced NETs and lack of further treatment options is underway at the University Dresden in Germany. Four patients were treated during the third quarter, and investigators are planning additional treatments before the end of the year.

IND submissions are expected in November with subsequent trial activation in the first half of 2024 for NIH-sponsored studies in pre- and post-Lutathera NET patients.
VMT01 Recent Highlights

Completed recruitment for the first patient cohort in the Company-sponsored Phase 1/2a dose escalation/dose expansion clinical trial of [212Pb]VMT01 in patients with histologically confirmed melanoma and positive MC1R imaging scans. Three patients have been dosed at 111 MBq (3mCi), closing cohort 1. No serious adverse events or dose-limiting toxicities have been observed. The Company anticipates opening the second patient cohort, which will receive 185 MBq (5mCi) per dose, in December 2023 and anticipates the completion of screening in the first quarter of 2024.

Nearing completion of analysis of the dosimetry portion of the Company’s TIMAR-1 clinical trial, a first-in-human study evaluating the suitability of [203Pb]VMT01 for SPECT/CT imaging and [68Ga]VMT02 for PET/CT imaging of MC1R-expressing metastatic melanoma. Perspective is actively working on the Clinical Study Report and anticipates it will be released in the first half of 2024.
Brachytherapy Recent Highlights

Third quarter 2023 revenue was the highest since the second quarter of 2022, with a return to growth over the third quarter of 2022.

Appointed sales, marketing and clinical team members along with a senior customer service representative to supplement Perspective’s dedicated commercial team.

Launched marketing initiatives to increase direct patient communication and engagement on Cesium-131 brachytherapy.

Facilitated timely access to GT Medical’s GammaTile for challenging brain cancers through increased production of Cesium-131 brachytherapy seeds that allowed GT Medical to address short notice orders with increased confidence.

Presented long-term data for Cesium-131 brachytherapy in the treatment of prostate cancer at the American Society for Radiation Oncology (ASTRO) annual conference. In his presentation, Dr. Mohamed Abdelhakiem of the UPMC Hillman Cancer Center described urinary data collected from 341 patients treated with Cesium-131 between 2006 and 2022.

Presented preliminary long-term data for Cesium-131 utilized in salvage treatment of recurrent cervical and uterine cancers at the ASTRO annual conference. Dr. Zeta Chow of the University of Kentucky showed data that indicated Cesium-131 brachytherapy is a promising alternative to pelvic exenteration, a significant surgical procedure.

Publication of peer reviewed article in the journal of Brachytherapy highlighting Cesium-131 clinical data from Dr. Benoit and colleagues at the University of Pittsburgh School of Medicine. The results support Cesium-131 and provide additional data on dose parameters for improved urinary side effect profile without affecting disease free survival. [https://www.brachyjournal.com/article/S1538-4721(23)01632-X/…
Discovery Program Milestones

Presented data at EANM. Dijie Liu, Principal Research Scientist at Perspective, presented mouse model data highlighting the efficacy of [203/212Pb]VMT-α-NET in treating metastatic neuroblastoma tumors. The study showed successful tumor uptake via sequential SPECT imaging and demonstrated a maximum tolerated dose of [212Pb]VMT-α-NET as 2.22 MBq without acute toxicity, with a 100% overall survival rate at 90-days observed in the group receiving three fractionated doses of 740 kBq of [212Pb]VMT-α-NET.

Presented collaborative data at the World Molecular Imaging Congress. Dr. Michael K. Schultz, Chief Science Officer of Perspective presented data highlighting the effectiveness of [212Pb]VMT-α-NET in treating neuroendocrine tumors in a tumor xenograft mouse model. The results highlighted the significant therapeutic efficacy of treatment with three fractionated doses of [212Pb]VMT-α-NET, which resulted in a 70% complete response rate and 80% survival at 120 days.

Presented encouraging data on novel guest/host platform for effective in vivo image-guided pre-targeted alpha particle therapy at the World Molecular Imaging Congress. Dr. Amritjyot Kaur of Stony Brook University showed that the radioligand [203Pb]PSC-PEG3-Adma demonstrated extended lag times, impressive tumor-to-tissue ratios and has the potential to further reduce radiation toxicity using [203Pb]PSC-PEG3-Adma as a guide.

Publication of a peer-reviewed article in Nuclear Medicine and Biology reporting on collaborative research with the University of Alberta, to accelerate the availability of imaging surrogate isotope Pb-203 for image-guided dosimetry planning of Pb-212 labeled radiopeptide conjugates. The collaboration has established an approach to production that can be readily adopted by other cyclotron facilities that produce high yields and excellent specific activity. [https://pubmed.ncbi.nlm.nih.gov/36708660/]
Third Quarter 2023 Financial Summary

Total revenue for the three months ended September 30, 2023 was $2.19 million, compared to $1.72 million for the same period in 2022, an increase of 27%.

Sales revenues for the quarter ended September 30, 2023, was $1.9 million, compared to $1.7 million for the same period in 2022, an increase of 11%.

Prostate brachytherapy represented 55% of total revenue for the quarter ended September 30, 2023 compared to 68% for the same period in 2022.
Gross profit was $738,000 for the three months ended September 30, 2023 compared to $414,000 for the same period in 2022.

Research and development expenses were $5.7 million for the three months ended September 30, 2023 compared to $708,000 for the same period in 2022, an increase of 708%. Management continues to believe that research and development expenses may increase as the Company continues to advance its clinical programs.

Total operating expenses for the quarter ended September 30, 2023 were $11.3 million, compared to $4.6 million for the same period in 2022, an increase of 144%.

Net loss for the three months ended September 30, 2023 was $10.4 million or $0.04 per share basic and diluted, compared to $4.1 million or $0.03 per share basic and diluted for the same period in 2022.

Cash and cash equivalents as of September 30, 2023 was $18.0 million as compared to $43.9 million on December 31, 2022. Based on the Company's current operating plan, the Company believes that its existing cash and cash equivalents will be sufficient to fund its operating expenses and capital expenditure requirements into late second quarter of 2024.

About Perspective Therapeutics, Inc.
Perspective Therapeutics, Inc., is a diversified medical technology and radiopharmaceutical company that is pioneering advanced treatment applications for cancers throughout the body. The Company has a proprietary technology that utilizes the alpha emitting isotope Lead-212 to deliver powerful radiation specifically to cancer cells via specialized targeting peptides. The Company is also developing complementary imaging diagnostics that incorporate the same targeting peptides which provide the opportunity to personalize treatment and optimize patient outcomes. This "theranostic" approach enables the ability to see the specific tumor and then treat it to potentially improve efficacy and minimize toxicity associated with many other types of cancer treatments.

The Company's melanoma (VMT01) and neuroendocrine tumor (VMT-α-NET) programs have entered Phase 1/2a imaging and therapy trials for the treatment of metastatic melanoma and neuroendocrine tumors at several leading academic institutions in the United States. The Company has also developed a proprietary Lead-212 generator to secure key isotopes for clinical trial and commercial operations.

In addition to its targeted alpha therapy programs, Perspective is the sole producer of Cesium-131 brachytherapy seeds which is commercially available in the United States for the treatment of prostate cancer and other solid tumors.

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 belief regarding the sufficiency of its cash resources to fund its operating expenses and capital expenditure requirements; the Company's clinical development plans and the expected timing thereof; the expected timing for availability and release of data; the Company’s timing and expectations regarding regulatory communications, submissions and approvals; expectations regarding the potential market opportunities for the Company's product candidates; the potential functionality, capabilities, and benefits of the Company's product candidates and the potential application of these product candidates for other disease indications; the Company's expectations, beliefs, intentions, and strategies regarding the future; the Company's expectations regarding the addition of clinical trial sites; the Company’s belief that research and development expenses may increase as the Company continues to advance its clinical programs; the Company's expectations regarding potential competitors; the Company's plans for bolstering sales efforts; the Company's expectations the impact of changes in reimbursement amounts for its products; 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, including, without limitation: the potential that regulatory authorities may not grant or may delay approval for the Company's product candidates; uncertainties and delays relating to the design, enrollment, completion, and results of clinical trials; unanticipated costs and expenses; the Company’s ability to continue as a going concern; early clinical trials may not be indicative of the results in later clinical trials; clinical trial results may not support regulatory approval or further development in a specified indication or at all; actions or advice of regulatory authorities may affect the design, initiation, timing, continuation and/or progress of clinical trials or result in the need for additional clinical trials; the Company's ability to obtain and maintain regulatory approval for the Company's product candidates; delays, interruptions or failures in the manufacture and supply of the Company's product candidates; the size and growth potential of the markets for the Company's product candidates, and the Company's ability to service those markets; the Company's cash and cash equivalents may not be sufficient to support its operating plan for as long as anticipated; the Company's expectations, projections and estimates regarding expenses, future revenue, capital requirements, and the availability of and the need for additional financing; the Company's ability to obtain additional funding to support its clinical development programs; the availability or potential availability of alternative products or treatments for conditions targeted by the Company that could affect the availability or commercial potential of its product candidates; the ability of the Company to manage growth and successfully integrate its businesses; the Company's ability to maintain its key employees; whether there is sufficient training and use of the Company's products and product candidates; the market acceptance and recognition of the Company's products and product candidates; the Company's ability to maintain and enforce its intellectual property rights; the Company's ability to maintain its therapeutic isotope supply agreement with the Department of Energy; the Company's ability to continue to comply with the procedures and regulatory requirements mandated by the FDA for additional trials, Phase 1 and 2 approvals, Fast Track approvals, and 510(k) approval and reimbursement codes; and any changes in applicable laws and regulations. Other factors that may cause the Company's actual results to differ materially from those expressed or implied in the forward-looking statements in this press release are described under the heading "Risk Factors" in the Company's most recent Transition Report on Form 10-KT and the Company's most recent Quarterly Report on Form 10-Q, each 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 press release are made as of this date, and the Company undertakes no duty to update such information whether as a result of new information, future events or otherwise, except as required under applicable law.


https://www.wallstreet-online.de/nachricht/17546462-perspect…

[Edelweiss70]

Antwort auf Beitrag Nr.: 74.642.747 von Edelweiss70 am 16.10.23 18:31:01

Perspektive therapeutics
Newswire
8.11.23


Perspective Therapeutics Announces First Patient Dosed in Phase 1/2a Study of [(212)Pb]VMT-α-NET for Treatment of Advanced SSTR2-Positive Neuroendocrine Tumors
November 8, 2023
SEATTLE, Nov. 08, 2023 (GLOBE NEWSWIRE) -- Perspective Therapeutics, Inc. ("Perspective" or "the Company") (NYSE AMERICAN: CATX), announced today that the first patient was dosed at Washington University in St Louis in the Company's Phase 1/2a trial evaluating the safety and efficacy of [212Pb]VMT-α-NET, a targeted alpha-particle therapy (TAT), in patients with unresectable or metastatic somatostatin receptor type 2 (SSTR2) expressing neuroendocrine tumors (NETs). The trial is a multi-center, open-label dose escalation, dose expansion study of [212Pb]VMT-α-NET in patients who have not received prior peptide receptor radionuclide therapy (PRRT).

"We are proud of our team's commitment and progress in bringing our radionuclide therapy to patients suffering from these difficult-to-treat neuroendocrine tumors," said Thijs Spoor, Chief Executive Officer of Perspective Therapeutics. "Based on the promising clinical data observed in the investigator-led study in India that was presented at the recent European Association of Nuclear Medicine meeting, we believe [212Pb]VMT-α-NET has the potential to provide significant improvements in clinical outcomes compared to standard of care [177Lu]DOTATATE. With our FDA Fast Track Designation for first-line treatment in all neuroendocrine tumors, we plan to rapidly advance this product through clinical development."

"Although [177Lu]DOTATATE is available to a subset of patients with NETs, we know that few develop objective anatomic responses to therapy and ultimately many patients progress on treatment," commented Richard Wahl, M.D., Professor of Radiology & Radiation Oncology, Mallinckrodt Institute of Radiology, Washington University School of Medicine in St Louis. "The development of Perspective's [212Pb]VMT-α-NET targeted alpha particle therapy is an important next step in the evolution of treatments for SSTR2-expressing tumors. We are excited to participate in the trial."

"We are excited about our collaboration with investigators from top-tier research centers who are evaluating [212Pb]VMT-α-NET in patients with intractable SSTR2-expressing neuroendocrine tumors," said Markus Puhlmann, Chief Medical Officer of Perspective Therapeutics. "Our goal is to demonstrate that systemic delivery of [212Pb]VMT-α-NET is safe and has the potential to selectively target tumor cells while sparing healthy tissues. We expect to present preliminary findings in early 2024."

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Perspective Therapeutics Completes Recruitment for First Patient Cohort in Phase 1/2a Dose Escalation Trial of VMT01 in Malignant Melanoma



SEATTLE, Oct. 16, 2023 (GLOBE NEWSWIRE) -- Perspective Therapeutics, Inc. (“Perspective” or “the Company”) (NYSE AMERICAN: CATX), today announced the completion of recruitment for the first patient cohort in its Phase 1/2a dose escalation study of 212Pb-VMT01 (clinicaltrials.gov identifier NCT05655312), its targeted alpha-particle therapy, in development for the treatment of MC1R-positive metastatic melanoma.

“We are encouraged by the pace of enrollment in the trial which we believe is indicative of the tremendous unmet need for patients with unresectable and intractable melanomas,” said Chief Medical Officer Markus Puhlmann, MD MBA, of Perspective Therapeutics.



“We are grateful to our clinical collaborators for their diligence in working closely with patients to deliver our targeted alpha-particle therapy, and we look forward to providing an update in the coming months.”

Perspective Therapeutics Completes Recruitment for First Patient Cohort in Phase 1/2a Dose Escalation Trial of VMT01 in Malignant Melanoma
SEATTLE, Oct. 16, 2023 (GLOBE NEWSWIRE) -- Perspective Therapeutics, Inc. (“Perspective” or “the Company”) (NYSE AMERICAN: CATX), today announced the completion of recruitment for the first patient cohort in its Phase 1/2a dose escalation study of 212Pb-VMT01 (clinicaltrials.gov identifier NCT05655312), its targeted alpha-particle therapy, in development for the treatment of MC1R-positive metastatic melanoma.

“We are encouraged by the pace of enrollment in the trial which we believe is indicative of the tremendous unmet need for patients with unresectable and intractable melanomas,” said Chief Medical Officer Markus Puhlmann, MD MBA, of Perspective Therapeutics. “We are grateful to our clinical collaborators for their diligence in working closely with patients to deliver our targeted alpha-particle therapy, and we look forward to providing an update in the coming months.”




powered by finative
“MC1R is a receptor that is displayed on the surface of melanoma

About the study
This ongoing trial (clinicaltrials.gov identifier NCT05655312) is a multi-center open-label dose escalation, dose expansion study of 212Pb-VMT01 in subjects with histologically confirmed melanoma and positive MC1R imaging scans. The first part of the study is a dose escalation phase to determine the Maximum Tolerated radioactivity Dose (MTD) or Maximum Feasible radioactivity Dose (MFD) following a single administration of 212Pb-VMT01. Patients with stage IV or unresectable stage III metastatic melanoma who have progressed on at least 1 approved first-line therapy will be scheduled to receive up to 3 administrations of 212Pb-VMT01 approximately 8 weeks apart. The first patient cohort is scheduled to receive 111 MBq (3mCi) per dose. The second cohort will receive administered activities of 185 MBq (5mCi), with cohorts 3 and 4 receiving 370 MBq (10 mCi) and 555 MBq (15 mCi) respectively, if the MTD or MFD is not reached during escalation. According to the Modified Toxicity Probability Interval 2 (mTPI-2) study design, intermediate de-escalation doses are also possible to allow selection of the optimal activity dose to take forward into the dose expansion part of the study.

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Antwort auf Beitrag Nr.: 74.393.831 von Edelweiss70 am 28.08.23 21:10:56

Ist hier irgendetwas verkündet worden was wir noch nicht wussten ???? Dieser Kursaufschlag von 120% ist schon sehr spannend. Hatte schon mit einem neuen Couverage von Oppenheimer gerechnet aber so bleibt es einfach nur spannend




https://perspectivetherapeutics.com/press-releases/perspecti…

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RICHLAND, WASH. & CORALVILLE, IOWA, Aug. 28, 2023 (GLOBE NEWSWIRE)

-- – Perspective Therapeutics, Inc. (“Perspective” or “the Company”) (NYSE AMERICAN: CATX), today announced that it will present new clinical and preclinical data for 212Pb-VMT-α-NET, a Targeted Alpha-Particle Therapy, at the upcoming 36th Annual Congress of the European Association of Nuclear Medicine (EANM). The conference is being held in Vienna, Austria, from September 9-13, 2023.

“Our team at Perspective Therapeutics continues to work diligently to advance much needed targeted alpha therapy using 212Pb,” said Thijs Spoor, Chief Executive Officer at Perspective Therapeutics. “We are particularly excited about the early clinical results from 212Pb-VMT-α-NET in patients suffering from different types of difficult-to-treat neuroendocrine tumors. These results support our belief that targeted alpha therapies have the potential to revolutionize our approach to eliminating cancers and intractable tumors.”

“We are excited to have early results presented by Dr. Dharmender Malik of Fortis Memorial research institute on the safety and efficacy of 212Pb-VMT-α-NET especially in patients with somatostatin receptor positive, metastatic neuroendocrine and medullary thyroid tumors,” said Markus Puhlmann, MD, MBA, Chief Medical Officer at Perspective Therapeutics. “Additionally, we will present data from our metastatic mouse model of neuroblastoma exploring the efficacy of 203/212Pb-VMT-α-NET for image-guided treatment in this metastatic neuroblastoma tumor model.”

Details about these presentations can be found below and on the EANM website (eanm23.eanm.org). Additionally, copies of the abstracts can be found in the EANM ’23 Abstract Book on the EANM website.

Presentation One:

This presentation will discuss early clinical results from the study of 212Pb-VMT-α-NET in ten patients with somatostatin receptor (SSTR)-expressing progressive neuroendocrine tumors and metastatic medullary thyroid carcinomas. 212Pb-VMT-α-NET demonstrated an encouraging safety profile and treatment resulted in partial responses in a number of patients.

Title: Early results of 212Pb-VMT-α-NET Targeted Alpha Therapy in Metastatic Gastro-entero-pancreatic Neuroendocrine Tumors: First in Human Clinical Experience on Safety and Efficacy
Session: Theranostics Track – What’s New in Endocrine Tumors
Abstract Number: OP-673
Presenter: D. Malik, Consultant Nuclear Medicine and PET-CT, MBBS, DNB, FANMB & RSO-II at Fortis Memorial research institute (FMRI), Gurugram, India at Fortis Healthcare Pvt.

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Wallstreet-online
news
11.8.23


Hier nochmal der link zu den Quartalszahlen

https://www.wallstreet-online.de/nachricht/17234880-perspect…

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Perspective Therapeutics Reports Second Quarter Fiscal 2023 Results and Recent Business Highlights

RICHLAND, Wash. and CORALVILLE, Iowa, Aug. 11, 2023 (GLOBE NEWSWIRE) -- Perspective, Therapeutics, Inc. (“Perspective” or “the Company”) (NYSE AMERICAN: CATX), a precision oncology company developing alpha-particle therapies and complementary diagnostic imaging agents and an innovator in seed brachytherapy powering expanding treatment options for multiple cancers, reports second quarter financial results for the period ended June 30, 2023 and recent business highlights.

“We made substantial progress on our pipeline during Q2 2023 with the initiation of Phase 1/2a clinical trials for VMT-α-NET for neuroendocrine tumors and VMT01 for melanoma and we expect preliminary results from initial cohorts by end of the year,” said Thijs Spoor, Perspective Therapeutics’ CEO. “We are supplying both U.S. trials with drug product from our GMP manufacturing facility in Coralville, Iowa. We expect to bring additional CDMO manufacturing sites online in the coming months to enable broader coverage of sites across the U.S. Isotope will be supplied using Perspective’s proprietary VMT-α-GEN 212Pb benchtop generator.”
Andrew Bright, Perspective Therapeutics’ EVP of Brachytherapy noted, “Our brachytherapy business has emerged from the recent merger with an engaged and enthusiastic team that is focused on expanding the use of Cesium-131 brachytherapy. This quarter we have supplemented the team with talent in several key leadership areas. With a strong team in place, we’re focused on securing new business and re-gaining old business. We have a renewed focus on our strategic collaboration with GT Medical Technologies based on a shared belief that Cesium-131 is ideal for delivering radiotherapy to a key group of brain cancer patients. Our sales efforts will be bolstered by long-term Cesium-131 data in prostate cancer and additional peer reviewed data of Cesium-131 use in other cancers.”

Key Operation Highlights

The appointment of Heidi Henson as Audit Committee Chair of the Board of Directors. Ms. Henson brings over 25 years of executive leadership roles in the life sciences. In past executive leadership roles, Ms. Henson has served as the Chief Financial Officer of Pardes Biosciences, Imbria Pharmaceuticals, Respivant Sciences, Kura Oncology, Wellspring Biosciences, and Araxes Pharma.
The appointment of Andrew Bright as Executive Vice-President of Brachytherapy. Mr. Bright brings to Perspective over 30 years in leadership within the medical device industry, including over 20 years in brachytherapy. Mr. Bright was part of the commercial enterprise responsible for initial widespread adoption and growth of brachytherapy in the 1990’s and was involved in the development and introduction of some of the most successful and clinically relevant products in the industry.
The appointment of Shane Cobb as Executive Vice President of Operations. Mr. Cobb brings a wealth of operational nuclear pharmacy industry experience to Perspective. He worked for 35 years in roles of increasing responsibility at Roche, Medi+Physics, Amersham, Nycomed Amersham, GE Healthcare, and RLS. Adding to his extensive knowledge of the space, during his time at GE Healthcare, he led multiple global scale projects including bringing a new Mo-99 generator offering to the US, spearheading safety improvement initiatives, developing production workflow systems for 31 cleanrooms to meet USP 797 compliance, and leading the first nuclear pharmacies in the US to receive Joint Commission accreditation for quality standards.
Launch of Australian subsidiary to accelerate the commencement of early-stage clinical R&D work. The launch of this entity is intended to accelerate Perspective’s translational pipeline products from preclinical into early phase proof of concept human clinical trials.
VMT01 Clinical Highlights

Initiated clinical trial sites and commenced the enrollment period for 212Pb labeled therapeutic product candidate VMT01 for the treatment of melanoma. VMT01 is entering therapeutic trials at leading U.S. institutions.
Multiple patients screened and first patient dosed in Phase 1/2a Dose Escalation Trial for VMT01 in the treatment of metastatic melanoma expressing MC1R. Preliminary data readout from dose escalation study is expected by the end of 2023.
First in human imaging data from VMT01 were presented at the 2023 Annual Society for Nuclear Medicine and Molecular Imaging (SNMMI) by Geoffrey Johnson, MD, PhD, the Chair of Nuclear Medicine at Mayo Clinic. Dr. Johnson noted that both the SPECT and PET imaging versions of VMT01 showed favorable uptake in melanoma tumors in a subset of patients, confirming VMT01/VMT02 as selection tools for patients to receive targeted alpha therapy with 212Pb-VMT01.
Preclinical combination data with checkpoint inhibitors were presented at the 2023 International Symposium on Radiopharmaceutical Sciences (iSRS). Data displayed synergy between targeted alpha therapy with 212Pb and immune checkpoint inhibitors.
VMT-α-NET Recent Milestones

Continued administrations of multiple cycles of administering VMT-α-NET in 10 patients in an investigator-initiated trial at Fortis Memorial Research Institute. We expect to disclose preliminary results in Q3 2023.
Initiated clinical trial sites and commenced the enrollment period for 212Pb labeled therapeutic product candidate VMT-α-NET. VMT-α-NET for neuroendocrine cancers is entering therapeutic trials at leading US institutions.
Continued recruitment in University of Iowa imaging and dosimetry study with 203Pb VMT-α-NET.
Brachytherapy Recent Highlights

A favorable comparison between Cesium-131 brachytherapy and Stereotactic Body Radiation Therapy, along with long-term Cesium-131 data, was presented at the American Brachytherapy Society annual meeting. The data showed that Cesium-131 brachytherapy offers prostate cancer patients the prospect of disease-free survival of 96% measured at ten years after treatment.
Bander et al. published a retrospective review of brain tumor treatment using surgery and Cesium-131 brachytherapy in the Journal of Neuro-Oncology. The study highlighted the superior local tumor control and lower complication rates of Cesium-131 compared to Iodine-125 data. (Bander, ED, et al., Safety and efficacy of Cesium-131 brachytherapy for brain tumors. Journal of Neurosurgery 163(2): 355-365. (2023)).
Established an initiative with GT Medical Technologies, Inc. (GT Medical) to broaden access to their GammaTile Therapy product, a unique delivery method for placing Cesium-131 during the last five minutes of brain tumor resection surgery.
The Centers for Medicare & Medicaid Services announced in July 2023 its proposed Medicare Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems payment rates for 2024. Under these rates, Perspective’s stranded pre-loaded Cesium-131 seeds would see an increase in reimbursement per seed. The final rule will be issued in November 2023.
Manufacturing and Supply Milestones

Updated all regulatory, operational, and related compliance activities to ensure all FDA related labeling, documentation, packaging, and customer facing materials reflects Perspective Therapeutics, with no disruption or inconvenience to our customers.
Multiple clinical GMP products have now been manufactured and shipped to clinical sites from Perspective’s GMP facility in Coralville.
Substantial progress towards transfer of manufacturing to multiple third party contract development and manufacturing organization sites well underway.
212Pb generators manufactured and shipped worldwide have shown robustness of supply.
Additional supplies of Th-228 feedstock have been identified to enable plentiful quantities of 212Pb to be purified as development of Perspective’s pipeline of products progresses towards commercialization.
Continued to increase its manufacturing in support of GT Medical’s objective of delivering GammaTile Therapy to more patients with difficult to treat brain cancers.
Second Quarter and Half Year 2023 Financial Summary

Revenue - Revenue for the three months ended June 30, 2023 was $2.1 million, as compared to $2.5 million in the same period in 2022, a decline of 17%. The year-over-year decline in revenue was primarily a result of the loss of a large brachytherapy customer partially offset by grant revenue related to our alpha-particle therapy operations.

Gross Profit - Gross profit was $248,000 for the three months ended June 30, 2023, as compared to $926,000 for the same period in 2022, a decline of 73%. The year over year decline was primarily a result of the decrease in sales due to the loss of a large brachytherapy customer, higher brachytherapy production costs, and a $298,000 write-off of Blu Build inventory as the Company discontinued selling its loader, and were partially offset by grant revenue from our alpha-particle therapy business.

Research and development (R&D) expenses - R&D for the three months ended June 30, 2023 and 2022 comparison was an increase in costs of $4.9 million related to the development of the Company’s alpha-particle therapy drug products gained through the merger with Viewpoint, partially offset by a decrease in the Company’s legacy research and development expenses.

Management believes that research and development expenses will increase as we continue to invest in the development of new drugs and products.

Net loss - For the second quarter of 2023, the Company reported a net loss of $11.1 million, compared to a net loss of $2.1 million in the same period in 2022.

For the first half of fiscal 2023 ended June 30, 2023, revenue decreased 23% to $4.2 million versus $5.4 million in the prior year comparable period. Prostate brachytherapy represented 42% of total revenue for the first six months of fiscal 2023 compared to 73% for the first six months of fiscal 2022. Total operating expenses for the first six months of fiscal 2023 increased 299% to $23.3 million, versus $5.8 million in the prior year comparable period. The net loss for the first six months of fiscal 2023 was $11.5 million, or ($0.05) per basic and diluted share, compared to a net loss of $3.4 million, or ($0.02) per basic and diluted share, in the prior year comparable period. Basic and diluted per share results are based on weighted average shares outstanding of approximately 254 million for the six months ended June 30, 2023, versus 142 million in the comparable prior year period.

Cash and cash equivalents - As of June 30, 2023, cash, cash equivalents, and restricted cash was $28.5 million as compared to cash, cash equivalents, restricted cash, and short-term investments totaled $43.9 million as of December 31, 2022.

About Perspective Therapeutics, Inc.
Perspective Therapeutics, Inc., is a medical technology and radiopharmaceutical company that is pioneering advanced treatment applications for cancers throughout the body. The Company is the sole producer of Cesium-131 brachytherapy seeds and has a proprietary technology that utilizes the isotope Lead-212 to deliver powerful alpha radiation specifically to cancer cells via specialized targeting peptides. The Company is also developing complementary imaging diagnostics that incorporate the same targeting peptides which provide the opportunity to personalize treatment and optimize patient outcomes. This “theranostic” approach enables the ability to see the specific tumor and then treat it to potentially improve efficacy and minimize toxicity associated with many other types of cancer treatments.

The Company’s melanoma (VMT-01) and neuroendocrine tumor (VMT-α-NET) programs are entering Phase 1/2a imaging and therapy trials for the treatment of metastatic melanoma and neuroendocrine tumors at several leading academic institutions. The Company has also developed a proprietary lead-212 generator to secure isotope supply for clinical trial and 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 clinical development plans and the expected timing thereof; the expected timing for availability and release of data; the Company’s timing and expectations regarding regulatory communications, submissions and approvals; expectations regarding the potential market opportunities for the Company’s product candidates; the potential functionality, capabilities, and benefits of the Company’s product candidates; the potential size of the commercial market for the Company’s product candidates; the Company’s expectations, beliefs, intentions, and strategies regarding the future; the Company’s expectations regarding the addition of manufacturing sites; the Company’s expectations regarding supplying isotope using its proprietary benchtop generator; the Company’s expectations regarding potential competitors; the Company’s plans for bolstering sales efforts; the Company’s expectations regarding changes in reimbursement amounts for its products; the Company’s ability to transfer its manufacturing to third parties; 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, including, without limitation, the potential that regulatory authorities may not grant or may delay approval for the Company’s product candidates; uncertainties and delays relating to the design, enrollment, completion, and results of clinical trials; unanticipated costs and expenses; early clinical trials may not be indicative of the results in later clinical trials; clinical trial results may not support regulatory approval or further development in a specified indication or at all; actions or advice of regulatory authorities may affect the design, initiation, timing, continuation and/or progress of clinical trials or result in the need for additional clinical trials; the Company’s ability to obtain and maintain regulatory approval for the Company’s product candidates; delays, interruptions or failures in the manufacture and supply of the Company’s product candidates; the size and growth potential of the markets for the Company’s product candidates, and the Company’s ability to service those markets; the Company’s cash and cash equivalents may not be sufficient to support its operating plan for as long as anticipated; the Company’s expectations, projections and estimates regarding expenses, future revenue, capital requirements, and the availability of and the need for additional financing; the Company’s ability to obtain additional funding to support its clinical development programs; the availability or potential availability of alternative products or treatments for conditions targeted by the Company that could affect the availability or commercial potential of its product candidates; the ability of the Company to manage growth and successfully integrate its businesses; whether the Company can maintain its key employees; whether there is sufficient training and use of the Company’s products and product candidates; the market acceptance and recognition of the Company’s products and product candidates; the Company’s ability to maintain and enforce its intellectual property rights; whether the Company can maintain its therapeutic isotope supply agreement with the Department of Energy; whether the Company will continue to comply with the procedures and regulatory requirements mandated by the FDA for additional trials, Phase 1 and 2 approvals, Fast Track approvals, and 510(k) approval and reimbursement codes; and any changes in applicable laws and regulations. Other factors that may cause the Company’s actual results to differ materially from those expressed or implied in the forward-looking statements in this press release are described under the heading “Risk Factors” in the Company’s most recent Transition Report on Form 10-KT and the Company’s most recent Quarterly Report on Form 10-Q, each 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 press release are made as of this date, and the Company undertakes no duty to update such information whether as a result of new information, future events or otherwise, except as required under applicable law.

Investor Relations Contact:
LifeSci Advisors
Chuck Padala
E: [e-mail]


Perspective Therapeutics, Inc. and Subsidiaries
Condensed Consolidated Balance Sheets (Unaudited)
(In thousands, except shares)

June 30, December 31,
2023 2022
ASSETS
Current assets:
Cash and cash equivalents $ 28,319 $ 20,993
Short-term investments - 22,764
Accounts receivable, net 1,113 1,363
Inventory 1,094 1,409
Note receivable - 6,109
Prepaid expenses and other current assets 1,428 577

Total current assets 31,954 53,215

Property and equipment, net 7,043 1,684
Right of use asset, net 805 378
Restricted cash 182 182
Inventory, non-current 2,269 2,396
Intangible assets 50,000 -
Goodwill 27,319 -
Other assets, net 573 236

Total assets $ 120,145 $ 58,091

LIABILITIES AND STOCKHOLDERS' EQUITY

Current liabilities:
Accounts payable and accrued expenses $ 4,906 $ 1,541
Lease liability 262 276
Accrued protocol expense 387 233
Accrued radioactive Accrued radioactive waste disposal 20 129
Accrued payroll and related taxes 2,259 212
Accrued vacation 684 285
Other notes payable, current 71 -

Total current liabilities 8,589 2,676
Non-current liabilities:
Lease liability, non-current 543 116
Note payable 1,701 -
Asset retirement obligation 659 657

Total liabilities 11,492 3,449
Commitments and contingencies

Stockholders' equity:
Preferred stock, $.001 par value; 7,000,000 shares authorized: Series B: 5,000,000 shares allocated; no shares issued and outstanding - -
Common stock, $.001 par value; 750,000,000 shares authorized; 280,479,421 and 142,112,766 shares issued and outstanding 280 142
Additional paid-in capital 225,782 160,432
Accumulated deficit (117,409 ) (105,932 )

Total stockholders' equity 108,653 54,642

Total liabilities and stockholders' equity $ 120,145 $ 58,091

Perspective Therapeutics, Inc. and Subsidiaries
Condensed Consolidated Statements of Operations (Unaudited)
(Dollars and shares in thousands, except for per-share amounts)

Three months ended Six months ended
June 30, June 30,
2023 2022 2023 2022

Sales, net $ 1,500 $ 2,505 $ 3,330 $ 5,415
Grant revenue 588 - 821 -
Total revenue 2,088 2,505 4,151 5,415
Cost of sales 1,840 1,579 3,416 3,048
Gross profit 248 926 735 2,367

Operating expenses:
Research and development 5,653 796 9,510 1,345
Sales and marketing 911 654 1,723 1,341
General and administrative 5,073 1,582 12,096 3,163
Change in estimate of asset retirement obligation (15 ) - (15 ) -
Loss on disposal of property and equipment - - 22 -
Total operating expenses 11,622 3,032 23,336 5,849

Operating loss (11,374 ) (2,106 ) (22,601 ) (3,482 )

Non-operating income (expense):
Interest income 294 28 668 57
Interest expense (28 ) - (46 ) -
Other income 2 2 -
Non-operating income, net 268 28 624 57

Net loss before deferred income tax benefit (11,106 ) (2,078 ) (21,977 ) (3,425 )

Deferred income tax benefit - - 10,500 -

Net loss $ (11,106 ) $ (2,078 ) $ (11,477 ) $ (3,425 )

Basic and diluted loss per share $ (0.04 ) $ (0.01 ) $ (0.05 ) $ (0.02 )

Weighted average shares used in computing net loss per share:
Basic and diluted 279,988 142,040 254,432 142,040