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CATX US Equity

Perspective Therapeutics, Inc.Health Care · Pharmaceutical Preparations · CIK 728387 · FY ends Dec 31
$3.48
+0.27 (+8.41%)
USD · as of 2026-08-19 · marketstack

CATX · 10-K · period ended 2024-12-31

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filed 2025-03-26 · EDGAR original ↗

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ITEM 7 – MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

You should read the following discussion and analysis of our financial condition and results of operations together with our audited consolidated financial statements and the related notes appearing at the end of this Annual Report on Form 10-K (“Annual Report” or “Form 10-K”). Some of the information contained in this discussion and analysis or set forth elsewhere in this Annual Report, including information with respect to our plans and strategy for our business and related financing, includes forward-looking statements that involve risks and uncertainties. You should read “Cautionary Note Regarding Forward-Looking Statements” and Item1A. Risk Factors of this Annual Report for a discussion of important factors that could cause actual results to differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis. Unless the context otherwise requires, references in this Annual Report to the “Company,” “Perspective,” “we,” “us” and “our,” except where the context requires otherwise, refer to Perspective Therapeutics, Inc. and its subsidiaries. References to “Viewpoint” refer to Viewpoint Molecular Targeting, Inc., a wholly owned subsidiary, and references to “Isoray” refer to Isoray Medical, Inc., a wholly owned subsidiary.

Overview

We are a radiopharmaceutical development company that is pioneering advanced treatment applications for cancers throughout the body. We have proprietary technology that utilizes the alpha-emitting isotope Lead-212 (212Pb) to deliver powerful radiation specifically to cancer cells via specialized targeting moieties. We are also developing complementary imaging diagnostics that incorporate the same targeting moieties, which provides 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.

Our melanoma (VMT01) and neuroendocrine tumor (VMT-α-NET) programs are in Phase 1/2a imaging and therapy trials for the treatment of metastatic melanoma and neuroendocrine tumors in the U.S. We are growing our regional network of drug product finishing facilities, enabled by our proprietary 212Pb generator, to deliver patient-ready products for clinical trials and commercial operations.

VMT-α-NET

We designed VMT-α-NET to target and deliver 212Pb to target cancer-specific receptors on tumor cells expressing somatostatin receptor type 2 (SSTR2), a protein that is overexpressed in neuroendocrine tumors (NETs) and other cancers. [212Pb]VMT-α-NET is a TAT in development for patients with unresectable or metastatic SSTR2-expressing tumors who have not previously received peptide-targeted radiopharmaceutical therapy, such as Lutathera. NETs are a group of rare, heterogeneous tumors that develop in different organs of the body and arise from specialized cells in the neuroendocrine system.

We have initiated dosing of patients in Cohorts 1 and 2 of our Phase 1/2a study of [212Pb]VMT-α-NET in patients with unresectable or metastatic SSTR2-expressing NETs. In April 2024, we announced that this program was selected by the U.S. Food and Drug Administration (FDA) to participate in the Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot (CDRP) Program. The 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. The observation period was completed for dose limiting toxicity (DLT) in seven patients enrolled in Cohort 2 during the second quarter of 2024. Subsequently, the safety monitoring committee (SMC) determined that the safety data observations during the DLT period supported proceeding with dose escalation to Cohort 3 and increasing the number of patients dosed at 5 mCi. Based on interactions with the FDA prior to the initiation of patient dosing in this study, which occurred in late 2023, the decision to open Cohort 3 will follow consultation and alignment with the agency. FDA interactions are ongoing with regards to the initiation of the next dosing cohort.

In June 2024, we announced multiple updates featuring our alpha-particle radiopharmaceuticals at the Society of Nuclear Medicine and Molecular Imaging 2024 Annual Meeting (SNMMI). The data presentations highlighted favorable safety profiles and potential benefits of our lead clinical candidates. Specifically, we reported on a Phase 0 imaging trial that is evaluating the optimal imaging timepoint(s) for diagnostic/dosimetric performance of Lead-203 ([203Pb]) VMT-α-NET in neuroendocrine tumors. Investigators analyzed 48 lesions across nine patients, and the results showed that tumor uptake of [203Pb]VMT-α-NET peaked at approximately four hours post-injection, with 98% of maximum uptake observed at one hour. The results suggest that imaging with [203Pb]VMT-α-NET at four hours post-injection has the best overall diagnostic performance, followed closely by imaging at one hour.

Also at SNMMI, an investigator reported on [212Pb]VMT-α-NET planning based on [203Pb]VMT-α-NET predictive dosimetry in an investigator-sponsored trial. The investigators applied patient-specific dosimetry in a Phase 0 imaging trial (NCT05111509) of [203Pb]VMT-a-NET and in the first cohort of a Phase 1 absorbed-dose escalation study (NCT06148636) of [212Pb]VMT-α-NET. Ten patients with β-peptide receptor radionuclide therapy (PRRT)-relapsed or refractory gastroenteropancreatic (GEP)-NETs received [203Pb]VMT-α-NET (5 mCi) followed by sequential blood sampling, planar imaging and quantitative single-photon emission computed tomography/computed tomography (qSPECT/CT) imaging at 1 hour, 4 hours, 24 hours and 48 hours post-administration. Three of 10 patients received amino acid infusions while seven patients did not receive amino acids.

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The dosimetry showed that the average renal doses for patients who received amino acids was 0.46±0.20 Gy/mCi, as compared to 0.56±0.16 Gy/mCi for patients who did not receive amino acids; the difference was not statistically significant. For the three patients who received [212Pb]VMT-α-NET treatment, based upon their individual dosimetry results, they were prescribed 5.3, 7.3, and 13.3 mCi cumulative activity (delivered over two cycles), respectively, to reach the cohort target renal dose of 3.5 Gy. Higher levels of targeted renal-absorbed doses are in the protocol for subsequent cohorts.

Additionally at SNMMI, the lead investigator reported on an exploratory first-in-human use of [212Pb]VMT-α-NET in adult patients with histologically confirmed metastatic NETs and medullary thyroid carcinomas in an investigator-led research study in India. The investigator reported updated safety and anti-tumor activity of [212Pb]VMT-α-NET administered at 67 μCi/kg (2.5 MBq/kg) every eight weeks in 13 patients as of the data cut-off date of May 31, 2024. All patients received prior treatments, eight of whom received prior PRRT treatment. Six patients remained eligible for further treatments as of the data cut-off date.

The investigator concluded that the toxicity profile suggests the potential for dose escalation to achieve optimal treatment responses. Confirmed tumor response per RECIST 1.1 was reported to be observed in eight of the 13 patients, while unconfirmed responses were observed in two additional patients who eventually had progressive disease and died. Median progression free survival was reported to be 16.4 months (95% confidence interval: 3.5 to NA). The investigator also reported higher absorbed doses in the tumors compared to select other tissues.

Subsequently, in October 2024, at the 37th Annual Congress of the European Association of Nuclear Medicine (EANM) in Hamburg, Germany, the investigator presented an update on a subset of the previously reported investigator-led research study in India. The cut-off date was September 15, 2024, and the study focused on 10 patients with well-differentiated GEP-NETs. These patients were treated with [212Pb]VMT-α-NET at a dosage of 67 μCi/kg (2.5 MBq/kg), with an interval of eight weeks for up to six cycles. Treatment was well tolerated with a modest and manageable adverse effect profile. Confirmed tumor response per RECIST 1.1 was observed in six of the 10 GEP-NETs patients. The investigator again concluded that the toxicity profile suggests the potential for dose escalation to achieve optimal treatment responses. Long-term survival data will mature with continued follow up.

Additionally, dosimetry estimates were collected from five of the 10 GEP-NETs patients discussed above. The results demonstrated that SPECT/CT imaging with [212Pb]VMT-α-NET showed prompt tumor accumulation, high tumor retention and rapid renal excretion in all patients. Overall, the findings suggest that post-treatment imaging of [212Pb]VMT-α-NET is feasible and can potentially serve as a valuable tool to evaluate and monitor patients through a full course of treatment.

In November 2024, at the North American Tumor Society’s NANETS Multidisciplinary NET Medical Symposium, we announced initial results from our multi-center open-label dose escalation, dose expansion study (clinicaltrials.gov identifier NCT05636618) of [212Pb]VMT-α-NET in patients with unresectable or metastatic SSTR2-positive NETs who have not received prior radiopharmaceutical therapy and have shown radiological evidence of disease progression in the 12 months prior to enrollment. The data cut-off date for the presentation was October 31, 2024.

Per the study protocol, the two patients who made up Cohort 1 received administered activity of 2.5 mCi per dose regardless of body weight. Based on their respective body weights, the median administered activity per kilogram of weight was 45.5 μCi/kg per dose. The seven patients who made up Cohort 2 received administered activity of 5.0 mCi per dose regardless of body weight. Based on their respective body weights, the median administered activity per kilogram of weight was 62.1 μCi/kg per dose, ranging from 31.8 μCi/kg to 84.6 μCi/kg per dose. One patient in Cohort 2 received two doses of 84.6 μCi/kg per dose, then received the third and fourth doses at a reduced activity level of 42.4 μCi/kg per dose due to an adverse event that was determined by the investigator to be unrelated.

No DLTs were observed among any patients. No grade 4 or 5 treatment emergent or serious adverse events (AEs) were observed. Two grade 3 AEs – one case of diarrhea and one case of syncope – were observed. No decline in renal function was observed. Hematologic AEs, such as decreased lymphocyte count and anemia, were all grades 1 and 2. No treatment discontinuations due to AEs occurred.

Eight of nine patients had durable control of disease. Six of nine patients had measurable reduction of tumor volume, one of whom had a confirmed response as defined by RECIST v1.1. The patient who experienced an objective response received the first two doses at 84.6 μCi/kg per dose, then received the remaining two doses at a reduced activity level of 42.4 μCi/kg. One patient was deemed to have progressive disease after one dose under RECIST v1.1, by unambiguous progression of non-target lesions.

In January 2025, we announced updated interim results from this same clinical trial at the 2025 American Society of Clinical Oncology Gastrointestinal Cancers Symposium with a data cut-off date of January 10, 2025. All nine patients in Cohort 1 and Cohort 2 had completed treatments per the study protocol, and the study team had at least one scan for all patients after their final treatments. No DLTs, grade 4 or 5 treatment emergent or serious AEs were reported since the start of the study. No new grade 3 AEs were observed aside from the two events discussed earlier. No decline in renal function was observed. Hematologic AEs, such as decreased lymphocyte count and anemia, were all grades 1 and 2. No treatment discontinuations due to AEs occurred.

Further anti-tumor activities have been observed with longer follow up, and there were two unconfirmed responses and one confirmed response as defined by RECIST v1.1 in Cohort 2. As of the January 10, 2025, data cut-off date, the patient who experienced a confirmed objective response has been in response for 17 weeks and remains in the study. This patient received the first two [212Pb]VMT-α-NET

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doses at administered dose of 5.0 mCi (equivalent to 84.6 μCi/kg), then received the remaining two doses at the next lower activity level of 2.5 mCi (equivalent to 42.4 μCi/kg) due to an adverse event that was determined by the investigator to be unrelated to [212Pb]VMT-α-NET.

One patient was observed to experience an initial (unconfirmed (as of January 10, 2025)) response in the fifth scan after their first dose, which was the first scan conducted after the end of their treatment period. This patient experienced gradual tumor regression throughout the study, with the magnitude of change meeting the criteria for response on their most recent scan. This patient received four doses of 5.0 mCi (equivalent to 68.7 μCi/kg) of [212Pb]VMT-α-NET.

A third patient was observed to experience an initial (unconfirmed (as of January 10, 2025)) response in the seventh scan after their first dose, which was the third scan conducted after the end of their treatment period. This patient received four doses of 5.0 mCi (equivalent to 31.7 μCi/kg) of [212Pb]VMT-α-NET. Gradual tumor regression was first observed in the fifth scan after their first dose, with the magnitude of change meeting the criteria for response on their most recent scan.

Five patients continued to have stable disease. One patient was deemed to have progressive disease after one dose under RECIST v1.1, by unambiguous progression of non-target lesions.

After Cohort 2 reopened for enrollment in August 2024 and through year-end 2024, an additional 11 patients were dosed. Thus, a total of 18 patients received treatment in Cohort 2 through December 31, 2024. Since the start of 2025 through the end of February 2025, an incremental 12 patients have been dosed. Thus, a total of 30 patients have received treatment in Cohort 2 as of February 28, 2025. Cohort 2 remains open for recruitment.

VMT01

We are also leveraging our TAT platform with our second program candidate, VMT01, which is currently in Phase 1/2a clinical trials. We designed VMT01 to target and deliver 212Pb to tumor sites expressing melanocortin 1 receptor (MC1R), a protein that is overexpressed in melanoma cancers. [212Pb]VMT01 is a TAT in development for second-line or later treatment of patients with progressive MC1R-positive metastatic melanoma.

In preclinical experiments [212Pb]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 on the basis of these results, the FDA granted Fast Track Designation for the clinical development of [212Pb]VMT01. This study is 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. Patients were required to have already received standard of care. Eligible patients may receive up to three treatments with [212Pb]VMT01, eight weeks apart.

In March 2024, we entered into a clinical trial collaboration with Bristol Myers Squibb to evaluate the safety and tolerability of [212Pb]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 [212Pb]VMT01 in patients with histologically confirmed melanoma and positive MC1R imaging scans in our ongoing Phase 1/2a clinical study of [212Pb]VMT01.

In October 2024, we announced initial results from the first two dosing cohorts. Three patients were enrolled in Cohort 1 (who received 3 mCi of [212Pb]VMT01), while seven patients were enrolled in Cohort 2 (who received 5 mCi of [212Pb]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 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.

All patients in Cohort 1 completed three treatments, with one patient experiencing an unconfirmed RECIST version 1.1 objective response after completion of treatment, and two patients experiencing stable disease at 9 and 11 months from the start of treatment, respectively, as reported on October 11, 2024. In Cohort 2, patients progressed after either the first cycle (three patients) or the second cycle (four patients). These findings are consistent with published and ongoing preclinical studies showing immunostimulatory effects at lower radiation doses.

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 has been approved and cohort 3 at 1.5 mCi per dose is active and open for enrollment. The combination cohort at 1.5 mCi per dose with nivolumab is also active and open for enrollment. On March 17, 2025, we announced that the first patient was dosed in the combination cohort.

PSV359

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Tumor stroma cells do not typically express cancer-specific markers like SSTR2 or MC1R. FAP-α is primarily expressed on tumor stroma cells, but also on some cancer cells. FAP-α is a pan-cancer target that is highly expressed in many cancers. Our in-house discovery team discovered PSV359, a novel cyclic peptide targeting human FAP-α, via phage display methods. We believe PSV359 is an optimized peptide with potential best-in-class characteristics that has been demonstrated in preclinical models. In March 2024, we released the first-in-human clinical SPECT/CT imaging which suggested very favorable tumor targeting and retention by the PSV359 compound, while clearing from normal organs rapidly and completely.

In October 2024, we announced first-in-human SPECT/CT images of [203Pb]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.

Preclinical results for PSV359 were presented during the SNMMI and the EANM 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 [203/212Pb]PSV359 in preclinical xenograft models. Overall, strong anti-tumor clinical activity of [212Pb]PSV359 was found in both HT1080-human FAP-α (FAP-α on cancer cells) and U87MG (FAP-α in stromal tissues) xenograft models.

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. We expect to initiate dosing in mid 2025.

Other Pipeline Candidates

In January 2024, we announced that we have a license agreement with Mayo Clinic for the rights to Mayo Clinic’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 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.

Also in January 2024, we entered into an exclusive in-licensing of Stony Brook University’s Cuburbit[7]uril-admantane (CB7-Adma) pre-targeting platform which covers the global intellectual property rights to such platform. Pre-targeting using the CB7-Adma platform involves two steps. First, an antibody that binds with high specificity to a cancer-specific protein is administered via intravenous injection. This antibody is chemically modified to include the CB7 chemical entity and accumulates over time at the tumor site. Then, a radionuclide held tightly by our proprietary chelator attached to an Adma group is administered. The Adma group binds to the CB7 group that was previously attached to the cancerous cells with specificity, delivering radiation dose selectively to the tumor sites. Central to this innovation is CB7-Adma (host-guest) complex formation, driving the interaction between the antibody and radioligand. The chosen host-guest pair, CB7-Adma, has demonstrated promising in vivo stability, modularity and low immunogenicity. The platform’s potential was validated through in vivo profiling of ligands, employing a CB7-modified carcinoembryonic antigen targeting antibody. The agreement with Stony Brook University will expire on the later of the expiration date of the last to expire licensed patents or 20 years from the date of the first sale of a product utilizing the intellectual property. Preclinical optimization of this platform is underway, and initial targeting antibodies are being identified for further investigation.

Intellectual Property (IP)

Two patents have recently been granted on key assets for which we have exclusive licenses from the University of Iowa. US 12,128,115, granted by the United States Patent and Trademark Office on October 29, 2024, is directed to the use of compounds comprising PSC for performing chelating reaction with divalent metals, including Pb2+, and the use of such compounds for diagnosing and treating diseases. AU 2017281940, granted by IP Australia on October 31, 2024, is directed to melanoma-targeting radiopharmaceutical compounds and the use of such compounds for treating melanoma. In addition, since the end of 2024, a patent has been issued in Australia which pertains to the creation of radiopharmaceutical compounds using lead-specific chelators. The full term of this patent expires in April 2039. We believe these patents further strengthen our IP portfolio.

Funding Requirements

We have had recurring losses since inception. We expect our expenses to increase in connection with our ongoing activities, particularly as we advance and expand preclinical activities, clinical trials and potential commercialization of our program candidates. Our costs are also expected to increase as we:

continue the development of our clinical-stage assets, including VMT01, VMT-α-NET and PSV359;

continue the development of our other program candidates;

continue to initiate and progress other supporting studies required for regulatory approval of our program candidates;

initiate preclinical studies and clinical trials for any additional indications for our current program candidates and any future program candidates that we may pursue;

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continue to build our portfolio of program candidates through the acquisition or in-license of additional program candidates or technologies;

continue to develop, maintain, expand and protect our intellectual property portfolio;

pursue regulatory approvals for our current and future program candidates that successfully complete clinical trials;

continue to build our manufacturing capabilities;

support our marketing and distribution infrastructure to commercialize any future program candidates for which we may obtain marketing approval; and

hire additional clinical, medical, development and other personnel.

As of December 31, 2024, we had cash, cash equivalents and short-term investments of $226.9 million. We believe our cash, cash equivalents and short-term investments will be sufficient to fund our current planned operations for at least the next 12 months from the date the consolidated financial statements in this report were issued and into late 2026. Monthly operating expenses are budgeted to increase for research and development and general and administrative expenses as management works to implement its strategy to advance our clinical assets in their clinical trials and to progress our preclinical assets towards clinical trials. Management anticipates a significant increase in expenses, particularly in research and development, as we undertake these activities.

Manufacturing Equipment

On September 18, 2024, we entered into a Master Equipment and Services Agreement (MESA) and statements of work (SOWs) thereunder with Comecer SpA (Comecer), pursuant to which we agreed to purchase from Comecer manufacturing equipment for the production of our radiopharmaceutical products including, but not limited to, isotope processing hot cells and production suites and related equipment (collectively, the Deliverables) and services for installation and validation of the Deliverables at several of our production facilities in the United States. The aggregate consideration for such equipment and services pursuant to the MESA and SOWs is approximately €49.0 million payable in cash, excluding certain incidental costs such as taxes, customs and duties, local transport, insurance and rigging. We may also elect to purchase certain additional equipment and services pursuant to the SOWs. The MESA provides for the payment of certain amounts in installments over the course of the production, installation and validation of the Deliverables.

Facility Acquisitions

On July 15, 2024, August 2, 2024 and October 31, 2024, we purchased a building in the Houston, TX, metropolitan area for $4.7 million, a building in the Chicago, IL, metropolitan area for $5.0 million, and a building in the Los Angeles, CA, metropolitan area for $11.0 million, respectively, which we intend to use for the manufacture of our program candidates upon completion of modifications and installation of equipment.

In March 2024, we acquired the assets and associated lease of Lantheus’ radiopharmaceutical manufacturing facility in Somerset, NJ. We have begun to convert the facility, which has three production suites, to manufacture finished radiopharmaceutical products. As a Current Good Manufacturing Practice (CGMP) compliant facility, we intend to utilize the facility to manufacture clinical supply of high quality 203Pb-labeled tumor-specific peptides to visualize and diagnose tumors, and 212Pb-labeled radiopharmaceuticals to treat target tumors with TAT. As of October 2024, this facility became operational to supply investigational products to support our clinical studies, in addition to the Coralville, IA, facility which has been producing our investigational products since 2023. Moreover, with three CGMP suites at the facility, we expect to have the capacity to meet future clinical trial and commercial demands at major cancer treatment centers throughout the Northeastern U.S. We intend to continue to expand our manufacturing and supply network in the future as we anticipate increasing our clinical trial activities.

We continue to evaluate the suitability of additional facilities as we look to expand our research and development capabilities.

2024 At-the-Market (ATM) Agreement

On August 13, 2024, we entered into a Controlled Equity OfferingSM Sales Agreement (2024 ATM Agreement) with Cantor Fitzgerald & Co. and RBC Capital Markets, LLC (each, an ATM Agent, and together, the ATM Agents) pursuant to which we, from time to time, may offer and sell shares (2024 ATM Shares) of our Common Stock, through or to the ATM Agents having an aggregate sales price of up to $250.0 million.

Subject to the terms and conditions of the 2024 ATM Agreement, each ATM Agent is required to use its commercially reasonable efforts to sell the ATM Shares from time to time, based upon our instructions. We have provided the ATM Agents with customary indemnification rights, and the ATM Agents will be entitled to a commission of up to 3.0% of the gross proceeds from each sale of the ATM Shares effectuated through or to the applicable ATM Agent selling the ATM Shares.

Sales of the 2024 ATM Shares, if any, under the 2024 ATM Agreement may be made in transactions that are deemed to be “at the market offerings” as defined in Rule 415 under the Securities Act of 1933, as amended. We have no obligation to sell any of the 2024 ATM Shares and may at any time suspend offers under the 2024 ATM Agreement or terminate the 2024 ATM Agreement.

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The Common Stock to be sold under the 2024 ATM Agreement, if any, will be issued and sold pursuant to our shelf registration statement on Form S-3 (File No. 333-279692) (the May 2024 Registration Statement), which became effective upon filing with the SEC on May 24, 2024, as amended from time to time. On August 13, 2024, we filed a prospectus supplement to the May 2024 Registration Statement with the SEC in connection with the offer and sale of the 2024 ATM Shares pursuant to the 2024 ATM Agreement.

As of December 31, 2024, we had not completed any transactions pursuant to the 2024 ATM Agreement. On February 18, 2025, we sold 3,379,377 shares of our common stock under the 2024 ATM Agreement at an average price of approximately $3.02 per common share, resulting in gross proceeds of approximately $10.2 million.

Amended and Restated Equity Incentive Plan

On May 31, 2024, we held our 2024 Annual Meeting of Stockholders (Annual Meeting). At the Annual Meeting, our stockholders approved our Third Amended and Restated 2020 Equity Incentive Plan (the Amended and Restated Plan) which, among other things, (a) increased the aggregate number of shares of Common Stock authorized for issuance under the Amended and Restated Plan by 4,870,092 for a total of 12,500,000 shares of Common Stock, and (b) adjusted the “evergreen” provision included therein, such that the number of shares of Common Stock available for the grant of awards under the Amended and Restated Plan automatically increases on January 1 of each year in an amount equal to 5% of the number of shares of Common Stock issued and outstanding on December 31 of the immediately preceding year (subject to adjustment in the event of stock splits and other similar events); provided, however, that our Board of Directors may act prior to January 1 of a given year to provide that there will be no increase in the share limit for such year or provide that the increase for such year will be a lesser number of shares of Common Stock. On August 14, 2024, we filed a Form S-8 to register 4,870,092 additional shares of Common Stock authorized for issuance under the Amended and Restated Plan as approved by stockholders at the Annual Meeting. On January 1, 2025, the number of shares of Common Stock available for grant increased by 3,533,573 pursuant to the “evergreen” provision in the Amended and Restated Plan. We anticipate filing a Form S-8 to register these additional shares during 2025.

Brachytherapy Divestiture

On April 12, 2024 (GT Medical Closing Date), we completed the sale of substantially all of the assets (GT Medical Closing) of Isoray to GT Medical Technologies, Inc. (GT Medical). As previously disclosed, on December 7, 2023, we entered into an Asset Purchase Agreement (the GT Medical APA) with Isoray and GT Medical. Pursuant to the GT Medical APA, Isoray sold to GT Medical, and GT Medical purchased from Isoray, all of Isoray’s right, title and interest in and to substantially all of the assets of Isoray related to Isoray’s commercial Cesium-131 business including equipment, certain contracts and leases, inventory and intellectual property. Subject to limited exceptions set forth in the GT Medical APA, GT Medical did not assume the liabilities of Isoray.

Pursuant to the terms of, and subject to the conditions specified in, the GT Medical APA, at the GT Medical Closing, (i) GT Medical issued to Isoray 279,516 shares of GT Medical’s common stock, par value $0.0001 per share, representing 0.5% of GT Medical’s issued and outstanding capital stock on a fully diluted basis as of the GT Medical Closing Date and (ii) Isoray has the right to receive, and GT Medical is obligated to pay, certain cash royalty payments during each of the first four years beginning upon the GT Medical Closing Date (each such year, a Measurement Period), as summarized below:

with respect to GT Medical’s net sales of Cesium-131 brachytherapy seeds for cases that do not utilize GT Medical’s GammaTile Therapy: (a) if such net sales for a Measurement Period are $10.0 million or less, 3.0% of such net sales; (b) if such net sales for a Measurement Period are greater than $10.0 million and less than $15.0 million, 4.0% of such net sales; and (c) if such net sales for a Measurement Period are $15.0 million or more, 5.0% of such net sales; and

with respect to GT Medical’s net sales of GT Medical’s GammaTile Therapy utilizing Cesium-131 brachytherapy seeds: 0.5% of such net sales for a Measurement Period.

As a result of the transaction, we have effectively exited the brachytherapy segment and are focused exclusively on our radiopharmaceutical development segment, our only operating segment and reporting segment. The sale of the brachytherapy segment represents a strategic shift that had a major effect on our operations. We accounted for the transaction as discontinued operations on the date the divestiture was announced. Accordingly, we are reporting the results of the brachytherapy segment operations and cash flows, and balance sheet classifications for the current and comparative periods as discontinued operations. Prior to the consummation of the sale, we were neither actively marketing the brachytherapy business for sale nor had intentions to abandon it.

For additional information regarding our brachytherapy divestiture, see our Forms 8-K filed with the SEC on December 12, 2023, April 3, 2024 and April 16, 2024.

Critical Accounting Policies and Estimates

Management’s discussion and analysis of our financial condition and results of operations are based upon our consolidated financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States (GAAP). The preparation of these financial statements requires management to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses, and the related disclosure of contingent liabilities. On an ongoing basis, management evaluates

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past estimates and judgments, including those related to accrued liabilities, derivative liabilities and contingencies. 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.

While our significant accounting policies are described in greater detail in Note 2, Summary of Significant Accounting Policies, to the consolidated financial statements in this Form 10-K, we believe the following accounting policies are those most critical to the judgments and estimates used in the preparation of our consolidated financial statements.

Accrued Research and Development Expenses

As part of the process of preparing our financial statements, we estimate our accrued research and development expenses as of each balance sheet date in the financial statements based on facts and circumstances known to us at that time. This process involves reviewing open contracts and purchase orders, communicating with our personnel to identify services that have been performed on our behalf and estimating the level of service performed and the associated cost incurred for the service when we have not yet been invoiced or otherwise notified of actual costs. The majority of our service providers invoice us in arrears for services performed, based on a pre-determined schedule or when contractual milestones are met, but some require advance payments. If timelines or contracts are modified based upon changes in the protocol or scope of work to be performed, we modify our estimates and accruals accordingly on a prospective basis.

There may be instances in which payments made to our vendors will exceed the level of services provided and result in a prepayment of the expense. If the actual timing of the performance of services or the level of effort varies from the estimate, we adjust the accrual or the amount of prepaid expenses accordingly.

Although we do not expect our estimates to be materially different from amounts actually incurred, our understanding of the status and timing of services performed relative to the actual status and timing of services performed may vary and may result in reporting amounts that are too high or too low in any particular period. To date, there have not been any material adjustments to our prior estimates of accrued research and development expenses.

Legal Contingencies

We may, in the ordinary course of business, be involved in legal proceedings involving securities, contractual and employment relationships, product liability claims, patent rights, environmental matters, and a variety of other matters, the outcomes of which are not within our complete control and may not be known for extended periods of time. Legal costs associated with defending these matters are expensed as incurred.

We record a liability in our consolidated financial statements for damages and/or costs related to claims, settlements and judgments where we have assessed that the loss is probable and an amount can be reasonably estimated.

Goodwill and In-Process Research and Development (IPR&D)

The fair value of acquired intangible assets is determined using an income-based approach referred to as the multi-period excess-earnings approach.

Goodwill represents the excess of the cost of net assets acquired in business combinations over the fair value of the identifiable tangible and intangible assets acquired and liabilities assumed in a business combination. We test goodwill and indefinite-lived intangibles for impairment at least annually in the fourth quarter by assessing qualitative factors to determine whether it is more likely than not that the fair value of the assets is below their carrying value. We will also test these assets more frequently whenever events or circumstances change that would more likely than not reduce the fair value below the carrying amount. Such events or changes in circumstance include significant deterioration in overall economic conditions, changes in the business climate or a decline in our market capitalization. To test goodwill and indefinite-lived intangible assets for impairment, we may perform both a qualitative assessment and quantitative assessment. For the qualitative assessment, we consider operating results and scientific data from clinical and preclinical studies as well as circumstances impacting the operations or cash flows of the reporting unit or indefinite-lived intangible assets, including macroeconomic conditions and industry and market conditions. If a qualitative assessment indicates the fair value of the asset is more likely than not less than its carrying value, then a quantitative assessment is performed which is based on an income-based valuation approach for indefinite-lived intangible assets or a comparison of the estimated fair value of the entity using market inputs for goodwill. If it is determined that an impairment exists, we recognize an impairment loss for the amount by which the carrying amount of the reporting unit or indefinite-lived intangible asset exceeds its estimated fair value. Fair value estimates are based on assumptions believed to be reasonable at the time, but such assumptions are subject to inherent uncertainty, and actual results may differ materially from those estimates.

IPR&D assets represent the fair value of incomplete research and development (R&D) projects that had not reached technological feasibility as of the date of the acquisition. Initially, these assets are classified as IPR&D and are not subject to amortization. IPR&D assets that reach commercialization are amortized on a straight-line basis over their estimated useful life. Estimated useful lives are determined considering the period the assets are expected to contribute to future cash flows. IPR&D is tested for impairment at least

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annually or more frequently if events occur or circumstances change that would indicate a potential reduction in the fair values of the assets below their carrying value. Impairment charges are recognized to the extent the carrying value of IPR&D is determined to exceed its fair value. Post-acquisition R&D expenses related to these projects are expensed as incurred.

We performed our annual qualitative impairment analysis as of October 31, 2024. We noted that we continue to invest in our IPR&D assets and that these assets continue to progress in clinical and preclinical studies. In addition, there have been no material delays in our anticipated timelines regarding our IPR&D assets. Based on these results, we determined there was no impairment to our IPR&D assets.

We also performed our annual qualitative goodwill impairment analysis as of October 31, 2024, and determined that the fair value of our sole reporting unit exceeded its book value. However, we began experiencing a decline in our stock market price in November, consistent with the overall life sciences industry, and performed an interim goodwill impairment analysis as of December 31, 2024. In connection with that analysis, we determined that our goodwill was impaired. For additional information regarding this assessment, see Note 10, Goodwill, Intangible Assets and Other Assets, Net, to the consolidated financial statements in this Form 10-K.

Grant Revenue Recognition

We enter into contracts with governmental agencies for services. These contracts are analyzed to determine if they should be accounted for under a revenue recognition model pursuant to Accounting Standards Codification (ASC) 606, Revenue from Contracts with Customers, or a grant model pursuant to ASC 958, Not-for-Profit Entities. If accounted for pursuant to a grant model, we must determine if the grant is conditional or unconditional, and if any conditional barriers exist which must be overcome. If unconditional, the grant is recognized as revenue immediately, and if conditional, the grant is recognized as revenue as and when the barriers are overcome. We concluded that payments received under the current grants represent conditional, nonreciprocal contributions, as described in ASC 958, and that the grants are not within the scope of ASC 606, as the organizations providing the grants do not meet the definition of a customer. The significant barrier to the current conditional grants is that the expenses incurred must meet the qualifications as established by the respective governmental agencies, so that the grant revenue is recognized as the qualified expenses are incurred. Expenses for grants are tracked using a project code specific to the grant, and the employees also track hours worked by using the project code. Under ASC 958, grants related to income are presented as part of the consolidated statements of operations, either separately or under a general heading. Both methods are acceptable under ASC 958. We have elected to record grants related to income separately on the Consolidated Statements of Operations and Comprehensive Loss as “grant revenue.” The related expenses are recorded within R&D and general and administrative.

Results of Operations

We previously presented our results in two segments: Drug Operations and Brachytherapy. Due to the sale of our brachytherapy segment to GT Medical in the second quarter of 2024 and the classification of the assets and operations of the brachytherapy segment as discontinued operations in our consolidated financial statements, we have now determined that we operate in only one segment. The following does not include a discussion of the results of our discontinued operations. For additional information regarding our discontinued operations, see Note 5, Discontinued Operations, to the consolidated financial statements in this Form 10-K.

The following table sets forth our results of operations for the periods presented (in thousands):

Year Ended December 31,

Operating expenses:

Loss on disposal of property and equipment 27 - 27

Grant Revenue

Our alpha-therapy business is pre-revenue and, accordingly, none of the revenues reflect sales of any of our alpha-therapy products, which are still under development. Grant revenue for all periods presented relates to our work for the National Institutes of Health.

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Operating Expenses

Research and Development

Research and development expenses were $41.6 million for the year ended December 31, 2024, compared to $21.3 million for the year ended December 31, 2023, an increase of $20.3 million. The increase in research and development expenses was primarily related to the expanded development of our TAT drug programs, including higher personnel costs and third-party research and development fees.

Management believes that research and development expenses will continue to increase as we continue to invest in the development of novel radiopharmaceutical drugs and products and expand our manufacturing capabilities. We are currently reviewing how potential tariffs might impact our costs for supplies, equipment and materials used in the development and production of our TAT drug products. We will continue to analyze announcements of new tariffs and their implementation dates while we evaluate any potential impact along with alternatives suppliers.

General and Administrative

General and administrative expenses consist primarily of the costs related to our executive, finance, human resources and information technology functions.

General and administrative expenses were $26.6 million for the year ended December 31, 2024, compared to $21.1 million for the year ended December 31, 2023, an increase of $5.5 million. The increase in general and administrative expenses for the year ended December 31, 2024 was primarily due to increased personnel costs as well as increased fees for professional services.

Goodwill Impairment

Goodwill impairmentwas $24.1 million for the year ended December 31, 2024, compared to $0.0 million for the year ended December 31, 2023, an increase of $24.1 million. Due to the volatility in the capital markets, particularly in the life sciences capital markets, we performed an impairment analysis as of December 31, 2024 as called for by GAAP. The analysis determined that, due to our low market capitalization, the goodwill that arose during the merger with Viewpoint Molecular Targeting, Inc. was impaired, and we expensed the full amount of goodwill that had been recorded on our balance sheet. As part of the impairment analysis, we determined that none of our other assets, including our IPR&D assets, which comprise our clinical assets and some of our preclinical assets, were impaired.

Loss on Disposal of Property and Equipment

Loss on disposal of property and equipment for the year ended December 31, 2024, was due to the disposition of approximately 4.2 acres of land in Richland, WA, that had been purchased in 2017 in anticipation of constructing a facility for our discontinued brachytherapy operations. Due to the divestiture of the brachytherapy operations, we disposed of this land in October 2024. The loss on disposal of property and equipment for the year ended December 31, 2024, was de minimis.

Liquidity and Capital Resources

We assess our liquidity in terms of our ability to generate cash to fund our operating, investing and financing activities. We have historically financed our operations primarily through selling equity to investors. During the year ended December 31, 2024, we entered into various agreements and raised approximately $306.7 million in gross proceeds. The following table summarizes our cash flows for the periods presented (in thousands):

Year Ended December 31,

Net cash used in operating activities $ (18,294 ) $ (36,913 )

Net cash (used in) provided by investing activities (218,931 ) 24,373

Net cash provided by financing activities 289,385 785

Net increase (decrease) in cash and cash equivalents $ 52,160 $ (11,755 )

Cash Flows from Operating Activities

Net cash used in operating activities of $18.3 million in the year ended December 31, 2024 was primarily due to a net loss of approximately $79.3 million, as adjusted for non-cash expenses totaling $29.2 million (such as goodwill impairment, share-based compensation and depreciation and amortization), partially offset by $31.8 million in changes in operating assets and liabilities, primarily related to the $28.0 million in cash we received pursuant to that certain option agreement, dated January 8, 2024, by and between us and Lantheus Alpha Therapy, LLC.

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Net cash used in operating activities of $36.9 million in the year ended December 31, 2023 was primarily due to a net loss of approximately $46.5 million, as adjusted for non-cash expenses totaling $6.7 million (such as the loss recognized on classification as held for sale and depreciation and amortization), partially offset by an increase of approximately $2.9 million in changes in operating assets and liabilities, primarily from accounts payable and accrued expenses, including accrued personnel expenses.

Cash Flows from Investing Activities

Net cash used in investing activities of $218.9 million in the year ended December 31, 2024 was primarily due to our purchases of $164.8 million of available-for-sale securities and $54.4 million of property and equipment, partially offset by proceeds of $0.3 million from the sale of property and equipment.

Net cash provided by investing activities of $24.4 million in the year ended December 31, 2023 was primarily due to $22.8 million in proceeds from the maturity of previously held short-term investments in U.S. Treasury Bills and $2.7 million in cash acquired as part of the merger with Viewpoint, partially offset by approximately $1.1 million in additions to property and equipment and other assets.

Cash Flows from Financing Activities

Net cash provided by financing activities of $289.4 million in the year ended December 31, 2024 was primarily related to the various capital markets transactions and other agreements we entered into, partially offset by repayment of a note payable. For additional information regarding the cash we raised, see Sources of Liquidity below.

Net cash provided by financing activities of $0.8 million in the year ended December 31, 2023 was primarily related to approximately $0.9 million received from the exercise of stock options and the issuance of common stock, partially offset by the costs related to Common Stock issued in exchange for Viewpoint common stock and the repayment of notes payable.

Sources of Liquidity

2024 At-the-Market (ATM) Agreement

On August 13, 2024, we entered into a Controlled Equity OfferingSM Sales Agreement (2024 ATM Agreement) with Cantor Fitzgerald & Co. and RBC Capital Markets, LLC (each, an ATM Agent, and together, the ATM Agents) pursuant to which we, from time to time, may offer and sell shares (2024 ATM Shares) of our Common Stock, through or to the ATM Agents having an aggregate sales price of up to $250.0 million.

Subject to the terms and conditions of the 2024 ATM Agreement, each ATM Agent is required to use its commercially reasonable efforts to sell the ATM Shares from time to time, based upon our instructions. We have provided the ATM Agents with customary indemnification rights, and the ATM Agents will be entitled to a commission of up to 3.0% of the gross proceeds from each sale of the ATM Shares effectuated through or to the applicable ATM Agent selling the ATM Shares.

Sales of the 2024 ATM Shares, if any, under the 2024 ATM Agreement may be made in transactions that are deemed to be “at the market offerings” as defined in Rule 415 under the Securities Act of 1933, as amended. We have no obligation to sell any of the 2024 ATM Shares and may at any time suspend offers under the 2024 ATM Agreement or terminate the 2024 ATM Agreement.

The Common Stock to be sold under the 2024 ATM Agreement, if any, will be issued and sold pursuant to our shelf registration statement on Form S-3 (File No. 333-279692) (the May 2024 Registration Statement), which became effective upon filing with the SEC on May 24, 2024, as amended from time to time. On August 13, 2024, we filed a prospectus supplement to the May 2024 Registration Statement with the SEC in connection with the offer and sale of the 2024 ATM Shares pursuant to the 2024 ATM Agreement.

As of December 31, 2024, we had not completed any transactions pursuant to the 2024 ATM Agreement. On February 18, 2025, we sold 3,379,377 shares of our common stock under the 2024 ATM Agreement at an average price of approximately $3.02 per common share, resulting in gross proceeds of approximately $10.2 million.

May 2024 Registered Offering

On May 24, 2024, we entered into an underwriting agreement with BofA Securities, Inc., as representative of the underwriters named therein, in connection with our previously announced underwritten offering (Registered Offering) of 5,151,588 shares (Registered Offering Shares) of our Common Stock and, in lieu of Registered Offering Shares to certain investors, pre-funded warrants (May 2024 Pre-funded Warrants) to purchase 146,425 shares of Common Stock. The price to the investors for the Registered Offering Shares was $15.10 per Registered Offering Share, and the price to the investors for the May 2024 Pre-funded Warrants was $15.09 per May 2024 Pre-funded Warrant, which represents the per share price for the Registered Offering Shares less the $0.01 per share exercise price for each such May 2024 Pre-funded Warrant. The Registered Offering closed on May 29, 2024. BofA Securities, Inc., Oppenheimer & Co. Inc. and RBC Capital Markets, LLC acted as joint book-running managers for the Registered Offering and B. Riley Securities, Inc. acted as a co-manager for the Registered Offering. JonesTrading Institutional Services LLC acted as a financial advisor for the Registered Offering.

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Our gross proceeds from the Registered Offering were approximately $80.0 million, before underwriting discounts and commissions and estimated expenses of the Offering. We intend to use the net proceeds from the Registered Offering for: (i) the continued clinical development of VMT-α-NET, VMT-01/02 and PSV359; (ii) the continued development of PSV4XX and additional preclinical product candidates as well as a broader development platform; and (iii) the build out, operation and expansion of manufacturing facilities, as well as for working capital and other general corporate purposes. A portion of the net proceeds may also be used to acquire, license or invest in complementary products, technologies, intellectual property or businesses, although we have no present commitments or agreements to do so.

The May 2024 Pre-funded Warrants became exercisable subsequent to the filing and effectiveness of an amendment to our Amended and Restated Certificate of Incorporation with the Secretary of State of the State of Delaware on June 14, 2024. The exercise price and the number of shares of Common Stock issuable upon exercise of each May 2024 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 May 2024 Pre-funded Warrants will not expire and are exercisable in cash or by means of a cashless exercise. A holder of May 2024 Pre-funded Warrants may not exercise such May 2024 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 May 2024 Pre-funded Warrants. A holder of May 2024 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.

March 2024 Private Placement with Institutional Investors

On March 4, 2024, we entered into an investment agreement with certain accredited institutional investors pursuant to which we agreed to issue and sell, in a private placement (March 2024 Private Placement), 9,200,998 shares of our Common Stock, for a purchase price of $9.50 per share, representing the closing price of the Common Stock on March 1, 2024. The closing of the March 2024 Private Placement occurred on March 6, 2024. The gross proceeds to us from the March 2024 Private Placement were approximately $87.4 million, before deducting fees and other estimated transaction expenses.

Investment Agreement

On January 8, 2024, we entered into an investment agreement (Lantheus Investment Agreement) with Lantheus Alpha Therapy, LLC, a Delaware limited liability company and wholly owned subsidiary of Lantheus Holdings, Inc. (Lantheus), pursuant to which we agreed to sell and issue to Lantheus in a private placement transaction certain shares (Lantheus Shares) of our Common Stock. The closing of the purchase and sale of the Lantheus Shares to Lantheus by us (Lantheus Closing) was subject to us raising at least $50.0 million of gross proceeds (excluding Lantheus’ investment) in a qualifying third-party financing transaction, which occurred on January 22, 2024. The number of Lantheus Shares sold was 5,634,235, representing 19.99% of the outstanding shares of Common Stock as of January 8, 2024. Pursuant to the Lantheus Investment Agreement, we agreed to cooperate in good faith to negotiate and enter into a registration rights agreement with Lantheus, obligating us to file a registration statement on Form S-3 with the SEC to register for resale the Lantheus Shares issued at the Lantheus Closing. We filed such Form S-3 on March 29, 2024, and the SEC declared it effective on April 9, 2024 (File No. 333-278362). The Lantheus Investment Agreement also contains agreements between us and Lantheus whereby Lantheus is provided certain board observer and information rights of us, as well as standstill provisions prohibiting Lantheus from taking certain actions for a specified period of time, subject to certain exceptions.

January 2024 Public Offering

On January 17, 2024, we entered into an underwriting agreement (Underwriting Agreement) with Oppenheimer & Co. Inc., as representative of the underwriters named therein (Underwriters), in connection with our underwritten public offering (Public Offering) of 13,207,521 shares (Public Shares) of our Common Stock and in lieu of Public Shares to certain investors, pre-funded warrants (Jan. 2024 Pre-funded Warrants) to purchase 3,008,694 shares of Common Stock. The price to the public for the Public Shares was $3.70 per Public Share, and the price to the public for the Jan. 2024 Pre-funded Warrants was $3.69 per Jan. 2024 Pre-funded Warrant, which represents the per share price for the Public Shares less the $0.01 per share exercise price for each such Jan. 2024 Pre-funded Warrant. Under the terms of the Underwriting Agreement, we granted the Underwriters an option, exercisable for 30 days, to purchase up to an additional 2,432,432 shares of Common Stock at the same price per share as the Public Shares, which such option was fully exercised by the Underwriters on January 18, 2024. The Public Offering closed on January 22, 2024.

The gross proceeds to us from the Public Offering were approximately $69.0 million, before underwriting discounts and commissions and estimated expenses of the Public Offering.

The Public Offering was made pursuant to our shelf registration statement on Form S-3 (File No. 333-275638), declared effective by the SEC on December 14, 2023, a base prospectus dated December 14, 2023, and the related prospectus supplement dated January 17, 2024.

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The Jan. 2024 Pre-funded Warrants were exercisable at any time after the date of issuance. The exercise price and the number of shares of Common Stock issuable upon exercise of each Jan. 2024 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 Jan. 2024 Pre-funded Warrants did not have an expiration date and were exercisable in cash or by means of a cashless exercise. A holder of Jan. 2024 Pre-funded Warrants could not exercise such Jan. 2024 Pre-funded Warrants if the aggregate number of shares of Common Stock beneficially owned by such holder, together with its affiliates, would beneficially own more than 4.99% 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 Jan. 2024 Pre-funded Warrants. A holder of Jan. 2024 Pre-funded Warrants could increase or decrease this percentage not in excess of 19.99% by providing at least 61 days’ prior notice to us. The holder of these exercised all of the Jan. 2024 Pre-funded Warrants during the fourth quarter of 2024 by means of the cashless exercise provision and within the other constraints noted above.

2023 ATM Agreement

On April 11, 2024, we sold shares of our Common Stock pursuant to that certain At Market Issuance Sales Agreement, dated as of November 17, 2023, by and among us, Oppenheimer & Co. Inc., B. Riley Securities, Inc. and JonesTrading Institutional Services LLC (2023 ATM Agreement). The sales resulted in gross proceeds to us of approximately $49.5 million. The 2023 ATM Agreement was terminated in August 2024. For additional information regarding the 2023 ATM Agreement, see our Form S-3 filed on November 17, 2023, Form S-3/A filed on December 7, 2023, and Note 3, Investments and Agreements, in this Form 10-K.

Funding Requirements

We expect our expenses to increase in connection with our ongoing activities, particularly as we advance and expand preclinical activities, clinical trials and potential commercialization of our program candidates. Our costs are also expected to increase as we:

continue the development of our clinical-stage assets, including VMT01, VMT-α-NET and PSV359;

continue the development of our other program candidates;

continue to initiate and progress other supporting studies required for regulatory approval of our program candidates;

initiate preclinical studies and clinical trials for any additional indications for our current program candidates and any future program candidates that we may pursue;

continue to build our portfolio of program candidates through the acquisition or in-license of additional program candidates or technologies;

continue to develop, maintain, expand and protect our intellectual property portfolio;

pursue regulatory approvals for our current and future program candidates that successfully complete clinical trials;

continue to build our manufacturing capabilities;

support our marketing and distribution infrastructure to commercialize any future product candidates for which we may obtain marketing approval; and

hire additional clinical, medical, development and other personnel.

At December 31, 2024, we had cash, cash equivalents and short-term investments of $226.9 million. We believe our cash, cash equivalents and short-term investments will be sufficient to fund our current planned operations and capital investments into late 2026. Monthly operating expenses are budgeted to increase for research and development and general and administrative expenses as management works to implement our strategy to advance our clinical assets in our clinical trials and to progress our preclinical assets towards clinical trials. Management anticipates a significant increase of expenses, particularly in research and development, as we undertake these activities.

We expect we will need to raise additional capital until we are profitable, which may never occur. If no additional capital is raised through either additional public or private equity financings, debt financings, strategic relationships, alliances and licensing agreements, or a combination thereof, we may delay, limit or reduce discretionary spending in areas related to research and development activities and other general and administrative expenses in order to fund our operating costs and working capital needs.

We have based these estimates on assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than we expect. We expect that we will require additional capital to pursue in-licenses or acquisitions of other program candidates. If we receive regulatory approvals for our program candidates, we expect to incur commercialization expenses related to program manufacturing, sales, marketing and distribution, depending on where we choose to commercialize or whether we commercialize jointly or on our own.

Because of the numerous risks and uncertainties associated with research, development and commercialization of our program candidates, we are unable to estimate the exact amount of our working capital requirements. Our future funding requirements will depend on and could increase significantly as a result of many factors, including:

the scope, progress, results and costs of researching and developing our program candidates, and conducting preclinical studies and clinical trials;

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the costs, timing and outcome of regulatory review of our program candidates;

the costs and timing of hiring new employees to support our continued growth;

the costs of preparing, filing, and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending intellectual property-related claims;

the extent to which we acquire or in-license other program candidates and technologies; and

our ability to generate cash, and successfully obtain additional working capital, to fund our operating, investing and financing activities.

Until such time, if ever, that we can generate program revenue sufficient to achieve profitability, we expect to finance our cash needs through a combination of public and private equity offerings, debt financings, other third-party funding, strategic alliances, licensing arrangements or marketing and distribution arrangements. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interest of our existing stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our existing stockholders. Debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we raise additional funds through other third-party funding, strategic alliances, licensing arrangements, outright sales of program candidates or marketing and distribution arrangements, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings when needed, we will be required to delay, limit, reduce or terminate our program development or future commercialization efforts or grant rights to develop and market programs or program candidates that we would otherwise prefer to develop and market ourselves.

Capital expenditures

Management regularly reviews our research and development and general and administrative functions to evaluate the most efficient deployment of capital to ensure that the appropriate materials, systems and personnel are available to support clinical trials, preclinical activities and product supply.

Financing activities

When we do require capital in the future, we expect to finance our cash needs through sales of equity, possible strategic collaborations, debt financing or through other sources that may be dilutive to existing stockholders. Management anticipates that if it raises additional financing that it will be at a discount to the market price and it will be dilutive to stockholders.

Other Commitments and Contingencies

Our purchase commitments and obligations include all open purchase orders and contractual obligations entered into in the ordinary course of business, including commitments with contract manufacturers and suppliers, for which we have not received the goods or services and acquisition and licensing of intellectual property. Although open purchase orders are considered enforceable and legally binding, the terms generally allow us the option to cancel, reschedule and/or adjust our requirements based on our business needs prior to the delivery of goods or performance of services.

On July 1, 2023, we entered into a lease with Unico Properties LLC for office space in Seattle, WA that terminates in October 2028. Upon entering into this lease, we recognized a right-of-use asset and lease liability of approximately $0.8 million on the balance sheet based upon the present value of the future base payments discounted at an 8% discount rate using the rate of interest that we would have to pay to borrow on a collateralized basis over a similar term an amount equal to the lease payments in a similar economic environment as the lease does not provide an implicit discount rate. For additional information related to the our leases, see Note 11, Leases in this Form 10-K.

Effective April 1, 2024, we entered into a lease with the Board of Regents, State of Iowa, for lab and office space at the BioVentures Center. The lease terminates in March 2026. Upon entering into this lease, we recognized a right-of-use asset and lease liability of approximately $1.1 million on the balance sheet based upon the present value of the future base payments discounted at an 8% discount rate using the rate of interest that we would have to pay to borrow on a collateralized basis over a similar term an amount equal to the lease payments in a similar economic environment as the lease does not provide an implicit discount rate.

We acquired a lease from Progenics, an affiliate of Lantheus, for a production facility in Somerset, NJ, effective on March 1, 2024 (see Note 3, Investments and Agreements, in this Form 10-K). The lease terminates on November 29, 2028. Upon entering into this lease, we recognized a right-of-use asset and lease liability of approximately $0.3 million on the balance sheet based upon the present value of the future base payments discounted at an 8% discount rate using the rate of interest that we would have to pay to borrow on a collateralized basis over a similar term an amount equal to the lease payments in a similar economic environment as the lease does not provide an implicit discount rate.

On August 8, 2024, we assumed a lease from Progenics for office space in Somerset, NJ. The lease terminates on November 30, 2028. Upon entering into this lease, we recognized a right-of-use asset and lease liability of approximately $0.6 million on the balance sheet

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based upon the present value of the future base payments discounted at an 8% discount rate using the rate of interest that we would have to pay to borrow on a collateralized basis over a similar term an amount equal to the lease payments in a similar economic environment as the lease does not provide an implicit discount rate.

On September 18, 2024, we entered into a Master Equipment and Services Agreement (MESA) and statements of work (SOWs) thereunder with Comecer SpA (Comecer), pursuant to which we agreed to purchase from Comecer manufacturing equipment for the production of our radiopharmaceutical products including, but not limited to, isotope processing hot cells and production suites and related equipment (collectively, the Deliverables) and services for installation and validation of the Deliverables at several of our production facilities in the United States. The aggregate consideration for such equipment and services pursuant to the MESA and SOWs is approximately €49.0 million payable in cash, excluding certain incidental costs such as taxes, customs and duties, local transport, insurance and rigging. We may also elect to purchase certain additional equipment and services pursuant to the SOWs. The MESA provides for the payment of certain amounts in installments over the course of the production, installation and validation of the Deliverables.

Off-Balance Sheet Arrangements

We have no off-balance sheet arrangements.

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ITEM 7A – QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

As a smaller reporting company, the Company is not required to provide Item 7A disclosure in this Annual Report.

ITEM 8 – FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA

Information required by this Item 8 is incorporated by reference to our Consolidated Financial Statements and the Report of Independent Registered Public Accounting Firm beginning at page F-1 of this Annual Report.

ITEM 9 – CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE

None.

ITEM 9A – CONTROLS AND PROCEDURES

Disclosure Controls and Procedures

Under the supervision and with the participation of our management, including our principal executive officer and principal financial officer, we conducted an evaluation of the design and operation of our disclosure controls and procedures, as such term is defined under Rules 13a-15(e) and 15d-15(e) promulgated under the Securities Exchange Act of 1934, as amended (Exchange Act), as of December 31, 2024. Based on that evaluation, our principal executive officer and our principal financial officer concluded that the design and operation of our disclosure controls and procedures were effective. The design of any system of controls is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions, regardless of how remote. However, management believes that our system of disclosure controls and procedures are designed to provide a reasonable level of assurance that the objectives of the system will be met.

Management’s Annual Report on Internal Control over Financial Reporting

Management is responsible for establishing and maintaining adequate internal control over financial reporting as defined in Rules 13a-15(f) and 15d-15(f) of the Exchange Act. Our internal control over financial reporting is designed to provide reasonable assurance concerning both the reliability of our financial reporting and the preparation of our financial statements in accordance with generally accepted accounting principles. This control includes policies and procedures that obligate us to maintain reasonably detailed records that accurately and fairly reflect our transactions and the disposition of our assets, provide assurance that our transactions are properly recorded, ensure that our receipts and expenditures are authorized by management and, where applicable, our Board of Directors, and prevent or allow us to timely detect material unauthorized acquisitions, uses or dispositions of our assets.

We have evaluated the effectiveness of our internal control over financial reporting as defined in Rules 13a-15(f) and 15d-15(f) of the Exchange Act using the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission in Internal Control Integrated Framework (2013). This evaluation was performed under the supervision and with the participation of our management, including our chief executive officer and our principal financial officer, both of whom concluded that our internal control over financial reporting was effective as of December 31, 2024. Our evaluation of the effectiveness of our internal control over financial reporting in future periods may differ due to changing conditions or noncompliance with the policies and procedures we have established.

Changes in Internal Control over Financial Reporting

There have not been any changes in our internal control over financial reporting (as such term is defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) during the most recent fiscal quarter that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

ITEM 9B – OTHER INFORMATION

Trading Plans

During the three months ended December 31, 2024, none of our directors or executive officers adopted, modified or terminated any “Rule 10b5-1 trading arrangement” or “non-Rule 10b5-1 trading arrangement,” as each term is defined in Item 408 of Regulation S-K.

ITEM 9C - DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS

Not applicable.

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PART III

ITEM 10 – DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE

The information required by this item and not set forth below will be set forth in our definitive proxy statement for our 2025 Annual Meeting of Stockholders (Proxy Statement) to be filed with the U.S. Securities and Exchange Commission (SEC) within 120 days after the end of the fiscal year covered by this Form 10-K and is incorporated into this Form 10-K by reference.

ITEM 11 – EXECUTIVE COMPENSATION

The information required by this item and not set forth below will be set forth in our Proxy Statement to be filed with the SEC within 120 days after the end of the fiscal year covered by this Form 10-K and is incorporated into this Form 10-K by reference.

ITEM 12 – SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS

The information required by this item and not set forth below will be set forth in our Proxy Statement to be filed with the SEC within 120 days after the end of the fiscal year covered by this Form 10-K and is incorporated into this Form 10-K by reference.

ITEM 13 – CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE

The information required by this item and not set forth below will be set forth in our Proxy Statement to be filed with the SEC within 120 days after the end of the fiscal year covered by this Form 10-K and is incorporated into this Form 10-K by reference.

ITEM 14 – PRINCIPAL ACCOUNTANT FEES AND SERVICES

The information required by this item and not set forth below will be set forth in our Proxy Statement to be filed with the SEC within 120 days after the end of the fiscal year covered by this Form 10-K and is incorporated into this Form 10-K by reference.

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PART IV

ITEM 15 – EXHIBITS AND FINANCIAL STATEMENT SCHEDULES

1.

For a list of the financial statements included herein, see Index to the financial statements of this Form 10-K, incorporated into this Item by reference.

2.

Financial statement schedules have been omitted because they are either not required or not applicable or the information is included in the financial statements or the notes thereto.

3.

Exhibits:

Exhibit # Description

4.1* Description of Securities.

10.4*! Form of Perspective Therapeutics, Inc. Stock Option Agreement.

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19.1* Insider Trading Policy.

21.1* Subsidiaries of the Company.

23.1* Consent of WithumSmith+Brown, PC.

23.2* Consent of Assure CPA, LLC

101.INS* Inline XBRL Instance Document.

101.SCH* Inline XBRL Taxonomy Extension Schema Document.

101.CAL* Inline XBRL Taxonomy Extension Calculation Linkbase Document.

101.DEF* Inline XBRL Taxonomy Extension Definition Linkbase Document.

101.LAB* Inline XBRL Taxonomy Extension Label Linkbase Document.

101.PRE* Inline XBRL Taxonomy Extension Presentation Linkbase Document.

* Filed Herewith

** Furnished Herewith

! Denotes Management Contract or Compensatory Plan or Arrangement

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+ Certain portions of this exhibit (indicated by asterisks) have been omitted pursuant to Item 601(b)(10)(iv) of Regulation S-K.

# Certain schedules and exhibits have been omitted pursuant to Item 601(a)(5) of Regulation S-K. The Company will furnish supplementally a copy of any omitted schedule or exhibit to the Securities and Exchange Commission upon request. The Company may request confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended, for any schedules or exhibits so furnished.

ITEM 16 – FORM 10-K SUMMARY

None.

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SIGNATURES

Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

Dated: March 26, 2025

PERSPECTIVE THERAPEUTICS, INC., a Delaware corporation

By: /s/ Johan (Thijs) Spoor

Johan (Thijs) Spoor, Chief Executive Officer, Director

Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates indicated.

Dated: March 26, 2025

/s/ Johan (Thijs) Spoor

/s/ Juan Graham

Juan Graham, Chief Financial Officer

Principal Financial Officer

/s/ Jonathan Hunt

Jonathan Hunt, Chief Accounting OfficerPrincipal Accounting Officer

/s/ Lori A. Woods

Lori A. Woods, Chairperson

/s/ Heidi Henson

Heidi Henson, Director

/s/ Robert F. Williamson III

Robert F. Williamson III, Director

/s/ Frank Morich

Frank Morich, Director

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Perspective Therapeutics, Inc. and Subsidiaries

Index to Consolidated Financial Statements

Consolidated Balance Sheets F-6

Consolidated Statements of Operations and Comprehensive Loss F-7

Consolidated Statements of Cash Flows F-8

Consolidated Statements of Changes in Stockholders’ Equity F-10

Notes to the Consolidated Financial Statements F-11

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REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

To the Stockholders and Board of Directors

Perspective Therapeutics, Inc.:

Opinion on the Consolidated Financial Statements

We have audited the accompanying consolidated balance sheet of Perspective Therapeutics, Inc. and Subsidiaries (collectively, the “Company”) as of December 31, 2024, the related consolidated statements of operations and comprehensive loss, changes in stockholders’ equity, and cash flows for the year then ended, and the related notes (collectively referred to as the “consolidated financial statements”). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2024, and the results of its operations and its cash flows for the year then ended, in conformity with accounting principles generally accepted in the United States of America.

Basis for Opinion

These consolidated financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s consolidated financial statements based on our audit. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (“PCAOB”) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.

We conducted our audit in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audit we are required to obtain an understanding of internal control over financial reporting, but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.

Our audit included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the consolidated financial statements. Our audit also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements. We believe that our audit provides a reasonable basis for our opinion.

Critical Audit Matter

The critical audit matter communicated below is a matter arising from the current period audit of the consolidated financial statements that was communicated or required to be communicated to the audit committee and that: (1) relate to accounts or disclosures that are material to the consolidated financial statements and (2) involved our especially challenging, subjective, or complex judgments. The communication of critical audit matters does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate opinion on the critical audit matter or on the accounts or disclosures to which it relates.

Accounting Treatment of the Lantheus Option Agreement

Description of the Matter

The Company recorded current and noncurrent deferred income from the Lantheus option agreement of $1.4 million and $26.6 million, respectively, at December 31, 2024. As described in Note 3 to the consolidated financial statements, the term of the option agreement includes several exclusive options related to VMT-α-NET and preclinical development programs that were granted to Lantheus. The amount received under the agreements is a nonrefundable upfront payment.

Auditing the Company’s accounting treatment of the option agreement was complex and required significant judgments primarily in assessing the accounting treatment and evaluating estimates of the total expected inputs under the cost method for the deferred income that will be recognized over time.

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How We Addressed the Matter in Our Audit

We obtained an understanding of and evaluated the design of controls relating to the Company’s review and evaluation of the option agreement. We evaluated the significant accounting policies relating to the Company’s analyses, as well as management’s application of the policies, for appropriateness and reasonableness. We obtained an understanding of the valuation methodology including the key inputs and management assumptions.

To test the accounting treatment and valuation of the option agreement, we performed audit procedures that included, among other things, obtaining an understanding of the Company’s process to account for the option agreement, obtaining and auditing the technical accounting memo by evaluating the applicable technical guidance and application, reviewing the option agreement for key terms, evaluating the reasonableness of management’s assumptions used as inputs within the valuation model and testing the accuracy of the underlying data used in the valuation model. We also involved a valuation specialist to assist in evaluating the valuation methodology and significant assumptions used in the valuation model.

We have served as the Company's auditor since 2024.

San Francisco, California

March 26, 2025

PCAOB ID Number 100

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REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

To the shareholders and the board of directors of Perspective Therapeutics, Inc. and Subsidiaries

Opinion on the Consolidated Financial Statements

We have audited the accompanying consolidated balance sheets of Perspective Therapeutics, Inc. and its subsidiaries (“the Company”) as of December 31, 2023, and the related consolidated statements of operations, changes in stockholders’ equity and cash flows for the year then ended, and the related notes (collectively referred to as the consolidated financial statements). In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2023, and the results of its operations and its cash flows for the year then ended, in conformity with accounting principles generally accepted in the United States of America.

Basis for Opinion

These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.

We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits, we are required to obtain an understanding of internal control over financial reporting, but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.

Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.

Critical Audit Matters

The critical audit matters communicated below are matters arising from the current period audit of the consolidated financial statements that were communicated or required to be communicated to the audit committee and that (i) relate to accounts or disclosures that are material to the consolidated financial statements and (ii) involved our especially challenging, subjective, or complex judgments. The communication of critical audit matters does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matters below, providing separate opinions on the critical audit matters or on the accounts or disclosures to which they relate.

Acquisition of Viewpoint Molecular Targeting, Inc - Valuation of In-process Research and Development Intangible Assets

As disclosed in Note 4 to the consolidated financial statements, during 2023, the Company completed the acquisition of Viewpoint Molecular Targeting, Inc. for total consideration of approximately $68.6 million. The transaction was accounted for as business combination. Of the acquired net assets, in-process research and development (“IPR&D”) intangible asset of $50.0 million was recorded. The fair value of acquired IPR&D intangible asset was determined using the multi-period excess earnings method. The significant assumptions used to estimate the fair value of the IPR&D intangible asset included forecasted cash flows and discount rates.

Auditing the Company's valuation of the IPR&D intangible asset was complex and required significant auditor judgment due to the significant estimation uncertainty in evaluating certain assumptions required to estimate the fair value. The fair value measurement was sensitive to underlying assumptions including certain assumptions that form the basis of the

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forecasted results (e.g., operating income and growth rates). The significant assumptions are forward-looking and could be affected by future economic and market conditions.

Addressing the matter involved performing procedures and evaluating audit evidence in connection with forming our overall opinion on the consolidated financial statements. These procedures included evaluating:

(i)

Management’s processes relating to the acquisition accounting and management’s valuation of the IPR&D intangible asset;

(ii)

The appropriateness of the valuation method;

(iii)

The reasonableness of the significant assumptions;

(iv)

The results of sensitivity analysis on the fair value of the IPR&D intangible asset from changes in the assumptions; and

(v)

The reasonableness of certain forecasted cash flows assumptions which included consideration of:

a.

company specific factors of the acquired business;

b.

consistency with external market and industry data; and

c.

whether the assumptions were consistent with evidence obtained in other areas of the audit.

/s/ Assure CPA, LLC

We served as the Company’s auditor from 2005 through 2024.

Spokane, Washington

March 28, 2024, except for Note 1, as to which the date is March 26, 2025

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PART I - FINANCIAL INFORMATION

ITEM 1 - FINANCIAL STATEMENTS

Perspective Therapeutics, Inc. and Subsidiaries

Consolidated Balance Sheets

(In thousands, except shares and par value data)

December 31, December 31,

ASSETS

Current assets:

Short-term investments 165,336 -

Prepaid expenses and other current assets 4,128 1,133

Current assets held for sale, discontinued operations - 5,301

Noncurrent assets:

Restricted cash - 182

Intangible assets, in-process research and development 50,000 50,000

LIABILITIES AND STOCKHOLDERS’ EQUITY

Current liabilities:

Accounts payable and accrued expenses $ 10,343 $ 6,909

Deferred Income (Note 3) 1,400 -

Current liabilities of discontinued operations - 5,072

Noncurrent liabilities:

Lease liability, net of current portion 1,428 780

Note payable, net of current portion 1,625 1,676

Deferred Income, net of current portion (Note 3) 26,600 -

Other noncurrent liabilities 55 -

Commitments and contingencies (Note 17)

Stockholders’ equity:

Accumulated other comprehensive loss (51 ) -

Total liabilities and stockholders’ equity $ 341,101 $ 97,891

1.

Amounts for prior periods presented have been retroactively adjusted to reflect the 1-for-10 reverse stock split effected on June 14, 2024. See Note 1 for details.

The accompanying notes are an integral part of these consolidated financial statements.

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Perspective Therapeutics, Inc. and Subsidiaries

Consolidated Statements of Operations and Comprehensive Loss

(Dollars and shares in thousands, except for per-share amounts)

Year Ended December 31,

Operating expenses:

Goodwill impairment 24,062 -

Loss on disposal of property and equipment 27 -

Non-operating income (expense):

Interest and other expense, net (48 ) (82 )

Equity in loss of affiliate (8 ) (17 )

Total non-operating income, net 10,459 835

Net loss from continuing operations (80,427 ) (40,106 )

Net loss from discontinued operations (949 ) (9,053 )

Net loss before deferred income tax benefit (81,376 ) (49,159 )

Basic and diluted loss per share:

Loss from continuing operations1 $ (1.22 ) $ (1.40 )

Loss from discontinued operations1 (0.01 ) (0.34 )

Basic and diluted loss per share1 $ (1.23 ) $ (1.74 )

Unrealized loss on available-for-sale securities $ (51 ) $ -

1.

Amounts for prior periods presented have been retroactively adjusted to reflect the 1-for-10 reverse stock split effected on June 14, 2024. See Note 1 for details.

The accompanying notes are an integral part of these consolidated financial statements.

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Perspective Therapeutics, Inc. and Subsidiaries

Consolidated Statements of Cash Flows

(In thousands, except shares)

Year Ended December 31,

CASH FLOWS FROM OPERATING ACTIVITIES:

Adjustments to reconcile net loss to net cash used in operating activities:

Depreciation expense and amortization 2,306 986

Loss on disposal of property and equipment 27 22

Net accretion of discounts on available-for-sale securities (607 ) -

Goodwill impairment 24,062 -

Deferred income tax benefit (2,097 ) (2,651 )

Changes in operating assets and liabilities:

Accounts receivable, net of allowance 1,049 198

Inventory related to discontinued operations (Note 5) 11 359

Interest receivable (880 ) -

Prepaid expenses and other current assets (1,911 ) (325 )

Accounts payable and accrued expenses 1,890 1,573

Other noncurrent liabilities 55 -

Net cash used in operating activities (18,294 ) (36,913 )

CASH FLOWS FROM INVESTING ACTIVITIES:

Additions to property and equipment (54,414 ) (1,072 )

Proceeds from the sale of property and equipment 335 -

Additions to other assets (72 ) (18 )

Purchases of available-for-sale securities (164,780 ) -

Proceeds from maturity of held-to-maturity investments 78,730 22,764

Purchases of held-to-maturity investments (78,730 ) -

Net cash acquired in acquisition of Viewpoint - 2,699

Net cash (used in) provided by investing activities (218,931 ) 24,373

CASH FLOWS FROM FINANCING ACTIVITIES:

Repayment of notes payable (48 ) (68 )

Proceeds from sales of common stock, pursuant to exercise of warrants, net 125 -

Proceeds from sales of common stock, pursuant to exercise of options 1,253 554

Proceeds from the issuance of common stock 275,807 364

Proceeds from the issuance of Pre-funded Warrants, net1 12,248 -

Net cash provided by financing activities 289,385 785

Cash, cash equivalents and restricted cash beginning of period 9,420 21,175

CASH, CASH EQUIVALENTS AND RESTRICTED CASH END OF PERIOD $ 61,580 $ 9,420

Restricted cash - 182

1.

See Note 3, Investments and Agreements, for additional information.

The accompanying notes are an integral part of these consolidated financial statements.

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Perspective Therapeutics, Inc. and Subsidiaries

Consolidated Statements of Cash Flows, continued

(In thousands, except shares)

Year Ended December 31,

Supplemental schedule of noncash investing and financing activities:

Recognition of operating lease liability and right-of-use asset $ 2,115 $ 811

Modification of operating lease liability and right-of-use asset - 557

Fair value of Viewpoint assets acquired including goodwill - 82,628

Assumption of Viewpoint stock options and warrants at fair value - (7,836 )

Note receivable and accrued interest from Viewpoint forgiven - (6,171 )

2.

Amount for prior period presented has been retroactively adjusted to reflect the 1-for-10 reverse stock split effected on June 14, 2024. See Note 1 for details.

The accompanying notes are an integral part of these consolidated financial statements.

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Perspective Therapeutics, Inc. and Subsidiaries

Consolidated Statements of Changes in Stockholders’ Equity

(In thousands, except shares)

Common Stock

Issuance of common stock pursuant to exercise of options 191,319 - 554 - - 554

Share-based compensation - - 3,738 - - 3,738

Issuance of May 2024 Pre-funded Warrants, net2 - - 2,040 - - 2,040

Unrealized loss on available-for-sale securities (51 ) - (51 )

Share-based compensation - - 5,387 - - 5,387

1.

Amounts for prior periods presented have been retroactively adjusted to reflect the 1-for-10 reverse stock split effected on June 14, 2024. See Note 1 for details.

2.

See Note 3, Investments and Agreements, for additional information.

The accompanying notes are an integral part of these consolidated financial statements.

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Perspective Therapeutics, Inc. and Subsidiaries

Notes to the Consolidated Financial Statements

1.

Description of Business

Perspective Therapeutics, Inc. is a radiopharmaceutical development company that is pioneering advanced treatment applications for cancers throughout the body. The accompanying consolidated financial statements are those of Perspective Therapeutics, Inc., and its wholly owned subsidiaries, referred to herein as “Perspective Therapeutics” or the “Company.”

Merger

On February 3, 2023, the Company completed the merger of Isoray Acquisition Corp., a Delaware corporation and wholly owned subsidiary of the Company, with Viewpoint Molecular Targeting, Inc. (Viewpoint) (such transaction being the Merger). Pursuant to the Merger, the Company issued 13,654,507 shares of its common stock, par value $0.001 per share (Common Stock), representing approximately 49% of its fully diluted outstanding capital stock as of the close of the Merger. Viewpoint is an alpha-particle radiopharmaceutical company in the alpha-emitter market developing oncology therapeutics and complementary imaging agents. For additional information, see Note 4, Merger, in this Form 10-K.

Discontinued Operations

On April 12, 2024, the Company completed the sale of its Cesium-131 brachytherapy business and substantially all of the assets of Isoray Medical, Inc. (Isoray), a wholly owned subsidiary of Perspective Therapeutics, to GT Medical Technologies, Inc., a Delaware corporation (GT Medical) (such transaction being the GT Medical Closing). Pursuant to the GT Medical Closing, GT Medical issued to Isoray 279,516 shares of GT Medical’s common stock, par value $0.0001 per share, representing 0.5% of GT Medical’s issued and outstanding capital stock on a fully diluted basis as of the closing. Accordingly, the financial information and operating results of the Cesium-131 brachytherapy business have been presented as discontinued operations in the consolidated financial statements for all periods presented. Unless otherwise noted, discussion within these notes to the consolidated financial statements relates to continuing operations. For additional information, see Note 5, Discontinued Operations, in this Form 10-K.

Reverse Stock Split

On June 14, 2024, the Company effected a 1-for-10 reverse stock split (Reverse Split) of the Company’s issued and outstanding shares of Common Stock, and the Common Stock began trading on a split-adjusted basis on June 17, 2024. The Reverse Split did not reduce the total number of authorized shares of Common Stock or the Company’s preferred stock, par value $0.001 per share (Preferred Stock), or change the par values of the Common Stock or Preferred Stock. The Reverse Split affected all stockholders uniformly and did not affect any stockholder’s ownership percentage of the shares of Common Stock (except to the extent that the Reverse Split resulted in some of the stockholders receiving cash in lieu of fractional shares). All outstanding options and warrants entitling their holders to purchase shares of Common Stock were adjusted as a result of the Reverse Split, in accordance with the terms of each such security. In addition, the number of shares reserved for future issuance pursuant to the Company’s equity incentive plans was also adjusted accordingly. As a result, all historical per share data, number of shares issued and outstanding, and outstanding options and warrants for the periods presented in the accompanying consolidated financial statements and notes thereto have been adjusted retroactively in this Form 10-K, where applicable, to reflect the Reverse Split.

Segment Information

A segment is defined as a component of an entity that has discrete financial information available for regular evaluation by the Chief Operating Decision Maker (CODM) and is used to make decisions on how to allocate resources and assess performance. The Company has one operating and reportable segment, which is its radiopharmaceutical development segment. The accounting policies of the radiopharmaceutical development segment are the same as those reported in Note 2, Summary of Significant Accounting Policies. The measurement of segment profit or loss is reported as “net loss” in the Consolidated Statements of Operation and Comprehensive Loss. The Company monitors its cash, cash equivalents and short-term investments, as reported on the Consolidated Balance Sheets, to determine funding for its research and development. To allocate resources, the Company’s CODM, who is its Chief Executive Officer, regularly reviews scientific data from clinical and preclinical studies and forecasted expenses for continued operations. The Company currently does not generate revenue from commercial products and incurs the majority of its expenses in the United States.

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Liquidity

The Company assesses its liquidity in terms of its ability to generate cash to fund its operating, investing and financing activities. The Company has had a history of operating losses and an absence of significant recurring cash inflows from revenue. At December 31, 2024, the Company had cash, cash equivalents and short-term investments of $226.9 million and total accumulated deficit of $231.7 million. The Company has historically financed its operations primarily through selling equity.

The Company believes that its $226.9 million of cash, cash equivalents and short-term investments as of December 31, 2024 will enable it to fund its current planned operations into late 2026, though it may raise additional capital through a combination of equity offerings, debt financings, collaborations, strategic alliances and marketing, distribution or licensing arrangements and/or government funding and grants.

The accompanying consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the ordinary course of business. The operating plan may change as a result of many factors currently unknown to management, and there can be no assurance that the current operating plan will be achieved in the timeframe anticipated by management or at all, and the Company may need to seek additional funds sooner than anticipated. The consolidated financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result from potential unknown factors.

The Company anticipates that as the result of continuing operating losses and the significant net operating losses available from prior fiscal years, its effective income tax rate for fiscal year 2024 will be 0%.

Reclassifications

In addition to the discontinued operations discussed above, the Company made certain reclassifications to prior period amounts in the consolidated financial statements and accompanying notes to conform to the current period presentation. The reclassification of these items had no impact on net loss, financial position or cash flows in the current or prior periods. Specifically, the following items were updated:

Consolidated Balance Sheets and Consolidated Statements of Cash Flows

Accrued payroll and related taxes and accrued vacation were combined to create accrued personnel; and

Accrued protocol expense and accrued waste disposal were included in accounts payable and accrued expenses.

Consolidated Statements of Cash Flows

Depreciation expense and amortization of other assets were combined to create depreciation expense and amortization; and

Foreign currency adjustments, lease expense, equity in loss of affiliate (see the Consolidated Statements of Operations and Comprehensive Loss), write-off of inventory associated with a discontinued product (see Note 5, Discontinued Operations), accretion of asset retirement obligation and change in estimate of asset retirement obligation were combined to create other, net.

2.

Summary of Significant Accounting Policies

Basis of Presentation and Principles of Consolidation

The accompanying consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States (GAAP). The consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. All significant intercompany transactions and balances have been eliminated in consolidation.

Cash Equivalents

The Company considers currency on hand, demand deposits, time deposits, and all highly liquid investments with an original maturity of three months or less at the date of purchase to be cash and cash equivalents. Cash and cash equivalents are held in various financial institutions in the United States.

Short-Term Investments

Available-for-Sale Securities

The Company has available-for-sale securities with original maturities of more than three months from the date of purchase that are specifically identified to fund operations. The available-for-sale securities are classified as current assets even though the stated maturity date may be one year or beyond the current balance sheet date as this reflects management’s intention to use the proceeds from the sale of these investments to fund the Company’s operations as necessary. The available-for-sale securities are carried at fair value with

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unrealized gains and non-credit-related losses recorded in other comprehensive loss and included as a separate component of stockholders’ equity. The cost of available-for-sale securities is adjusted for amortization of premiums or accretion of discounts to maturity, and such amortization or accretion, as well as dividend and interest income, are included in interest income in the Consolidated Statements of Operations and Comprehensive Loss. Realized gains and losses from the sale of available-for-sale securities will be determined on a specific identification basis and included in interest income on the Company’s Consolidated Statements of Operations and Comprehensive Loss. Available-for-sale securities that are sold during the reporting period will not be remeasured prior to sale, resulting in a net presentation of changes in fair value.

Held-to-Maturity Investments

From time to time, the Company has invested in U.S. Treasury Bills in which it had the intent and ability to hold until the date of maturity. As such, these investments were carried at amortized cost and classified as held to maturity. At December 31, 2024 and December 31, 2023, the Company had no held-to-maturity investments.

Allowance for Credit Losses

For available-for-sale securities in an unrealized loss position, pursuant to Accounting Standards Update (ASU) 2016-13, Financial Instruments - Credit Losses: Measurement of Credit Losses on Financial Instruments, the Company first assesses whether it intends to sell, or if it is more likely than not that it will be required to sell, the security before recovery of its amortized cost basis. If either of the criteria regarding the intent or requirement to sell is met, the security’s amortized cost basis is written down to fair value through earnings. For securities that do not meet the aforementioned criteria, the Company evaluates whether the decline in fair value has resulted from the credit losses or other factors. In making this assessment, the Company considers the extent to which fair value is less than amortized cost, any changes in interest rates, market conditions, changes to the underlying credit ratings and forecasted recovery, among other factors. If this assessment indicates a credit loss exists, the present value of cash flows expected to be collected from the security is compared to the amortized cost basis of the security. If the present value of cash flows expected to be collected is less than the amortized costs basis, a credit loss exists and an allowance for credit losses is recorded, limited by the amount that the fair value is less than the amortized cost basis. The credit-related portion of unrealized losses and any subsequent improvements are recorded in interest income through an allowance account. Any impairment that has not been recorded through an allowance for credit losses is recognized in comprehensive loss on the Consolidated Statements of Operations and Comprehensive Loss, as applicable.

The Company elected the practical expedient to exclude the applicable accrued interest receivables from both the fair value and amortized cost basis of available-for-sale securities. Accrued interest receivable is recorded in prepaid expenses and other current assets in the Consolidated Balance Sheets. Uncollectible accrued interest receivables associated with an impaired security are reversed against interest income upon identification of the impairment.

Property and Equipment

Property and equipment is capitalized and carried at cost less accumulated depreciation. Depreciation expense is recorded to operating expenses. Normal maintenance and repairs are charged to expense as incurred. When any assets are sold or otherwise disposed of, the cost and accumulated depreciation are reversed with any resulting gain or loss being recognized on the Consolidated Statements of Operations and Comprehensive Loss.

Depreciation is computed using the straight-line method over the following estimated useful lives (in years):

Research and development equipment 3 to 7

Office equipment 2 to 10

Furniture and fixtures 2 to 10

Leasehold improvements are amortized over the shorter of the lease term or the estimated useful life of the asset.

Source: SEC EDGAR (public domain) · 10-K for the period ended 2024-12-31, filed 2025-03-26 · accession 0000950170-25-045242

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