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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 2025-12-31

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filed 2026-03-16 · 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 pioneering advanced treatments 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 neuroendocrine tumor (VMT-α-NET), melanoma (VMT01) and solid tumor (PSV359) programs are in Phase 1/2a imaging and therapy trials 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 targeted alpha therapy (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 initially dosed two patients in Cohort 1 (treated at 2.5 mCi per dose) and seven patients in Cohort 2 (treated at 5.0 mCi per dose) of our Phase 1/2a study of [212Pb]VMT-α-NET in patients with unresectable or metastatic SSTR2-expressing NETs, regardless of body weight. Subsequent review for dose-limiting toxicity (DLT) during the safety observation period in the seven patients enrolled in Cohort 2 by the Safety Monitoring Committee (SMC) led the SMC to recommend escalating further in a third cohort and enrolling additional patients at 5.0 mCi to better understand efficacy and safety. During the second quarter of 2025, enrollment for Cohort 2 closed with an additional 39 patients having received at least one treatment, for a total of 46 patients including the seven who were enrolled for DLT observation.

In late June 2025, we announced the opening of Cohort 3 in which patients will receive up to four fixed administered doses of [212Pb]VMT-α-NET at 6.0 mCi every eight weeks if they weigh more than 60 kg (133 lb), or 100μCi/kg of body weight if they weigh less than or equal to 60 kg. Eight Cohort 3 patients then commenced treatment with VMT-α-NET and contributed to the DLT assessment by the SMC. The DLT assessment is now complete, and we are cleared to treat more patients at this dose, with eight additional patients already treated as of February 28, 2026, for a total of 16 patients. By mid-2026, the eight DLT patients would have had the opportunity for at least 32 weeks of follow up since beginning treatment, which is sufficient time to have completed at least one scan following the full course of treatment.

During October 2025, updated interim results from our ongoing Phase 1/2a clinical trial (NCT05636618) of [212Pb]VMT-α-NET in patients with unresectable or metastatic SSTR2-expressing NETs with a data cut-off date of September 12, 2025, were presented at the European Society for Medical Oncology (ESMO) Congress 2025, the 2025 North American Neuroendocrine Tumor Society (NANETS) Multidisciplinary NET Medical Symposium, and the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics. In this analysis, 55 patients across three dose cohorts received at least one treatment of VMT-α-NET. Two patients in Cohort 1 and 23 patients in Cohort 2 had at least nine months of follow up since their initial treatment.

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During January 2026, updated interim results with a data cut-off date of December 10, 2025, were presented at the 2026 ASCO Gastrointestinal Cancers Symposium (ASCO-GI 2026). The 56 patients in the safety analysis comprised two patients in Cohort 1 (2.5 mCi), 46 patients in Cohort 2 (5.0 mCi) and eight patients in Cohort 3 (6.0 mCi), each of whom had received at least one treatment. There were no DLTs, no treatment-related discontinuations, and no serious renal complications, dysphagia or clinically significant treatment-related myelosuppression reported. Grade 3 or higher treatment-emergent adverse events were reported in 21 patients (37.5%). One of these patients, who was enrolled in Cohort 3, experienced a transient Grade 4 event (lymphocyte count decrease). This event was transient and resolved without medical intervention. The patient continues to receive [212Pb]VMT-α-NET treatment. There were no Grade 5 events. Serious adverse events were reported in five patients, with none deemed related to the study medication.

In October 2025 at ESMO, we reported interim efficacy data for two patients in Cohort 1 and 23 patients in Cohort 2. At ASCO-GI 2026, we presented updated efficacy analysis for the same 25 patients from ESMO with an additional 13 weeks of follow up since the presentation at ESMO. Of the 25 patients, 19 (76%) were without progression and remained alive, including both of the patients in Cohort 1. Nine (39%) patients in Cohort 2 were observed to have response according to investigator-assessed RECIST v1.1. Eight (35%) of those responses were confirmed and previously reported at ESMO; one additional patient experienced an initial response in their most recent tumor assessment after the prior update at ESMO. As the patient remains on the study, the patient is expected to receive a subsequent tumor assessment. Seven patients were observed to have deepening of best response, including one patient with stable disease.

As of February 28, 2026, the first 23 patients in Cohort 2 would have had the opportunity for at least 48 weeks of follow up since beginning treatment, and by mid-2026, we expect all 46 patients in Cohort 2 would have had the opportunity for at least 48 weeks of follow up since beginning treatment.

We believe our clinical data package positions us for meaningful regulatory engagement in 2026 to align on the path forward.

During the dose finding phase of the study, we enrolled primarily NETs patients whose disease originated in the pancreas or the digestive track. We have allowance for enrollment of NETs patients whose disease originated in the lung (of which small cell lung cancer is a subset), and pheochromocytoma/paraganglioma NETs, as well as SSTR2+ meningioma.

VMT01

We are also leveraging our TAT platform with our product candidate, VMT01, which is currently in Phase 1/2a clinical trials. We designed VMT01 to target and deliver 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 U.S. Food and Drug Administration (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 and received 3 mCi of [212Pb]VMT01, while seven patients were enrolled in Cohort 2 and 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 adverse events (AEs) led to treatment discontinuation. Treatment emergent AEs were mostly grades 1 and 2. None of the four cases of grade 3 treatment emergent AEs were deemed to be treatment related. There were no grade 4 or 5 treatment emergent AEs. No renal toxicities had been reported as of October 11, 2024 (there were no clinically significant changes in blood urea nitrogen or serum creatinine) in spite of dosimetry estimated renal radiation that approached the higher end of conventional dosing.

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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 was approved, and Cohort 3 at 1.5 mCi per dose was opened for enrollment. The combination cohort at 1.5 mCi per dose with nivolumab was also opened for enrollment. The first patients in the combination and monotherapy cohorts received their first treatments in March and April 2025, respectively. As of July 31, 2025, a total of five patients had received their initial monotherapy treatments of VMT01 at 1.5 mCi per dose, once every eight weeks for up to three doses. Additionally, two patients had received VMT01 1.5 mCi with nivolumab. Both cohorts are now closed for enrollment.

In September 2025, we announced that the first patient received [212Pb]VMT01 at 3.0 mCi in combination with nivolumab, as part of a new cohort. Additionally, the [212Pb]VMT01 3.0 mCi monotherapy cohort reopened for enrollment. The SMC recommended evaluating [212Pb]VMT01 at a higher dose based on its review of five patients dosed with [212Pb]VMT01 at 1.5 mCi in the monotherapy cohort and two patients dosed with [212Pb]VMT01 at 1.5 mCi together with nivolumab.

As of February 28, 2026, a total of 10 patients had received VMT01 treatment following the re-opening of the [212Pb]VMT01 3.0 mCi monotherapy cohort and the opening of the cohort in which patients are receiving [212Pb]VMT01 at 3.0 mCi in combination with nivolumab. Six patients had received VMT01 at 3.0 mCi in combination with nivolumab. Four patients had received 3.0 mCi of VMT01 as monotherapy, in addition to the three patients who received this monotherapy dose in late 2023. Both cohorts are now closed for enrollment.

By late 2026, the 10 patients who had received VMT01 3.0 mCi treatment since the initiation or re-opening of these cohorts in September 2025 would have had the opportunity for at least 24 weeks of follow up after their initial doses, which is sufficient time to receive at least one scan after their full treatment (up to three doses every eight weeks).

PSV359

Tumor stroma cells do not typically express cancer-specific markers like SSTR2 or MC1R. Fibroblast activation protein alpha (FAP-α) is primarily expressed on tumor stroma cells, but also on some cancer cells. FAP-α, a pan-cancer target, is a protein abundantly expressed in certain cancer cells as well as cancer-associated fibroblasts in tumor lesions and involved in promoting disease progression. 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 single-photon emission computed tomography (SPECT)/computed tomography (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 Society of Nuclear Medicine and Molecular Imaging 2024 Annual Meeting and the 37th Annual Congress of the European Association of Nuclear Medicine meetings in June and October 2024, respectively. Researchers presented a novel cyclic peptide targeting human FAP-α, which was discovered by us via phage display methods. FAP-α is a protein abundantly expressed in certain cancer cells as well as cancer-associated fibroblasts in tumor lesions and involved in promoting disease progression. The peptide was conjugated to a lead (Pb)-specific chelator via a molecular linker to form a novel construct, PSV359. The purpose of this study was to evaluate the in vitro and in vivo performance of [203/212Pb]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.

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We filed an IND application for PSV359 in December 2024, and we received a “study may proceed” letter (i.e., approval to conduct the trial) from the FDA in the first quarter of 2025. In April 2025, we announced the first patient was treated with [212Pb]PSV359. As of February 28, 2026, two patients have been treated with [212Pb]PSV359 at 2.5 mCi (Cohort 1) and six patients have been treated with [212Pb]PSV359 at 5.0 mCi (Cohort 2), for a total of eight patients. By late 2026, these patients would have had the opportunity for at least 32 weeks of follow up after their initial doses, which is sufficient time to have completed at least one scan after the full course of treatment (up to four doses every eight weeks). Activation activities are underway for additional sites.

Other Pipeline Candidates

In January 2024, we entered into an exclusive, worldwide license agreement with Stony Brook University for the global intellectual property rights to the Cuburbit[7]uril-admantane (CB7-Adma) pre-targeting 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

We continue to strengthen our intellectual property portfolio in support of our platform technologies, product candidates and other programs. Our patent covering our VMT-α-GEN 212Pb-generation technology was issued in the U.S. in March 2026, and the corresponding European patent application has been allowed. Our AlphaPRIMETM 212Pb-generation technology is patented in the U.S., and related patent applications have been allowed in China and Europe. We believe these developments further enhance the geographic scope and depth of protection for our core radiopharmaceutical technologies and manufacturing platforms.

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 product candidates. Our costs are also expected to increase as we:

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

continue the development of our product candidates and other programs;

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

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

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

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

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

continue to build our manufacturing capabilities, including potential expansion of our manufacturing footprint;

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.

As of December 31, 2025, we had cash, cash equivalents and short-term investments of $144.7 million. In February 2026, we announced the closing of an underwritten offering of securities with gross proceeds of $175.0 million before deducting underwriting discounts and commissions and other offering-related expenses. We believe our cash, cash equivalents and short-term investments as of December 31, 2025, together with the net proceeds from the February 2026 offering, will be sufficient to fund our current clinical milestones and operational investments for at least the next 12 months from the date the consolidated financial statements in this report were issued and into late 2027. 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.

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Manufacturing and Supply

We assemble and manufacture our finished radiopharmaceutical candidates by chelating or trapping an atom of 212Pb within a specialized chelator or chemical “cage” and connecting the 212Pb within its cage to the targeting peptide with our linker technology. For clinical supply, we intend to use a combination of third-party contract manufacturing organizations, or CMOs, and our own manufacturing sites complying with the FDA’s current good manufacturing practices, or CGMP, to manufacture and distribute our doses. For the drug precursors and isotopes that comprise our TAT platform, a variety of clinical phase manufacturers have been engaged and utilized. We procure chelator-modified peptide precursors from peptide manufacturers who are capable of producing clinical phase precursor material.

In May 2025, we entered into a supply agreement with the U.S. Department of Energy (DOE) under which we will purchase Thorium-228 from the DOE during 2025 and 2026. The supply agreement includes a “take-or-pay” provision pursuant to which we are committed to purchasing approximately $8.4 million of Thorium-228 during the term of the agreement.

In 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 product candidates 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 and Modifications

In 2024, we purchased buildings located in the metropolitan areas of Houston, TX, Chicago, IL, and Los Angeles, CA, which we intend to use for the manufacture of our product candidates upon completion of modifications and installation of equipment.

Also in 2024, we acquired the assets and associated lease of Lantheus’ radiopharmaceutical manufacturing facility in Somerset, NJ. Soon after the acquisition, we began the onboarding and operationalization processes and, in October 2024, we achieved the first shipment and patient dosing from our Somerset facility. With three manufacturing suites that can meet CGMP requirements, the Somerset facility is expected to have the capacity to meet future clinical trial and commercial demands at major cancer treatment centers throughout the Northeastern U.S.

In October 2025, we entered into an agreement with a general contractor to begin building modifications at our facility in the Chicago, IL metropolitan area along with preparations for the eventual installation of some of the Comecer manufacturing equipment and associated clean rooms.

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

2026 Registered Offering

On February 2, 2026, we entered into an underwriting agreement with Piper Sandler & Co. and UBS Securities LLC, as representatives of the underwriters named therein, in connection with our previously announced underwritten offering (2026 Offering) of 39,576,088 shares (2026 Offering Shares) of our common stock, par value $0.001 per share (Common Stock), and, in lieu of 2026 Offering Shares to certain investors, pre-funded warrants (2026 Pre-funded Warrants) to purchase 6,598,046 shares of Common Stock. The price to the investors for the 2026 Offering Shares was $3.79 per 2026 Offering Share, and the price to the investors for the 2026 Pre-funded Warrants was $3.789 per 2026 Pre-funded Warrant, which represents the per share price for the 2026 Offering Shares less the $0.001 per share exercise price for each such 2026 Pre-funded Warrant. The 2026 Offering closed on February 3, 2026.

Our gross proceeds from the 2026 Offering were approximately $175.0 million, before underwriting discounts and commissions and other offering-related expenses.

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The exercise price and the number of shares of Common Stock issuable upon exercise of each 2026 Pre-funded Warrant are subject to appropriate adjustment in the event of certain stock dividends and distributions, stock splits, stock combinations, reclassifications or similar events affecting the Common Stock as well as upon any distribution of assets, including cash, stock or other property, to our stockholders. The 2026 Pre-funded Warrants will not expire and are exercisable in cash or by means of a cashless exercise. A holder of the 2026 Pre-funded Warrants may not exercise such 2026 Pre-funded Warrants if the aggregate number of shares of Common Stock beneficially owned by such holder, together with its affiliates, would be more than 4.99% or 9.99%, as elected by such holder, of the issued and outstanding shares of Common Stock following such exercise, as such percentage ownership is determined in accordance with the terms of the 2026 Pre-funded Warrants. A holder of the 2026 Pre-funded Warrants may increase or decrease this percentage not in excess of 19.99% by providing at least 61 days’ prior notice to us.

The 2026 Offering was made pursuant to our shelf registration statement on Form S-3 (File No. 333-279692), as amended, which was most recently declared effective on April 8, 2025, a related base prospectus dated April 8, 2025, and a free writing prospectus and prospectus supplement each dated February 2, 2026.

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 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.

Any Common Stock sold under the 2024 ATM Agreement 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 initially became effective on May 24, 2024 and which was subsequently amended on March 26, 2025 and April 4, 2025, with Post-Effective Amendment #3 being declared effective by the SEC on April 8, 2025. On August 13, 2024, we initially filed a prospectus supplement to the May 2024 Registration Statement with the SEC in connection with the offer and sale of up to $250.0 million of the 2024 ATM Shares pursuant to the 2024 ATM Agreement. We re-filed the ATM prospectus supplement with each of the post-effective amendments to the May 2024 Registration Statement.

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 share of Common Stock, resulting in gross proceeds of approximately $10.2 million.

Legislative Update

On July 4, 2025, the President signed tax legislation known as the One Big Beautiful Bill Act (OBBBA) into law. The OBBBA includes a broad range of tax reform provisions affecting businesses, including extending and modifying certain provisions of the 2017 Tax Cuts & Jobs Act.

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 generally accepted accounting principles 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 related disclosure of contingent liabilities. On an ongoing basis, management evaluates critical accounting estimates and judgments, including those related to accrued liabilities, intangible assets 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.

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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.

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. 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 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.

Our IPR&D assets represent the estimated fair value of the pipeline of radiotherapy product candidates we acquired from Viewpoint in February 2023. During the fourth quarter of 2025, as part of our annual qualitative analysis, we determined we will no longer pursue further development of an early-stage preclinical asset within our IPR&D portfolio. In connection with and as a result of this assessment, we recorded a $10.0 million noncash impairment loss for the three months ended December 31, 2025. No IPR&D impairment loss was recorded in 2024.

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 in the Consolidated Statements of Operations and Comprehensive Loss as “grant revenue.” The related expenses are recorded within R&D and general and administrative.

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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 4, 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

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

Operating Expenses

Research and Development

Research and development expenses were $84.2 million for the year ended December 31, 2025, compared to $41.6 million for the year ended December 31, 2024, an increase of $42.6 million. The increase in research and development expenses was primarily related to increased clinical site activities, drug program costs and delivery costs along with higher personnel costs, including share-based compensation. Additionally, we recorded a $10.0 million noncash impairment loss for the three months ended December 31, 2025, after we determined that we will no longer pursue further development of an early-stage preclinical asset within our in-process research and development portfolio.

Management expects personnel costs to continue to increase in the coming years as we expand headcount to support the development of our product candidates, advance additional radiopharmaceutical programs and scale manufacturing capabilities. We are investing in equipment and modifications for the three buildings we acquired in 2024 located in the Houston, TX, Chicago, IL, and Los Angeles, CA, metropolitan areas, which are intended to be used for manufacturing our product candidates upon completion.

We are also actively strengthening our current manufacturing capabilities to support the clinical supply of radiopharmaceuticals through the expansion of clinical production lines at our locations in Coralville, IA, and Somerset, NJ. In Coralville, we built a second production suite that became operational in 2025. The Somerset facility, with its three manufacturing suites that can meet CGMP requirements, is expected to have the capacity to meet future clinical trial and commercial demands at major cancer treatment centers throughout the Northeastern U.S. An existing production suite in Somerset is being upgraded to support Phase 3 activities, with installation targeted for completion by mid-2026. A fourth production suite has also been installed and completed, and we expect it to be operational in 2026.

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Management believes that the cost of certain raw materials used in the production of our novel radiopharmaceutical drugs and product candidates may increase in the coming years, including as a result of increased demand for materials required for the production of radiopharmaceuticals. We are also currently evaluating how potential U.S. and international trade policies, including tariffs, might impact our costs for supplies, equipment and materials used in the development and production of our TAT drug product candidates. We currently source much of the raw materials that are used to produce our product candidates in the U.S. Some equipment and other materials that will be used at our manufacturing sites is sourced from outside the U.S. Based on our analysis of recent developments related to U.S. tariffs, we do not expect to experience material incremental tariff-related cost impacts in 2026. We will continue to monitor policy developments related to tariffs and the implementation dates of new tariffs, as well as potential opportunities to source materials and equipment from alternative suppliers, as we continue to evaluate the potential impacts of tariffs.

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 $30.2 million for the year ended December 31, 2025, compared to $26.6 million for the year ended December 31, 2024, an increase of $3.6 million. The increase in general and administrative expenses for the year ended December 31, 2025 was primarily due to increased personnel costs, partially offset by decreased fees for professional services.

Goodwill Impairment

As a result of a decline in our stock price and related market capitalization in November 2024 that continued into December 2024, we performed a quantitative impairment assessment of our goodwill. The goodwill was determined to be fully impaired as of December 31, 2024, and we recorded a goodwill impairment charge of $24.1 million for the year ended December 31, 2024. This impairment charge reduced the balance of goodwill to $0 at December 31, 2024.

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. In connection with 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. The following table summarizes our cash flows for the periods presented (in thousands):

Year Ended December 31,

Cash Flows from Operating Activities: The increase of $64.2 million in net cash used in operating activities for the year ended December 31, 2025, compared to the same period in 2024, was due to changes of $30.1 million in operating assets and liabilities, an increase of $23.8 million in net loss and a decrease of $10.2 million in noncash activities.

Cash Flows from Investing Activities: The increase of $260.2 million in net cash provided by investing activities for the year ended December 31, 2025, compared to the same period in 2024, was primarily due to an increase of $95.2 million in maturities of short-term investments, a $123.7 million decrease in the purchase of short-term investments and a $41.7 million decrease in additions to property and equipment.

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Cash Flows from Financing Activities: Net cash provided by financing activities for the year ended December 31, 2025 was primarily related to proceeds received from the sale of Common Stock pursuant to the 2024 ATM Agreement (defined below). Net cash provided by financing activities of $289.0 million for the year ended December 31, 2024 was primarily related to various capital markets transactions and other agreements we entered into.

For additional information regarding the cash we raised, see Sources of Liquidity below.

Sources of Liquidity

2026 Registered Offering

On February 2, 2026, we entered into an underwriting agreement with Piper Sandler & Co. and UBS Securities LLC, as representatives of the underwriters named therein, in connection with our previously announced underwritten offering (2026 Offering) of 39,576,088 shares (2026 Offering Shares) of our Common Stock, and, in lieu of 2026 Offering Shares to certain investors, pre-funded warrants (2026 Pre-funded Warrants) to purchase 6,598,046 shares of Common Stock. The price to the investors for the 2026 Offering Shares was $3.79 per 2026 Offering Share, and the price to the investors for the 2026 Pre-funded Warrants was $3.789 per 2026 Pre-funded Warrant, which represents the per share price for the 2026 Offering Shares less the $0.001 per share exercise price for each such 2026 Pre-funded Warrant. The 2026 Offering closed on February 3, 2026.

Our gross proceeds from the 2026 Offering were approximately $175.0 million, before underwriting discounts and commissions and other offering-related expenses.

The exercise price and the number of shares of Common Stock issuable upon exercise of each 2026 Pre-funded Warrant are subject to appropriate adjustment in the event of certain stock dividends and distributions, stock splits, stock combinations, reclassifications or similar events affecting the Common Stock as well as upon any distribution of assets, including cash, stock or other property, to our stockholders. The 2026 Pre-funded Warrants will not expire and are exercisable in cash or by means of a cashless exercise. A holder of the 2026 Pre-funded Warrants may not exercise such 2026 Pre-funded Warrants if the aggregate number of shares of Common Stock beneficially owned by such holder, together with its affiliates, would be more than 4.99% or 9.99%, as elected by such holder, of the issued and outstanding shares of Common Stock following such exercise, as such percentage ownership is determined in accordance with the terms of the 2026 Pre-funded Warrants. A holder of the 2026 Pre-funded Warrants may increase or decrease this percentage not in excess of 19.99% by providing at least 61 days’ prior notice to us.

The 2026 Offering was made pursuant to our shelf registration statement on Form S-3 (File No. 333-279692), as amended, which was most recently declared effective on April 8, 2025, a related base prospectus dated April 8, 2025, and a free writing prospectus and prospectus supplement each dated February 2, 2026.

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 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.

Any Common Stock sold under the 2024 ATM Agreement 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 initially became effective upon filing with the SEC on May 24, 2024 and which was subsequently amended on March 26, 2025 and April 4, 2025, with Post-Effective Amendment #3 being declared effective by the SEC on April 8, 2025. On August 13, 2024, we initially filed a prospectus supplement to the May 2024 Registration Statement with the SEC in connection with the offer and sale of up to $250.0 million of the 2024 ATM Shares pursuant to the 2024 ATM Agreement. We re-filed the ATM prospectus supplement with each of the post-effective amendments to the May 2024 Registration Statement.

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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.

Our gross proceeds from the Registered Offering were approximately $80.0 million, before underwriting discounts and commissions and other offering-related expenses.

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 holders of the pre-funded warrants exercised all of the May 2024 Pre-funded Warrants during the second quarter of 2025 by means of the cashless exercise provision and within the other constraints noted above.

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.

LantheusInvestment 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, 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.

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The gross proceeds to us from the Public Offering were approximately $69.0 million, before underwriting discounts and commissions and other offering-related expenses.

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.

The Jan. 2024 Pre-funded Warrants were exercisable at any time after the date of issuance. The holder of the Jan. 2024 Pre-funded Warrants 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 (2023 ATM Agreement), dated as of November 17, 2023, by and among us, Oppenheimer & Co. Inc., B. Riley Securities, Inc. and JonesTrading Institutional Services LLC. The sales resulted in gross proceeds to us of approximately $49.5 million. For additional information regarding the 2023 ATM Agreement, see our Form S-3 filed on November 17, 2023 and Form S-3/A filed on December 7, 2023.

Funding Requirements

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

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

continue the development of our other preclinical programs;

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

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

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

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

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

continue to build our manufacturing capabilities, including potential expansion of our manufacturing footprint;

support the development of 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, 2025, we had cash, cash equivalents and short-term investments of $144.7 million. In February 2026, we announced the closing of an underwritten offering of securities with gross proceeds of $175.0 million before deducting underwriting discounts and commissions and other offering-related expenses. We believe our cash, cash equivalents and short-term investments as of December 31, 2025, together with the net proceeds from the February 2026 proceeds, will be sufficient to fund our current clinical milestones and operational investments into late 2027. Operating expenses are expected to increase for research and development and general and administrative expenses as we work to implement our strategy to advance our clinical assets in our clinical trials, expand our manufacturing capabilities and progress our preclinical assets towards clinical trials. We anticipate a significant increase in 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 product candidates. If we receive regulatory approvals for our product 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.

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Because of the numerous risks and uncertainties associated with research, development and commercialization of our product 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 product candidates, and conducting preclinical studies and clinical trials;

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

the potential impact of U.S. and international trade policies, including tariffs, on our costs for supplies, equipment and materials used in the development and production of our TAT drug product candidates;

the potential impact of disruptions at the FDA, including due to a lapse in appropriations and/or decreased funding for the FDA, on our business; 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 product 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 product 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 drug product candidate 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.

In July 2023, we entered into a lease 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 lease 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 our leases, see Note 10, Leases in this Form 10-K.

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Effective April 2024, we entered into a lease for lab space in Coralville, IA. The lease terminates in March 2028. 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 lease 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 in March 2024 (see Note 3, Investments and Agreements, in this Form 10-K). The lease terminates in November 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 lease 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.

In August 2024, we assumed a lease from Progenics for office space in Somerset, NJ. The lease terminates in November 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 based upon the present value of the future lease 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.

In September 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.

In October 2025, we entered into an agreement with a general contractor to begin building modifications at our facility in the Chicago, IL metropolitan area along with preparations for the eventual installation of some of the Comecer manufacturing equipment and associated clean rooms. We currently estimate that the aggregate cost of these modifications will be approximately $27.5 million. However, actual costs may differ.

In November 2025, we entered into a lease for office space in Coralville, IA. The lease terminates in November 2028. Upon entering into this lease, we recognized a right-of-use asset and lease liability of approximately $0.2 million on the balance sheet based upon the present value of the future lease 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.

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, 2025. 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, 2025. 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, 2025, 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 2026 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

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21.1* Subsidiaries of the Company.

23.1* Consent of WithumSmith+Brown, PC.

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

+ 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 16, 2026

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 date indicated.

Dated: March 16, 2026

/s/ Johan (Thijs) Spoor

/s/ Joel Sendek

Joel Sendek, 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

/s/ Maria E. Martinez

Maria E. Martinez, Director

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Perspective Therapeutics, Inc. and Subsidiaries

Index to Consolidated Financial Statements

Report of Independent Registered Public Accounting Firm (PCAOB ID: 100) F-2

Consolidated Balance Sheets F-3

Consolidated Statements of Operations and Comprehensive Loss F-4

Consolidated Statements of Cash Flows F-5

Consolidated Statements of Changes in Stockholders’ Equity F-6

Notes to the Consolidated Financial Statements F-7

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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 sheets of Perspective Therapeutics, Inc. and Subsidiaries (collectively, the “Company”) as of December 31, 2025 and 2024, the related consolidated statements of operations and comprehensive loss, changes in stockholders’ equity, and cash flows for each of the two years in the period ended December 31, 2025, 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, 2025 and 2024, and the results of its operations and its cash flows for each of the two years in the period ended December 31, 2025, 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 these 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 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 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 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 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 audits 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 audits provide a reasonable basis for our opinion.

Critical Audit Matters

Critical audit matters 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: (1) relate to accounts or disclosures that are material to the consolidated financial statements and (2) involved our especially challenging, subjective, or complex judgments. We determined that there are no critical audit matters.

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

/s/ WithumSmith+Brown, PC

San Francisco, California

March 16, 2026

PCAOB ID Number 100

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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:

Accounts receivable, net of allowance for doubtful accounts: $375 and $543 6 116

Prepaid expenses and other current assets 3,646 4,128

Noncurrent assets:

Intangible assets, in-process research and development 40,000 50,000

LIABILITIES AND STOCKHOLDERS’ EQUITY

Current liabilities:

Accounts payable and accrued expenses $ 20,511 $ 10,343

Deferred Income (Note 3) - 1,400

Noncurrent liabilities:

Lease liability, net of current portion 1,005 1,428

Note payable, net of current portion 1,569 1,625

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

Other noncurrent liabilities 386 55

Commitments and contingencies (Note 16)

Stockholders’ equity:

Accumulated other comprehensive income (loss) 110 (51 )

Total liabilities and stockholders’ equity $ 266,972 $ 341,101

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 (376 ) (48 )

Other income from a related party (Note 3) 1,400 -

Equity in loss of affiliate (2 ) (8 )

Net loss from continuing operations (104,428 ) (80,427 )

Net gain (loss) from discontinued operations 514 (949 )

Net loss before deferred income tax benefit (103,914 ) (81,376 )

Deferred income tax benefit 793 2,097

Basic and diluted loss per share:

Loss from continuing operations $ (1.41 ) $ (1.22 )

Gain (loss) from discontinued operations 0.01 (0.01 )

Basic and diluted loss per share $ (1.40 ) $ (1.23 )

Unrealized gain (loss) on available-for-sale securities $ 161 $ (51 )

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:

Foreign currency adjustments 250 (65 )

Depreciation expense and amortization 3,251 2,306

Loss on disposal of property and equipment - 27

Net accretion of discounts on available-for-sale securities (2,723 ) (607 )

Loss on divestiture - 59

Goodwill impairment - 24,062

In-process research and development impairment 10,000 -

Deferred income tax benefit (793 ) (2,097 )

Changes in operating assets and liabilities:

Inventory related to discontinued operations (Note 4) - 11

Interest receivable (142 ) (880 )

Prepaid expenses and other current assets 624 (1,911 )

Accounts payable and accrued expenses 147 1,890

Other noncurrent liabilities 331 55

Net cash used in operating activities (82,484 ) (18,294 )

CASH FLOWS FROM INVESTING ACTIVITIES:

Additions to property and equipment (12,749 ) (54,414 )

Proceeds from the sale of property and equipment - 335

Additions to other assets (135 ) (72 )

Maturities of available-for-sale securities 173,950 -

Purchases of available-for-sale securities (119,838 ) (164,780 )

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

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

Net cash provided by (used in) investing activities 41,228 (218,931 )

CASH FLOWS FROM FINANCING ACTIVITIES:

Repayment of notes payable (52 ) (48 )

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

Proceeds from sales of common stock, pursuant to exercise of options 371 1,253

Proceeds from the sales of common stock and Pre-funded Warrants, net1 - 288,055

Proceeds from the issuance of common stock pursuant to the ATM, net1 9,986 -

Net cash provided by financing activities 10,305 289,385

Net (decrease) increase in cash and cash equivalents (30,951 ) 52,160

Cash and cash equivalents at beginning of period 61,580 9,420

CASH AND CASH EQUIVALENTS AT END OF PERIOD $ 30,629 $ 61,580

Supplemental schedule of noncash investing and financing activities:

Property and equipment in accounts payable and accrued expenses $ 9,771 $ -

Recognition of operating lease liability and right-of-use asset 205 2,115

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 Changes in Stockholders’ Equity

(In thousands, except shares)

Common Stock

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

Issuance of common stock pursuant to exercise of options 141,297 - 371 - - 371

Unrealized gain on available-for-sale securities 161 - 161

Share-based compensation - - 8,966 - - 8,966

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.”

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 4, Discontinued Operations, in this Annual Report on Form 10-K (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, par value $0.001 per share (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 in 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.

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, 2025, the Company had cash, cash equivalents and short-term investments of $144.7 million and total accumulated deficit of $334.8 million. In February 2026, the Company announced the closing of an underwritten offering with gross proceeds of $175.0 million before deducting underwriting discounts and commissions and other offering-related expenses. The Company has historically financed its operations primarily through selling equity.

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The Company believes that its $144.7 million of cash, cash equivalents and short-term investments as of December 31, 2025, together with the net proceeds from the February 2026 offering, will be sufficient to fund its current clinical milestones and operational investments into late 2027, 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.

Reclassifications

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, loss on divestiture was included in other noncash expense, net, as reported in the Consolidated Statements of Cash Flows.

2.

Summary of Significant Accounting Policies

Basis of Presentation and Principles of Consolidation

The accompanying consolidated financial statements have been prepared in accordance with generally accepted accounting principles 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 unrealized gains and non-credit-related losses recorded in other comprehensive income (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, 2025 and December 31, 2024, the Company had no held-to-maturity investments.

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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 in 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 in the Consolidated Statements of Operations and Comprehensive Loss.

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

Asset Minimum Maximum

Buildings 40

Research and development equipment 3 to 7

Office equipment 2 to 10

Furniture and fixtures 2 to 10

Vehicles 5 to 10

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

Property and equipment that is acquired but not yet placed in service is recorded in the Consolidated Balance Sheets at cost, and no depreciation expense or accumulated depreciation is recognized until the property and equipment is placed in service.

Management periodically reviews the net carrying value of all its long-lived assets on an asset-by-asset basis. An impairment loss is recognized if the carrying amount of a defined asset group is not recoverable and exceeds its fair value.

Although management has made its best estimate of the factors that affect the carrying value based on current conditions, it is reasonably possible that changes could occur which could adversely affect management’s estimate of net cash flows expected to be generated from its assets that could result in an impairment adjustment.

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Prepaid Expenses and Other Assets

Prepaid expenses and other assets, which include website development costs, trademarks, patents and licenses, are stated at cost, less accumulated amortization. For website development, costs incurred in the planning stage are expensed as incurred whereas costs associated with the application and infrastructure development, graphics development, and content development are capitalized. Amortization of website development costs is computed using the straight-line method over the estimated economic useful lives of the asset. Trademarks and patents include costs, primarily legal, incurred in obtaining them. Amortization of trademarks and patents is computed using the straight-line method over the estimated economic useful lives of the assets. Licenses include costs related to licenses pertaining to the use of technology or operational licenses. These licenses are recorded at stated cost, less accumulated amortization. Amortization of licenses is computed using the straight-line method over the estimated economic useful lives of the assets. The Company periodically reviews the carrying values of other assets and evaluates the recorded basis for any impairment. Any impairment is recognized when the expected future operating cash flows to be derived from the licenses are less than their carrying value.

Fair Value Measurement

When required to measure assets or liabilities at fair value, the Company uses a fair value hierarchy based on the level of independent, objective evidence surrounding the inputs used. The Company determines the level within the fair value hierarchy in which the fair value measurements in their entirety fall. The categorization within the fair value hierarchy is based upon the lowest level of input that is significant to the fair value measurement. Level 1 uses quoted prices in active markets for identical assets or liabilities, Level 2 uses significant other observable inputs, and Level 3 uses significant unobservable inputs. The amount of the total gains or losses for the period is included in earnings that are attributable to the change in unrealized gains or losses relating to those assets and liabilities still held at the reporting date. The Company has no financial assets or liabilities that are adjusted to fair value on a recurring basis.

Certain assets and liabilities, including net assets acquired in business combinations, are measured at fair value on a nonrecurring basis; that is, the assets or liabilities are not measured at fair value on an ongoing basis but are subject to fair value adjustments only in certain circumstances (for example, when there is evidence of impairment or an acquisition of a business). The Company’s investments, which include cash equivalents and short-term investments, are measured and recorded at fair value on a recurring basis. The carrying amounts of financial instruments, which include short-term investments, prepaid expenses and other current assets, accounts payable and accrued expenses, note payable and equity method investment are considered to be representative of their respective fair value because of the short-term nature of most of the investments and because the instruments could be exchanged in a current transaction between willing parties.

Comprehensive Loss

Comprehensive loss is defined as the change in equity during a period from transactions and other events and circumstances from non-owner sources, including unrealized gains and losses on investments and foreign currency gains and losses.

Share-Based Compensation

The Company measures and recognizes expense for all share-based payments at fair value. The Company uses the Black-Scholes option valuation model to estimate fair value for all stock options and stock warrants on the date of grant. For stock options that vest over time, the Company recognizes compensation cost on a straight-line basis over the requisite service period for the entire award. The Company recognizes forfeitures as they occur.

Research and Development Costs

Research and development costs, including salaries, research materials, administrative expenses and contractor fees, are charged to operations as incurred. The cost of equipment used in research and development activities which has alternative uses is capitalized as part of fixed assets and not treated as an expense in the period acquired. Depreciation of capitalized equipment used to perform research and development is classified as research and development expense in the year recognized.

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Income Taxes

Income taxes are accounted for under the liability method in accordance with Accounting Standards Codification (ASC) 740, Income Taxes. Under this method, the Company provides deferred income taxes for temporary differences that will result in taxable or deductible amounts in future years based on the reporting of certain costs in different periods for financial statement and income tax purposes. This method also requires the recognition of future tax benefits such as net operating loss carry-forwards, to the extent that realization of such benefits is not subject to an allowance. A valuation allowance is recognized on deferred tax assets when it is more likely than not that some or all of these deferred tax assets will not be realized. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in operations in the period that includes the enactment of the change. In the event that the Company is assessed penalties and/or interest, penalties will be charged to other operating expense and interest will be charged to interest expense in the period that they are assessed. The Company recognizes liabilities for uncertain tax positions based on a two-step process, whereby (1) it is determined whether it is more likely than not that the tax positions will be sustained based on the technical merits of the position and (2) for those tax positions that meet the “more likely than not” recognition threshold, the largest amount of tax benefit that is greater than 50% likely of being realized upon ultimate settlement with the related tax authority would be recognized.

Leases

The Company accounts for its leases under ASC 842, Leases. Under this guidance, arrangements meeting the definition of a lease are classified as operating or financing leases and are recorded in the Consolidated Balance Sheets as both a right-of-use asset and lease liability, calculated by discounting fixed lease payments over the lease term at the rate implicit in the lease or the Company’s incremental borrowing rate. Lease liabilities are increased by interest and reduced by payments each period, and the right-of-use asset is amortized over the lease term. For operating leases, interest on the lease liability and the amortization of the right-of-use asset result in straight-line rent expense over the lease term. Variable lease expenses are recorded when incurred.

In-Process Research and Development (IPR&D)

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. Post-acquisition R&D expenses related to these projects are expensed as incurred.

The Company tests 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. The Company 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 indefinite-lived intangible assets for impairment, the Company may perform both a qualitative assessment and quantitative assessment. For the qualitative assessment, the Company considers 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. If it is determined that an impairment exists, the Company recognizes 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.

The Company performed its annual qualitative IPR&D impairment analyses as of October 31, 2025, and determined it will no longer pursue further development of a preclinical asset within its IPR&D portfolio. For additional information regarding the IPR&D annual qualitative analysis, see Note 9, Intangible Assets and Other Assets, Net.

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Grant Revenue Recognition

The Company enters into contracts with governmental agencies for services. These contracts are analyzed in order to determine if they should be accounted for under a revenue recognition model pursuant to 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, the Company 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. The Company 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. The Company has elected to record grants related to income separately in the Consolidated Statements of Operations and Comprehensive Loss as “grant revenue.” The related expenses are recorded within R&D and general and administrative.

Loss per Share

Basic and diluted loss per share is calculated by dividing net loss by the weighted average number of shares of Common Stock outstanding and does not include the impact of any potentially dilutive common stock equivalents. In January 2024 and May 2024, the Company issued pre-funded warrants in connection with the Public Offering (as defined below) and the Registered Offering (as defined below), respectively (see Note 3, Investments and Agreements, in this Form 10-K). As the pre-funded warrants’ exercise price is nominal and there are no conditions that must be satisfied prior to their exercise, the pre-funded warrants are included in the calculation of the basic and diluted earnings per share as of December 31, 2025. At each of December 31, 2025 and 2024, the calculation of diluted weighted average shares did not include common stock warrants or options that were potentially convertible into Common Stock as those would be antidilutive due to the Company’s net loss position.

Securities not considered in the calculation of diluted loss per share, but that could be dilutive in the future, are as follows:

Equity Method Investment

Investments in companies for which the Company has the ability to exercise significant influence, but do not control, are accounted for under the equity method. Under the equity method of accounting, the Company’s share of the net earnings or losses of the investee are included in other income (expense) in the Consolidated Statements of Operations and Comprehensive Loss. At the end of each reporting period, the Company considers whether impairment indicators exist to evaluate whether an equity method investment is impaired and, if so, record an impairment loss. Investments are accounted for on a one-quarter lag. As changes in ownership percentage of the Company’s investments occur, the Company assesses whether it can exercise significant influence and account for under the equity method. If its ownership percentage of the company in which it has investment changes, the Company recognizes a gain or loss on the investment in the period of change. Included in the consolidated financial statements for the year ended December 31, 2025 is the Company’s proportional share of losses, which was de minimis.

Use of Estimates

The preparation of consolidated financial statements in accordance with GAAP requires management of the Company to make estimates and assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes of the Company including, but not limited to, the allowance for doubtful accounts receivable; the estimated useful lives used in calculating depreciation and amortization on the Company’s property and equipment, patents, trademarks and other assets; equity method investment; and inputs to the Black-Scholes calculation used in determining the expense related to share-based compensation including volatility and estimated lives of options granted. Accordingly, actual results could differ from those estimates and affect the amounts reported in the consolidated financial statements.

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Discontinued Operations

The Company categorizes the assets and liabilities of a business component as discontinued operations once management commits to a plan to sell, the business segment is available for immediate sale, management has initiated a plan to sell at a price that is reasonable in relation to its fair value, management anticipates the sale will occur within one year, and it is unlikely that significant changes will be made to the plan to sell. In addition, the business component must be comprised of operations and cash flows that are clearly distinguished from the rest of the entity. The results of discontinued operations are aggregated and presented separately in the Consolidated Balance Sheets and Consolidated Statements of Operations and Comprehensive Loss.

Recently Adopted and Recently Issued Accounting Pronouncements

In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740), which expands income tax disclosure requirements, including additional information pertaining to rate reconciliation, income taxes paid and other disclosures. This update is effective for annual periods beginning after December 15, 2024. The Company adopted ASU 2023-09 for the year ended December 31, 2025, and applied the new disclosure requirements prospectively to the current annual period. Prior period disclosures have not been adjusted to reflect the new disclosure requirements. Adoption of this ASU did not have a material impact on the financial statements and resulted only in expanded income tax disclosures. For additional information, see Note 14, Income Taxes.

Accounting Standards Updates to Become Effective in Future Periods

In July 2025, the FASB issued ASU 2025-05, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses for Accounts Receivable and Contract Assets, which allows all entities a practical expedient to assume that current conditions as of the balance sheet date do not change for the remaining life of the assets. This update is effective for fiscal years beginning after December 15, 2025, with early adoption permitted. Entities that elect the practical expedient should apply the guidance prospectively. The Company adopted ASU 2025-05 on January 1, 2026, and the adoption had no material impact on its consolidated financial statements.

In November 2024, the FASB issued ASU 2024-03, Income Statement-Reporting Comprehensive Income-Expense Disaggregation Disclosures, which requires companies to disclose disaggregated information about any relevant expense caption presented on the face of the income statement within continuing operations in the following required expense categories, as applicable: (1) purchases of inventory, (2) employee compensation, (3) depreciation, (4) intangible asset amortization and (5) depreciation, depletion and amortization recognized as part of oil- and gas-producing activities or other depletion expenses. This update will be effective beginning after December 15, 2026. The Company is currently evaluating the impact that adoption of ASU 2024-03 will have on its consolidated financial statements.

In December 2025, the FASB issued ASU 2025-11, Interim Reporting (Topic 270): Narrow-Scope Improvements, which clarifies interim disclosure requirements and the applicability of Topic 270. This update will be effective beginning after December 15, 2027. The Company is currently evaluating the impact that adoption of ASU 2025-11 will have on its consolidated financial statements.

Also in December 2025, the FASB issued ASU 2025-10, Government Grants (Topic 832): Accounting for Government Grants Received by Business Entities, which establishes authoritative guidance on the recognition, measurement, presentation and disclosure of government grants received by business entities. This update will be effective beginning after December 15, 2028, and interim reporting periods within those annual reporting periods. The Company is currently evaluating the impact that adoption of ASU 2025-10 will have on its consolidated financial statements.

Significant Accounting Policies Related to Discontinued Operations

Accounts Receivable

Accounts receivable relate to the Company’s discontinued operations (see Note 4, Discontinued Operations)and are stated at the amount that management of the Company expects to collect from outstanding balances. Management provides for probable uncollectible amounts through an allowance for doubtful accounts. Additions to the allowance for doubtful accounts are based on management’s judgment, considering historical experience with write-offs, collections and current credit conditions. Balances which remain outstanding after management has used reasonable collection efforts are written off through a charge to the allowance for doubtful accounts and a credit to the applicable accounts receivable. Payments received subsequent to the time that an account is written off are treated as bad debt recoveries.

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Revenue Recognition

The Company recognizes revenue based on the five-step model for revenue recognition as prescribed by ASU 2014-09, Revenue from Contracts with Customers (Topic 606), as follows: (1) identify the contract with the customer; (2) identify the performance obligations in the contract; (3) determine the transaction price; (4) allocate the prices to the performance obligations; and (5) recognize revenue. The Company has some agreements that contain general commercial terms and product prices but do not contain an obligation to provide goods to the customer. The Company’s performance obligation, which is established when the customer submits a purchase order and the Company accepts the order, is to deliver the product based on the purchase order received. The Company typically recognizes revenue at the time of shipment, at which time the title passes to the customer, and there are no further performance obligations.

Asset Retirement Obligation

The estimated fair value of the future retirement costs of the Company’s leased assets and the costs for the decontamination and reclamation of equipment located within the leased assets are recorded as a liability on a discounted basis when a contractual obligation exists; an equivalent amount is capitalized to property and equipment. The initial recorded obligation is discounted using the Company’s credit-adjusted risk-free rate and is reviewed periodically for changes in the estimated future costs underlying the obligation. The Company amortizes the initial amount capitalized to property and equipment and recognizes accretion expense in connection with the discounted liability over the estimated remaining useful life of the leased assets. Adjustments and changes to either the timing or amount of the original present value estimate underlying the obligation are made in the period incurred.

3.

Investments and Agreements

2026 Registered Offering

On February 2, 2026, the Company entered into an underwriting agreement with Piper Sandler & Co. and UBS Securities LLC, as representatives of the underwriters named therein, in connection with its previously announced underwritten offering (2026 Offering) of 39,576,088 shares (2026 Offering Shares) of the Company’s Common Stock, and, in lieu of 2026 Offering Shares to certain investors, pre-funded warrants (2026 Pre-funded Warrants) to purchase 6,598,046 shares of Common Stock. The price to the investors for the 2026 Offering Shares was $3.79 per 2026 Offering Share, and the price to the investors for the 2026 Pre-funded Warrants was $3.789 per 2026 Pre-funded Warrant, which represents the per share price for the 2026 Offering Shares less the $0.001 per share exercise price for each such 2026 Pre-funded Warrant. The 2026 Offering closed on February 3, 2026.

The gross proceeds to the Company from the 2026 Offering were approximately $175.0 million, before underwriting discounts and commissions and other offering-related expenses.

The exercise price and the number of shares of Common Stock issuable upon exercise of each 2026 Pre-funded Warrant are subject to appropriate adjustment in the event of certain stock dividends and distributions, stock splits, stock combinations, reclassifications or similar events affecting the Common Stock as well as upon any distribution of assets, including cash, stock or other property, to the Company’s stockholders. The 2026 Pre-funded Warrants will not expire and are exercisable in cash or by means of a cashless exercise. A holder of the 2026 Pre-funded Warrants may not exercise such 2026 Pre-funded Warrants if the aggregate number of shares of Common Stock beneficially owned by such holder, together with its affiliates, would be more than 4.99% or 9.99%, as elected by such holder, of the issued and outstanding shares of Common Stock following such exercise, as such percentage ownership is determined in accordance with the terms of the 2026 Pre-funded Warrants. A holder of the 2026 Pre-funded Warrants may increase or decrease this percentage not in excess of 19.99% by providing at least 61 days’ prior notice to the Company.

The 2026 Offering was made pursuant to our shelf registration statement on Form S-3 (File No. 333-279692), as amended, which was most recently declared effective on April 8, 2025, a related base prospectus dated April 8, 2025, and a free writing prospectus and prospectus supplement each dated February 2, 2026.

2024 At-the-Market (ATM) Agreement

On August 13, 2024, the Company 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 the Company from time to time may offer and sell shares (2024 ATM Shares) of its Common Stock, through or to the ATM Agents having an aggregate sales price of up to $250.0 million.

F-14

Table of Contents

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 the Company’s instructions. The Company has 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 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. The Company has 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.

Any Common Stock sold under the 2024 ATM Agreement will be issued and sold pursuant to the Company’s shelf registration statement on Form S-3 (File No. 333-279692) (the May 2024 Registration Statement), which initially became effective on May 24, 2024, and which was subsequently amended on March 26, 2025 and April 4, 2025, with Post-Effective Amendment #3 being declared effective by the SEC on April 8, 2025. On August 13, 2024, the Company initially filed a prospectus supplement to the May 2024 Registration Statement with the SEC in connection with the offer and sale of up to $250.0 million of the 2024 ATM Shares pursuant to the 2024 ATM Agreement. The Company re-filed the ATM prospectus supplement with each of the post-effective amendments to the May 2024 Registration Statement.

On February 18, 2025, the Company sold 3,379,377 shares of its 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, the Company entered into an underwriting agreement with BofA Securities, Inc., as representative of the underwriters named therein, in connection with its previously announced underwritten offering (Registered Offering) of 5,151,588 shares (Registered Offering Shares) of 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.

The gross proceeds to the Company from the Registered Offering were approximately $80.0 million, before underwriting discounts and commissions and other offering-related expenses.

The May 2024 Pre-funded Warrants became exercisable subsequent to the filing and effectiveness of an amendment to the Company’s 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 were 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 the Company’s stockholders. The May 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 the May 2024 Pre-funded Warrants could 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 have been 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 the May 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 the Company. The holders of the May 2024 Pre-funded Warrants exercised all of such warrants during the second quarter of 2025 by means of the cashless exercise provision and within the other constraints noted above.

March 2024 Private Placement with Institutional Investors

On March 4, 2024, the Company entered into an investment agreement (March 2024 Investment Agreement) with certain accredited institutional investors (Institutional Investors) pursuant to which the Company agreed to issue and sell, in a private placement (the March 2024 Private Placement), 9,200,998 shares of 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.

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The gross proceeds to the Company from the March 2024 Private Placement were approximately $87.4 million, before deducting fees payable to the Placement Agents (as defined below) and other estimated transaction expenses.

The March 2024 Private Placement was conducted pursuant to a Placement Agency Agreement, dated March 4, 2024 (the Placement Agency Agreement), by and between the Company and Oppenheimer & Co. Inc., as representative of the placement agents named therein (the Placement Agents). Per the Placement Agency Agreement, the Company agreed to: (i) pay the Placement Agents a cash fee equal to 5.85% of the gross proceeds received by the Company from the sale of the shares; and (ii) reimburse the Placement Agents for certain fees and expenses.

Lantheus Agreements

Investment Agreement

On January 8, 2024, the Company 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 the Company agreed to sell and issue to Lantheus in a private placement transaction certain shares (Lantheus Shares) of Common Stock. The closing of the purchase and sale of the Lantheus Shares to Lantheus by the Company (Lantheus Closing) was subject to the Company 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, the Company agreed to cooperate in good faith to negotiate and enter into a registration rights agreement with Lantheus, obligating the Company to file a registration statement on Form S-3 with the SEC to register for resale the Lantheus Shares issued at the Lantheus Closing. The Company 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 of the Company and Lantheus whereby Lantheus is provided certain board observer and information rights of the Company, subject to certain exceptions.

The Lantheus Investment Agreement also provides Lantheus with certain pro rata participation rights to maintain its ownership position in the Company in the event that the Company makes any public or non-public offering of any equity or voting interests in the Company or any securities that are convertible or exchangeable into (or exercisable for) equity or voting interests in the Company, subject to certain exceptions.

Pursuant to the Lantheus Investment Agreement, the Company is required to notify Lantheus within 10 business days of the end of a fiscal quarter in which the Company issued shares of Common Stock pursuant to at-the-market programs, including the 2024 ATM Agreement, of (i) the number of shares of Common Stock issued during such fiscal quarter pursuant to the 2024 ATM Agreement and (ii) the average price per share received by the Company before commissions (ATM Average Price). Upon receipt of such notice, Lantheus may elect, at its option, to purchase all or a portion of its Pro Rata Portion (as defined in the Lantheus Investment Agreement) of such shares at an aggregate price equal to the number of shares purchased multiplied by the ATM Average Price for such quarter (ATM Participation Right). Pursuant to the Lantheus Investment Agreement, Lantheus may not exercise the ATM Participation Right more than two times per calendar year.

Asset Purchase Agreement

On January 8, 2024, the Company entered into an Asset Purchase Agreement (Progenics APA) with Progenics Pharmaceuticals, Inc., a Delaware corporation (Progenics) and affiliate of Lantheus, pursuant to which the Company acquired certain assets and the associated lease of Progenics’ radiopharmaceutical manufacturing facility in Somerset, NJ, for a purchase price of $8.0 million in cash. The transactions contemplated by the Progenics APA closed on March 1, 2024.

Option Agreement

On January 8, 2024, the Company entered into an option agreement (Option Agreement) with Lantheus whereby Lantheus was granted an exclusive option to negotiate an exclusive, worldwide, royalty- and milestone-bearing right and license to [212Pb]VMT-α-NET, the Company’s clinical-stage alpha therapy developed for the treatment of neuroendocrine tumors. If good-faith negotiations fail, Lantheus has a one-year right to reenter negotiations if a third party offers to purchase or license the [212Pb]VMT-α-NET program. Additionally, Lantheus has a right to co-fund the Investigational New Drug (IND) application, enabling studies for early-stage therapeutic candidates targeting prostate-specific membrane antigen and gastrin-releasing peptide receptor and, prior to IND filing, a right to negotiate for an exclusive license to such candidates. In consideration of the rights granted by the Company to Lantheus pursuant to the Option Agreement, Lantheus paid to the Company a one-time payment of $28.0 million, subject to certain withholding provisions associated with the closing of the Progenics APA.

Source: SEC EDGAR (public domain) · 10-K for the period ended 2025-12-31, filed 2026-03-16 · accession 0000728387-26-000004

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