Perspective Therapeutics, Inc.

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

In addition to historical information, this Annual Report on Form 10-K (“Annual Report” or “Form 10-K”), contains certain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 (PSLRA). This statement is included for the express purpose of availing Perspective Therapeutics, Inc. of the protections of the safe harbor provisions of the PSLRA.

This Form 10-K, including Management’s Discussion and Analysis of Financial Condition and Results of Operations in Part II, Item 7, contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the Securities Act), and Section 21E of the Securities Exchange Act of 1934, as amended (the Exchange Act). All statements contained in this Form 10-K other than statements of historical fact, including, without limitation, statements regarding our future financial condition, results of operations, business strategy and plans and objectives of management for future operations, industry trends and other future events are forward-looking statements. In some cases, you can identify forward-looking statements by terminology, such as “believe,” “expect,” “anticipate,” “intend,” “estimate,” “forecast,” “project,” “may,” “could,” “might,” “plan,” “should,” “will,” “would” or the negative of these terms and other similar expressions, although not all forward-looking statements contain these identifying terms. Forward-looking statements in this Form 10-K include, among other things:

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the timing, progress and results of our preclinical studies and clinical trials of our current and future product candidates, including statements regarding the timing of our planned regulatory communications, submissions and approvals, initiation and completion of studies or trials and related preparatory work and the period during which the results of the trials will become available, and our research and development programs;

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our ability to obtain and maintain regulatory approvals for our future product candidates, including our ability to obtain Fast Track designation from the U.S. Food and Drug Administration (FDA) under our Investigational New Drug application for our novel asset, PSV359;

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

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our manufacturing infrastructure, capabilities and strategy, including the scalability and commercial viability of our manufacturing methods and processes, and the potential expansion of our regional network of drug product candidate finishing facilities;

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our expectation that our manufacturing infrastructure will have the capacity to meet future clinical trial and commercial demands at major treatment centers;

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our ability to expand our supply network and distribution capabilities;

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our ability to identify patients with the diseases treated by our product candidates and to enroll these patients in our clinical trials;

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the risk that unconfirmed responses reported in preliminary or interim data from our clinical trials may not ultimately result in confirmed responses to treatment after follow-up evaluations or audit and verification procedures;

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our expectations regarding the potential functionality, capabilities and benefits of our product candidates, if approved, for commercial use;

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the potential size of the commercial market for our product candidates and other programs;

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our expectations regarding the scope of any approved indication for any product candidate or other program;

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our ability to successfully commercialize our product candidates;

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our ability to leverage technology to identify and develop future product candidates;

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our estimates of our expenses, ongoing losses, future revenue, capital requirements and our need for or ability to obtain additional funding before we can expect to generate any revenue from product sales;

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our belief regarding the sufficiency of our cash resources to fund our current planned clinical milestones and operational investments into late 2027;

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our competitive position and expectations regarding developments and projections relating to our competitors or our industry;

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the potential impacts 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 targeted alpha therapy drug product candidates; and

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expectations, beliefs, intentions and strategies regarding the future.

These statements are based on certain assumptions and analyses made by us in light of our experience and our assessment of historical trends, current conditions and expected future developments as well as other factors we believe are appropriate under the circumstances. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond our control) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. Whether actual results will conform to the expectations and predictions of management is subject to a number of risks and uncertainties as updated in this Form 10-K in Item 1A under the heading “Risk Factors” below that may cause actual results to differ materially. Consequently, all of the forward-looking statements made in this Form 10-K are qualified by such risks and uncertainties, and there can be no assurance that the actual results anticipated by management will be realized or, even if substantially realized, that they will have the expected consequences to or effects on our business operations. Readers are cautioned not to place undue reliance on such forward-looking statements as they speak only of our views as of the date the statement was made (or any earlier date indicated in such statement). While we may update certain forward-looking statements from time to time, we undertake no obligation to do so, whether as a result of new information, future events or otherwise, except as required by applicable law. Our U.S. Securities and Exchange Commission (SEC) filings are available publicly on the SEC’s website at www.sec.gov.

NOTE REGARDING COMPANY REFERENCES

Unless the context requires otherwise, references to “Perspective,” “the Company,” “our company,” “we,” “us” and “our” refer to Perspective Therapeutics, Inc., and, as the context requires, 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.

BASIS OF PRESENTATION

On June 14, 2024, we filed a Certificate of Amendment to our Certificate of Incorporation with the Secretary of State of the State of Delaware to effect a 1-for-10 reverse stock split of our issued and outstanding shares of common stock, par value $0.001 per share (Reverse Split), which became effective on that date. All historical share and per share amounts reflected throughout this Annual Report on Form 10-K have been adjusted to reflect the Reverse Split. However, our periodic and current reports, and all other documents that were filed prior to June 14, 2024, do not give effect to the Reverse Split.

SUMMARY OF RISK FACTORS

Investing in our common stock involves significant risks. Some of the principal risks related to our business include the following. These risks are discussed more fully under “Item 1A - Risk Factors” of this Annual Report.

Risks Related to Our Business, Financial Results and Need for Additional Capital

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We are a clinical-stage biopharmaceutical company and have a limited operating history upon which to base an investment decision.

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We will require substantial additional capital to fund our operations. Additional funds may be dilutive to shareholders or impose operational restrictions. Further, if additional capital is not available, we may need to delay, limit or eliminate our research, development and commercialization programs and modify our business strategy.

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We have incurred losses in nearly every year since our inception, and we anticipate that we will not achieve profits for the foreseeable future.

Risks Related to Our Business and Industry

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Our product candidates are in early stages of development and must go through clinical trials, which are very expensive, time consuming and difficult to design and implement. The outcomes of clinical trials are uncertain, and delays in the completion or termination of any clinical trial of our product candidates could harm our business, financial condition and prospects.

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We rely on single vendors to provide supplies and services used in the development and production of our alpha-particle therapies.

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If we encounter difficulties enrolling patients in our clinical trials, our clinical development activities could be delayed or otherwise adversely affected.

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Because the results of preclinical studies and early clinical trials are not necessarily predictive of future results, any product candidate we advance into clinical trials may not have favorable results in later clinical trials, if any, or receive regulatory approval.

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Delays in the commencement, execution or completion of our clinical trials could result in increased costs and delay our ability to pursue regulatory approval and commercialization of our product candidates.

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We may be required to suspend, repeat or terminate our clinical trials if they are not conducted in accordance with regulatory requirements, the results are negative or inconclusive, or the trials are not well designed.

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The approval processes of regulatory authorities are lengthy, time consuming, expensive and inherently unpredictable; if we experience unanticipated delays or are unable to obtain approval for our product candidates from applicable regulatory authorities, we will not be able to market and sell those product candidates in those countries or regions and our business will be substantially harmed.

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Disruptions at the FDA, including due to a lapse in appropriations and/or decreased funding for the FDA, could prevent the FDA from performing functions on which our business relies, which could negatively impact our business.

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We receive federal funding to conduct certain research on our product candidates and other programs, and recent federal policy changes could disrupt that funding.

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Our product candidates may cause undesirable side effects or have other properties that could delay or prevent their regulatory approval, limit the commercial profile of the approved labeling, or result in significant negative consequences following marketing approval, if any.

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If we are unable to execute our sales and marketing strategy for our product candidates, if commercialized, and are unable to gain market acceptance, we may be unable to generate sufficient revenue to sustain our business.

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Because we license technology underlying some of our product candidates from third parties, any dispute with our licensors or non-performance by us or by our licensors may adversely affect our ability to develop and commercialize the applicable product candidates.

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We may form or seek strategic alliances or enter into additional licensing arrangements in the future, and we may not realize the benefits of such alliances or licensing arrangements.

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We may rely partially on third parties to manufacture our clinical pharmaceutical supplies and could continue to rely on third parties to produce commercial supplies of any approved product candidate, and our dependence on third party suppliers could adversely impact our business.

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We may not be successful in managing the build-out of our manufacturing facilities and associated costs or satisfying manufacturing-related regulatory requirements.

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We rely on third parties to conduct our clinical trials, and if these third parties do not meet their deadlines or otherwise conduct the trials as required, our clinical development programs could be delayed or unsuccessful, and we may not be able to obtain regulatory approval for or commercialize our product candidates when expected or at all.

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We have in-sourced part of the research, development and clinical operations functions previously assigned to clinical research organizations, and we may not be able to efficiently execute those operations, or the cost savings expected from this transition may not materialize, which may adversely affect the financial performance of our business and our ability to advance our pipeline.

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We may seek orphan drug designation, rare pediatric disease designation or other FDA designations but may not receive such designation. Even if the FDA grants the designation, we may not receive orphan drug exclusivity or a priority review voucher if the product candidate does not meet the FDA requirements at the time of approval or licensure.

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We have received Fast Track designation for VMT-α-NET and VMT01, but such designation may not actually lead to a faster development or regulatory review or approval process. Additionally, the FDA may rescind the designation if it determines the applicable product candidate no longer meets the qualifying criteria for Fast Track.

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We will face intense competition and may not be able to compete successfully.

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We may rely on market exclusivity periods that may not be or remain available to us.

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If any product candidate that we successfully develop does not achieve broad market acceptance among physicians, patients, healthcare payors and the medical community, the revenues that it generates from their sales will be limited.

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Coverage and adequate reimbursement may not be available for our products, if commercialized, which could make it difficult for us to sell any future products profitably.

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Due to the significant resources required for the development of our drug candidates, we must prioritize development of certain drug candidates and/or certain disease indications and may expend our limited resources on candidates or indications that do not yield a successful program and fail to capitalize on drug candidates or indications that may be more profitable or for which there is a greater likelihood of success.

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If we fail to attract and retain key management, scientific and clinical development personnel, we may be unable to successfully develop or commercialize our product candidates.

Legal and Regulatory Risks Related to Our Operations

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Significant disruptions of information technology systems or cybersecurity incidents could materially adversely affect our business, results of operations and financial condition.

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Our employees and independent contractors, including principal investigators, consultants, commercial collaborators, service providers and other vendors, may engage in misconduct or other improper activities, including noncompliance with regulatory pricing standards and requirements, which could have an adverse effect on our results of operations.

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If we fail to comply with applicable healthcare regulations, we could face substantial penalties, and our business, operations and financial condition could be adversely affected.

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Healthcare reform measures could hinder our programs’ commercial success.

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Failure to comply with government regulations could harm our business.

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Our business exposes us to product liability claims.

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Our business involves environmental risks.

Risks Related to Intellectual Property Matters

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Our success will depend upon intellectual property, proprietary technologies and regulatory market exclusivity periods, and we may be unable to protect our intellectual property.

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Our ability to compete may be adversely affected if we do not adequately protect our proprietary rights.

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Potential patent litigation could be costly and disruptive and may have an adverse effect on our business, financial condition and results of operations.

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The value of our granted patents and our patents pending is uncertain.

Risks Related to Ownership of Shares of Common Stock and Public Company Status

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The concentration of our common share ownership will likely limit the ability of other shareholders to influence corporate matters.

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Our stock price has been and may continue to be volatile.

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The price of our common stock may be adversely affected by the future issuance and sale of shares of our common stock or other equity securities.

PART I