Perspective Therapeutics Inc

For the period ended Dec 31, 2023. Filed Mar 28, 2024.

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A company's yearly report to the SEC, with audited financial statements. It is the fullest account a company gives of its business, its finances and the risks it sees.

FY2023 · Filed Mar 28, 2024

CATX$0.86+1.9%Stored close · as of Nov 9, 2026

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Contents

Page
PART I
ITEM 1 –	BUSINESS	4
ITEM 1A –	RISK FACTORS	34
ITEM 1B –	UNRESOLVED STAFF COMMENTS	53
ITEM 1C –	CYBERSECURITY	53
ITEM 2 –	PROPERTIES	54
ITEM 3 –	LEGAL PROCEEDINGS	54
ITEM 4 –	MINE SAFETY DISCLOSURES	55
PART II
ITEM 5 –	MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES	55
ITEM 6 –	[RESERVED]	55
ITEM 7 –	MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS	56
ITEM 7A –	QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK	64
ITEM 8 –	FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA	64
ITEM 9 –	CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE	64
ITEM 9A –	CONTROLS AND PROCEDURES	64
ITEM 9B –	OTHER INFORMATION	65
ITEM 9C –	DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS	65
PART III
ITEM 10 –	DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE	65
ITEM 11 –	EXECUTIVE COMPENSATION	68
ITEM 12 –	SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS	74
ITEM 13 –	CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE	76
ITEM 14 –	PRINCIPAL ACCOUNTANT FEES AND SERVICES	77
PART IV
ITEM 15 –	EXHIBITS AND FINANCIAL STATEMENT SCHEDULES	78
SIGNATURES	80

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.

CAUTION REGARDING FORWARD-LOOKING INFORMATION

In addition to historical information, this 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.

All statements contained in this Form 10-K, other than statements of historical facts, 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,” “project,” “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:

●	the timing, progress and results of our preclinical studies and clinical trials of our current and future program 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;
●	our ability to obtain and maintain regulatory approvals for our future program candidates;
●	our manufacturing capabilities and strategy, including the scalability and commercial viability of our manufacturing methods and processes;
●	our ability to identify patients with the diseases treated by our program candidates and to enroll these patients in our clinical trials;
●	our expectations regarding the potential functionality, capabilities and benefits of our program candidates, if approved for commercial use;
●	the potential size of the commercial market for our program candidates;
●	our expectations regarding the scope of any approved indication for any program candidate;
●	our ability to successfully commercialize our program candidates;
●	our ability to leverage technology to identify and develop future program candidates;
●	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;
●	our belief regarding the sufficiency of our cash resources to fund our operating expenses and capital expenditure requirements into 2026;
●	our competitive position and expectations regarding developments and projections relating to our competitors or our industry; and
●	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. However, 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” beginning on page 34 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 these cautionary statements 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 the Company’s 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.

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

●	We are a clinical-stage biopharmaceutical company and have a limited operating history upon which to base an investment decision.
●	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.
●	We have incurred losses in nearly every year since our inception, and we anticipate that we will not achieve profits for the foreseeable future. To date, we have had no product revenues other than from our brachytherapy business, which is expected to be divested in the first half of 2024.

Risks Related to Our Business and Industry

●	Coverage and adequate reimbursement may not be available for our products, if commercialized, which could make it difficult for us to sell our products profitably.
●	Our program 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 of or the termination of any clinical trial of our program candidates could harm our business, financial condition and prospects.
●	We obtain our supply of Thorium-228 from a single supplier.
●	If we encounter difficulties enrolling patients in our clinical trials, our clinical development activities could be delayed or otherwise adversely affected.
●	Because the results of preclinical studies and early clinical trials are not necessarily predictive of future results, any program candidate we advance into clinical trials may not have favorable results in later clinical trials, if any, or receive regulatory approval.
●	Delays in the commencement or completion of our clinical trials could result in increased costs and delay our ability to pursue regulatory approval and commercialization of our program candidates.
●	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.
●	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 program candidates from applicable regulatory authorities, we will not be able to market and sell those program candidates in those countries or regions and our business will be substantially harmed.
●	We intend to rely on third-party collaborators to market and sell our programs, and those third-party collaborators may not have the resources to pursue approvals, which in turn could severely limit our potential markets and ability to generate revenue.
●	Our program 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.
●	If we are unable to execute our sales and marketing strategy for our programs and are unable to gain market acceptance, we may be unable to generate sufficient revenue to sustain our business.
●	Because we license some of our program 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 program candidates.
●	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.
●	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 program candidate, and our dependence on third party suppliers could adversely impact our business.
●	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 program candidates when expected or at all.
●	We may seek orphan drug designation, rare pediatric disease designation or other United States Food and Drug Administration ("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 program candidate does not meet the FDA requirements at the time of approval or licensure.
●	We have received Fast Track designation for VMT-α-NET, 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 program candidate no longer meets the qualifying criteria for Fast Track.
●	We will face intense competition and may not be able to compete successfully.
●	Our success will depend upon intellectual property, proprietary technologies and regulatory market exclusivity periods, and we may be unable to protect our intellectual property.
●	We intend to rely on market exclusivity periods that may not be or remain available to us.
●	We must deploy our sales and marketing capabilities to market, distribute and sell our programs if any of our program candidates are approved, and may not be effective in doing so.
●	If any program 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.
●	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.
●	If we fail to attract and retain key management and clinical development personnel, we may be unable to successfully develop or commercialize our program candidates.
●	Our ability to compete may decline if we do not adequately protect our proprietary rights.

Risks Related to Our Discontinued Brachytherapy Industry and Operations

●	Continuing regulatory liability may exist from our discontinued operations.
●	We are subject to the risk that certain third parties may mishandle our product.

Legal and Regulatory Risks Related to the Our Operations

●	Significant disruptions of information technology systems or breaches of data security could materially adversely affect our business, results of operations and financial condition.
●	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.
●	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.
●	We are subject to U.S. and foreign anti-corruption and anti-money laundering laws with respect to our operations, and noncompliance with such laws can subject us to criminal and/or civil liability and harm our business.
●	Healthcare reform measures could hinder our programs’ commercial success.
●	If, once we offer commercialized drug products, we participate in the Medicaid Drug Rebate Program and other governmental pricing programs, failure to comply with obligations under these programs could result in additional price concession requirements, penalties, sanctions and fines, which could have a material adverse effect on our business, operations and financial condition.
●	Pending and future patent litigation could be costly and disruptive and may have an adverse effect on our financial condition and results of operations.
●	The value of our granted patents, and our patents pending, is uncertain.
●	Failure to comply with government regulations could harm our business.
●	Our business exposes us to product liability claims.
●	Our business involves environmental risks.

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

●	Our reporting obligations as a public company are costly.
●	Our common stock price is likely to be volatile and may be adversely affected by the future issuance and sale of shares of our stock or other equity interests.
●	We do not expect to pay any dividends for the foreseeable future.

PART I

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