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| | | PART I | | |
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| Item 1. | | Business | | 5 |
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| Item 1A. | | Risk Factors | | 34 |
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| Item 1B. | | Unresolved Staff Comments | | 76 |
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| Item 1C. | | Cybersecurity | | 76 |
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| Item 2. | | Properties | | 77 |
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| Item 3. | | Legal Proceedings | | 77 |
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| Item 4. | | Mine Safety Disclosures | | 78 |
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| | | | | |
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| | | PART II | | |
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| Item 5. | | Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities | | 79 |
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| Item 6. | | [Reserved] | | 79 |
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| Item 7. | | Management’s Discussion and Analysis of Financial Condition and Results of Operations | | 80 |
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| Item 7A. | | Quantitative and Qualitative Disclosures about Market Risk | | 88 |
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| Item 8. | | Financial Statements and Supplementary Data | | 89 |
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| Item 9. | | Changes in and Disagreements with Accountants on Accounting and Financial Disclosure | | 117 |
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| Item 9A. | | Controls and Procedures | | 117 |
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| Item 9B. | | Other Information | | 117 |
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| | | | | |
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| | | PART III | | |
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| Item 10. | | Directors, Executive Officers and Corporate Governance | | 119 |
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| Item 11. | | Executive Compensation | | 119 |
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| Item 12. | | Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters | | 119 |
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| Item 13. | | Certain Relationships and Related Transactions, and Director Independence | | 119 |
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| Item 14. | | Principal Accountant Fees and Services | | 119 |
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| | | | | |
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| | | PART IV | | |
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| Item 15. | | Exhibits and Financial Statement Schedules | | 120 |
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| | | Signatures | | 123 |
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Forward-looking statements
This Annual Report on Form 10-K for the year ended December 31, 2025 (this “Annual Report”) contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and the Private Securities Litigation Reform Act of 1995. Written or oral statements that constitute forward-looking statements may be made by us or on our behalf. Words such as “expect,” “anticipate,” “intend,” “plan,” “believe,” “estimate,” “may,” “will,” “should,” “could,” “target,” “strategy,” “intend,” “project,” “guidance,” “likely,” “usually,” “potential,” or the negative of these words or variations of such words, similar expressions, or comparable terminology are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. There are a number of important risks and uncertainties that could cause our actual results to differ materially from those indicated by forward-looking statements. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make. These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry and markets in which we operate, and management’s beliefs and assumptions. These statements are not guarantees of future performance and involve certain risks, uncertainties and assumptions that are difficult to predict and may cause our actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by any forward-looking statements. These risks, uncertainties and other factors include, but are not limited to, risks associated with the following:
| ● | our ability to develop and commercialize our current and future product candidates; |
| ● | our ability to expand our pipeline of product candidates and the success of future product candidate advancements, including the success of future preclinical studies and clinical trials, and our ability to commercialize our products; |
| ● | the reliability of the results of the clinical trials relating to human safety and possible adverse effects resulting from the administration of our product candidates; |
| ● | our ability to obtain potential regulatory approvals on the timelines anticipated, or at all; |
| ● | our ability to obtain additional patents or extend existing patents on the timelines anticipated, or at all; |
| ● | our ability to identify and consummate potential future strategic partnerships or business combinations; |
| ● | our expectations regarding the potential market size and the size of the patient populations for our product candidates, if approved for commercial use; |
| ● | our anticipated financial or operational results; |
| ● | our ability to obtain additional capital resources; |
| ● | risks related to the conflict in Israel and the Gaza Strip and the conflict in Ukraine on the global economy, including causing or contributing to global supply chain disruption, price fluctuations, including increased costs for raw materials, and other significant economic effects; |
| ● | breaches or other data privacy incidents, or disruptions in our information technology systems; |
| ● | our ability to continue to satisfy the listing requirements of the Nasdaq Global Market (“Nasdaq”); and |
| ● | risks detailed under the caption “Risk Factors” in this Annual Report and in our other reports filed with the U.S. Securities and Exchange Commission (“SEC”), from time to time hereafter. |
We have based the forward-looking statements included in this Annual Report on information available to us on the date of this annual report. Except as required by law we undertake no obligation to revise or update any forward-looking statements, whether as a result of new information, future events or otherwise. You are advised to consult any additional disclosures that we may make in reports that we, in the future, may file with the SEC, including annual reports on Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K.
All forward-looking statements included herein are expressly qualified in their entirety by the foregoing cautionary statements. Unless otherwise indicated, the information in this Annual Report is as of December 31, 2025.
Note regarding trademarks
“Altimmune,” our logo and any other trademarks, trade names or service marks of the Company appearing in this Annual Report are the property of the Company. The other trademarks, trade names and service marks appearing in this Annual Report are the property of their respective owners. We do not intend our use or display of other companies’ trademarks, trade names or service marks to imply an endorsement or sponsorship of us by such companies, or any relationship with such companies. Solely for convenience, trademarks and trade names referred to in this Annual Report may appear without the® or TM symbol.
The risk factors detailed in Item 1A entitled “Risk Factors” in this Annual Report on Form 10-K are the risks that we believe are material to our investors and a reader should carefully consider them. Those risks are not all of the risks we face and other factors not presently known to us or that we currently believe are immaterial may also affect our business if they occur. The following is a summary of the risk factors detailed in Item 1A:
Risks Related to Our Business, Financing Requirements, Product Development and Clinical Trials
| ● | we have incurred significant losses since our founding and anticipate that we will continue to incur significant losses for the foreseeable future and may never achieve or maintain profitability |
| ● | our profitability depends on our ability to develop and commercialize our current and future product candidates |
| ● | our ability to raise capital may be limited by applicable laws and regulations |
| ● | we may encounter substantial delays in our clinical trials, or our clinical trials may fail to demonstrate the safety and efficacy of our product candidates to the satisfaction of applicable regulatory authorities |
| ● | we may find it difficult to enroll patients in our clinical trials, which could delay or prevent clinical trials of our product candidates |
| ● | it may be difficult to predict the time and cost of product development for our product candidates, and unforeseen problems may prevent further development or approval of our product candidates |
| ● | we rely, and expect to continue to rely, on third parties to conduct preclinical studies and clinical trials for our product candidates, and if they do not properly and successfully perform their obligations to us, we may not be able to obtain regulatory approvals for our product candidates |
| ● | we face substantial competition from other pharmaceutical and biotechnology companies, which may result in others discovering, developing or commercializing products before, or more successfully, than we do |
| ● | we are heavily dependent on the success of our leading product candidate, pemvidutide. If we ultimately are unable to develop, obtain regulatory approval for or commercialize pemvidutide, or any other product candidate, our business will be substantially harmed |
| ● | labor shortages and constraints in the supply chain could adversely affect our results of operations |
| ● | our overall performance depends in part on global macroeconomic, political and geopolitical uncertainties |
Risks Related to the Regulatory Approval Process
| ● | our product candidates may cause undesirable side effects or have other properties that delay or prevent their regulatory approval or limit their commercial potential |
| ● | our ability to obtain regulatory approval and market our products, including in non-U.S. jurisdictions |
| ● | ongoing regulatory obligations and review that may result in significant additional expenses and restrictions, even if our product candidates are approved |
Risks Related to Our Intellectual Property
| ● | the cost and difficulty of protecting our proprietary rights and the potential that our intellectual property rights do not adequately protect our product candidates |
| ● | our ability to protect our intellectual property rights throughout the world |
| ● | the adequacy of our patent terms to protect our competitive position on our products for an adequate amount of time |
| ● | third-party claims of intellectual property infringement or misappropriation, including circumstances involving our employees, independent contractors or consultants |
Risks Related to Commercialization of our Product Candidate
| ● | our ability to attain significant market acceptance of our product candidates, if approved, among physicians, patients, third-party payers and others in the medical community |
| ● | our reliance on third parties to manufacture our products in sufficient quantities to meet commercial demand the ability of our contract manufacturers to manufacture any such product to the specifications and the quantities that are needed along the timelines that are specified |
| ● | the use of emerging technologies, including artificial intelligence, in our development and commercialization efforts may expose us to cybersecurity, regulatory and liability risks |
Risks Related to Reimbursement and Government Regulation
| ● | disruptions and uncertainty at government regulatory agencies, including the FDA |
| ● | our ability to obtain coverage and reimbursement in certain market segments for our product candidates, if they are approved |
| ● | the imposition of price controls |
| ● | our ability to comply with federal and state health care and other laws, and the complexity of our regulatory compliance obligations |
| ● | the unknown impact of recent health care reform legislation and other changes in the health care industry and in health care spending |
Risks Related to our Securities
| ● | the volatility of the trading price of our common stock and substantial price fluctuations on heavy volume |
Risks Related to our Indebtedness
| ● | restrictions on our operating activities due to covenants under our term loan obligation and the risk of repayment upon an event of default |
| ● | our level of indebtedness and debt service obligations and their impact on our financial condition and ability to fund operations |
