Altimmune (ALT) risk factors, FY2024 10-K

Risks Related to Our Business, Financing Requirements, Product Development and Clinical Trials

1. 01We 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
2. 02Our profitability depends on our ability to develop and commercialize our current and future product candidates
3. 03We will require substantial additional financing to achieve our goals, and a failure to obtain this necessary capital when needed would force us to delay, limit, reduce or terminate our product development or commercialization efforts
4. 04Our ability to raise capital may be limited by applicable laws and regulations
5. 05Raising additional capital may cause dilution to stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates on unfavorable terms
6. 06Our product candidates are in an early stage of development, there is a high risk of failure, and we may never succeed in developing marketable products or generating product revenue
7. 07Interim and preliminary results from our clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to additional audit, validation and verification procedures that could result in material changes in the final data
8. 08The manufacture of our product candidates is complex and we may encounter difficulties in production, particularly with respect to acquisition of materials, process development or scaling-up of our manufacturing capabilities
9. 09We 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
10. 10We may find it difficult to enroll patients in our clinical trials, which could delay or prevent clinical trials of our product candidates
11. 11We may not be able to initiate or continue clinical trials if we cannot enroll a sufficient number of eligible subjects to participate in the clinical trials required by regulatory agencies
12. 12It 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
13. 13We 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
14. 14We 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
15. 15license novel compounds that could make the products that we develop obsolete. We also face competition from smaller companies who, like us, rely on investors to fund research and development and compete for co-development and licensing opportunities from large and established pharmaceutical companies
16. 16We 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
17. 17Even if a current or future product candidate receives marketing approval, it may fail to achieve the degree of market acceptance by physicians, patients, third-party payers and others in the medical community necessary for commercial success
18. 18We may not be able to comply with the requirements of foreign jurisdictions in conducting trials within the United Kingdom, European Union (“EU”) or any other foreign country
19. 19If we fail to attract and keep senior management and key scientific personnel, we may be unable to successfully develop our products, conduct our clinical trials and commercialize our product candidates
20. 20A pandemic, epidemic or outbreak of an infectious disease in the United States such as the COVID-19 pandemic may adversely affect our business
21. 21Labor shortages and constraints in the supply chain could adversely affect our results of operations
22. 22Our overall performance depends in part on worldwide economic conditions and uncertainties
23. 23We may not be able to utilize a significant portion of our net operating loss carryforwards, which could harm our results of operations

Risks Related to the Regulatory Approval Process

1. 24Our product candidates may cause undesirable side effects or have other properties that delay or prevent their regulatory approval or limit their commercial potential
2. 25Fast track designation by the FDA may not lead to a faster development or regulatory review or approval process, and does not assure FDA approval of any product candidates that we may develop
3. 26If the FDA or comparable foreign regulatory authorities approve generic or biosimilar versions of any of our products that receive marketing approval, or if we do not obtain the exclusivity periods for our approved products that we hope to achieve, the sales of our products could be adversely affected

Risks Related to Our Intellectual Property

1. 27We may not be able to protect our intellectual property rights throughout the world
2. 28Patent terms may be inadequate to protect our competitive position on our products for an adequate amount of time
3. 29We may become involved in lawsuits to protect or enforce our intellectual property, which could be expensive, time consuming and unsuccessful
4. 30Third-party claims of intellectual property infringement or misappropriation may prevent or delay our development and commercialization efforts
5. 31further using such trade secrets, limiting our ability to develop our product candidates, and we may be required to pay damages
6. 32We may be subject to claims that our employees, independent contractors or consultants have wrongfully used or disclosed alleged trade secrets of their former employers, or our employees may challenge the inventorship of our patents
7. 33We have in-licensed a portion of our intellectual property, and, if we fail to comply with our obligations under these arrangements, we could lose such intellectual property rights or owe damages to the licensor of such intellectual property
8. 34We may need to license certain intellectual property from third parties, and such licenses may not be available on commercially reasonable terms or at all
9. 35Confidentiality agreements with employees and third parties may not prevent unauthorized disclosure of proprietary information
10. 36If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest and our business may be adversely affected

Risks Related to Commercialization of the Company’s Product Candidates

1. 37Our future commercial success depends upon attaining significant market acceptance of our product candidates, if approved, among physicians, patients, third-party payers and others in the medical community
2. 38We rely on, and expect to continue to rely on, third parties to manufacture our product candidates and related materials for our products, if approved, as well as for our clinical trials and preclinical studies, and these third parties may not perform satisfactorily
3. 39If we are unable to manufacture our products in sufficient quantities, or at sufficient yields, or are unable to obtain regulatory approvals for a manufacturing facility for our products, we may experience delays in product development, clinical trials, regulatory approval and commercial distribution
4. 40If we are unable to establish sales, marketing and distribution capabilities, we may not be successful in commercializing our product candidates if they are approved
5. 41We may encounter difficulties in managing our growth and expanding our operations successfully
6. 42We may not be successful in establishing and maintaining strategic partnerships, which could adversely affect our ability to develop and commercialize products
7. 43our product candidates could delay the development and commercialization of our product candidates and reduce their competitiveness even if they reach the market
8. 44As part of our business strategy, we may pursue acquisitions of assets or licenses of assets, including preclinical, clinical or commercial stage products or product candidates, businesses, strategic alliances, joint ventures and collaborations, to expand our existing technologies and operations
9. 45If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of our product candidates
10. 46A breakdown in our information technology systems could result in a significant disruption to our business

Risks Related to Reimbursement and Government Regulation

1. 47Coverage and reimbursement may be limited or unavailable in certain market segments for our product candidates, if they are approved, which could make it difficult for us to sell our products profitably
2. 48Price controls may be imposed, which may adversely affect our future profitability
3. 49We are subject to multiple and substantial federal and state health care and other laws, and the complexity of our regulatory compliance obligations is likely to increase in the event our product candidates are commercialized
4. 50The impact of recent health care reform legislation and other changes in the health care industry and in health care spending on the Company is currently unknown and may adversely affect our business model
5. 51Changes in funding for the FDA and other domestic and foreign government authorities could hinder their ability to hire and retain key leadership and other personnel, or otherwise prevent new products and services from being developed or commercialized in a timely manner, which could negatively impact our business
6. 52licensing of sales representatives. In addition, several states require pharmaceutical companies to implement compliance programs or marketing codes of conduct
7. 53We must comply with data privacy and security laws and regulations, and failure to comply with these laws and regulations could expose us to significant liabilities
8. 54We are subject to extensive government regulatory compliance and ethics oversight, and we will need to develop more extensive compliance and ethics policies in the future
9. 55Our employees, independent contractors, principal investigators, consultants, commercial partners and vendors may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements
10. 56We must comply with environmental laws and regulations, and failure to comply with these laws and regulations could expose us to significant liabilities

Risks Related to our Securities

1. 57The trading price of our common stock has been volatile with substantial price fluctuations on heavy volume, which could result in substantial losses for purchasers of our common stock and existing stockholders
2. 58Our stock price has been and, in the future, may be subject to substantial volatility. Since our common stock began trading on a post-reverse stock split basis on September 14, 2018 and through December 31, 2024, our stock has traded in a range with a low of $1.51 and a high of $36.25
3. 59Future sales and issuances of our common stock or rights to purchase common stock could result in substantial dilution to the percentage ownership of our stockholders
4. 60If we do not meet the continued listing standards of NASDAQ our common stock could be delisted from trading, which could limit investors’ ability to make transactions in our common stock and subject us to additional trading restrictions
5. 61Shares that we may issue in the future in connection with certain capital-raising transactions and shares available for future issuance upon exercise of warrants and options could dilute our stockholders and depress the market price of our common stock
6. 62We can give no assurances that we will ever pay dividends