AIM ImmunoTech (AIM) risk factors, FY2024 10-K

Risks Related to Ownership of Our Securities

1. 01We have a history of losses, expect to continue to incur losses in the near term and may not achieve or sustain profitability in the future, and as a result, there is a substantial doubt about our ability to continue as a going concern
2. 02We are currently not in compliance with the Exchange continued listing requirements. If we are unable to regain compliance with the Exchange’s listing requirements, our securities could be delisted, which could affect our common stock market price and liquidity and reduce our ability to raise capital
3. 03If we are not able to comply with the applicable continued listing requirements or standards of the NYSE American, our common stock could be delisted from the Exchange
4. 04We may seek to raise additional funds or develop strategic relationships by issuing securities that would dilute your ownership. Depending on the terms available to us, if these activities result in significant dilution, it may negatively impact the trading price of our common stock
5. 05An active, liquid and orderly trading market for our common stock may not develop, the price of our stock may be volatile, and you could lose all or part of your investment
6. 06If our shares of common stock become subject to the penny stock rules, it would become more difficult to trade our shares
7. 07If we were to dissolve, the holders of our securities may lose all or substantial amounts of their investments
8. 08If securities or industry analysts do not publish or cease publishing research or reports about us, our business or our market, or if they change their recommendations regarding our securities adversely, our stock price and trading volume could decline
9. 09We will require additional financing which may not be available
10. 10We may continue to incur substantial losses and our future profitability is uncertain
11. 11Our drug and related technologies are investigational and subject to regulatory approval. If we are unable to obtain regulatory approval in a timely manner, or at all, our operations will be materially harmed and our stock adversely affected
12. 12We may be subject to product liability claims from the use of Ampligen, Alferon N Injection, or other of our products which could negatively affect our future operations. We have limited product liability and clinical trial insurance
13. 13Uncertainty of health care reimbursement for our products exists
14. 14There are risks of liabilities associated with handling and disposing of hazardous materials
15. 15Failures of our information technology infrastructure could have a material adverse effect on operations
16. 16The loss of services of key personnel could hurt our chances for success
17. 17The accounting principles generally accepted in the United States of America (“GAAP”) requires estimates, judgements and assumptions which inherently contain uncertainties
18. 18We currently, and may in the future, have assets held at financial institutions that may exceed the insurance coverage offered by the Federal Deposit Insurance Corporation (“FDIC”), and the loss of such assets would have a severe negative affect on our operations and liquidity
19. 19The development of Ampligen is subject to significant risks
20. 20The development of Alferon N Injection is subject to significant risks
21. 21Possible side effects from the use of Ampligen or Alferon N Injection could adversely affect potential revenues and physician/patient acceptability of our product
22. 22If approved, one or more of the potential side effects of the drug might deter usage of Ampligen in certain clinical situations and therefore, could adversely affect potential revenues and physician/patient acceptability of our product
23. 23It is not possible to predict the future of COVID-19, and related Post-COVID Conditions, as a global public health threat or the development of related therapies. No assurance can be given that Ampligen will aid in or be applied to the treatment of this virus
24. 24Operating in foreign countries carries with it many risks
25. 25We may not be profitable unless we can protect our patents and/or receive approval for additional pending patents
26. 26The patent position of biotechnology and pharmaceutical firms is highly uncertain and involves complex legal and factual questions
27. 27There is no guarantee that our trade secrets will not be disclosed or known by our competitors
28. 28Risks Associated with Our R&D
29. 29Risks Associated with Our Manufacturing
30. 30There are no long-term agreements with suppliers of required materials and services for Ampligen and there are a limited number of raw material suppliers. If we are unable to obtain the required raw materials and/or services, we may not be able to manufacture Ampligen
31. 31There are a limited number of organizations in the United States available to provide the final steps in the manufacturing for Alferon N Injection and Ampligen. To formulate, fill, finish and package our products (“fill and finish”), we require an FDA-approved third party CMO
32. 32There is no assurance that, upon success, manufacture of a drug on a limited-scale basis for investigational use would lead to a successful transition to commercial, large-scale production
33. 33We have limited manufacturing experience for Ampligen and Alferon N Injection. We may not be profitable unless we can produce Ampligen, Alferon N Injection or other products in commercial quantities at costs acceptable to us
34. 34If we are unable to achieve licensing, collaboration and/or joint ventures, our marketing strategy for Ampligen will be part of the differing health care systems around the world along with the different marketing and distribution systems that are used to supply pharmaceutical products to those systems
35. 35We have limited marketing and sales capability. If we are unable to obtain additional distributors and our current and future distributors do not market our products successfully, we may not generate significant revenues or become profitable
36. 36Our commercialization strategy for Alferon N Injection may include the utilization of internal functions and/or licensing/co-marketing agreements that would utilize the resources and capacities of one or more strategic partners
37. 37Rapid technological change may render our products obsolete or non-competitive
38. 38Our products may be subject to substantial competition
39. 39The market price of our stock may be adversely affected by market volatility
40. 40We may issue shares to be used to meet our capital requirements or use shares to compensate employees, consultants and/or Directors
41. 41Provisions of our Certificate of Incorporation and Delaware law could defer a change of our Management, which could discourage or delay offers to acquire us
42. 42Since 2022, activist groups have attempted to replace our Board with candidates of their own at each of our last three annual meetings of stockholders and litigation ensued