Inmune Bio (INMB) risk factors, FY2024 10-K

RISKS RELATED TO OUR BUSINESS

1. 01There is doubt about our ability to continue as a going concern
2. 02We face intense competition in the markets targeted by our lead product candidates. Many of our competitors have substantially greater resources than we do, and we expect that all of our product candidates under development will face intense competition from existing or future drugs
3. 03Competition and technological change may make our product candidates and technologies less attractive or obsolete
4. 04We have incurred losses since inception and anticipate that we will continue to incur losses for the foreseeable future. We are not currently profitable, and we may never achieve or sustain profitability
5. 05Even if we are able to commercialize any product candidate that we develop, the product may become subject to unfavorable pricing regulations, third-party payor reimbursement practices or healthcare reform initiatives that could harm our business
6. 06We are subject to various government regulations
7. 07If we are unable to keep up with rapid technological changes in our field or compete effectively, we will be unable to operate profitably
8. 08Clinical drug development involves a lengthy and expensive process with an uncertain outcome. We may incur additional costs or experience delays in completing, or ultimately be unable to complete the development and commercialization of our product candidate
9. 09Success in early development does not mean that later development will be successful because, for example, drug candidates in later-stage clinical trials may fail to demonstrate sufficient safety and efficacy despite having progressed through initial clinical trials
10. 10The results of preclinical studies and early-stage clinical trials may not be predictive of future results. Initial success in clinical trials may not be indicative of results obtained when these trials are completed or in later-stage trials
11. 11Interim top-line and preliminary data from our planned clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data
12. 12If clinical trials of our product candidates fail to demonstrate safety and efficacy to the satisfaction of the FDA and comparable non-U.S. regulators, we may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of our product candidates
13. 13If we experience any of a number of possible unforeseen events in connection with clinical trials of any of our product candidates, potential marketing approval or commercialization of that product candidate could be delayed or prevented
14. 14If we experience delays or difficulties in the enrollment of patients in clinical trials, we may not achieve our clinical development on our anticipated timeline, or at all, and our receipt of necessary regulatory approvals could be delayed or prevented
15. 15We will need to obtain FDA approval of any proposed product brand names, and any failure or delay associated with such approval may adversely impact our business
16. 16We may fail to comply with regulatory requirements
17. 17Even if our product candidates receive marketing approval, they may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial success and the market opportunity for the product candidates may be smaller than we estimate
18. 18Even if we obtain regulatory approvals for CORDStrom, INKmune and/or any product from our DN-TNF platform those approvals and ongoing regulation of our products may limit how we manufacture and market our products, which could prevent us from realizing the full benefit of our efforts
19. 19If our product candidates receive marketing approval and we, or others, later discover that the drug is less effective than previously believed or causes undesirable side effects that were not previously identified, our ability to market the drugs could be compromised
20. 20Any product candidate for which we obtain marketing approval, along with the manufacturing processes, qualification testing, post-approval clinical data, labeling and promotional activities for such product, will be subject to continual and additional requirements of the FDA and other regulatory authorities
21. 21We currently have no marketing and sales organization and have no experience in marketing products. If we are unable to establish marketing and sales capabilities or enter into agreements with third parties to market and sell our product candidates, we may not be able to generate product revenue
22. 22We face substantial competition from other pharmaceutical and biotechnology companies and our operating results may suffer if we fail to compete effectively
23. 23We rely on key personnel and, if we are unable to retain or motivate key personnel or hire qualified personnel, we may not be able to grow effectively
24. 24Product liability lawsuits against us could divert our resources, cause us to incur substantial liabilities and limit commercialization of any products that we may develop
25. 25We will need to increase the size and capabilities of our organization, and we may experience difficulties in managing this growth
26. 26We are subject to a multitude of manufacturing risks, any of which could substantially increase our costs and limit supply of our drug candidates
27. 27We and our contract manufacturers are subject to significant regulation with respect to manufacturing our drug candidates. The manufacturing facilities on which we rely may not continue to meet regulatory requirements
28. 28If we or our third-party manufacturers use hazardous and biological materials in a manner that causes injury or violates applicable law, we may be liable for damages
29. 29We plan to rely on third parties to conduct clinical trials for our product candidates. Any failure by a third party to meet its obligations with respect to the clinical development of our product candidate may delay or impair our ability to obtain regulatory approval for our product candidates
30. 30Current and future legislation may increase the difficulty and cost of commercializing our drug candidates and may affect the prices we may obtain if our drug candidates are approved for commercialization
31. 31Government regulations could impact our ability to price our products
32. 32Deterioration in general economic conditions in the United States, Canada and globally, including the effect of prolonged periods of inflation on our suppliers, third-party service providers and potential partners, could harm our business and results of operations
33. 33Public health threats could have an adverse effect on our operations and financial results
34. 34We are exposed to risks related to currency exchange rates
35. 35Our employees, principal investigators, consultants and commercial partners may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements and insider trading, which could cause significant liability for us and harm our reputation
36. 36A cybersecurity incident and other technological disruptions could negatively affect our business and our relationships with customers
37. 37Use of social media platforms presents new risks

Risks Related to our Intellectual Property

1. 38We depend on obtaining certain patents and protecting our proprietary rights
2. 39If we fail to protect our intellectual property rights, our ability to pursue the development of our technologies and products would be negatively affected
3. 40By working with research collaborators patent rights may be jointly owned by different parties
4. 41We are dependent on our licensing agreement with Xencor, and the termination of this agreement would harm our business
5. 42Our officers and Chairman of the Board own the company that we license our INKmune patent from
6. 43Changes in U.S. patent law could diminish the value of patents in general, thereby impairing our ability to protect our products

Risks Related to our Common Stock

1. 44We do not intend to pay dividends for the foreseeable future
2. 45We are subject to the reporting requirements of federal securities laws, which can be expensive and may divert resources from other projects, thus impairing our ability grow
3. 46Our stock price may be volatile
4. 47You may have difficulty trading and obtaining quotations for our common stock
5. 48Additional stock offerings in the future may dilute your percentage ownership of our company
6. 49Anti-takeover provisions in our stockholder rights plan could make a third-party acquisition of us difficult
7. 50Sales of our common shares by our employees, including our executive officers, could cause the trading price of our common shares to fall or prevent it from increasing for numerous reasons, and sales by such persons could be viewed negatively by other investors