Matinas BioPharma Holdings (MTNB) risk factors, FY2024 10-K

Risks Related to Our Financial Position and Need for Additional Capital

1. 01Our business to date has been significantly dependent on the success of MAT2203, and we have decided to pause further development of MAT2203 and devote significant time and resources to identifying and evaluating strategic alternatives, which may not be successful
2. 02Any such strategic transaction may require us to incur non-recurring or other charges, may increase our near-and long-term expenditures and may pose significant integration challenges or disrupt our management or business, which could adversely affect our business
3. 03We have expressed substantial doubt about our ability to continue as a going concern and we have incurred significant losses since our inception. We expect to incur losses over the next several years and may never achieve or maintain profitability
4. 04The financial statements do not give any effect to any adjustments in the amounts and classification of assets and liabilities that may be necessary should we be unable to continue as a going concern. Some adjustments could be material
5. 05We will need substantial additional funding. If we are unable to raise capital when needed, we could be forced to delay, reduce, or eliminate our product development programs or commercialization efforts
6. 06Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates
7. 07Our stockholders may be subject to substantial dilution by exercises of outstanding options and warrants
8. 08Our operating history to date may make it difficult to evaluate the success of our business and to assess our future viability

Risks Related to Product Development, Regulatory Approval, Manufacturing and Commercialization

1. 09We are early in our development efforts, which may not be successful
2. 10We cannot be certain that any of our product candidates will receive regulatory approval, without which we will not be able to market any of our product candidates. Any delay in the approval process will harm our business
3. 11We depend in part on technology owned or licensed to us by third parties, the loss of which would terminate or delay the further development of our product candidates, injure our reputation, or force us to pay higher royalties
4. 12We may not have or be able to obtain sufficient quantities of our products to meet our supply and clinical studies obligations and our business, financial condition and results of operation may be adversely affected
5. 13If we are unable to successfully commercialize our current or future product candidates our ability to generate revenue will be limited
6. 14If our preclinical and clinical studies do not produce positive results, if our clinical trials are delayed or if serious side effects are identified during such studies or trials, we may experience delays, incur additional costs and ultimately be unable to commercialize our product candidates
7. 15If we cannot enroll enough patients to complete our clinical trials, our business, financial condition, and results of operations may be adversely affected
8. 16Reductions in staffing and funding at FDA and other federal agencies could cause delays in the development and approval of our current and future product candidates
9. 17We may not be able to maintain orphan drug designation or exclusivity for our anti-infective product candidates
10. 18Any breakthrough therapy designation granted by the FDA for our product candidates may not lead to a faster development or regulatory review or approval process, and it does not increase the likelihood that our product candidates will receive marketing approval
11. 19Designation of our product candidates as qualified infectious disease products is not assured and, in any event, even if granted, may not actually lead to a faster development or regulatory review, and would not assure FDA approval of our product candidates
12. 20Even if we receive regulatory approval for MAT2203 or any other future product candidates we may develop, we still may not be able to successfully commercialize such products and the revenue that we generate from its sales, if any, may be limited
13. 21We currently have no sales and marketing organization. If we are unable to establish satisfactory sales and marketing capabilities, we may not successfully commercialize any of our product candidates, even if regulatory approval is obtained
14. 22If we are unable to file for approval of MAT2203 under Section 505(b)(2) of the FDCA or if we are required to generate additional data related to safety and efficacy to obtain approval under Section 505(b)(2), we may be unable to meet our anticipated development and commercialization timelines
15. 23We face competition from other biotechnology and pharmaceutical companies and our operating results will suffer if we fail to compete effectively
16. 24Further, although we believe that our proprietary LNC Platform, experience, and knowledge in our areas of focus provide us with competitive advantages, potential competitors for MAT2203 could reduce our commercial opportunities
17. 25Future legislation, and/or regulations and policies adopted by the FDA may increase the time and cost required for us to conduct and complete clinical trials
18. 26Changes in health care law and implementing regulations may have a material adverse effect on us
19. 27Our future growth depends, in part, on our ability to penetrate foreign markets, where we would be subject to additional regulatory burdens and other risks and uncertainties
20. 28If we market our product candidates in a manner that violates healthcare fraud and abuse laws, or if we violate government price reporting laws, we may be subject to civil or criminal penalties
21. 29We have been and expect to be significantly dependent on our collaborative agreements for the development of MAT2203, which exposes us to the risk of reliance on the performance of third parties
22. 30We expect that we will rely on third parties to conduct clinical trials for our product candidates, which exposes us to the risk of reliance on the performance of third parties
23. 31Outbreaks of communicable diseases may materially and adversely affect our business, financial condition and results of operations
24. 32Adverse global conditions, including economic uncertainty, may negatively impact our financial results

Risks Relating to Our Intellectual Property Rights and Regulatory Exclusivity

1. 33We depend on certain technologies that are licensed to us. We do not control these technologies and any loss of our rights to them could prevent us from discovering, developing and commercializing product candidates
2. 34It is difficult and costly to protect our intellectual property rights, and we cannot ensure the protection of these rights
3. 35If we fail to obtain or maintain patent or trade secret protection for our technologies, third parties could use our proprietary information, which could impair our ability to compete in the market and adversely affect our ability to generate revenues and attain profitability
4. 36Our product candidates may infringe the intellectual property rights of others, which could increase our costs and delay or prevent our development and commercialization efforts

General Company-Related Risks

1. 37We will need to increase the size of our organization to grow our business, and we may experience difficulties in managing this growth
2. 38If we are not successful in attracting and retaining highly qualified personnel, we may not be able to successfully implement our business strategy. In addition, the loss of the services of certain key employees would adversely impact our business prospects
3. 39If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of our product candidates
4. 40Our internal computer systems, or those of our CROs or other contractors or consultants, may fail or suffer security breaches, which could result in a material disruption of our product development programs
5. 41We may acquire businesses or products, or form strategic alliances, in the future, and we may not realize the benefits of such acquisitions

Risks related to our Securities

1. 42Pursuant to the terms of our Series A Preferred Stock, we may be obligated to pay significant royalties
2. 43The rights of the holders of common stock may be impaired by the potential issuance of preferred stock
3. 44We do not intend to pay dividends on our common stock in the foreseeable future
4. 45An active public trading market for our common stock may not be sustained
5. 46Our share price has been and could remain volatile
6. 47If securities or industry analysts do not publish research or reports about our business, or if they change their recommendations regarding our stock adversely, our stock price and trading volume could decline
7. 48If we are unable to maintain an effective system of internal control over financial reporting, the reliability of our financial reporting, investor confidence in us and the value of our common stock could be adversely affected
8. 49We could be delisted from the NYSE American, which could seriously harm the liquidity of our stock and our ability to raise capital
9. 50Upon dissolution of our company, you may not recoup all or any portion of your investment
10. 51Our certificate of incorporation allows for our board to create new series of preferred stock without further approval by our stockholders, which could adversely affect the rights of the holders of our common stock
11. 52Anti-takeover provisions of our certificate of incorporation, bylaws and Delaware law could make an acquisition of us, which may be beneficial to our stockholders, more difficult and may prevent attempts by our stockholders to replace or remove the current members of our board and management
12. 53Stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or employees may be limited
13. 54Our ability to use our net operating loss carryforwards and certain other tax attributes may be limited