Azitra (AZTR) risk factors, FY2025 10-K

Risks Relating to Our Business

1. 01We are an early-stage clinical biopharmaceutical company with limited operating history
2. 02We have a history of significant operating losses and anticipate continued operating losses for the foreseeable future
3. 03We expect we will need additional financing to execute our business plan and fund operations, which additional financing may not be available on reasonable terms or at all56% rewritten
4. 04The clinical and commercial utility of our microbial library and genetic engineering platform is uncertain and may never be realized54% rewritten
5. 05may fail to show the desired safety and efficacy in clinical development despite positive results in preclinical studies or even if they successfully advance through earlier clinical trialsNew
6. 06We will need to grow the size of our organization, and we may experience difficulties in managing this growth
7. 07If 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 our senior management would adversely impact our business prospects
8. 08We currently have no sales and marketing organization. If we are unable to establish satisfactory sales and marketing capabilities or secure a third-party sales and marketing relationship, we may not be able to successfully commercialize any of our product candidates
9. 09If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of our product candidates
10. 10Our internal computer systems, or those of our collaborators or other contractors or consultants, may fail or suffer security breaches, which could result in a material disruption of our product development programs
11. 11We face significant competition from other biotechnology and pharmaceutical companies targeting medical dermatological indications, and our operating results will suffer if we fail to compete effectively
12. 12Emerging issues related to the development and use of artificial intelligence could give rise to legal or regulatory action, damage our reputation, or otherwise materially harm our businessNew

Risks Related to Product Regulation

1. 13Our success is entirely dependent on our ability to obtain the marketing approval for our product candidates by the FDA and the regulatory authorities in foreign jurisdictions in which we intend to market our product candidates, of which there can be no assurance28% rewritten
2. 14promulgated good manufacturing practices requirements. These additional requirements may impact budgets and timelinesNew
3. 15Our clinical trials may fail to demonstrate substantial evidence of the safety and efficacy of our product candidates or any future product candidates, which would prevent or delay or limit the scope of regulatory approval and commercialization
4. 16Results of preclinical studies of our product candidates may not be predictive of the results of future preclinical studies or clinical trials
5. 17Any termination or suspension of, or delays in the commencement or completion of, any necessary studies of any of our product candidates for any indications could result in increased costs to us, delay or limit our ability to generate revenue and adversely affect our commercial prospects
6. 18Even if we receive regulatory approval for any of our product candidates, we may not be able to successfully commercialize the product and the revenue that we generate from its sales, if any, may be limited27% rewritten
7. 19payors or to receive the necessary pricing approvals from government bodies regulating the pricing and usage of therapeutics; andNew
8. 20The occurrence of any event or penalty described above may inhibit our ability to commercialize our product candidates and generate revenue. Adverse regulatory action, whether pre- or post-approval, can also potentially lead to product liability claims and increase our product liability exposure
9. 21Obtaining and maintaining regulatory approval of our product candidates in one jurisdiction does not mean that we will be successful in obtaining regulatory approval of our product candidates in other jurisdictions
10. 22Even though we may apply for orphan drug designation for a product candidate, we may not be able to obtain orphan drug marketing exclusivity
11. 23Current and future legislation may increase the difficulty and cost for us to obtain marketing approval of and commercialize our product candidates and affect the prices we may obtain
12. 24Third-party coverage and reimbursement and health care cost containment initiatives and treatment guidelines may constrain our future revenues
13. 25Because of the breadth of these laws and the narrowness of the statutory exceptions and safe harbors available, it is possible that some of our future business activities could be subject to challenge under one or more of such laws

Risks Relating to Our Intellectual Property Rights

1. 26It is difficult and costly to protect our intellectual property rights, and we cannot ensure the protection of these rights
2. 27Our product candidates may infringe the intellectual property rights of others, which could increase our costs and delay or prevent our development and commercialization efforts
3. 28We may be subject to claims that we have wrongfully hired an employee from a competitor or that we or our employees have wrongfully used or disclosed alleged confidential information or trade secrets of their former employers

Risks Related to Owning Our Common Stock

1. 29The market price of our shares may be subject to fluctuation and volatility. You could lose all or part of your investment
2. 30Our charter limits our ability to issue sharesNew
3. 31Our failure to meet the continued listing requirements of the NYSE American could result in a delisting of our common stock51% rewritten
4. 32Future capital raises may dilute your ownership and/or have other adverse effects on our operations
5. 33Shares eligible for future sale may adversely affect the market for our common stock
6. 34We are an “emerging growth company” under the JOBS Act and we cannot be certain if the reduced disclosure requirements applicable to emerging growth companies will make our common stock less attractive to investors
7. 35Our status as an “emerging growth company” under the JOBS Act may make it more difficult to raise capital as and when we need it
8. 36We have not paid dividends on our common stock in the past and have no immediate plans to pay such dividends
9. 37If equity research analysts do not publish research or reports about our business or if they issue unfavorable commentary or downgrade our shares, the price of our shares could decline
10. 38We may be at an increased risk of securities class action litigation
11. 39Our charter documents and Delaware law may inhibit a takeover that stockholders consider favorable
12. 40Changes in accounting standards and subjective assumptions, estimates and judgments by management related to complex accounting matters may materially impact reporting of our financial condition and results of operations
13. 41A potential failure to maintain effective internal control over financial reporting in accordance with Section 404 of the Sarbanes-Oxley Act could have a material adverse effect on our business, financial condition, and results of operations
14. 42The limited amount of public company experience of our management team could adversely impact our ability to comply with the reporting requirements of U.S. securities laws, which could have a materially adverse effect on our business
15. 43We have and will continue to incur significant increased costs as a result of being a public company that reports to the SEC and our management will be required to devote substantial time to meet compliance obligations
16. 44Unfavorable geopolitical and macroeconomic developments could adversely affect our business, financial condition or results of operations