Azitra, Inc.

Item 1A. Risk Factors

This Quarterly Report on Form 10-Q contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Those forward-looking statements include our expectations, beliefs, intentions and strategies regarding the future. You should carefully consider the risk factors discussed in the Risk Factors section in our Form 10-K for

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the year ended December 31, 2025 (the "2025 Form 10-K") as, in light of those risks, the forward-looking events and circumstances discussed in this report may not occur and actual results could differ materially and adversely from those anticipated or implied in our forward-looking statements. Other than as set forth below, there have been no material changes in the risk factors included in our 2025 Form 10-K. The risk factors described in our 2025 Form 10-K are not the only risks facing our company. Additional risks and uncertainties not currently known to us or that we currently deem to be immaterial also may materially adversely affect our business, financial condition or future results.

Changes in U.S. and international trade policies may adversely impact our business and operating results.

We currently rely on foreign third-party manufacturers and service providers in connection with certain aspects of our clinical operations. The U.S. government and persons involved in the Trump administration have made statements and taken certain actions that have led to, and may continue to lead to, changes to U.S. and international trade policies. In April 2025, the U.S. government commenced collecting a 10% tariff on imports from many countries, with higher levies on goods from larger trading partners. Since that time, the scope, rates and application of announced tariffs have been modified on multiple occasions, and further changes may occur. If maintained, tariffs and the potential escalation of trade disputes with foreign countries could pose a risk to our business and could result in higher operating expenses. The extent and duration of any tariffs and the resulting impact on general economic conditions and on our business are uncertain and depend on various factors, such as negotiations between the United States and other countries, the response of such countries, exemptions or exclusions that may be granted, availability and cost of alternative sources of supply of materials we purchase from companies targeted with tariffs. The foreign country hardest hit by the U.S. tariffs to date has been China; however, we do not currently import any goods or services from China. The tariffs have not been applied to the provision of services by foreign service providers as of the date of this filing, however there can be no assurance that the U.S. administration will not attempt to apply tariffs to the provision of overseas services going forward. There can be no assurance that U.S. policies on tariffs and international trade will not increase the cost of manufacturing our product candidates and supporting materials and import or export of raw materials and finished product candidates used in our and our collaborators preclinical studies and clinical trials.

Our outstanding warrants and options are exercisable for a number of shares of common stock that substantially exceeds the number of shares of our common stock currently outstanding, and future exercises, sales and other issuances of our common stock could result in substantial dilution to our stockholders and could cause the market price of our common stock to decline.

As of June 30, 2026, we had 60,603,742 shares of common stock outstanding, and there were outstanding warrants to purchase an aggregate of 219,470,313 shares of common stock, including pre-funded warrants to purchase 42,411,822 shares of common stock at an exercise price of $0.0001 per share and Series B Warrants and Series C Warrants to purchase an aggregate of 168,846,252 shares of common stock at an exercise price of $0.123 per share, as well as outstanding options to purchase 651,871 shares of common stock. The exercise of outstanding warrants and options, sales under the ELOC and other issuances of equity or equity-linked securities would dilute, in some cases substantially, the ownership interests of our existing stockholders. In addition, substantially all of the shares of common stock issuable upon exercise of our outstanding warrants have been, or are required to be, registered for resale under the Securities Act, and sales of a substantial number of shares of our common stock in the public market, or the perception that such sales may occur, could cause the market price of our common stock to decline and could impair our ability to raise capital through future sales of equity securities. The exercise price of the Series C Warrants is also subject to a downward reset in certain circumstances described in Note 6 to our unaudited condensed financial statements included elsewhere in this report, which could result in issuances of common stock at prices below the current exercise price.

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We are not in compliance with the NYSE American continued listing standards. If we are unable to regain compliance within the applicable plan period, or thereafter fail to maintain compliance, the NYSE American may delist our common stock, which would adversely affect the market price and liquidity of our common stock and our ability to raise capital.

As described elsewhere in this report, on October 1, 2025 and March 13, 2026, we received deficiency letters from the NYSE American with respect to the minimum stockholders equity requirements of Sections 1003(a)(ii) and 1003(a)(iii), respectively, of the NYSE American Company Guide. The NYSE American accepted our plan of compliance and granted a plan period through April 1, 2027, during which we must make progress consistent with the plan and provide quarterly updates to the NYSE American staff. Although our stockholders equity as of June 30, 2026 was approximately $7.3 million, which exceeds the applicable minimum stockholders equity requirements, any determination that we have regained compliance will be made by the NYSE American, and we expect to continue to incur net losses, which could cause our stockholders equity to again fall below the applicable requirements. If we fail to regain compliance by the end of the plan period, fail to make progress consistent with the plan or otherwise fail to comply with the NYSE Americans continued listing standards (including as a result of a low selling price of our common stock), the NYSE American may commence delisting proceedings. Delisting would likely reduce the liquidity and market price of our common stock, reduce the number of investors willing or permitted to hold our common stock and impair our ability to raise capital, including under the ELOC and our existing registration statements.