SAB Biotherapeutics, Inc.

Previous report

We filed a registration statement to register for resale the shares of common stock issuable upon conversion of all shares of Series B Preferred Stock, including shares of Series B Preferred Stock issuable upon the exercise of warrants, which was declared effective by the SEC on September 30, 2025. The sale of such underlying shares of common stock would represent the sale of a significant number of our securities in the public market, and the perception that such sales may occur, may cause the market price of our securities to decline significantly.

Previous report

In connection with the Series B Offering, we filed a registration statement to register for sale up to 250,000,000 shares of common stock issuable upon conversion of all shares of Series B Preferred Stock, including shares of Series B Preferred Stock issuable upon exercise of the Enrollment Date Warrants and Release Date Warrants, which registration statement was declared effective September 30, 2025 (as supplemented by the prospectus supplement filed November [ ], 2025, the “Resale Registration Statement”). The registration of these securities, the sale of these securities in the public market, or the perception that holders of a large number of securities intend to sell their securities, could reduce the market price of our common stock and public warrants. Although each stockholder for whom the shares of common stock registered for resale under the Resale Registration Statement is not permitted to convert their shares of Series B Preferred Stock into shares of common stock to the extent that after giving effect to such conversion, such holder would (together with such holder’s affiliates and related parties) beneficially own in excess of 4.99% (or 9.99% at the election of the holder) of the shares of common stock outstanding immediately after giving effect to such conversion, the market price of our common stock could decline if the holders of such shares sell them over time or are perceived by the market as intending to sell them.

Previous report

The ability of the FDA to review and/or approve new products can be affected by a variety of factors, including government budget and funding levels, statutory, regulatory, and policy changes, the FDA’s ability to hire and retain key personnel and accept the payment of user fees, and other events that may otherwise affect the FDA’s ability to perform routine functions. Average review times at the FDA have fluctuated in recent years as a result. In addition, government funding of other government agencies that fund research and development activities is subject to the political process, which is inherently fluid and unpredictable.

Previous report

Disruptions at the FDA and other federal agencies, including substantial leadership departures, personnel cuts, and policy changes, may also slow the time necessary for new drugs to be reviewed and/or approved, which would harm our business. Changes and cuts in FDA staffing have been reported within the pharmaceutical industry as creating instances of delays in the FDA’s responsiveness or in its ability to review IND submissions or applications, issue regulations or guidance, or implement or enforce regulatory requirements in a timely fashion or at all.

Previous report

A prolonged government shutdown or significant leadership, personnel, and/or policy changes, or other substantial modification in agency activities (including due to global health concerns or geopolitical factors) could significantly impact the ability of the FDA or other regulatory authorities to timely review and process our regulatory submissions, which could have a material adverse effect on our business. In addition, government funding of other agencies on which our operations may rely, including those that fund research and development activities and clinical trials, is subject to the political process, which is inherently fluid and unpredictable. Disruptions at agencies that fund our research and development activities and our clinical trials, or changes to such agencies’ budgets, may negatively impact our operations and ongoing clinical trials and may limit our ability to seek additional funding in the future. Future shutdowns or other disruptions could also affect other government agencies such as the SEC, which may also impact our business by delaying review of our public filings, to the extent such review is necessary, and our ability to access the public markets.