BioCardia, Inc.

In addition to the risk described below and the other information set forth in this report, you should carefully consider the factors discussed in Part I, Item 1A. Risk Factors in our Annual Report on Form 10-K for the year ended December 31, 2024, which could materially affect our business, financial condition, or future results, are incorporated by reference herein. The risks described in this report, our Annual Report on Form 10-K for the year ended December 31, 2024, and our Quarterly Reports on Form 10-Q filed periodically with the SEC 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 may also materially adversely affect our business, financial condition or future results.

If we do not continue to satisfy the Nasdaq continued listing requirements, our securities could be delisted from the Nasdaq.

The listing of our common stock on the Nasdaq Capital Market (Nasdaq) is contingent on our compliance with the Nasdaq’s conditions for continued listing. We were previously not in compliance with the Nasdaq listing requirements. Although we have regained compliance, a future failure to maintain compliance with the Nasdaq’s continued listing requirements could result in our being subject to delisting by the Nasdaq. In the event our securities are no longer listed for trading on Nasdaq, our trading volume and security price may decrease and we may experience further difficulties in raising capital, which could materially affect our operations and financial results. Further, delisting from the Nasdaq could also have other negative effects, including potential loss of confidence by partners, lenders, suppliers and employees and could also trigger various defaults under our financing arrangements and other outstanding agreements.

Our ability to utilize Form S-3 is temporarily limited without a waiver from the SEC.

As a result of our inadvertent failure to include certain management certificates in our Quarterly Report on Form 10-Q filed on August 11, 2025, which were subsequently filed in an amendment to such Form 10-Q on October 29, 2025, we are unable to have new registration statements on Form S-3 declared effective or utilize existing registration statements on Form S-3 after the filing of our Annual Report on Form 10-K for the year ended December 31, 2025, including our shelf registration statement on Form S-3 (File No. 333-275099), in each case unless we obtain a waiver from the SEC. While we plan to seek such a waiver, if the SEC does not grant such waiver, we will not be able to use Form S-3 until, among other things, we have made certain filings timely for a period of at least twelve calendar months, which at a minimum would not be until September 1, 2026. We expect that being unable to utilize Form S-3 will materially and adversely impact our ability to raise capital and execute our business plan.

Should we not have an effective registration statement on Form S-3, we would not be able to utilize our at-the-market program. Furthermore, if we seek to access the capital markets through a different registered offering during the period of time that we may be unable to use Form S-3, we may be required to publicly disclose the proposed offering and the material terms thereof before the offering commences, we may experience delays in the offering process due to SEC review of a Form S-1 registration statement and we may incur increased offering and transaction costs, among other considerations. Disclosing a public offering prior to the formal commencement of an offering may result in downward pressure on our stock price. If we are unable to raise capital through a registered offering, we would be required to conduct our equity financing transactions on a private placement basis, which may be subject to pricing, size and other limitations imposed under the Nasdaq rules, or seek other sources of capital. The foregoing limitations on our financing approaches could prevent us from raising capital to fund our business operations, pursuing transactions or implementing business strategies that would be beneficial to our business.

None.

None.

Not applicable.