UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 OR 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): October 9, 2020

125 Shoreway Road, Suite B

San Carlos, California 94070

(Address of principal executive offices and zip code) 

Registrant’s telephone number, including area code: (650) 226-0120

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 Securities registered pursuant to Section 12(b) of the Act:

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2 of this chapter) ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Today, October 9, 2020, the Company has updated and reiterated the following corporate milestones, which are targeted for completion in the fourth quarter of 2020:

Cautionary Statement Regarding Forward-Looking Statements

This filing contains “forward looking statements” made pursuant to the safe harbor provision of the Private Securities Litigation Reform Act of 1995 that are subject to certain risks and uncertainties, as well as assumptions, that could cause actual results to differ materially from historical results and those presently anticipated or projected. Forward-looking statements in this filing include the timing of patient treatment and the acceptance by the FDA of an Investigational New Drug application. These forward-looking statements and their implications are based on the current expectations of the management of the BioCardia only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: the registrant may encounter delays or obstacles in completing the pre-specified Data Safety Monitoring Board Review for BCDA-01 and in treating the first patient in its BCDA-02 trial; the INDs for BCDA-03 and BCDA-04 may not be accepted by the FDA; and publication of clinical safety papers may be delayed or not occur, which could cause the actual results or performance of BioCardia to differ materially from that contemplated in such forward-looking statements. BioCardia cautions investors not to place undue reliance on forward-looking statements, which speak only as of the date hereof. BioCardia disclaims any obligation to update these forward-looking statements. For a more detailed description of the risks and uncertainties affecting BioCardia, reference is made to BioCardia’s reports filed from time to time with the Securities and Exchange Commission.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.