Washington, D.C. 20549





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


Date of Report (Date of earliest event reported): July 2, 2020





(Exact name of registrant as specified in its charter)








(State or other jurisdiction

of incorporation)



File Number)


(IRS Employer

Identification No.)



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:


☐   Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)


☐   Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)


☐   Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))


☐   Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))


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


Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Common Stock, par value $0.001


The Nasdaq Capital Market

Warrant to Purchase Common Stock


The Nasdaq Capital Market


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. ☐




Item 8.01     Other Events.


BioCardia, Inc. (the “Company”) has submitted its detailed response to the Food and Drug Administration (the “FDA”) addressing FDA comments and questions relating to the Company’s Investigational New Drug application for its Nerokinin-1 Receptor Positive Mesenchymal Precursor Cell Program (BCDA-03), for the treatment of patients with ischemic heart failure. The response also incorporates clinical protocol changes which follow the FDA’s Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency, which was issued March 2020. The Company received confirmation that the FDA received the submission on July 2, 2020.






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.






/s/ Peter Altman, Ph.D.


Peter Altman, Ph.D.


President and Chief Executive Officer



Date: July 7, 2020