バイオカルディアの適時開示・その他

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): September 18, 2024

BIOCARDIA, INC.

(Exact name of registrant as specified in its charter)

Delaware		001-38999		23-2753988
(State or other jurisdiction of incorporation)		(Commission File Number)		(IRS Employer Identification No.)

320 Soquel Way Sunnyvale, California 94085
(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	BCDA	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.

On September 18, 2024, BioCardia, Inc. (the “Company”) issued a press release announcing that is has received formal written notice from The Nasdaq Stock Market, LLC’s office of General Counsel (“Nasdaq”) that the Company has demonstrated compliance with Listing Rule 5550(b)(1) (the “Equity Rule”) of the Nasdaq Stock Market, as required by the Hearings Panel’s (“Panel”) decision dated May 13, 2024. Accordingly, the Panel has determined to continue the listing of the Company’s securities on The Nasdaq Stock Market and is closing this matter. The Company understands that Nasdaq will continue to monitor Company’s ongoing compliance with The Nasdaq Stock Market’s continued listing requirements.

A copy of the press release is attached as Exhibit 99.1 to the current report on Form 8-K.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

Exhibit Number		Description

99.1		BioCardia, Inc. press release dated September 18, 2024
104		Cover Page Interactive Data File (embedded within the Inline XBRL Document.

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.

BIOCARDIA, INC.

/s/ Peter Altman, Ph.D.
Peter Altman, Ph.D.
President and Chief Executive Officer

Date: September 18, 2024

EX-99.1 2 ex_725189.htm EXHIBIT 99.1 ex_725189.htm

Exhibit 99.1

BioCardia Regains Full Compliance with Nasdaq Listing Requirements

Sunnyvale, Calif. – September 18, 2024 - BioCardia, Inc. [Nasdaq: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, announced today that the Company has regained full compliance with the Nasdaq Capital Market’s Listing Requirements as required by the Hearing Panel’s (the “Panel”) decision on May 13, 2024.

On September 17, 2024, BioCardia received notice from Nasdaq confirming that the Company has demonstrated compliance with Listing Rule 5550(b)(1) (the “Equity Rule”) of The Nasdaq Stock Market. Accordingly, the Panel has determined to continue the listing of the Company’s securities on the Nasdaq Stock Market and is closing this matter.

This confirmation follows the Company’s successful efforts to improve its balance sheet, including raising new capital to continue development of its therapeutic candidates and advance its approved products.

“It has been a busy past few weeks, with the FDA approving the CardiAMP® Cell Therapy Heart Failure II protocol amendment to use our proprietary Cell Population Analysis screening to define each patient’s treatment plan, the University of Wisconsin treating our last roll-in patient in the CardiAMP Cell Therapy Chronic Myocardial Ischemia Trial, Helix™ partner CellProthera having a positive pre-IND meeting with the FDA for their cell therapy in acute myocardial infarction, our securing FDA market clearance for our Morph® DNA™ product family, and our closing a $7.2M financing to support our efforts ahead,” said Peter Altman, PhD, BioCardia’s President and CEO. “We are delivering on our mission to develop and enhance therapies to treat cardiovascular and pulmonary disease, with our near-term focus on finalizing CardiAMP HF I trial data for Japan PMDA and FDA, randomizing first patients in the confirmatory pivotal CardiAMP HF II trial, supporting Helix biotherapeutic delivery partners, and manufacturing Morph DNA products for commercial use.”

About BioCardia:

BioCardia, Inc., headquartered in Sunnyvale, California, is a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary disease. CardiAMP® autologous and CardiALLO™ allogeneic cell therapies are the Company’s biotherapeutic platforms with three clinical stage product candidates in development. These therapies are enabled by its Helix™ biotherapeutic delivery and Morph® vascular navigation product platforms.

Forward Looking Statements

This press release contains forward-looking statements that are subject to many risks and uncertainties. Forward-looking statements include, among other things, references to the Company’s investigational product candidates, the potential benefits of CardiAMP cell therapy for patients, enrollment in our clinical trials, future regulatory submissions and approvals, whether Helix partner CellProthera will advance their therapeutic development with BioCardia, and the potential market for the Company’s approved products. These forward-looking statements are made as of the date of this press release, and BioCardia assumes no obligation to update the forward-looking statements.

We may use terms such as “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately” or other words that convey the uncertainty of future events or outcomes to identify these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained herein, we caution you that forward-looking statements are not guarantees of future performance and that our actual results may differ materially from the forward-looking statements contained in this press release as a result of one or more risk factors. As a result of these factors, we cannot assure you that the forward-looking statements in this press release will prove to be accurate. Additional factors that could materially affect actual results can be found in BioCardia’s Form 10-K filed with the Securities and Exchange Commission on March 27, 2024, under the caption titled “Risk Factors” and in its subsequently filed Quarterly Reports on Form 10-Q. BioCardia expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law.

###

Media Contact:

Miranda Peto, Marketing / Investor Relations

Email: mpeto@BioCardia.com

Phone: 650-226-0120

Investor Contact:

David McClung, Chief Financial Officer

Email: investors@BioCardia.com

Phone: 650-226-0120