8-K

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 14, 2022

BIOCARDIA, INC.

(Exact name of registrant as specified in its charter)

Delaware	0-21419	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
Warrant to Purchase Common Stock	BCDAW	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 7.01 Regulation FD Disclosure.

On September 14, 2022, BioCardia, Inc. (the “Company”) issued a press release announcing that data from its CardiAMP© Cell Therapy Heart Failure pivotal trial (ClinicalTrials.gov Identifier: NCT02438306), will be presented at the Heart Failure Society of America Annual Meeting 2022 on October 1, 2022 in a poster format at 6:10pm entitled, “Autologous Cell Therapy For HFrEF: Efficacy Outcomes At Two Years For The Roll-in Cohort Of A Phase III Pivotal Trial.” A copy of the press release is attached hereto as Exhibit 99.1 to this current report on Form 8-K.

The information furnished pursuant to this Item 7.01, including Exhibit 99.1 hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities under that section, nor shall it be deemed to be incorporated by reference in any filing made by the Company under the Securities Act of 1933, as amended, or the Exchange Act, except as otherwise expressly set forth by specific reference in such filing. 

Item 9.01   Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.	Description
99.1 104	BioCardia, Inc. press release dated September 14, 2022 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 14, 2022

EX-99.1

Exhibit 99.1

FOR IMMEDIATE RELEASE

CardiAMP Cell Therapy Heart Failure Trial Two Year Roll In Cohort Data to be Presented at
Heart Failure Society of America Annual Meeting

Clinical Leadership and Management Call to Follow

Sunnyvale, Calif. September 14, 2022 – BioCardia®, Inc. [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of  cardiovascular and pulmonary diseases,  today announces that new data from its CardiAMP® Cell Therapy for Heart Failure pivotal trial (ClinicalTrials.gov Identifier: NCT02438306), will be presented at the Heart Failure Society of America (HFSA) Annual Meeting on October 1, 2022 at 6:00pm titled, “Autologous Cell Therapy For HFrEF: Efficacy Outcomes at Two Years for The Roll-in Cohort of a Phase III Pivotal Trial.”  This year’s HFSA meeting provides a hybrid format; in-person at the Gaylord National Harbor in Washington, D.C., or global live on-line access.

This data from the CardiAMP Cell Therapy Heart Failure trial will be released Monday, October 3, 2022, with anticipated details for a conference call with trial clinical leadership and management to follow.  The planned conference call is expected to review the data presented at the Heart Failure Society of America meeting, detail the status of the trial, and discuss efforts being taken to implement an adaptive statistical analysis plan as recommended by the recent independent Data Safety Monitoring Board (DSMB) review. 

“We look forward to presenting the two-year roll in cohort results from the CardiAMP Cell Therapy for Heart Failure Trial at this year’s HFSA annual meeting,” stated BioCardia’s Vice President of Clinical, Debby Holmes-Higgin.   “In addition, we look forward to detailing efforts towards the implementation of the adaptive statistical analysis plan, which may further reduce trial risk and enable the DSMB to review the data early for efficacy.”

About BioCardia®

BioCardia, Inc., headquartered in Sunnyvale, California, is a developer of two biotherapeutic platforms – the CardiAMP autologous bone marrow derived mononuclear cell therapy for cardiovascular indications, and the NK1R+ allogenic bone marrow derived mesenchymal stem cell therapies for cardiovascular and pulmonary diseases.  These platforms underlie four product candidates, each with the potential to meaningfully benefit millions of patients. Three of these investigational therapies are enabled by the Company’s proprietary biotherapeutic delivery platforms, which the Company also selectively licenses to other biotherapeutic development firms.

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 presentation of data from the CardiAMP Heart Failure Trial and future conference calls. 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 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 29, 2022, under the caption titled “Risk Factors.” BioCardia expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law. 

Media Contact:
Anne Laluc, Marketing
Email: alaluc@BioCardia.com
Phone: 650-226-0120

Investor Contact:
David McClung, Chief Financial Officer
Email: investors@BioCardia.com
Phone: 650-226-0120

XML

Document And Entity Information	Sep. 14, 2022
Document Information [Line Items]
Entity, Registrant Name	BIOCARDIA, INC.
Document, Type	8-K
Document, Period End Date	Sep. 14, 2022
Entity, Incorporation, State or Country Code	DE
Entity, File Number	0-21419
Entity, Tax Identification Number	23-2753988
Entity, Address, Address Line One	320 Soquel Way
Entity, Address, City or Town	Sunnyvale
Entity, Address, State or Province	CA
Entity, Address, Postal Zip Code	94085
City Area Code	650
Local Phone Number	226-0120
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Entity, Emerging Growth Company	false
Amendment Flag	false
Entity, Central Index Key	0000925741
CommonStockParValue0001 Custom [Member]
Document Information [Line Items]
Title of 12(b) Security	Common Stock, par value $0.001
Trading Symbol	BCDA
Security Exchange Name	NASDAQ
WarrantToPurchaseCommonStock Custom [Member]
Document Information [Line Items]
Title of 12(b) Security	Warrant to Purchase Common Stock
Trading Symbol	BCDAW
Security Exchange Name	NASDAQ