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): October 7, 2021

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.)

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	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 8.01 Other Events.

On October 7, 2021, BioCardia, Inc. (the “Company”) issued a press release announcing that the first cross-over patient has been treated in the ongoing Phase III Pivotal CardiAMP Cell Therapy Heart Failure Trial. A cross-over patient is one who was previously in the control group of the study, has completed follow-up, and elects to receive therapy. The patient was treated with the CardiAMP autologous bone marrow cell therapy procedure at Stanford University, by interventional cardiologist Dr. David Lee, in the trial led by Principal Investigator, cardiologist Dr. Phillip Yang. A copy of the press release is attached hereto as Exhibit 99.1 to this current report on Form 8-K and is incorporated herein by reference.

Item 9.01   Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.	Description
99.1	BioCardia, Inc. press release dated October 7, 2021
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: October 7, 2021

EX-99.1

Exhibit 99.1

FOR IMMEDIATE RELEASE

BioCardia Announces First Cross-Over Patient Treated in CardiAMP Cell Therapy Heart Failure Trial

October 07, 2021

SAN CARLOS, Calif. – BioCardia®, Inc. [Nasdaq: BCDA] a company focused on developing cellular and cell derived therapeutics for the treatment of  cardiovascular and pulmonary diseases, today announced the treatment of the first cross-over patient in the ongoing Phase III Pivotal CardiAMP® Cell Therapy in Heart Failure Trial for the treatment of ischemic heart failure. A cross-over patient is one who was previously in the control group of the study, has completed follow-up, and elects to receive therapy.

The patient was treated with the CardiAMP autologous bone marrow cell therapy procedure at Stanford University, by interventional cardiologist Dr. David Lee, in the trial led by Principal Investigator, cardiologist Dr. Phillip Yang. The cell therapy procedure is a minimally invasive catheter-based approach, which allowed the patient to be discharged from the hospital the morning after the study procedure per the protocol.

“Patients are the true heroes in the CardiAMP Cell Therapy trials, and by allowing them the cross-over option, all patients have the opportunity to receive the investigational therapy” said BioCardia CEO Peter Altman, Ph.D. “We are honored to collaborate with the world class Stanford cardiologists who have made a significant commitment of their time and energies to the ongoing study of the CardiAMP autologous cell therapy for patients with heart failure. With their help and that of their colleagues at hospital centers across the United States, we are working to complete the current trial with the best safety profile and patient care as soon as possible.”

A protocol amendment approved by the FDA allows patients in the trial who were initially randomly assigned to the control arm and did not receive therapy to elect to cross-over and receive the investigational autologous CardiAMP Cell Therapy after completing the two-year follow-up. The approval of the study’s cross-over arm was based in part on the study’s Data Safety Monitoring Board’s formal assessments during the trial. The amendment also included provisions for following cross-over patients for a period of one additional year under the clinical protocol.

About BioCardia

BioCardia, Inc.,  headquartered in San Carlos, 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 underly 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. 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 30, 2021, under the caption titled “Risk Factors.” BioCardia expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law. 

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

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

XML

Document And Entity Information	Oct. 07, 2021
Document Information [Line Items]
Entity, Registrant Name	BIOCARDIA, INC.
Document, Type	8-K
Document, Period End Date	Oct. 07, 2021
Entity, Incorporation, State or Country Code	DE
Entity, File Number	0-21419
Entity, Tax Identification Number	23-2753988
Entity, Address, Address Line One	125 Shoreway Road
Entity, Address, Address Line Two	Suite B
Entity, Address, City or Town	San Carlos
Entity, Address, State or Province	CA
Entity, Address, Postal Zip Code	94070
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