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): December 6, 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 8.01 Other Events.

On December 6, 2022, BioCardia, Inc. (the “Company”) issued a press release announcing that the U.S. Food and Drug Administration has approved the Company’s Investigational New Drug (IND) application to initiate a first-in-human phase I/II clinical trial of its Neurokinin-1 receptor positive (NK1R+) allogeneic human mesenchymal stem cell therapy for the treatment of patients with ischemic heart failure. 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 December 6, 2022
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: December 6, 2022

EX-99.1

Exhibit 99.1

FOR IMMEDIATE RELEASE

BioCardia Announces FDA Approval of IND Application for Allogeneic NK1R+ Human Mesenchymal Stem Cells for Ischemic Heart Failure

Approval marks second clinical trial approved by FDA this year for

Company’s NK1R+ MSC platform

Allogeneic CardiALLO therapy for heart failure to complement autologous cell therapy currently enrolling in Phase III CardiAMP Heart Failure clinical trial

SUNNYVALE, Calif. -- December 6, 2022 -- BioCardia, Inc. [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced Food and Drug Administration (FDA) approval of its Investigational New Drug (IND) application to initiate a first-in-human Phase I/II clinical trial of its Neurokinin-1 receptor positive (NK1R+) allogeneic human mesenchymal stem cell (MSC) therapy for the treatment of patients with ischemic heart failure.

This trial is designed for patients with New York Heart Association Class II and III ischemic heart failure with reduced ejection fraction (ischemic HFrEF) whose own cell composition makes them ineligible for the Company’s Phase III CardiAMP® Heart Failure Trial studying autologous cell therapy that has received FDA Breakthrough Device Designation.

“We intend to provide a complete cell therapy solution for ischemic heart failure patients that encompasses both autologous and ‘off the shelf’ allogeneic cell therapies. Our therapies are synergistic in serving the full patient spectrum, as only about two-thirds of patients are expected to be responders to our autologous therapy,” said Peter Altman, PhD, BioCardia’s President and Chief Executive Officer. “We expect to see efficiencies in the upcoming CardiALLO™ trial for several reasons: we can leverage screening activity from the currently enrolling CardiAMP trial to direct ineligible patients into the CardiALLO trial; our allogeneic cell therapy is already manufactured and ready for use; and it will be delivered with our proprietary delivery system demonstrated in literature to be the safest and most efficient delivery method available today.”

He added, “We are excited to study the role our allogeneic NK1R+ MSC therapy may play in helping hearts recover from injury as its mechanism of action involves Substance P. This binds to NK1R+ and has been shown to be an important factor in the development of inflammation, which plays a central role in both heart failure and regenerative processes following myocardial injury.”

About Allogeneic CardiALLO NK1R+ MSC

Allogeneic NK1R+ MSC are culture-expanded, bone marrow-derived, mesenchymal stem cells that are Neurokinin 1 receptor positive. Neurokinin 1 is the primary receptor for Substance P, an important neuropeptide mediator of inflammation. The BioCardia cell therapy consists of cells from younger, extensively prescreened donors that are expanded to provide multiple dosage forms from a single donor. The cells are manufactured by BioCardia at its Sunnyvale facility. For the heart failure indication, these cells will be delivered to the heart using BioCardia’s Helix biotherapeutic delivery system, which is approved in the European Union and has been shown to result in three times as many cells being retained in the target heart tissue as competitive delivery approaches while having the lowest incidence of serious adverse events.

About BioCardia

BioCardia, Inc., headquartered in Sunnyvale, California, is a developer of cell and cell-derived therapies for cardiovascular and pulmonary disease. The Company has two biotherapeutic platforms, CardiAMP autologous bone marrow-derived mononuclear cell therapy for cardiovascular indications and the NK1R+ allogeneic bone marrow-derived mesenchymal stem cell therapies for cardiovascular and pulmonary diseases. These platforms underly several clinical-stage product candidates, each with the potential to meaningfully benefit millions of patients.

Forward Looking Statements:

This press release contains forward-looking statements and that are subject to many risks and uncertainties.  Forward looking statements include synergies and efficiencies in completing our clinical trials, the mechanism of action of our NK1R+ therapy and the future safety and efficacy of our investigational therapies. 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.

###

INVESTOR CONTACT:

David McClung, Chief Financial Officer

investors@BioCardia.com, (650) 226-0120

MEDIA CONTACT:

Michelle McAdam, Chronic Communications Inc.

michelle@chronic-comm.com, (310) 902-1274

XML

Document And Entity Information	Dec. 06, 2022
Document Information [Line Items]
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Document, Type	8-K
Document, Period End Date	Dec. 06, 2022
Entity, Incorporation, State or Country Code	DE
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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
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Soliciting Material	false
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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
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Security Exchange Name	NASDAQ