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 14, 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 1.01 Entry into a Material Definitive Agreement.

On December 14, 2021, BioCardia, Inc. (the “Company”) entered into a lease agreement (the “Lease”) with The Irvine Company, LLC (the “Landlord”) at 320 Soquel Way in Sunnyvale, California (the “Premises”) to support the manufacturing of the Company’s cell and device products and product candidates and provide office space.

Under the Lease, the Company has leased 9,369 square feet of the Premises. The lease term for the Premises commenced on December 15, 2021 (the “Lease Commencement Date”) and will expire January 14, 2027 with an option to extend for an additional thirty-six months.

The Company will pay a monthly base rent for the Premises at an initial monthly rate of $3.95 per rentable square foot increasing by approximately 3% per year on each annual anniversary of the Lease Commencement Date for the term of the Lease.

Throughout the term of the Lease, the Company is responsible for paying a share of all operating expenses incurred by the Landlord in the operation of the building. The Lease includes various covenants, indemnities, defaults, termination rights, and other provisions customary for lease transactions of this nature, including maintaining a $171,640 letter of credit to secure the performance of the Company’s obligations under the Lease.

The foregoing summary of the Lease does not purport to be complete, and is qualified in its entirety by reference to the full text of the Lease, which will be filed as an exhibit to the Company’s Annual Report on 10-K for the period ending December 31, 2021.

On December 15, 2021, the Company issued a press release announcing the Lease   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 2.03 Creation of a Direct Financial Obligation or an Obligation under an Off-Balance Sheet Arrangement of a Registrant.

The description set forth in Item 1.01 above is incorporated by reference in its entirety into this Item 2.03.

Item 9.01   Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.	Description
99.1	Press release dated December 15, 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: December 15, 2021

EX-99.1

Exhibit 99.1

FOR IMMEDIATE RELEASE

BioCardia Establishes New Manufacturing Facility to Enable Its Cell Therapy Product Candidates

Facility Being Built Out to Support CardiAMP Cell Therapy Systems, Allogeneic NK1R+ MSC and Biotherapeutic Delivery Device Manufacturing for Clinical Trials of Multiple Programs and Early Commercial Activities

SAN CARLOS, Calif. – December 15, 2021 - BioCardia, Inc. [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announces that it has entered into a long-term lease for a new facility in Sunnyvale, California. This facility is being built out to support the manufacturing of BioCardia’s cell and device products and product candidates across the Company’s therapeutic pipeline.

The new facility is expected to provide manufacturing capabilities across BioCardia’s portfolio, including its CardiAMP Cell Therapy Systems, NK1R+ mesenchymal stem cells, and Biotherapeutic Delivery Devices, with the ultimate goal of supporting clinical trials in multiple programs and early commercial activities.

“We have always believed that manufacturing during development needs to be kept close to capture new insights and innovate rapidly. Controlling manufacturing at this stage helps accelerate the development of our cell-based medicines, which we also believe is a key differentiator of BioCardia from many other cellular therapeutics companies,” said Peter Altman, BioCardia’s President and CEO. “We expect to soon see all four of the programs we discuss publicly in the clinic helping patients, with our in-house facilities providing the material.”

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. Forward-looking statements include, among other things, references the Company’s product candidates, expectations for its development programs and expectations related to the manufacturing capabilities of the facility. Such risks and uncertainties include, among others, the inherent uncertainties associated with developing new products or technologies, regulatory approvals, unexpected expenditures, the ability to raise the additional funding needed to continue to pursue BioCardia’s business and product development plans, the ability to enter into licensing and partnering arrangements, and overall market conditions. 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. 

###

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	Dec. 14, 2021
Document Information [Line Items]
Entity, Registrant Name	BIOCARDIA, INC.
Document, Type	8-K
Document, Period End Date	Dec. 14, 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, 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