Form 8-K - Current report

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): January 3, 2024

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 January 3, 2024, BioCardia, Inc. (the “Company”) issued a press release containing a letter to shareholders, which provides an update on business development related to its biotherapeutic delivery and Morph Access Innovations businesses. 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.

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 January 3, 2024 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: January 3, 2024

Exhibit 99.1

BioCardia Biotherapeutic Delivery and Morph Access Innovations

Business Development Update for Shareholders

Sunnyvale, January 3, 2024 – BioCardia, Inc. (Nasdaq: BCDA), a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases issues the following letter to shareholders:

Dear Shareholders,

BioCardia completed 2023 with three active clinical programs of its autologous and allogeneic cell therapies to treat heart disease, with a focus on ischemic heart failure of reduced ejection fraction. We expect to report clinical data from each of these programs in 2024. In coming months, we will provide a more detailed update on our therapeutic pipeline including expected timelines for data readouts and regulatory milestones.

Today, I am writing to share a brief update on our business development activities related to our Biotherapeutic Delivery Partnering (BDP) business and our Morph Access Innovations (Morph) business. Our BDP efforts are enhanced by the experience of almost 500 patients treated with the Helix transendocardial biotherapeutic delivery systems in twelve clinical trials. Morph products are used in each of our biotherapeutic delivery procedures, and have been used in thousands of vascular procedures over the years. The BDP and Morph businesses are derived from the experience and technology that we have developed in support of our own autologous and allogeneic cell therapy platforms.

In BDP, our team provides support for pre-clinical and clinical stage programs to enable and enhance our partner’s biotherapeutic development efforts. Efforts include review and preparation of protocols, sharing of strategic and regulatory insights, and providing technical input on strategies for handling and delivering biologic agents. We provide protocols and data collection templates as well as catheter products and technologies that are available today. We perform training for staff and physicians and support procedures using our biotherapeutic delivery systems. We believe that BioCardia having more opportunities to participate meaningfully in new high-value therapies through BDP is in our shareholders’ interests and outweighs concerns with respect to enabling competitive therapeutic programs.

We have two new biotherapeutic delivery partnerships we anticipate finalizing soon based on terms agreed upon in December 2023. Both potential partners have extensive positive large animal experience with our delivery systems, as do a number of additional potential partners. We have the ability to fully support several of these partners, sharing our knowledge, experience and technology to help advance their efforts.

We have also been active in partnering discussions for our Morph products for markets where our products and technologies enable high value therapies beyond biotherapeutic intervention. These markets include transseptal access, radial access coronary and peripheral procedures, and aorto-ostial access procedures. Our previous product experience in thousands of clinical procedures has led us to our recent Morph DNA™ designs. These bidirectional steerable sheath introducers and guide designs underlie our Avance™ transseptal steerable introducers. Currently, we have several larger firms performing active diligence towards potential Morph partnerships.

Our BDP and Morph partnering efforts are enhanced by both the performance of our offerings in our clinical programs and our extensive intellectual property portfolio. We have had recent patent issuances in Japan and EU that are in our partner’s interests. On October 7th, 2023, Japan’s Patent Office issued Patent No. 737497, and on December 13, 2023, the European Patent Office Issued Patent No. 2943123, both of which are titled, “Target site selection, entry and updates with automatic remote image annotation”. These patents claim ownership of inventions for how an interventional cardiologist working in the chambers of the heart may navigate relative to an imported echo, MRI, or CT image which have been obtained noninvasively prior to the procedure. Our inventive focus has been the targeting of biologic therapies, but the patent impact may be broader. This fusion imaging software approach is anticipated to be a significant product enhancement for our biotherapeutic delivery capabilities and regulated as software as a medical device. There are also recently published patent applications on both our Helix biotherapeutic delivery systems and our Morph steerable access technology that we continue to advance.

The coming year offers the potential for catalysts that could dramatically improve our prospects, timetable, and attractiveness as a business, both from our therapeutic programs themselves and from the technologies we have developed to advance these therapeutic programs. We are excited about what the future holds and are grateful for the opportunity to create an entirely new class of heart failure treatments and transform cardiovascular care. I look forward to sharing material news as it happens.

Thank you for your continued support, which makes everything we do possible.

Sincerely yours,

Peter A. Altman, Ph.D.

President and Chief Executive Officer, BioCardia, Inc.

About BioCardia®

BioCardia, Inc., headquartered in Sunnyvale, California, is developing 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 for the treatment of heart disease. BioCardia also acts as a biotherapeutic delivery partner supporting therapies for the treatment of heart failure, chronic myocardial ischemia and acute myocardial infarction. For more information visit: www.BioCardia.com.

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 advancing our four clinical programs, biotherapeutic delivery partnerships, and Morph steerable sheath and guide partnerships, statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations. 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. Factors that could cause or contribute to such differences include, but are not limited to, the Company’s liquidity position and its ability to raise additional funds, as well as the Company’s ability to successfully progress its clinical trials. 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, 2023, 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.

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Media Contact:
Miranda Peto, Marketing
Email: mpeto@BioCardia.com
Phone: 650-226-0120

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

Document And Entity Information	Jan. 03, 2024
Document Information [Line Items]
Entity, Registrant Name	BIOCARDIA, INC.
Document, Type	8-K
Document, Period End Date	Jan. 03, 2024
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
CommonStock Custom [Member]
Document Information [Line Items]
Title of 12(b) Security	Common Stock
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