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): May 1, 2024

BIOCARDIA, INC.

(Exact name of registrant as specified in its charter)

Delaware	001-38999	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 May 1, 2024, BioCardia, Inc. (the “Company”) issued a press release announcing primary endpoint results of the open label roll-in cohort of the CardiAMP® Cell Therapy in Chronic Myocardial Ischemia Trial. The data was presented in a webcast sponsored by BioCardia on April 30, 2024, by members of the Executive Steering Committee: Dr. Carl Pepine, Professor of Medicine at the University of Florida at Gainesville, and Dr. Amish Raval, Professor of Medicine at the University of Wisconsin at Madison.

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 May 1, 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: May 1, 2024

EX-99.1

Exhibit 99.1

BioCardia’s CardiAMP Cell Therapy Chronic Myocardial Ischemia Trial Results Show Patient Benefits in Important Outcomes

Sunnyvale, Calif., May 1, 2024 (GLOBE NEWSWIRE) -- BioCardia, Inc. (NASDAQ: BCDA), a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced the primary endpoint results of the open label roll-in cohort of the CardiAMP® Cell Therapy in Chronic Myocardial Ischemia Trial.

Study clinical cardiology leadership and members of the Executive Steering Committee, Dr. Carl Pepine, Professor of Medicine at the University Florida at Gainesville, and Dr. Amish Raval, Professor of Medicine at the University of Wisconsin at Madison, presented the early positive results on Tuesday, April 30, 2024 in a webcast sponsored by BioCardia.

Results from the open label roll-in cohort of patients having chronic myocardial ischemia with refractory angina showed an average increase in exercise tolerance of 107 seconds and an average of 82% reduction in angina episodes at the primary six-month follow-up endpoint compared to before receiving the study treatment. All of the patients responded positively to therapy, as measured by increased (improved) exercise tolerance and greatly reduced angina.

These early, open-label results compare favorably to those demonstrated by current FDA approved therapies, and are in line with previous compelling investigational trial results utilizing cost prohibitive cell therapy. The webcast can be accessed through the following link: https://event.choruscall.com/mediaframe/webcast.html?webcastid=neFatBOQ and the presentation slides are available on BioCardia’s website.

“The clinical research results presented for the roll-in cohort from our CardiAMP CMI Trial highlight BioCardia’s continuing efforts to transform the treatment paradigm in refractory angina through the promise of a one‑time cost effective minimally invasive autologous cell-based therapy,” said Peter Altman, President and CEO. “These results strongly support our continued development of this novel therapeutic approach and enhance the value of our CardiAMP cell therapy platform for shareholders and future partners.”

About Chronic Myocardial Ischemia with Refractory Angina

Chronic myocardial ischemia occurs in the setting of coronary artery disease when there is reduced blood flow to the heart. This causes angina, a type of chest pain which is characterized as refractory angina when this pain cannot be controlled by a combination of optimal medical therapy, angioplasty or bypass surgery, and is estimated to impact 600,000 to 1.8 million patients in the United States. Included in these patients are up to 15% of patients undergoing cardiac catheterization who have ischemia or angina and are suboptimal candidates for conventional revascularization. Although prognosis of refractory angina has improved in recent years, patients with refractory angina experience a significantly impaired quality of life with disproportionately high utilization of healthcare services. These observations reflect the great need for new therapies for these patients. Promising results in treating this patient population with an autologous bone marrow derived cell therapy have been shown previously⁽¹⁾.

Reference:

(1) Henry TD, Losordo DW, Traverse JH, Schatz RA, Jolicoeur EM, Schaer GL, Clare R, Chiswell K, White CJ, Fortuin FD, Kereiakes DJ, Zeiher AN, Sherman W, Hunt AS, and Povsic TJ. Autologous CD34 cell therapy improves exercise capacity, angina frequency and reduces mortality in no-option refractory angina: a patient-level pooled analysis of randomized double-blinded trials, European Heart Journal, 2018.

About the CardiAMP Cell Therapy Program

Designated by the FDA as a Breakthrough Therapy for Ischemic Heart Failure, CardiAMP Cell Therapy uses a patient’s own bone marrow cells delivered to the heart in a minimally invasive, catheter-based procedure to potentially stimulate the body’s natural healing response. CardiAMP Cell Therapy incorporates three proprietary elements not previously utilized in investigational cardiac cell therapy: a pre-procedural cell analysis for patient selection, a high target dosage of cells, and a proprietary delivery system that has been shown to be safer than other intramyocardial delivery systems and exponentially more successful in cell retention. The CardiAMP cell therapy trials for the indications of both chronic myocardial ischemia and ischemic heart failure are covered by the Center for Medicare and Medicaid for both treatment and control procedures. CAUTION - Limited by United States law to investigational use. 

About BioCardia, Inc.

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 works with partners to provide its proprietary biotherapeutic delivery system along with preclinical and clinical development services for biotherapeutic delivery to the heart.

Forward Looking Statements:

This press release contains forward-looking statements that are subject to many risks and uncertainties. Forward-looking statements may include, among other things, statements relating to the continued development and cost of BioCardia’s autologous cell-based therapies, the probability of success of the CardiAMP clinical trials, ability to offset clinical costs utilizing Medicare reimbursement and the ultimate success of our clinical cell therapy programs. These forward-looking statements are made as of the date of this press release.

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 advance 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 27, 2024, 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:
Miranda Peto, Marketing / Investor Relations
Email: mpeto@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	May 01, 2024
Document Information [Line Items]
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Document, Type	8-K
Document, Period End Date	May 01, 2024
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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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
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Security Exchange Name	NASDAQ