# EDGAR Filing Document

**Accession Number:** 0000925741
**File Stem:** 0001437749-23-002199
**Filing Date:** 2023-2
**Character Count:** 13092
**Document Hash:** 9a5720b5efa98fec85bc27ca28fe7559
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001437749-23-002199.hdr.sgml**: 20230201

**ACCESSION NUMBER**: 0001437749-23-002199

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 14

**CONFORMED PERIOD OF REPORT**: 20230201

**ITEM INFORMATION**: Regulation FD Disclosure

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20230201

**DATE AS OF CHANGE**: 20230201

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** BioCardia, Inc.
- **CENTRAL INDEX KEY:** 0000925741
- **STANDARD INDUSTRIAL CLASSIFICATION:** BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836]
- **IRS NUMBER:** 232753988
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-38999
- **FILM NUMBER:** 23574684

**BUSINESS ADDRESS:**
- **STREET 1:** 125 SHOREWAY ROAD
- **STREET 2:** SUITE B
- **CITY:** SAN CARLOS
- **STATE:** CA
- **ZIP:** 94070
- **BUSINESS PHONE:** 650-226-0123

**MAIL ADDRESS:**
- **STREET 1:** 125 SHOREWAY ROAD
- **STREET 2:** SUITE B
- **CITY:** SAN CARLOS
- **STATE:** CA
- **ZIP:** 94070

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** Tiger X Medical, Inc.
- **DATE OF NAME CHANGE:** 20110616

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** Cardo Medical, Inc.
- **DATE OF NAME CHANGE:** 20081027

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** CLICKNSETTLE COM INC
- **DATE OF NAME CHANGE:** 20000823

bcda20230131_8k.htm

**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): **February 1, 2023**

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| |
|:---|
| **BIOCARDIA, INC.** |
| (Exact name of registrant as specified in its charter) |

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| | | |
|:---|:---|:---|
| **Delaware** | **0-21419** | **23-2753988** |
| (State or other jurisdiction<br> of incorporation) | (Commission<br> File Number) | (IRS Employer<br> Identification No.) |

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| |
|:---|
| **320 Soquel Way** <br> **Sunnyvale, **California 94085** |
| (Address of principal executive offices and zip code) |

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**Registrant**'**s telephone number, including area code: (**650**) **226-0120**

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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:

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| | | |
|:---|:---|:---|
| 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 |

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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. ☐

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**Item 7.01 Regulation FD Disclosure.**

On February 1, 2023, BioCardia, Inc. (the "Company") and CellProthera, a private developer of cell-based therapies to repair ischemic tissues, issued a press release announcing an amendment to their Clinical Research Supply and Support Agreement, whereby CellProthera utilizes BioCardia's Helix<sup>TM</sup> transendocardial biotherapeutic delivery system for its ongoing Phase I/IIb EXCELLENT study of its lead product candidate ProtheraCytes<sup>TM</sup>. The amendment extends the long-term partnership between the companies to complete the phase I/IIb study, and incorporates the intention for both companies to work together to support CellProthera's next clinical study, potential early access commercialization, which could begin in 2024, and future full commercialization programs. Under the terms of the agreement, CellProthera is not required to partner with BioCardia therapeutic delivery devices for its commercial or subsequent clinical efforts. However, should it not, BioCardia would receive low single digit royalties on net sales of CellProthera's transendocardially delivered ProtheraCytes for its contributions to CellProthera's development efforts. A copy of the press release is attached hereto as Exhibit 99.1 to this current report on Form 8-K.

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

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| | |
|:---|:---|
| **Exhibit No.** | **Description** |
| 99.1<br> 104 | [<u>BioCardia, Inc. press release dated February 1, 2023</u>](ex_470514.htm)<br> Cover Page Interactive Data File (embedded within the Inline XBRL document) |

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**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.

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| |
|:---|
| **BIOCARDIA, INC.** |
| /s/ Peter Altman, Ph.D. |
| Peter Altman, Ph.D. |
| President and Chief Executive Officer |
| Date: February 1, 2023 |

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## Exhibit 99.1

**Exhibit 99.1**

**<u>FOR IMMEDIATE RELEASE</u>**

**BioCardia and CellProthera Enhance Collaboration for Development of ProtheraCytes<sup>TM</sup> for the Treatment of Acute Myocardial Infarction in Europe and Potential Early Access for Patients**

**SUNNYVALE, California USA and MULHOUSE, France, February 1, 2023** -<u>BioCardia, Inc.</u> [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, and <u>CellProthera</u>, a private developer of cell-based therapies to repair ischemic tissues, today announce an amendment to their Clinical Research Supply and Support Agreement.

The amendment extends the long-term partnership between both organizations. The agreement relates to CellProthera's use of BioCardia's Helix™ transendocardial biotherapeutic delivery system for its ongoing Phase I/IIb EXCELLENT study of its lead product candidate ProtheraCytes<sup>TM</sup>.

CellProthera has developed ProtheraCytes as a one shot minimally invasive autologous ATMP cell therapy to improve the quality of life of post-Acute Myocardial Infarction (AMI) patients who have no therapeutic solution to restore the heart's function, and to reduce ongoing hospitalizations and invasive medical treatments such as heart transplants. BioCardia's Helix Biotherapeutic Delivery System is the leading percutaneous catheter delivery system for cardiovascular regenerative medicine. It enables local delivery of cell and gene-based therapies to treat heart failure, myocardial infarction, ischemia, and cardiac conduction disorders.

CellProthera and BioCardia have extended the agreement to complete the ongoing Phase I/IIb EXCELLENT study. The agreement incorporates the intention for both organizations to work together regarding CellProthera's next clinical study, potential early access commercialization, which could begin in 2024, and future full commercialization programs.

"CellProthera's therapeutic solution meets a high unmet medical need and has considerable commercial potential. We remain optimistic that they will be demonstrating clinically meaningful and statistically significant benefits from their ongoing Phase I/IIb clinical trial for post-AMI patients that have no alternative therapeutic options," said Peter Altman, PhD., Chief Executive Officer, BioCardia. "We also look forward to the potential of early commercial access that may be granted in 2024 for the benefit of patients and continued clinical development together in the European Union and the United Kingdom."

"BioCardia's Helix delivery system has enabled CellProthera to enhance the delivery and retention of our cellular product in the heart while maintaining the status of a minimally invasive procedure. The Helix system has performed excellently," said Matthieu de Kalbermatten CEO, CellProthera. "As we complete enrollment in our Phase I/IIb program, this year, it is strategically important for CellProthera to strengthen its partnership with BioCardia for the ultimate benefit of patients, the physicians that treat them, and both companies' stakeholders."

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Under the terms of the agreement, CellProthera is not required to partner with BioCardia therapeutic delivery devices for its commercial or subsequent clinical efforts. However, should it not, BioCardia would receive low single digit royalty on net sales of CellProthera's transendocardially delivered ProtheraCytes for its contributions to CellProthera's development efforts.

**About CellProthera**

<u>CellProthera</u> is a regenerative cell therapy developer specializing in cardiovascular diseases with a leading program in myocardial infarction. CellProthera has developed a unique GMP-compliant cell expansion process as well as a proprietary automation technology for in vitro production of large quantity of purified, CD34+ stem cells. Its lead therapy ProtheraCytes<sup>TM</sup>, is an autologous cell therapy and has been developed for body regeneration and targeted to regenerate various damaged tissues, including cardiac tissue. ProtheraCytes is registered as an Advanced Therapy Medicinal Product by the European Medicines Agency (EMA). CellProthera's proprietary technology platform comprises an automated expansion device called StemXpand<sup>TM</sup> and its disposable kit StemPack®. CellProthera is headquartered in France and has 22 employees.

https://www.cellprothera.com/en/home/

**About BioCardia**

<u>BioCardia, Inc.</u>, 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.

https://www.biocardia.com/

**BioCardia Forward Looking Statements:**

This press release contains forward-looking statements and that are subject to many risks and uncertainties. Forward looking statements include, among other things, enrollment and completion of clinical studies, performance of delivery systems, success of the collaboration and commercialization and future payments. These forward-looking statements are made as of the date of this press release.

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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 the 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.

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**CellProthera Media Contact:**

**IB Communications**

Tel <u>+44 (0)20 89434685</u>

<u>cellprothera@ibcomms.agency</u>

**BioCardia Media Contact:**

Anne Laluc

info@biocardia.com, (650) 226-0120

**BioCardia Investor Contact:**

David McClung, Chief Financial Officer

<u>investors@biocardia.com</u>, (650) 226-0120