BioCardia, Inc 8-K, filed Feb 17, 2021
BioCardia, Inc. (BCDA)
About this 8-K
BioCardia, Inc filed this 8-K on February 17, 2021, reporting on events of February 15, 2021.
Items reported
- Item 5.02: Director or officer change, or executive pay
- Item 7.01: Regulation FD disclosure
- Item 9.01: Financial statements and exhibits
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 15, 2021
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BIOCARDIA, INC. |
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(Exact name of registrant as specified in its charter) |
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Delaware |
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0-21419 |
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23-2753988 |
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(State or other jurisdiction of incorporation) |
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(Commission File Number) |
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(IRS Employer Identification No.) |
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125 Shoreway Road, Suite B |
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(Address of principal executive offices and zip code) |
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 |
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Common Stock, par value $0.001 |
BCDA |
The Nasdaq Capital Market |
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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 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
On February 15, 2021 (the “Effective Date”), Henricus Duckers, M.D., Ph.D., FESC resigned from his position as the Chief Medical Officer of BioCardia, Inc. (the “Company”). Also on the Effective Date, Dr. Duckers entered into a consulting agreement (the “Consulting Agreement”) with the Company, under which Dr. Duckers will serve as an advisor to the executive steering committee of the CardiAMP Heart Failure clinical study on an as-needed and ongoing basis and will be paid $400 per hour.
Either Dr. Duckers or the Company may terminate the Consulting Agreement at any time and for any reason upon thirty days advance written notice. Upon such termination, Dr. Duckers will be paid for services actually rendered and will not be entitled to any additional compensation.
Dr. Ducker’s outstanding equity awards ceased vesting as of the Effective Date, and he will be able to exercise any outstanding equity awards for a period of 90 days following the Effective Date.
The description of the Consulting Agreement is qualified in its entirety by reference to the full text of the Consulting Agreement, which the Company expects to file as an exhibit to its next periodic report filed with the Securities and Exchange Commission.
Item 7.01 Regulation FD Disclosure.
On February 17, 2021, the Company issued a press release announcing an update to its clinical leadership team, including the appointment of Sujith Shetty as Chief Medical Officer of the Company. A copy of the press release is attached hereto as Exhibit 99.1 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
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Exhibit No. |
Description |
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99.1 |
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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. |
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| /s/ Peter Altman, Ph.D. | |
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Peter Altman, Ph.D. |
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President and Chief Executive Officer |
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Date: February 17, 2021 |
Exhibit 99.1
FOR IMMEDIATE RELEASE
BIOCARDIA ANNOUNCES CLINICAL LEADERSHIP CHANGES
SAN CARLOS, Calif. – February 17, 2021 – BioCardia®, Inc. [Nasdaq: BCDA] a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today announced clinical leadership changes.
Dr. Sujith Shetty who has been with the Company for almost two years in the capacity of Vice President of Clinical and Regulatory will assume the role of Chief Medical Officer, replacing Dr. Eric Duckers, who resigned as Chief Medical Officer of the Company to pursue other opportunities, effective as of February 15th, 2021. Simultaneous with his resignation, Dr. Duckers entered into a consulting agreement to continue to provide support for the ongoing CardiAMP Heart Failure Trial and its leadership team.
Ms. Debby Holmes-Higgin who has been with the Company for more than three years will continue to serve as Vice President of Clinical with expanded responsibilities.
Both Dr. Shetty and Ms. Holmes-Higgin will be supported by Dr. Hans-Peter Stoll, who recently assumed the role of consulting Medical Monitor for the CardiAMP clinical study. Dr. Stoll has extensive clinical experience having been most recently the Chief Medical Officer at Biosensors International, and served in key senior clinical roles at GE Healthcare, and Cordis, Johnson & Johnson.
“Evolution of the clinical team after the recent successful Data Safety Monitoring Board Review of the CardiAMP Heart Failure Trial is an important step for the success of the ongoing trial,” said Peter Altman, Ph.D., BioCardia’s President and CEO. “Dr. Shetty and Ms. Holmes-Higgin are world class executives in whom we have every confidence, and I am delighted that they will be supported both by Dr. Stoll as Medical Monitor and Dr. Duckers on a consulting basis.”
About BioCardia®
BioCardia, Inc., headquartered in San Carlos, California, is developing regenerative biologic therapies to treat cardiovascular and respiratory disease. CardiAMP autologous and Neurokinin-1 Receptor Positive allogenic cell therapies are the Company’s biotherapeutic platforms in clinical development. The Company's products include the Helix Biotherapeutic Delivery System and its steerable guide and sheath catheter portfolio. BioCardia also partners with other biotherapeutic companies to provide its Helix system and clinical support for their programs studying 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 risks and uncertainties. Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations.
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. These forward-looking statements reflect our view as of the time such statement is made and are not guarantees of future performance or developments. Actual results and events may differ materially from information contained in the forward-looking statements. 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) 545-6654