SEC Info - BioCardia, Inc. - ‘NT 10-K’ for 12/31/19

BioCardia, Inc. – ‘NT 10-K’ for 12/31/19

BioCardia, Inc. – ‘NT 10-K’ for 12/31/19

On: Tuesday, 3/31/20, at 4:02pm ET · Effective: 3/31/20 · For: 12/31/19 · Accession #: 1437749-20-6642 · File #: 1-38999

Notice of a Late Filing of a Form 10-K — Rule 12b-25
Filing Table of Contents

This is an HTML Document rendered as filed. [ Alternative Formats ]

Dates Referenced Herein and Documents Incorporated by Reference

On: Tuesday, 3/31/20, at 4:02pm ET · Effective: 3/31/20 · For: 12/31/19 · Accession #: 1437749-20-6642 · File #: 1-38999

Previous ‘NT 10-K’: ‘NT 10-K’ on 4/2/19 for 12/31/18 · Latest ‘NT 10-K’: This Filing

Notice of a Late Filing of a Form 10-K — Rule 12b-25Filing Table of Contents

This is an HTML Document rendered as filed. [ Alternative Formats ]

Dates Referenced Herein and Documents Incorporated by Reference

Notice of a Late Filing of a Form 10-K — Rule 12b-25
Filing Table of Contents

SEC Info℠

Home

Help

Please Sign In

  As Of               Filer                 Filing    For·On·As Docs:Size             Issuer                      Filing Agent

 3/31/20  BioCardia, Inc.                   NT 10-K    12/31/19    1:36K                                    RDG Filings/FA

Document/Exhibit                   Description                      Pages   Size 

 1: NT 10-K     Notice of a Late Filing of a Form 10-K              HTML     24K

C: <> <>

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 12b-25

NOTIFICATION OF LATE FILING

(Check One)	☒ Form 10-K ☐ Form 20-F ☐ Form 11-K ☐ Form 10-Q ☐ Form 10-D ☐ Form N-SAR ☐ Form N-CSR

	For Period Ended: December 31, 2019

	☐ Transition Report on Form 10-K
	☐ Transition Report on Form 20-F
	☐ Transition Report on Form 11-K
	☐ Transition Report on Form 10-Q
	☐ Transition Report on Form N-SAR

	For the Transition Period Ended:
Nothing in this form shall be construed to imply that the Commission has verified any information contained herein.

If the notification relates to a portion of the filing checked above, identify the Item(s) to which the notification relates:

PART I — REGISTRANT INFORMATION

BIOCARDIA, INC.

(Full Name of Registrant)

N/A

(Former Name if Applicable)

125 Shoreway Road, Suite B

(Address of Principal Executive Office (Street and Number))

San Carlos, CA 94070

(City, State and Zip Code)

PART II — RULES 12b-25(b) AND (c)

If the subject report could not be filed without unreasonable effort or expense and the registrant seeks relief pursuant to Rule 12b-25(b), the following should be completed. (Check box if appropriate)

	(a)	The reason described in reasonable detail in Part III of this form could not be eliminated without unreasonable effort or expense;

☒	(b)	The subject annual report, semi-annual report, transition report on Form 10-K, Form 20-F, Form 11-K, Form N-SAR or Form N-CSR, or portion thereof, will be filed on or before the fifteenth calendar day following the prescribed due date; or the subject quarterly report or transition report on Form 10-Q or subject distribution report on Form 10-D, or portion thereof, will be filed on or before the fifth calendar day following the prescribed due date; and

	(c)	The accountant’s statement or other exhibit required by Rule 12b-25(c) has been attached if applicable.

PART III — NARRATIVE

State below in reasonable detail why Forms 10-K, 20-F, 11-K, 10-Q, 10-D, N-SAR, N-CSR, or the transition report or portion thereof, could not be filed within the prescribed time period.

BioCardia, Inc. (“BioCardia” or the “Company”) was unable to file its Annual Report on Form 10-K for the fiscal year ended December 31, 2019 (the “Form 10-K”) within the prescribed time period without unreasonable effort or expense. The Company requires additional time to ensure the accuracy of its 2019 financial information due to delays related to the novel coronavirus (COVID-19) global outbreak that has required our workforce to work remotely. As a result of these delays, our auditors have not completed the audit of the financial statements for the year ended December 31, 2019.

The Company expects its financial statements to include disclosure that in March 2020, the World Health Organization declared the outbreak of COVID-19, a novel strain of Coronavirus, a global pandemic. This outbreak is causing major disruptions to businesses and financial markets worldwide as the virus spreads. The extent of the effect on the Company’s operational and financial performance will depend on future developments, including the duration, spread and intensity of the pandemic, and governmental, regulatory and private sector responses, all of which are uncertain and difficult to predict. Although the Company is unable to estimate the financial effect of the pandemic at this time, if the pandemic continues to evolve into a severe worldwide health crisis, it could have a material adverse effect on the Company’s business, clinical development programs, results of operations, financial condition and cash flows.

In addition, the Company expects to include the following risk factor in its Form 10-K.

The outbreak of the novel strain of coronavirus, SARS-CoV-2, which causes COVID-19, could adversely impact our business, including our preclinical studies and clinical trials.

Public health crises such as pandemics or similar outbreaks could adversely impact our business. In December 2019, a novel strain of coronavirus, SARS-CoV-2, which causes coronavirus disease 2019 (“COVID-19”), surfaced in Wuhan, China. Since then, COVID-19 has spread to multiple countries, including the United States. In response to the spread of COVID-19, we have closed our executive offices with our administrative employees continuing their work outside of our offices, restricted on-site staff to only those required to execute their job responsibilities and limited the number of staff in any given research and development laboratory.

As a result of the COVID-19 outbreak, or similar pandemics, we have and may in the future experience disruptions that could severely impact our business, preclinical studies and clinical trials, including:

•

delays or difficulties in enrolling patients in our clinical trials;

•

delays or difficulties in clinical site initiation, including difficulties in recruiting clinical site investigators and clinical site staff;

•

delays or disruptions in non-clinical experiments due to unforeseen circumstances at contract research organizations and vendors along their supply chain;

•

increased rates of patients withdrawing from our clinical trials following enrollment as a result of contracting COVID-19, being forced to quarantine, or not accepting home health visits;

•

diversion of healthcare resources away from the conduct of clinical trials, including the diversion of hospitals serving as our clinical trial sites and hospital staff supporting the conduct of our clinical trials;

•

interruption of key clinical trial activities, such as clinical trial site data monitoring, due to limitations on travel imposed or recommended by federal or state governments, employers and others or interruption of clinical trial subject visits and study procedures (particularly any procedures that may be deemed non-essential), which may impact the integrity of subject data and clinical study endpoints;

•

interruption or delays in the operations of the FDA and comparable foreign regulatory agencies, which may impact approval timelines;

•

interruption of, or delays in receiving, supplies of our product candidates from our contract manufacturing organizations due to staffing shortages, production slowdowns or stoppages and disruptions in delivery systems; and

•

limitations on employee resources that would otherwise be focused on the conduct of our preclinical studies and clinical trials, including because of sickness of employees or their families, the desire of employees to avoid contact with large groups of people, an increased reliance on working from home or mass transit disruptions.

These and other factors arising from the COVID-19 pandemic could worsen in countries that are already afflicted with COVID-19, could continue to spread to additional countries, or could return to countries where the pandemic has been partially contained, each of which could further adversely impact our ability to conduct clinical trials and our business generally, and could have a material adverse impact on our operations and financial condition and results.

In addition, the trading prices for our common stock and other biopharmaceutical companies have been highly volatile as a result of the COVID-19 epidemic. As a result, we may face difficulties raising capital through sales of our common stock or such sales may be on unfavorable terms. The COVID-19 outbreak continues to rapidly evolve. The extent to which the outbreak may impact our business, preclinical studies and clinical trials will depend on future developments, which are highly uncertain and cannot be predicted with confidence, such as the ultimate geographic spread of the disease, the duration of the outbreak, travel restrictions and actions to contain the outbreak or treat its impact, such as social distancing and quarantines or lock-downs in the United States and other countries, business closures or business disruptions and the effectiveness of actions taken in the United States and other countries to contain and treat the disease.

The Company previously identified a material weakness in internal control over financial reporting as of September 30, 2019, which resulted from a lack of consistent processes to appropriately perform effective and timely review of the accounting for and disclosure of non-routine transactions, which remains unremediated at December 31, 2019. The Company is in the process of completing its evaluation of internal control over financial reporting. Due to this material weakness in internal control over financial reporting, the Company has concluded that disclosure controls and procedures were not effective as of December 31, 2019. In addition, the Company expects to continue to report that there is substantial doubt about its ability to continue as a going concern.

The Company anticipates that it will file the Form 10-K no later than the fifteenth calendar day following the prescribed due date.

PART IV — OTHER INFORMATION

BIOCARDIA, INC.

(Name of Registrant as Specified in Charter)

has caused this notification to be signed on its behalf by the undersigned hereunto duly authorized.

Date	March 31, 2020	By	/s/ *David McClung*
			David McClung
			Chief Financial Officer

INSTRUCTION: The form may be signed by an executive officer of the registrant or by any other duly authorized representative. The name and title of the person signing the form shall be typed or printed beneath the signature. If the statement is signed on behalf of the registrant by an authorized representative (other than an executive officer), evidence of the representative’s authority to sign on behalf of the registrant shall be filed with the form.

ATTENTION
Intentional misstatements or omissions of fact constitute Federal Criminal Violations
(See 18 U.S.C. 1001).

This ‘NT 10-K’ Filing	Date	Other Filings

Filed on / Effective on:	3/31/20
For Period end:	12/31/19	4
	9/30/19	10-Q, NT 10-Q
		List all Filings

↑Top

Filing Submission 0001437749-20-006642 – Alternative Formats (Word / Rich Text, HTML, Plain Text, et al.)

Name and telephone number of person to contact in regard to this notification

David McClung

226-0120

(Name)

(Area Code)

(Telephone Number)

Have all other periodic reports required under Section 13 or 15(d) of the Securities Exchange Act of 1934 or Section 30 of the Investment Company Act of 1940 during the preceding 12 months or for such shorter period that the registrant was required to file such report(s) been filed? If answer is no, identify report(s). ☒ Yes ☐ No

Is it anticipated that any significant change in results of operations from the corresponding period for the last fiscal year will be reflected by the earnings statements to be included in the subject report or portion thereof? ☐ Yes ☒ No