BioCardia, Inc 10-Q for FY2020 Q1

About this 10-Q

Headline figures

BioCardia, Inc. (BCDA)

10-Q 2020-05-15 For: 2020-03-31

Added on April 06, 2026

BioCardia, Inc filed this 10-Q on May 15, 2020, covering the quarter ended March 31, 2020 (FY2020 Q1).

Large accelerated filer

Accelerated filer

Non-accelerated filer

Smaller reporting company

Emerging growth company

Quarter ended March 31, 2020, as reported in this filing, compared with the same period a year earlier where the filing states it.

Revenue: $38K; down 82.4% from $216K a year earlier
Net loss: $4.59M; compared with a net loss of $3.67M a year earlier

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Part I.	FINANCIAL INFORMATION	4

Item 1.	Unaudited Condensed Consolidated Financial Statements	4
	Condensed Consolidated Balance Sheets as of March 31, 2020 and December 31, 2019	4
	Condensed Consolidated Statements of Operations for the three months ended March 31, 2020 and 2019	5
	Condensed Consolidated Statements of Shareholders’ Equity (Deficit) for the three months ended March 31, 2020 and 2019	6
	Condensed Consolidated Statements of Cash Flows for the three months ended March 31, 2020 and 2019	7
	Notes to Unaudited Condensed Consolidated Financial Statements	8
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	18
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	26
Item 4.	Controls and Procedures	27

Part II.	OTHER INFORMATION	28

Item 1.	Legal Proceedings	28
Item 1A.	Risk Factors	29
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	30
Item 3.	Defaults Upon Senior Securities	30
Item 4.	Mine Safety Disclosures	30
Item 5.	Other Information	30
Item 6.	Exhibits	30

EXHIBIT INDEX		30
SIGNATURES		31

	March 31,			December 31,
	2020			2019
	(unaudited)
Assets

Current assets:
Cash and cash equivalents	$	2,587		$	5,585
Accounts receivable, net of allowance for doubtful accounts of $2 and $2 at March 31, 2020 and December 31, 2019		179			147
Inventory		—			4
Prepaid expenses and other current assets		453			642
Total current assets		3,219			6,378
Property and equipment, net		164			181
Operating lease right-of-use asset, net		947			1,065
Other assets		54			54
Total assets	$	4,384		$	7,678
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable	$	1,108		$	914
Accrued expenses and other current liabilities		2,854			2,561
Operating lease liability - current		548			528
Total current liabilities		4,510			4,003
Operating lease liability - noncurrent		468			614
Deferred revenue		689			691
Total liabilities		5,667			5,308
Stockholders’ equity:
Preferred stock, $0.001 par value, 25,000,000 shares authorized as of March 31, 2020 and December 31, 2019; no shares issued and outstanding as of March 31, 2020 and December 31, 2019		—			—
Common stock, $0.001 par value, 100,000,000 shares authorized as of March 31, 2020 and December 31, 2019; 6,848,355 and 6,825,183 shares issued and outstanding as of March 31, 2020 and December 31, 2019		7			7
Additional paid-in capital		104,374			103,433
Accumulated deficit		(105,664	)		(101,070	)
Total stockholders’ (deficit) equity		(1,283	)		2,370
Total liabilities and stockholders’ equity	$	4,384		$	7,678

	Three months ended March 31,
	2020			2019
Revenue:
Net product revenue	$	5		$	76
Collaboration agreement revenue		33			140
Total revenue		38			216
Costs and expenses:
Cost of goods sold		4			106
Research and development		2,786			2,166
Selling, general and administrative		1,857			1,631
Total costs and expenses		4,647			3,903
Operating loss		(4,609	)		(3,687	)
Other income (expense):
Interest income		16			23
Other expense		(1	)		(1	)
Total other income (expense), net		15			22
Net loss	$	(4,594	)	$	(3,665	)

Net loss per share, basic and diluted	$	(0.67	)	$	(0.86	)

Weighted-average shares used in computing net loss per share, basic and diluted		6,831,976			4,248,450

	Common stock				Additional		Accumulated
	Shares		Cost		paid in capital		deficit			Total
Balance at December 31, 2019		6,825,183	$	7	$	103,433	$	(101,070	)	$	2,370
Restricted stock units vested and issued		23,172		—		—		—			—
Share-based compensation		—		—		941		—			941
Net loss		—		—		—		(4,594	)		(4,594	)
Balance at March 31, 2020		6,848,355	$	7	$	104,374	$	(105,664	)	$	(1,283	)


Balance at December 31, 2018		4,845,697	$	5	$	90,148	$	(86,361	)	$	3,792
Restricted stock units vested and issued		2,268		—		—		—			—
Share-based compensation		—		—		690		—			690
Net loss		—		—		—		(3,665	)		(3,665	)
Balance at March 31, 2019		4,847,965	$	5	$	90,838	$	(90,026	)	$	817

	(a)	Description of Business

		BioCardia, Inc., (BioCardia or the Company), is a clinical-stage regenerative medicine company developing novel therapeutics for cardiovascular diseases with significant unmet medical needs. The Company’s lead therapeutic candidate is the CardiAMP® cell therapy system and its second therapeutic candidate is the CardiALLO™ cell therapy system. To date, the Company has devoted substantially all its resources to research and development efforts relating to its therapeutic candidates and biotherapeutic delivery systems including conducting clinical trials, developing manufacturing and sales capabilities, in-licensing related intellectual property, providing general and administrative support for these operations and protecting its intellectual property.

		BioCardia also has three enabling device product lines: (1) the CardiAMP cell processing system; (2) the Helix biotherapeutic delivery system, or Helix; and (3) the Morph vascular access product line, or Morph. The Company manages its operations as a single segment for the purposes of assessing performance and making operating decisions.

	(a)	Basis of Preparation

		The accompanying condensed consolidated balance sheets, statements of operations, shareholders’ equity, and cash flows as of March 31, 2020 and for the three months ended March 31, 2020 and 2019 are unaudited. The condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America (U.S. GAAP) and applicable rules and regulations of the Securities and Exchange Commission (SEC) for interim financial information and on a basis consistent with the annual financial statements and, in the opinion of management, reflect all adjustments which include only normal recurring adjustments, necessary to present fairly its financial position as of March 31, 2020, results of operations for the three months ended March 31, 2020 and 2019, and cash flows for the three months ended March 31, 2020 and 2019.

		These condensed consolidated financial statements should be read in conjunction with the audited financial statements and related notes included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2019, filed with the SEC on April 9, 2020. The results for the three months ended March 31, 2020 are not necessarily indicative of the results to be expected for the year ending December 31, 2020 or for any other interim period or for any other future year, particularly in light of the novel coronavirus pandemic, or COVID-19, and its impact on domestic and global economies. To limit the spread of COVID-19, governments have taken various actions including the issuance of stay-at-home orders and social distancing guidelines, causing some businesses to suspend operations and/or experience a reduction in demand for many products from direct or ultimate customers. Accordingly, businesses have adjusted, reduced or suspended operating activities. Beginning March 17, 2020, substantially all of the Company’s workforce began working from home. On April 6, manufacturing operations resumed at the Company’s facilities, with substantially all other staff continuing to work from home under the stay-at-home orders. The effects of the stay-at-home orders and BioCardia’s work-from-home policies may negatively impact productivity, disrupt the Company’s business and delay the Company’s development programs, regulatory and commercialization timelines, the magnitude of which will depend, in part, on the length and severity of the restrictions and other limitations on BioCardia’s ability to conduct the Company’s business in the ordinary course. BioCardia’s future research and development expenses and general and administrative expenses may vary significantly if the Company experiences an increased impact from COVID-19 on the costs and timing associated with the conduct of BioCardia’s clinical trials and other related business activities.

	(b)	Liquidity and Other Risks and Uncertainties

		Going Concern and Liquidity - The Company has incurred net losses and negative cash flows from operations since its inception and had an accumulated deficit of $105.7 million as of March 31, 2020. Management expects operating losses and negative cash flows to continue through at least the next several years. The Company expects to incur increasing costs as the pivotal CardiAMP Heart Failure trial is advanced and development of the CardiAMP and CardiALLO Cell Therapy Systems continue. Therefore, absent additional funding, management believes cash and cash equivalents of $2.6 million as of March 31, 2020 are not sufficient to fund the Company beyond the second quarter of 2020. These factors raise substantial doubt about the Company’s ability to continue as a going concern beyond one year from the date these financial statements are issued. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.

		The Company’s ability to continue as a going concern and to continue further development of its therapeutic candidates beyond the second quarter of 2020, will require the Company to raise additional capital. The Company plans to raise additional capital, potentially including debt and equity arrangements, to finance its future operations. While management believes this plan to raise additional funds will alleviate the conditions that raise substantial doubt, these plans are not entirely within its control and cannot be assessed as being probable of occurring. If adequate funds are not available, the Company may be required to reduce operating expenses, delay or reduce the scope of its product development programs, obtain funds through arrangements with others that may require the Company to relinquish rights to certain of its technologies or products that the Company would otherwise seek to develop or commercialize itself, or cease operations.

	(c)	Use of Estimates

		The preparation of the financial statements in accordance with U.S. GAAP requires management to make certain estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Actual results could differ materially from those estimates. Significant items subject to such estimates and assumptions include share-based compensation, the useful lives of property and equipment, right-of-use assets and related liabilities, incremental borrowing rate, allowances for doubtful accounts and sales returns, derivative instruments, clinical accruals, and inventory valuation.

	(d)	Principles of Consolidation

		The condensed consolidated financial statements include the accounts of the Company and its wholly owned subsidiary. All intercompany accounts and transactions have been eliminated during the consolidation process.

	(e)	Changes to Significant Accounting Policies

		The Company’s significant accounting policies are described in Note 2 of the notes to the consolidated financial statements included in its Annual Report on Form 10-K filed April 9, 2020 for the year ended December 31, 2019. There have been no changes to those policies.

	(f)	Recently Issued Accounting Pronouncements

		Recent accounting pronouncements issued by the FASB, including its Emerging Issues Task Force did not or are not believed by management to have a material impact on the Company’s financial statement presentation or disclosures.

	As of March 31, 2020

	Level 1		Level 2		Level 3		Total
Assets:
Money market funds	$	1,913	$	—	$	—	$	1,913

	As of December 31, 2019
	Level 1		Level 2		Level 3		Total
Assets:
Money market funds	$	4,637	$	—	$	—	$	4,637

	Operating Lease
	March 31, 2020
Remainder of 2020	$	473
For the year ending December 31, 2021		649
Total undiscounted lease payments		1,122
Less imputed interest		106
Total operating lease liabilities	$	1,016

	Number of		Weighted
	Common Stock		Average
	Warrants		Exercise Price
Balance, December 31, 2019		2,435,808	$	6.36
Warrants for common stock sold		—		—
Warrants for common stock exercised		—		—
Balance, March 31, 2020		2,435,808	$	6.36

	March 31,			December 31,
	2020			2019
Computer equipment and software	$	132		$	132
Laboratory and manufacturing equipment		550			550
Furniture and fixtures		60			55
Leasehold improvements		332			332
Construction in progress		69			69
Property and equipment, gross		1,143			1,138
Less: accumulated depreciation		(979	)		(957	)
Property and equipment, net	$	164		$	181

	Options outstanding
	Number of shares			Weighted average exercise price		Weighted average remaining contractual term (years)

Balance, December 31, 2019		821,464		$	18.99		6.6
Stock options granted		31,455			5.33
Stock options exercised		—			—
Stock options canceled		(16,947	)		16.32
Balance, March 31, 2020		835,972		$	7.20		7.4
Exercisable and vested, March 31, 2020		472,113		$	8.63		6.4

	Number of shares			Weighted average grant date fair value per share

Balance, December 31, 2019		36,981		$	10.56
RSUs granted		—			—
RSUs vested		(23,172	)		10.56
RSUs forfeited		(13,809	)		—
Balance, March 31, 2020		—		$	—

	March 31,
	2020		2019
Stock options to purchase common stock		835,972		608,596
Unvested restricted stock units		-		27,435
Common stock warrants		2,435,807		296,296
Total		3,271,779		932,327

	•	salaries and related overhead expenses, which include share-based compensation and benefits for personnel in research and development functions;

	•	fees paid to consultants and contract research organizations, or CROs, including in connection with our preclinical studies and clinical trials and other related clinical trial fees, such as for investigator grants, patient screening, laboratory work, clinical trial management and statistical compilation and analysis;

	•	costs related to acquiring and manufacturing clinical trial materials;

	•	costs related to compliance with regulatory requirements; and

	•	payments related to licensed products and technologies.

	Three months ending March 31,
	2020			2019
Net cash used in:
Operating activities	$	(2,993	)	$	(2,465	)
Investing activities		(5	)		(55	)
Financing activities		-			-
Net decrease in cash and cash equivalents	$	(2,998	)	$	(2,520	)

3.1(1)	Amended and Restated Certificate of Incorporation, as amended May 6, 2019
3.2(2)	Amended and Restated Bylaws
4.1*#	Form of Director Restricted Stock Unit Agreement under the BioCardia 2016 Equity Incentive Plan
10.1(3)^	Litigation Funding Agreement dated April 9, 2020, between BSLF, L.L.C. and BioCardia, Inc.
10.2(4)	Note dated May 1, 2020, between BioCardia Lifesciences, Inc. and Silicon Valley Bank
31.1*	Certification of Principal Executive Officer under Section 302 of the Sarbanes-Oxley Act of 2002.
31.2*	Certification of Principal Financial Officer under Section 302 of the Sarbanes-Oxley Act of 2002.
32.1**	Certification of Principal Executive Officer Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
32.2**	Certification of Principal Financial Officer Pursuant to Rule 13a-14(b) and Section 906 of the Sarbanes-Oxley Act of 2002.

101.INS+	XBRL Instance Document
101.SCH+	XBRL Taxonomy Extension Schema Document
101.CAL+	XBRL Taxonomy Extension Calculation Linkbase Document
101.DEF+	XBRL Taxonomy Extension Definition Linkbase Document
101.LAB+	XBRL Taxonomy Extension Label Linkbase Document
101.PRE+	XBRL Taxonomy Extension Presentation Linkbase Document

*	Filed herewith.
#	Indicates management contract or compensatory plan or arrangement.
**	Furnished herewith.
+	The financial information contained in these XBRL documents is unaudited and is furnished, not filed with the Securities and Exchange Commission.
^	Exhibits to this Exhibit have been omitted in accordance with Item 601(a)(5) of Regulation S-K. The Company will furnish supplemental copies of the omitted exhibits to the SEC upon its request.
(1)	Previously filed as Exhibit 3.1 of the Form 10-Q for the quarterly period ended June 30, 2019 filed by us on August 14, 2019.
(2)	Previously filed as Exhibit 3.2 to the Current Report on Form 8-K filed by us on April 11, 2017.
(3)	Previously filed as Exhibit 10.1 to the Current Report on Form 8-K filed by us on April 14, 2020.
(4)	Previously filed as Exhibit 10.1 to the Current Report on Form 8-K filed by us on May 8, 2020.

	BIOCARDIA, INC. (Registrant)


Date: May 15, 2020	By:	/s/ Peter Altman
		Peter Altman
		President and Chief Executive Officer
		(Principal Executive Officer)


Date: May 15, 2020	By:	/s/ David McClung
		David McClung
		Chief Financial Officer
		(Principal Financial and Accounting Officer)

PARTICIPANT:		BIOCARDIA, Inc.




Signature		By


Print Name		Title

Residence Address:

	(a)	Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

	(b)	Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

	(c)	Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

	(d)	Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant's internal control over financial reporting; and