BioCardia, Inc 10-Q for FY2021 Q1

BioCardia, Inc. (BCDA)

10-Q 2021-05-13 For: 2021-03-31

Added on April 06, 2026

About this 10-Q

BioCardia, Inc filed this 10-Q on May 13, 2021, covering the quarter ended March 31, 2021 (FY2021 Q1).

Headline figures

Quarter ended March 31, 2021, as reported in this filing, compared with the same period a year earlier where the filing states it.

Revenue: $46K; up 21.1% from $38K a year earlier
Net loss: $2.97M; compared with a net loss of $4.59M a year earlier

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Large accelerated filer	☐	Accelerated filer	☐

Non-accelerated filer	☒	Smaller reporting company	☒

		Emerging growth company	☐

Part I.	FINANCIAL INFORMATION	4

Item 1.	Unaudited Condensed Consolidated Financial Statements	4
	Condensed Consolidated Balance Sheets as of March 31, 2021 and December 31, 2020	4
	Condensed Consolidated Statements of Operations for the three months ended March 31, 2021 and 2020	5
	Condensed Consolidated Statements of Stockholders’ Equity (Deficit) for the three months ended March 31, 2021 and 2020	6
	Condensed Consolidated Statements of Cash Flows for the three months ended March 31, 2021 and 2020	7
	Notes to Unaudited Condensed Consolidated Financial Statements	8
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	16
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	22
Item 4.	Controls and Procedures	22

Part II.	OTHER INFORMATION	23

Item 1.	Legal Proceedings	23
Item 1A.	Risk Factors	23
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	23
Item 3.	Defaults Upon Senior Securities	23
Item 4.	Mine Safety Disclosures	23
Item 5.	Other Information	23
Item 6.	Exhibits	24

EXHIBIT INDEX		24
SIGNATURES		25

	March 31,			December 31,
	2021			2020
	(unaudited)
Assets
Current assets:
Cash and cash equivalents	$	21,502		$	21,407
Accounts receivable, net of allowance for doubtful accounts of $16 at both March 31, 2021 and December 31, 2020		190			232
Prepaid expenses and other current assets		344			401
Other receivable due from related party		623			618
Total current assets		22,659			22,658
Property and equipment, net		164			145
Operating lease right-of-use asset, net		432			567
Other assets		53			54
Total assets	$	23,308		$	23,424
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable	$	850		$	746
Accrued expenses and other current liabilities		2,248			2,205
Deferred revenue		1,180			683
Operating lease liability - current		468			614
Total liabilities		4,746			4,248
Stockholders’ equity:
Preferred stock, $0.001 par value, 25,000,000 shares authorized as of March 31, 2021 and December 31, 2020; no shares issued and outstanding as of March 31, 2021 and December 31, 2020		—			—
Common stock, $0.001 par value, 100,000,000 shares authorized as of March 31, 2021 and December 31, 2020; 16,792,893 and 16,297,381 shares issued and outstanding as of March 31, 2021 and December 31, 2020		17			16
Additional paid-in capital		137,588			135,234
Accumulated deficit		(119,043	)		(116,074	)
Total stockholders’ equity		18,562			19,176
Total liabilities and stockholders’ equity	$	23,308		$	23,424

BIOCARDIA, INC.
Condensed Consolidated Statements of Operations
(In thousands, except share and per share amounts)
(unaudited)

	Three months ended March 31,
	2021			2020
Revenue:
Net product revenue	$	—		$	5
Collaboration agreement revenue		46			33
Total revenue		46			38
Costs and expenses:
Cost of goods sold		—			4
Research and development		1,841			2,786
Selling, general and administrative		1,177			1,857
Total costs and expenses		3,018			4,647
Operating loss		(2,972	)		(4,609	)
Other income (expense):
Interest income		4			16
Other expense		(1	)		(1	)
Total other income (expense), net		3			15
Net loss	$	(2,969	)	$	(4,594	)

Net loss per share, basic and diluted	$	(0.18	)	$	(0.67	)

Weighted-average shares used in computing net loss per share, basic and diluted		16,569,268			6,831,976

	Common stock				Additional		Accumulated
	Shares		Cost		paid-in capital		deficit			Total
Balance at December 31, 2020		16,297,381	$	16	$	135,234	$	(116,074	)	$	19,176
Restricted stock units vested and issued		40,100		—		—		—			—
Sale of common stock		453,832		1		1,933		—			1,934
Exercise of common stock options		1,580		—		5		—			5
Share-based compensation		—		—		416		—			416
Net loss		—		—		—		(2,969	)		(2,969	)
Balance at March 31, 2021		16,792,893	$	17	$	137,588	$	(119,043	)	$	18,562

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	)

	*(a)*	*Description of Business*

		BioCardia, Inc. (we, us, our, BioCardia or the Company), is a clinical-stage regenerative medicine company developing novel therapeutics for cardiovascular and respiratory diseases with significant unmet medical needs. The Company’s lead therapeutic candidate is the CardiAMP® Cell Therapy System, which provides an autologous bone marrow derived cell therapy for treatment in two clinical indications: heart failure that develops after a heart attack and chronic myocardial ischemia. The Company’s second therapeutic platform is an investigational bone marrow derived allogeneic “off the shelf” Neurokinin-1 Receptor Positive mesenchymal stem cell therapy for the treatment of cardiac and pulmonary disease. 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.

	*(b)*	*Liquidity and Other Risks and Uncertainties*

		*Liquidity -* The Company has incurred net losses and negative cash flows from operations since its inception and had an accumulated deficit of $119.0 million as of March 31, 2021. 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 it advances its trials and development activities. Management believes cash and cash equivalents of $21.5 million as of March 31, 2021 are sufficient to fund the Company’s planned expenditures and meet its obligations for at least 12 months following the filing of this form 10-Q.

	*(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, inventory valuation, and assumptions used for revenue recognition.

	*(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 March 30, 2021 for the year ended December 31, 2020. There have been no changes to those policies.

	*(f)*	*Recent Accounting Pronouncements*

		Recent accounting pronouncements issued by the Financial Accounting Standards Board (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, 2021

	Level 1		Level 2		Level 3		Total
Assets
Money market funds	$	20,583	$	—	$	—	$	20,583
Cash in checking account		—		—		—		919
Total cash and cash equivalents	$	20,583	$	—	$	—	$	21,502

	As of December 31, 2020
	Level 1		Level 2		Level 3		Total
Assets
Money market funds	$	20,662	$	—	$	—	$	20,662
Cash in checking account		—		—		—		745
Total cash and cash equivalents	$	20,662	$	—	$	—	$	21,407

	Operating Lease March 31, 2021
Remainder of 2021	$	486
Total undiscounted lease payments		486
Less imputed interest		18
Total operating lease liabilities	$	468

	Number of		Weighted
	Common Stock		Average
	Warrants		Exercise Price
Balance, December 31, 2020		2,424,724	$	6.36
Warrants for common stock sold		—		—
Warrants for common stock exercised		—		—
Balance, March 31, 2021		2,424,724	$	6.36

	March 31,			December 31,
	2021			2020
Computer equipment and software	$	166		$	159
Laboratory and manufacturing equipment		574			550
Furniture and fixtures		59			59
Leasehold improvements		332			332
Construction in progress		72			70
Property and equipment, gross		1,203			1,170
Less accumulated depreciation		(1,039	)		(1,025	)
Property and equipment, net	$	164		$	145

		Lincoln Park Capital stock purchase agreement - On March 29, 2021, the Company and Lincoln Park Capital Fund, LLC (Lincoln Park) entered into a purchase agreement (the Purchase Agreement) and a registration rights agreement (the Registration Rights Agreement), pursuant to which the Company has the right to sell to Lincoln Park shares of the Company’s common stock having an aggregate value of up to $20 million, subject to certain limitations and conditions set forth in the Purchase Agreement (the Offering). As consideration for entering into the Purchase Agreement, the Company agreed to issue to Lincoln Park 75,000 shares of common stock as commitment shares. In addition, the Company agreed to issue to Lincoln Park up to an aggregate of 50,000 additional shares of common stock as a further commitment fee based on a pro-rata percentage of the $20 million of common stock issued to Lincoln Park under the Purchase Agreement.

		Pursuant to the Purchase Agreement, Lincoln Park purchased 373,832 shares of common stock, at a price of $5.35 per share, for a total gross purchase price of $2 million (the Initial Purchase) and the Company issued 80,000 shares of common stock as commitment shares, which included 5,000 commitment shares issued on a pro rata basis for the initial $2 million purchase. Thereafter, as often as every business day from and after one business day following the date of the Initial Purchase and over the 36-month term of the Purchase Agreement the Company has the right, from time to time, at its sole discretion and subject to certain conditions, to direct Lincoln Park to purchase up to 100,000 shares of common stock, with such amount increasing as the closing price of the common stock increases; provided Lincoln Park’s obligation under any single such purchase will not exceed $2 million, unless the Company and Lincoln Park mutually agree to increase the maximum amount of such single purchase (each, a Regular Purchase). If the Company directs Lincoln Park to purchase the maximum number of shares of common stock it then may sell in a Regular Purchase, then in addition to such Regular Purchase, and subject to certain conditions and limitations in the Purchase Agreement, the Company may direct Lincoln Park in an Accelerated Purchase to purchase an additional amount of common stock that may not exceed the lesser of (i) 300% of the number of shares purchased pursuant to the corresponding Regular Purchase in multiple Accelerated Purchases on the same trading day or (ii) 30% of the total number of shares of the Company’s common stock traded during a specified period on the applicable purchase date as set forth in the Purchase Agreement. Under certain circumstances and in accordance with the Purchase Agreement, the Company may direct Lincoln Park to purchase shares in multiple Accelerated Purchases on the same trading day.

		The Company controls the timing and amount of any sales of its common stock to Lincoln Park. There is no upper limit on the price per share that Lincoln Park must pay for its common stock under the Purchase Agreement. In no event may the Company issue or sell to Lincoln Park under the Purchase Agreement shares of the Company’s common stock in excess of 3,266,177 shares (including the commitment shares), which represents 19.99% of the shares of our common stock outstanding immediately prior to the execution of the Purchase Agreement (the Exchange Cap), unless (i) the Company obtains stockholder approval to issue shares of its common stock in excess of the Exchange Cap or (ii) the average price of all applicable sales of the Company’s common stock to Lincoln Park under the Purchase Agreement equals or exceeds $4.2736 per share. In all instances, the Company may not sell shares of its common stock to Lincoln Park under the purchase agreement if it would result in Lincoln Park beneficially owning more than 9.99% of its common stock.

		The Purchase Agreement does not limit the Company’s ability to raise capital from other sources at the Company’s sole discretion, except that during the 36 months after the date of the Purchase Agreement (subject to certain exceptions) the Company may not enter into any agreement to effect the issuance of its common stock or common stock equivalents in any “equity line of credit” or other similar continuous offering in which the Company may offer, issue or sell common stock or common stock equivalents at a future determined price, other than in connection with common stock issued pursuant to an “at-the-market offering” by the Company exclusively through a registered broker-dealer acting as agent of the Company pursuant to a written agreement between the Company and the registered broker-dealer. The Company has the right to terminate the Purchase Agreement at any time, at no cost to the Company.

		As of March 31, 2021, the Company had not made any sales of common stock to Lincoln Park under the Purchase Agreement other than the Initial Purchase.

		On January 29, 2020 (the repricing date), the Company’s Board of Directors repriced certain previously granted and still outstanding vested and unvested stock option awards held by employees, executives and certain service providers of the Company; as a result, the exercise price was lowered to $5.32 per share. No other terms of the repriced stock options were modified, and the repriced stock options will continue to vest according to their original vesting schedules and will retain their original expiration dates. As a result of the repricing, 515,036 vested and unvested stock options outstanding with original exercise prices ranging from $10.05 to $97.21, were repriced.

		The repricing on January 29, 2020 resulted in incremental stock-based compensation expense of $569,000, of which $412,000 related to vested employee stock option awards and was expensed on the repricing date, and $157,000 related to unvested stock option awards is being amortized on a straight-line basis over the approximately three year remaining weighted average vesting period of those awards.

	Options outstanding
	Number of shares			Weighted average exercise price		Weighted average remaining contractual term (years)		Aggregate intrisinsic value (in thousands)

Balance, December 31, 2020		1,114,306		$	5.89		7.5	$	177.1
Stock options granted		18,850			4.63
Stock options exercised		(1,580	)		2.49
Stock options forfeited		(44,643	)		4.30
Stock options expired		(125	)		5.32
Balance, March 31, 2021		1,086,808		$	5.94		6.9	$	423.8
Exercisable, March 31, 2021		661,430		$	7.29		5.6	$	73.0

		Unrecognized share-based compensation for employee and nonemployee options granted through March 31, 2021 is approximately $1.7 million to be recognized over a remaining weighted average service period of 2.2 years.

		Share-Based Compensation (RSUs)

		The following summarizes the activity of non-vested RSUs:

				Weighted
				average
				grant date
	Number of			fair value
	shares			per share
Balance, December 31, 2020		224,311		$	4.12
RSUs granted		18,792			4.34
RSUs released		(40,100	)		4.20
Balance, March 31, 2021		203,003		$	4.12

		During the three months ended March 31, 2021 and 2020, there was no income tax expense or benefit for federal or state income taxes in the accompanying condensed consolidated statements of operations due to the Company’s net loss and a full valuation allowance on the resulting deferred tax assets.

		As of March 31, 2021, the Company retains a full valuation allowance on its deferred tax assets in all jurisdictions. The realization of its deferred tax assets depends primarily on its ability to generate future taxable income which is uncertain. The Company does not believe that its deferred tax assets are realizable on a more-likely-than-not basis; therefore, the net deferred tax assets have been fully offset by a valuation allowance.

		On April 9, 2020, the Company entered into a Litigation Funding Agreement (the Funding Agreement) with BSLF, L.L.C. (the Funder), an entity owned and controlled by Andrew Blank, Chair of BioCardia’s board of directors, for the purpose of funding the Company’s legal proceedings and any and all claims, actions and/or proceedings relating to or arising from the case captioned Boston Scientific Corp., et al., v. BioCardia Inc., Case No. 3:19-05645-VC, U.S.D.C., N. D. Cal (the Litigation). BioCardia sought imposition of constructive trusts both on the patents naming Ms. Sarna as an inventor and the proceeds received from the sale of nVision to Boston Scientific, as well as damages, including unjust enrichment damages measured by the proceeds received from the sale of nVision to Boston Scientific.

		Under the terms of the Funding Agreement, the Funder agreed to fund the legal fees and costs incurred by the Company in connection with the Litigation on and after March 1, 2020 on a non-recourse basis. The Company agreed to repay the Funder from any proceeds arising from the Litigation (the Litigation Proceeds), (i) any taxes paid by or imposed upon Funder (other than taxes imposed upon Funder as a consequence of Funder’s income) with respect to the claims, the litigation proceeds or as a consequence of any settlement in connection with the Litigation, if any, plus (ii) an amount, without reduction, set-off or counterclaim, equal to the amount actually paid by the Funder pursuant to the Funding Agreement (the Actual Funding Amount) plus (iii) the greater of:

		(a) 50% of the remaining Litigation Proceeds, up to three times the Actual Funding Amount; or

		(b) 30% of the remaining Litigation Proceeds.

		Although the Company is required under the terms of the Funding Agreement to consult with the Funder regarding any settlement in connection with the Litigation and to allow Funder to participate in any real-time settlement negotiations, the Company has the sole and exclusive right to settle on whatever terms it deems acceptable.

		The Funding Agreement may be terminated by Funder upon ten days’ written notice to the Company. Funder is obligated to fund only the fees and costs incurred in the Litigation through the end of the month in which the termination notice was served. The Company may terminate the agreement upon ten days’ written notice to Funder from and after a failure by Funder to fulfill its obligations under the Funding Agreement if such failure or material breach is continuing at the end of such ten-day period. Under the terms of the agreement, the total due from the related party as of March 31, 2021 was approximately $623,000.

		Uncertainties - The results for the three months ended March 31, 2021 are not necessarily indicative of the results to be expected for the year ending December 31, 2021 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 and are continuing to adapt to these changing actions and guidelines.

		Beginning March 17, 2020, substantially all of the Company’s workforce began working from home. On April 6, 2020, manufacturing operations resumed at the Company’s facilities, with a number of other staff continuing to work from home. While the direct effects of the stay-at-home orders and BioCardia’s work-from-home policies have been largely mitigated as of March 31, 2021, the overall impact of the pandemic resulted in disruption to the Company’s business and in delays in the Company’s development programs and regulatory and commercialization timelines. The overall magnitude of the continuing impact will depend, in part, on the length and severity of changing restrictions and other limitations on BioCardia’s ability to conduct the Company’s business. 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.

		As the outbreak continues to mutate and spread, it may affect the Company’s operations and those of third parties on which the Company relies, including causing disruptions in the supply of the Company’s product candidates and the conduct of current and planned preclinical and clinical studies. BioCardia may need to limit operations and may experience limitations in employee resources. There are risks that the COVID-19 outbreak may be more difficult to contain if the outbreak reaches a larger population or broader geography, in which case the risks described herein could be elevated significantly. The extent to which the coronavirus impacts the Company’s results will depend on future developments, which are highly uncertain and cannot be predicted, including new information which may emerge concerning the severity of the coronavirus and the actions to contain the coronavirus or treat its impact, among others.

		Additionally, while the potential economic impact brought by, and the duration of, a coronavirus pandemic is difficult to assess or predict, the impact of the coronavirus on the global financial markets may reduce the Company’s ability to access capital, which could negatively impact the Company’s short-term and long-term liquidity, and the Company’s ability to complete its preclinical and clinical studies on a timely basis, or at all. The Company was successful in raising additional funding in 2020. However, the ultimate impact of coronavirus is highly uncertain and subject to change. The Company does not yet know the full extent of potential delays or impacts on its business, financing, preclinical and clinical trial activities or the global economy as a whole. However, these effects could have a material, adverse impact on the Company’s liquidity, capital resources, operations and business and those of the third parties on which BioCardia relies.

	•	salaries and related overhead expenses, which include, but are not limited to 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 ended
	2021			2020
Revenue:
Net product revenue	$	—		$	5
Collaboration agreement revenue		46			33
Total revenue		46			38
Costs and expenses:
Cost of goods sold		—			4
Research and development		1,841			2,786
Selling, general and administrative		1,177			1,857
Total costs and expenses		3,018			4,647
Operating loss		(2,972	)		(4,609	)
Other income (expense):
Interest income		4			16
Other expense		(1	)		(1	)
Total other income (expense)		3			15
Net loss	$	(2,969	)	$	(4,594	)

	Three Months ended March 31,
	2021			2020
Net cash provided by (used in):
Operating activities	$	(1,883	)	$	(2,993	)
Investing activities		(27	)		(5	)
Financing activities		2,005			—
Net increase (decrease) in cash and cash equivalents	$	95		$	(2,998	)

3.1(1)	Amended and Restated Certificate of Incorporation, as amended May 6, 2019
3.2(2)	Amended and Restated Bylaws
10.1(3)	Purchase Agreement, dated as of March 29, 2021, by and between BioCardia, Inc. and Lincoln Park Capital Fund, LLC
10.2(4)	Registration Rights Agreement, dated as of March 29, 2021, by and between BioCardia, Inc. and Lincoln Park Capital Fund, LLC
10.3*	Consulting Agreement dated February 15, 2021, by and between BioCardia, Inc. and Henricus Duckers, M.D., Ph.D., FESC.
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.
**	Furnished herewith.
+	The financial information contained in these XBRL documents is unaudited and is furnished, not filed with the Securities and Exchange Commission.
(1)	Previously filed as Exhibit 3.1 to 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 March 29, 2021.
(4)	Previously filed as Exhibit 10.2 to the Current Report on Form 8-K filed by us on March 29, 2021.

	BIOCARDIA, INC. (Registrant)


Date: May 13, 2021	By:	/s/ Peter Altman
		Peter Altman
		President and Chief Executive Officer
		(Principal Executive Officer)


Date: May 13, 2021	By:	/s/ David McClung
		David McClung
		Chief Financial Officer
		(Principal Financial and Accounting Officer)

Title of Clinical Study:	Randomized Controlled Pivotal Trial of Autologous Bone Marrow Mononuclear Cells Using the CardiAMP System in Patients with Post Myocardial Infarction Heart Failure (CardiAMP Heart Failure Trial)

Investigational Device:	The BioCardia® CardiAMP™ System, consisting of the CardiAMP cell separator and autologous bone marrow mononuclear cells delivered using the Helix transendocardial delivery catheter

Sponsor:	BioCardia, Inc.
	125 Shoreway Rd Suite B
	San Carlos, CA 94070

Consultant:

As a Steering Committee (SC) consultant for the Study, I certify that I, my spouse or dependent children (check the appropriate box for each statement):

[ ] Have [ X ] Do not have	Have an ownership interest, stock options, or other financial interest (i.e., equity interest) in the Sponsor (public or non-public) that owns the Investigational Device being evaluated in the Study.

[ ] Have [ X ] Do not have	Have property or other financial interest (i.e., proprietary interest) in the Investigational Device being evaluated in the Study; including, but not limited to, a patent or patent interest, trademark, copyright, licensing agreement, or any arrangement tied to a current or future right to receive royalties associated with the development or eventual commercialization of the Investigational Device.

[ ] Have [X ] Do not have	Receive payments from the Sponsor that owns the respective Investigational Device during the term of the conduct of the Study; nor do I anticipate receiving payments from the Sponsor during a 1 year period following completion of the Study. Applicable payments (i.e., financial interest) include, but are not limited to, grants to fund projects or research or compensation in the form of monetary payments, equipment, or retainers for consultation or honoraria.

	(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