BioCardia, Inc 10-K for FY2024

BioCardia, Inc. (BCDA)

10-K 2025-03-26 For: 2024-12-31

Added on April 06, 2026

About this 10-K

BioCardia, Inc filed this 10-K on March 26, 2025, covering the fiscal year ended December 31, 2024 (FY2024).

Headline figures

Fiscal year ended December 31, 2024, as reported in this filing, compared with the same period a year earlier where the filing states it.

Revenue: $58K; down 87.8% from $477K a year earlier
Net loss: $7.95M; compared with a net loss of $11.57M a year earlier

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Large accelerated filer	☐	Accelerated filer	☐

Non-accelerated filer	☒	Smaller reporting company	☒

		Emerging growth company	☐

PART I

Item 1.	Business	6

Item 1A.	Risk Factors	30

Item 1B.	Unresolved Staff Comments	66

Item 1C.	Cybersecurity	66

Item 2.	Properties	67

Item 3.	Legal Proceedings	67

Item 4.	Mine Safety Disclosures	67

PART II

Item 5.	Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities	67

Item 6.	Selected Financial Data	68

Item 7.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	68

Item 7A.	Quantitative and Qualitative Disclosures about Market Risk	77

Item 8.	Financial Statements and Supplementary Data	78

Item 9.	Changes in and Disagreements with Accountants on Accounting and Financial Disclosure	99

Item 9A.	Controls and Procedures	100

Item 9B.	Other Information	101

Item 9C.	Disclosure Regarding Foreign Jurisdiction that Prevent Inspections	101

PART III

Item 10.	Directors, Executive Officers and Corporate Governance	102

Item 11.	Executive Compensation	108

Item 12.	Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters	112

Item 13.	Certain Relationships and Related Transactions, and Director Independence	115

Item 14.	Principal Accounting Fees and Services	116

PART IV

Item 15.	Exhibits, Financial Statement Schedules	117

	(i)	expectations concerning our ability to raise additional funding from equity or debt financings and to continue as a going concern;
	(ii)	our ability to retain the listing of our securities on the Nasdaq Capital Market;
	(iii)	the plans and objectives of management for future operations, including plans or objectives relating to the development of our cell therapy systems;
	(iv)	the timing and conduct of the clinical trials for our products, including statements regarding the timing, progress and results of current and future preclinical studies and clinical trials as well as our research and development programs;
	(v)	the timing or likelihood of regulatory filing, approvals and required licenses for our cell therapy systems;
	(vi)	our ability to adequately protect our intellectual property rights and enforce such rights to avoid violation of the intellectual property rights of others;
	(vii)	the timing, costs and other aspects of the commercial launch of our products;
	(viii)	our estimates regarding the market opportunity, clinical utility, potential advantages and market acceptance of our products;
	(ix)	the impact of government laws and regulations;
	(x)	our ability to recruit and retain qualified clinical, regulatory and research and development personnel;
	(xi)	the availability of reimbursement or other forms of funding for our products from government and commercial payors;
	(xii)	difficulties in maintaining commercial scale manufacturing capacity and capability and our ability to generate growth;
	(xiii)	uncertainty in industry demand;
	(xiv)	general economic conditions and market conditions in our industry;
	(xv)	the effects of global events on our business, preclinical studies and clinical trials;
	(xvi)	threats or actual imposition of tariffs;
	(xvii)	our future financial performance, including any such statement contained in a discussion and analysis of financial condition by management or in the results of operations included pursuant to the rules and regulations of the Securities and Exchange Commission (SEC); and
	(xviii)	the assumptions underlying or relating to any statement described in points (i)-(xvii) above. These statements are not guarantees of future performance and are subject to numerous risks, uncertainties, and assumptions that are difficult to predict.

	•	completion of nonclinical laboratory tests and animal studies according to good laboratory practices, or GLP, regulations and applicable requirements for the humane use of laboratory animals or other applicable regulations;

	•	submission to the FDA of an IND application, which must become effective before human clinical trials may begin and must be updated annually or when significant changes are made;

	•	approval by an independent Institutional Review Board, or IRB, or ethics committee at each clinical site before the trial begins;

	•	performance of adequate and well-controlled human clinical trials according to the FDA’s regulations, commonly referred to as good clinical practices, or GCPs, and any additional requirements for the protection of human research subjects and their health information, to establish the safety, purity and potency of the proposed biological product for its intended use;

	•	preparation of and submission to the FDA of a BLA for marketing approval, after completion of all pivotal clinical trials;

	•	satisfactory completion of an FDA Advisory Committee review, if applicable;

	•	a determination by the FDA within 60 days of its receipt of a BLA to file the application for review;

	•	satisfactory completion of an FDA inspection of the manufacturing facility or facilities where the biological product is produced to assess compliance with GMP, to assure that the facilities, methods and controls are adequate to preserve the biological product’s identity, strength, quality and purity and, if applicable, the FDA’s current good tissue practices, or GTPs, for the use of human cellular and tissue products;

	•	potential FDA audit of the nonclinical study and clinical trial sites that generated the data in support of the BLA; and

	•	FDA review and approval, or licensure, of the BLA for particular indications for use in the United States, which must be updated annually when significant changes are made.

	•	the proposed product is biosimilar to the reference product;

	•	the proposed product is expected to produce the same clinical result as the reference product in any given patient; and

	•	refusal to grant export approval for our products;

	•	criminal prosecution; and

	●	We will require substantial additional financing to achieve our goals, and our failure to obtain this necessary capital when needed could force us to delay, limit, reduce or terminate our product development or commercialization efforts.
	●	Our existing and any future contractual arrangement that we expect will provide us access to capital may provide less capital than expected and on a delayed basis.

	●	If we or our suppliers fail to comply with the FDA’s QSRs, or QMSR, when it goes into effect in 2026, our manufacturing operations could be delayed or shut down and product sales could suffer.
	●	The requirements to obtain regulatory approval of the FDA and regulators in other jurisdictions can be costly, time-consuming, and unpredictable. If we are unable to obtain timely regulatory approval for our therapeutic candidates, our business may be substantially harmed.

	•	delays in recruiting suitable clinical sites and patients (i.e., subjects) to participate in clinical trials;

	•	imposition of a clinical hold by regulatory agencies for any reason, including negative clinical results, safety concerns or as a result of an inspection of manufacturing or clinical operations or trial sites;

	•	occurrence of serious adverse events in clinical trials that are associated with the therapeutic candidates or products that are viewed to outweigh its potential benefits;

	•	changes in regulatory requirements and guidance that require amending or submitting new clinical protocols; or

	•	disagreements between us and the FDA or other regulatory agencies interpreting the data from our clinical trials, including the determination from the DSMB to recommend pausing our Phase III pivotal CardiAMP Cell Therapy Trial pending the one-year follow-up outcomes analysis.

	•	size of the patient population;

	•	severity of the disease under investigation;

	•	design of the trial protocol;

	•	eligibility criteria for the particular trial;

	•	perceived risks and benefits of the product candidate being tested;

	•	proximity and availability of clinical trial sites for prospective patients;

	•	availability of competing therapies and clinical trials;

	•	efforts to facilitate timely enrollment in clinical trials;

	•	patient referral practices of physicians;

	•	ability to monitor patients adequately during and after treatment; and

	•	the degree of treatment effect in event-driven trials.

	•	recruiting and retaining talented people;

	•	training employees that we recruit;

	•	setting the appropriate system of incentives;

	•	managing additional headcount; and

	•	integrating a new business unit into an existing corporate architecture.

	•	adverse publicity, warning letters, fines, injunctions, consent decrees and civil penalties;

	•	repair, replacement, refunds, recall or seizure of our products;

	•	operating restrictions, partial suspension or total shutdown of production;

	•	refusing our requests for premarket approval of new products, new intended uses or modifications to existing products;

	•	withdrawing premarket approvals that have already been granted; and

	•	criminal prosecution.

	Years ended December 31,
	2024			2023
Revenue:
Collaboration agreement revenue	$	58		$	477
Costs and expenses:
Research and development		4,387			7,726
Selling, general and administrative		3,672			4,395
Total costs and expenses		8,059			12,121
Operating loss		(8,001	)		(11,644	)
Other income (expense):
Total other income, net		55			73
Net loss	$	(7,946	)	$	(11,571	)

INDEX TO CONSOLIDATED FINANCIAL STATEMENTS


Report of Independent Registered Public Accounting Firm (PCAOB ID #27)	79

Consolidated Balance Sheets	81

Consolidated Statements of Operations	82

Consolidated Statements of Stockholders’ Equity (Deficit)	83

Consolidated Statements of Cash Flows	84

Notes to Consolidated Financial Statements	85

BIOCARDIA, INC.
Consolidated Balance Sheets
(In thousands, except share and per share amounts)

	December 31,			December 31,
	2024			2023
Assets
Current assets:
Cash and cash equivalents	$	2,371		$	1,103
Accounts receivable, net of allowance for doubtful accounts of $0 and $34 as of December 31, 2024 and 2023, respectively		—			63
Prepaid expenses and other current assets		251			295
Total current assets		2,622			1,461
Property and equipment, net		33			94
Operating lease right-of-use asset, net		898			1,261
Other assets		171			171
Total assets	$	3,724		$	2,987
Liabilities and Stockholders’ Equity (Deficit)
Current liabilities:
Accounts payable	$	385		$	890
Accrued expenses and other current liabilities		1,551			2,385
Operating lease liability - current		385			333
Total current liabilities		2,321			3,608
Operating lease liability - noncurrent		566			982
Total liabilities		2,887			4,590
Commitments and contingencies (Notes 2, 5 and 13)
Stockholders’ equity (deficit):
Preferred stock, $0.001 par value, 25,000,000 shares authorized and no shares issued and outstanding as of December 31, 2024 and 2023		—			—
Common stock, $0.001 par value, 50,000,000 and 100,000,000 shares authorized, 4,600,910 and 1,577,769 shares issued and outstanding as of December 31, 2024 and 2023, respectively		5			2
Additional paid-in capital		160,953			150,570
Accumulated deficit		(160,121	)		(152,175	)
Total stockholders’ equity (deficit)		837			(1,603	)
Total liabilities and stockholders’ equity (deficit)	$	3,724		$	2,987

	Years ended December 31,
	2024			2023
Revenue:
Collaboration agreement revenue	$	58		$	477
Costs and expenses:
Research and development		4,387			7,726
Selling, general and administrative		3,672			4,395
Total costs and expenses		8,059			12,121
Operating loss		(8,001	)		(11,644	)
Other income (expense):
Total other income, net		55			73
Net loss	$	(7,946	)	$	(11,571	)

Net loss per share, basic and diluted	$	(2.90	)	$	(8.19	)

Weighted-average shares used in computing net loss per share, basic and diluted		2,743,828			1,411,998

	Common stock					Additional		Accumulated
	Shares			Cost		paid-in capital		deficit			Total
Balance at December 31, 2022		1,338,451		$	1	$	145,495	$	(140,604	)	$	4,892
Restricted stock units vested and issued		16,080			—		1		—			1
Sale of common stock under ATM, net of issuance costs of $179		14,349			—		262		—			262
Sale of common stock on June 21, 2023, net of issuance costs of $194		75,543			—		2,453		—			2,453
Sale of common stock on November 16, 2023, net of issuance costs of $312		133,333			1		987		—			988
Restricted stock units issued to settle management bonus obligations		—			—		342		—			342
Exercise of common stock options		13			—		—		—			—
Share-based compensation		—			—		1,030		—			1,030
Net loss		—			—		—		(11,571	)		(11,571	)
Balance at December 31, 2023		1,577,769		$	2	$	150,570	$	(152,175	)	$	(1,603	)
Restricted stock units vested and issued		60,409			—		—		—			—
Sale of common stock and warrants on February 13, 2024, net of issuance costs of $43		134,199			—		832		—			832
Sale of common stock under ATM, net of issuance costs of $94		428,864			—		2,383		—			2,383
Reverse stock split fractional share true up		(331	)		—		—		—			—
Sale of common stock and warrants on September 3, 2024, net of issuance costs of $926		2,400,000			3		6,271		—			6,274
Restricted stock units issued to settle management bonus obligations		—			—		156		—			156
Share-based compensation		—			—		741		—			741
Net loss		—			—		—		(7,946	)		(7,946	)
Balance at December 31, 2024		4,600,910		$	5	$	160,953	$	(160,121	)	$	837

BIOCARDIA, INC.
Consolidated Statements of Cash Flows
(In thousands)

Asset	Estimated useful lives (in years)

Computer equipment and software		3
Laboratory and manufacturing equipment		3
Furniture and fixtures		3
Leasehold improvements	5 years or lease term, if shorter

	As of December 31, 2024

	Level 1		Level 2		Level 3		Total
Assets:
Money market funds	$	2	$	—	$	—	$	2
Cash in savings account		—		—		—		2,058
Cash in checking account		—		—		—		311
Total cash and cash equivalent	$	2	$	—	$	—	$	2,371

	As of December 31, 2023
	Level 1		Level 2		Level 3		Total
Assets:
Money market funds	$	2	$	—	$	—	$	2
Cash in savings account		—		—		—		1,072
Cash in checking account		—		—		—		29
Total cash and cash equivalent	$	2	$	—	$	—	$	1,103

	2024			2023
Straight-line rent expense recognized for operating lease	$	482		$	482
Variable rent expense recognized for operating lease		91			69
Total rent expense	$	573		$	551

Weighted average remaining lease term (in years)		2.1			3.1
Weighted average discount rate		10.74	%		10.74	%

	2024		2023
Cash paid for amounts included in the measurement of lease liabilities	$	365	$	315
Cash lease expense (imputed interest expense component of net loss)		119		156
Total rent expense	$	484	$	471

2025	$	499
2026		514
2027		44
Total undiscounted lease payments	$	1,057
Less imputed interest		106
Total operating lease liabilities	$	951

	Number of			Weighted
	Common Stock			Average
	Equivalents			Exercise Price
Balance as of December 31, 2022		161,648		$	95.40
Warrants expired		(19,759	)		101.25
Balance as of December 31, 2023		141,889		$	94.50
Warrants for common stock sold		2,467,104			3.10
Warrants expired		(141,889	)		94.50
Balance as of December 31, 2024		2,467,104		$	3.10

	Years ended
	December 31,
	2024		2023
Research and development	$	413	$	465
Selling, general and administrative		328		565
Total share-based compensation	$	741	$	1,030

	Number of shares			Weighted average exercise price		Weighted average remaining contractual term (years)		Aggregate intrinsic value (in thousands)
Balance, December 31, 2022		145,513		$	60.60		7.5
Stock options granted		47,219			20.85
Stock options exercised		(13	)		22.35
Stock options forfeited		(26,512	)		36.30
Stock options expired		(423	)		241.35
Balance, December 31, 2023		165,784		$	52.67		6.8
Stock options granted		14,974			2.65
Stock options forfeited		(3,177	)		33.97
Stock options expired		(9,397	)		63.51
Balance, December 31, 2024		168,184		$	47.97		6.6	$	—
Exercisable, December 31, 2024		121,530		$	59.49		5.8	$	—
Options vested and expected to vest		168,184		$	47.97		6.6	$	—

				Weighted
				average
				grant date
	Number of			fair value
	shares			per share
Balance, December 31, 2022		1,435		$	64.95
RSUs granted		22,104			25.50
RSUs RSUs vested and settled		(16,080	)		28.95
RSUs forfeited		(7,459	)		25.50
Balance, December 31, 2023		—		$	n/a
RSUs granted		113,427			2.65
RSUs released		(60,409	)		2.65
RSUs forfeited		(53,018	)		2.65
Balance, December 31, 2024		—		$	n/a

	Class	Age	Position	Director Since (4)	Current Term Expires


Peter Altman, Ph.D.	I	58	President, Chief Executive Officer and Director	2002	2026
Bill Facteau(1)	I	55	Director	2023	2026
Jim Allen(2)	II	69	Director	2019	2027
Andrew Blank(2)(3)	II	68	Chairman of the Board of Directors	2019	2027
Richard Krasno, Ph.D.(1)(3)	III	83	Director	2016	2025
Jay M. Moyes(1)(3)	III	71	Director	2011	2025
Simon H. Stertzer, M.D.	III	89	Director	2002	2025

Name	Age	Position
Peter Altman, Ph.D.	58	President, Chief Executive Officer, and Director
David McClung	61	Chief Financial Officer
Edward Gillis	63	Senior Vice President of Devices