BCDAW BioCardia Inc

PART I. FINANCIAL INFORMATION

 

ITEM 1. UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

 

BIOCARDIA, INC.

Condensed Consolidated Balance Sheets

(In thousands, except share and per share amounts)

 

 

See accompanying notes to the unaudited condensed consolidated financial statements.

 

 

BIOCARDIA, INC.

Condensed Consolidated Statements of Operations

(In thousands, except share and per share amounts)

(unaudited)

 

 

See accompanying notes to the unaudited condensed consolidated financial statements.

 

 

BIOCARDIA, INC.

Condensed Consolidated Statements of Stockholders’ Equity (Deficit)

(In thousands, except share amounts)

(unaudited)

 

 

See accompanying notes to the unaudited condensed consolidated financial statements.

 

 

BIOCARDIA, INC.

Condensed Consolidated Statements of Cash Flows

(In thousands)

(unaudited)

 

 

See accompanying notes to the unaudited condensed consolidated financial statements.

 

 

BioCardia, Inc.

Notes to Unaudited Condensed Consolidated Financial Statements

 

(1)	Summary of Business and Basis of Presentation

 

Description of Business

 

BioCardia, Inc. (we, us, our, BioCardia or the Company), is a clinical-stage company focused on developing cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases with significant unmet medical needs. We are advancing two cell therapy platforms derived from bone marrow in clinical trials today. Our CardiAMP® autologous mononuclear cell therapy platform is being advanced for two clinical indications: ischemic heart failure with reduced ejection fraction (HFrEF) and refractory angina resulting from chronic myocardial ischemia (CMI). Our allogeneic mesenchymal stem cell (MSC) therapy platform is being advanced as an “off the shelf” cell therapy for two clinical indications: the treatment of ischemic HFrEF and for acute respiratory distress syndrome (ARDS). Our autologous and our allogeneic cell therapies intended for cardiac indications of HFrEF and CMI are enabled by our Helix™ minimally invasive intramyocardial therapeutic delivery platform. We partner this therapeutic delivery platform selectively with others seeking to develop biotherapeutic interventions for local delivery to the heart. To date, we have devoted substantially all our resources to research and development efforts relating to our 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 our intellectual property.

 

We manage our operations as a single segment for the purposes of assessing performance and making operating decisions.

 

(2)	Significant Accounting Policies

 

(a)

Basis of Preparation

 

The accompanying condensed consolidated balance sheets, statements of operations, stockholders’ equity (deficit), and cash flows as of March 31, 2024, and for the three months ended March 31, 2024 and 2023 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 our financial position as of March 31, 2024, results of operations for the three months ended March 31, 2024 and 2023, and cash flows for the three months ended March 31, 2024 and 2023. The results for the three months ended March 31, 2024 are not necessarily indicative of the results to be expected for the year ended December 31, 2024 or for any other interim period or for any other future year.

 

These condensed consolidated financial statements should be read in conjunction with the audited financial statements and related notes included in our Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on March 27, 2024.

 

(b)

Liquidity – Going Concern

 

We have incurred net losses and negative cash flows from operations since our inception and had an accumulated deficit of approximately $154.4 million as of March 31, 2024. Management expects operating losses and negative cash flows to continue through at least the next several years. We expect to incur increasing costs as we advance our trials and development activities. Therefore, absent additional funding, management believes cash and cash equivalents of $949,000 as of March 31, 2024 are not sufficient to fund our planned expenditures and meet our obligations beyond June 2024. These factors raise substantial doubt about our 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.

 

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Our ability to continue as a going concern and to continue further development of our therapeutic candidates beyond June 2024 will require us to raise additional capital. We plan to raise additional capital, potentially including debt and equity arrangements, to finance our 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, we may be required to reduce operating expenses, delay or reduce the scope of our product development programs, obtain funds through arrangements with others that may require us to relinquish rights to certain of our technologies or products that we would otherwise seek to develop or commercialize, 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 clinical accruals, share-based compensation, right-of-use assets and related liabilities, incremental borrowing rate, the useful lives of property and equipment, allowances for doubtful accounts and sales returns, 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, BioCardia Lifesciences, Inc. All intercompany accounts and transactions have been eliminated during the consolidation process.

 

(e)

Concentration of Credit Risk

 

Financial instruments that potentially subject us to a concentration of credit risk consist of cash and cash equivalents. Our cash at times exceeds federally insured limits of $250,000 per customer. On March 31, 2024, approximately 95% of our cash and cash equivalents were held by one financial institution and total amounts on deposit were $652,000 in excess of FDIC insurance limits. We have not recognized any losses from credit risks on such accounts since inception.

 

(f)

Changes to Significant Accounting Policies

 

Our significant accounting policies are described in Note 2 of the notes to the consolidated financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on March 27, 2024. There have been no changes to those policies.

 

(g)

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 our financial statement presentation or disclosures.

 

 

(3)	Fair Value Measurement

 

The fair value of financial instruments reflects the amounts that we estimate to receive in connection with the sale of an asset or paid in connection with the transfer of a liability in an orderly transaction between market participants at the measurement date (exit price). We follow a fair value hierarchy that prioritizes the use of inputs used in valuation techniques into the following three levels:

 

Level 1 – quoted prices in active markets for identical assets and liabilities.

 

Level 2 – observable inputs other than quoted prices in active markets for identical assets and liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities.

 

Level 3 – unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.

 

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The following table sets forth the fair value of our financial assets measured on a recurring basis and indicates the fair value hierarchy utilized to determine such fair value (in thousands):

 

		As of March 31, 2024
		Level 1				Level 2				Level 3				Total
Assets:
Money market funds		$	2			$	—			$	—			$	2
Cash in savings account			—				—				—				580
Cash in checking account			—				—				—				367
Total cash and cash equivalents		$	2			$	—			$	—			$	949

 

		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 equivalents		$	2			$	—			$	—			$	1,103

 

(4)	Property and Equipment, Net

 

Property and equipment, net consisted of the following (in thousands):

 

		March 31,				December 31,
		2024				2023
Computer equipment and software		$	161			$	161
Laboratory and manufacturing equipment			574				574
Furniture and fixtures			27				27
Leasehold improvements			26				26
Property and equipment, gross			788				788
Less accumulated depreciation			(713	)			(694	)
Property and equipment, net		$	75			$	94

Depreciation expense totaled $19,000 and $22,000 for the three months ended March 31, 2024 and 2023, respectively.

  

(5)	Operating Lease Right-of-Use (ROU) Asset, Net

 

We determine if an arrangement is a lease at inception by assessing whether it conveys the right to control the use of an identified asset for a period of time in exchange for consideration. Our operating lease relates to a property lease for its laboratory and corporate offices which expires in January 2027. BioCardia’s lease agreement does not contain any material residual guarantees or material restrictive covenants.

 

ROU assets and lease liabilities are recognized at the lease commencement date based on the present value of lease payments over the lease term. Our lease does not provide an implicit rate. We used an adjusted historical incremental borrowing rate, based on the information available at the approximate lease commencement date, to determine the present value of lease payments. Variable rent expense is made up of expenses for common area maintenance and shared utilities and were not included in the determination of the present value of lease payments. We have no finance leases.

 

Our lease expense was $121,000 for each of the three months ended March 31, 2024 and 2023. The cash paid under the operating lease for base rent for the three months ended March 31, 2024 and 2023 was $121,000 and $118,000, respectively. On March 31, 2024, the weighted average remaining lease term was 2.84 years, and the weighted average discount rate was 10.74%.

 

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Future minimum lease payments under the operating lease as of March 31, 2024 were as follows (in thousands):

 

Remainder of 2024		$	364
2025			499
2026			514
2027			44
Total undiscounted lease payments			1,421
Less imputed interest			193
Total operating lease liabilities		$	1,228

 

(6)	Accrued Expenses and Other Current Liabilities

 

Accrued expenses and other current liabilities consisted of the following (in thousands):             

 

		March 31,				December 31,
		2024				2023
Accrued expenses		$	116			$	75
Accrued salaries and employee benefits			837				661
Accrued clinical trial costs			1,140				1,017
Grant liability			471				471
Customer deposits			90				90
Payable to related party			42				71
Total		$	2,696			$	2,385

 

(7)	Stockholders’ Equity

 

Warrants - Set forth below is a table of activity of warrants for common stock and the related weighted average exercise price per warrant.

 

		Number of				Weighted
		Common Stock				Average
		Warrants				Exercise Price
Balance as of December 31, 2023			2,128,429			$	6.30
Warrants for common stock sold			1,006,488				0.44
Balance as of March 31, 2024			3,134,917			$	4.42

 

February 2024 Financing - On February 9, 2024, we entered into a Securities Purchase and Registration Rights Agreement relating to a private placement with certain qualified institutional buyers and institutional accredited investors, which closed on February 13, 2024. Pursuant to the agreement, we sold 2,012,978 shares of our common stock, and warrants to purchase 1,006,488 shares of our common stock at an exercise price equal to $0.4423 per warrant share, subject to certain adjustments, as provided under the terms of the warrant, which are exercisable at any time before February 13, 2026. The gross proceeds of the Offering were $875,000, with associated issuance costs of $43,000.

 

At-the-Market (ATM) Offerings - On April 12, 2022, we entered into a sales agreement (Cantor Sales Agreement) with Cantor Fitzgerald & Co. (Cantor) as the sales agent, pursuant to which we may offer and sell, from time to time, through Cantor, shares of common stock having an aggregate offering price of up to $10.5 million (ATM Offering). Under the terms of the Cantor Sales Agreement, Cantor was paid a commission of 3% of the aggregate proceeds from the sale of shares and reimbursed certain legal fees. The prospectus supplement expired in conjunction with the expiration of the corresponding registration statement on October 20, 2023. On June 20, 2023, we agreed with Cantor to indefinitely suspend sales under the ATM Offering, and on November 14, 2023, we agreed to terminate the Cantor Sales Agreement.

 

On December 6, 2023, we entered into an At The Market Offering Agreement (the Sales Agreement) with H.C. Wainwright & Co., LLC (HCW). Under the Sales Agreement, we may offer and sell our common stock, from time to time having an aggregate offering price of up to $2.75 million during the term of the Sales Agreement through or to HCW as sales agent or principal. We have filed a prospectus supplement relating to the offer and sale of the shares pursuant to the Sales Agreement. The offering and sale of the shares will be made pursuant to the Company’s previously filed and effective Registration Statement on Form S-3 (File No. 333-275099), which was initially filed with the Securities and Exchange Commission (the “SEC”) on October 19, 2023 and declared effective on December 5, 2023. We have agreed to pay HCW a commission equal to 3% of the gross proceeds from the sales of shares and have agreed to provide HCW with customary indemnification and contribution rights.

 

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During the three months ended March 31, 2024 and 2023, we sold an aggregate of 1,156,877 and 106,241 shares of common stock under the ATM Offerings at then-market prices for total gross proceeds of $591,000 and $244,000, with associated issuance costs of $32,000 and $13,000, respectively.

 

(8)	Share-Based Compensation

 

The share-based compensation expense is recorded in research and development, and selling, general and administrative expenses based on the employee's or non-employee’s respective function. No share-based compensation was capitalized during the periods presented. Share-based compensation expense for the three months ended March 31, 2024 and 2023 was recorded as follows (in thousands):

 

		Three months ended
		March 31,
		2024				2023
Research and development		$	115			$	139
Selling, general and administrative			89				139
Total share-based compensation		$	204			$	278

 

The following table summarizes the activity of stock options and related information:

 

		Number of shares				Weighted average exercise price				Weighted average remaining contractual term (years)				Aggregate intrinsic value (in thousands)
Balance, December 31, 2023			2,486,767			$	3.51				6.8			$	43
Stock options forfeited			(47,657	)			2.26
Balance, March 31, 2024			2,439,110			$	3.54				6.6			$	1
Exercisable, March 31, 2024			1,601,718			$	4.49				5.6			$	—

 

Unrecognized share-based compensation for employee and nonemployee options granted through March 31, 2024 is approximately $1.2 million to be recognized over a remaining weighted average service period of 2.1 years.

 

Share-Based Compensation (RSUs)

 

There were no RSUs outstanding and hence there is no unrecognized share-based compensation at March 31, 2024 and December 31, 2023.

 

(9)	Net Loss per Share

 

Basic net loss per share is calculated by dividing the net loss by the weighted average number of shares of common stock outstanding and fully vested restricted stock units. Diluted net loss per share is computed by dividing the net loss by the weighted-average number of common share equivalents outstanding for the period determined using the treasury-stock method. Common stock equivalents are comprised of unvested restricted stock units, warrants to purchase common stock and options outstanding under the stock option plans. For all periods presented, there is no difference in the number of shares used to calculate basic and diluted shares outstanding since the effects of potentially dilutive securities are antidilutive due to the net loss position.

 

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The following outstanding common stock equivalents were excluded from the computation of diluted net loss per share for the periods presented because including them would have been antidilutive: 

 

		March 31,
		2024				2023
Stock options to purchase common stock			2,439,110				2,168,450
Unvested restricted stock units			—				2,734
Common stock warrants			3,134,917				2,424,724
Total			5,574,027				4,595,908

 

(10)	Income Taxes

 

During the three months ended March 31, 2024 and 2023, there was no income tax expense or benefit for federal or state income taxes in the accompanying condensed consolidated statements of operations due to our net loss and a full valuation allowance on the resulting deferred tax assets.

 

As of March 31, 2024, we retain a full valuation allowance on our deferred tax assets in all jurisdictions. The realization of our deferred tax assets depends primarily on our ability to generate future taxable income which is uncertain. We do not believe that our 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.

 

(11)	Related Party Transactions

 

On April 9, 2020, we entered into a Litigation Funding Agreement (Funding Agreement) with BSLF, L.L.C. (Funder), an entity owned and controlled by Andrew Blank, Chair of BioCardia’s board of directors, for the purpose of funding our 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). On April 12, 2021, all parties to the Litigation entered into a confidential settlement agreement and all claims were dismissed.

 

In March 2022, we entered into confidential settlement agreements with our litigation service providers and the Funder to terminate the Funding Agreement and conclude all remaining matters thereunder (the Litigation Funding Settlement). Under the terms of the Litigation Funding Settlement, litigation and corporate counsel provided credits and refunds of legal fees totaling $688,000, which offset the amounts owed to us by the Funder under the Funding Agreement, and provided up to $300,000 in future discounts on legal services. As a result of the Litigation Funding Settlement, we will remit the discounts, as received, to the Funder on a quarterly basis. During the three months ended March 31, 2024 and 2023, we received discounts totaling $110,000 and $33,000, respectively. As of March 31, 2024 and December 31, 2023, we recorded a related party payable for discounts owed to the Funder in accrued expenses and other current liabilities of $42,000 and $71,000, respectively. With the accrual of $42,000 as of March 31, 2024, all of the future potential discounts have been collected on behalf of the Funder.

 

(12)	Contingencies

 

We may be subject to various claims, complaints, and legal actions that arise from time to time in the normal course of business. Management is not aware of any current legal or administrative proceedings that are likely to have an adverse effect on our business, financial position, results of operations, or cash flows.

 

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ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS                                                   

 

The following discussion of our financial condition and results of operations should be read in conjunction with our financial statements and related notes included elsewhere in this Quarterly Report on Form 10-Q. This discussion contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Any and all statements contained in this Quarterly Report that are not statements of historical fact may be deemed forward-looking statements. Terms such as “may,” “might,” “would,” “should,” “could,” “project,” “estimate,” “pro- forma,” “predict,” “potential,” “strategy,” “anticipate,” “attempt,” “develop,” “plan,” “help,” “believe,” “continue,” “intend,” “expect,” “future” and terms of similar import (including the negative of any of the foregoing) may be intended to identify forward-looking statements. However, not all forward-looking statements may contain one or more of these identifying terms. Forward-looking statements in this Quarterly Report may include, without limitation, statements regarding (i) the plans and objectives of management for future operations, including plans or objectives relating to the development of our cell therapy systems, our clinical trials, and our business development initiatives, (ii) a projection of income (including income/loss), earnings (including earnings/loss) per share, capital expenditures, dividends, capital structure or other financial items, (iii) our ability to raise additional capital, (iv) 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 SEC and (v) the assumptions underlying or relating to any statement described in points (i) – (iv) above. Our actual results may differ materially from those discussed below. Factors that could cause or contribute to such differences include, but are not limited to, those identified below and elsewhere in this Quarterly Report on Form 10-Q, and those listed in our Annual Report on Form 10-K for the year ended December 31, 2023, which is incorporated by reference herein. Historical results are not necessarily indicative of future results. Except as required by law, we undertake no obligation to update publicly any forward-looking statements for any reason after the date of this Quarterly Report on Form 10-Q to conform these statements to actual results or to changes in our expectations.

 

Overview

 

We are a clinical-stage company developing cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases with significant unmet medical needs. We are advancing two cell therapy platforms derived from the bone marrow in clinical trials today. Our CardiAMP® autologous mononuclear cell therapy platform is being advanced for two clinical indications: ischemic heart failure with reduced ejection fraction (HFrEF) and refractory angina resulting from chronic myocardial ischemia (CMI). Our immunomodulatory allogeneic mesenchymal stem cell (MSC) therapy platform is being advanced as an “off the shelf” cell therapy for two clinical indications: the treatment of ischemic HFrEF (CardiALLO™), which is actively enrolling, and acute respiratory distress syndrome (ARDS).

 

Our autologous CardiAMP and our allogeneic CardiALLO cell therapies intended for cardiac indications of HFrEF and CMI are enabled by our Helix™ minimally invasive intramyocardial therapeutic delivery platform. We partner this therapeutic delivery platform and provide development services selectively with others seeking to develop biotherapeutic interventions for local delivery to the heart.

 

To date, we have devoted substantially all of our resources to research and development efforts relating to our 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 our intellectual property. We have also generated modest revenues from sales of our approved products. We have funded our operations primarily through the sales of equity and convertible debt securities, and certain government and private grants.

 

CardiAMP Autologous Cell Therapy for Ischemic Heart Failure (BCDA-01)

 

The CardiAMP Cell Therapy Heart Failure Trial

 

The CardiAMP Heart Failure Trial is an ongoing randomized, double-blinded, controlled clinical trial in the United States with 125 patients enrolled, including a 10-patient roll-in cohort. The last patient randomizations were completed in October 2023 after the trial was determined to be unlikely to meet its primary efficacy endpoint at 12-month follow-up as designed, due primarily to patients in both the treatment and control groups improving on 6MWD, which had an overweight impact on the primary endpoint.

 

The July 2023 interim results from this study, with 110 of the 115 randomized patients, were presented at the Technology and Heart Failure Therapeutics meeting on March 4, 2024. Over a mean 20 months of follow-up, patients with advanced chronic heart failure who received a single endomyocardial dose of autologous CardiAMP cell therapy had a 37% relative risk reduction in all-cause heart death equivalents and a 9% relative risk reduction in non-fatal incidence of heart attacks, strokes and hospitalization due to heart failure (MACCE). Patients treated with CardiAMP cell therapy saw an almost 5% lower rate of heart death equivalents at up to two years compared to control patients treated with heart failure medication alone (8.3% vs. 13.2%, respectively). CardiAMP cell therapy was also associated with trends toward reduced ventricular tachyarrhythmias, enhanced heart function as measured by left ventricular ejection fraction, and improved NTproBNP.

 

 

In an important subgroup analysis of patients with elevated NTproBNP at baseline – encompassing 59% of total enrolled randomized patients – patients treated with CardiAMP cell therapy experienced an 86.2% relative risk reduction in heart death equivalents and a 23.9% relative risk reduction in MACCE. These patients saw more than a 17% lower rate of heart death equivalents at up to two years compared to control patients treated with heart failure medication alone (2.9% vs. 21.1%, respectively).

 

We are completing follow-up in CardiAMP HF and preparing this dataset for final lock in the fourth quarter of 2024, and for potential submission to Japan PMDA to support product approval in Japan. Results on all 125 patients enrolled with a minimum of one year follow-up are expected to be available in October 2024.

 

CardiAMP Confirmatory Phase III Trial in Ischemic HFrEF: The CardiAMP Cell Therapy Heart Failure II Trial

 

The CardiAMP Cell Therapy Heart Failure II Trial was approved by the FDA in the fourth quarter of 2023. The study is a Phase III, multi-center, randomized, double-blinded, sham-controlled study of up to 250 patients with NTproBNP levels >500 pg/ml at up to 40 centers in the United States. The primary endpoint is an outcomes composite score based on a three-tiered Finkelstein-Schoenfeld hierarchical analysis. The tiers, starting with the most serious events, would be (1) all-cause death, including cardiac death equivalents such as heart transplant or left ventricular assist device placement, ordered by time to event; (2) non-fatal Major Adverse Coronary and Cerebrovascular Events (MACCE), excluding those deemed procedure-related occurring within the first seven days post-procedure (heart failure hospitalization, stroke or myocardial infarction), ordered by time to event, and (3) change from baseline in quality of life at a minimum of 12 months and a maximum of 24 months. Additional prespecified secondary hierarchical and nonhierarchical endpoints are also being assessed.

 

The trial has greater than 90 percent power (statistical probability of success) to meet the primary endpoint based on the CardiAMP HF Trial interim results. The Study was activated in the first quarter of 2024 with a goal of completing enrollment two years after the first patient is enrolled.

 

CardiAMP Autologous Cell Therapy for Chronic Myocardial Ischemia (BCDA-02)

 

CardiAMP Cell Therapy system, under a second FDA approved investigational device exemption, is actively being studied in a second related clinical indication of chronic myocardial ischemia with refractory angina. This study is based on the strength of our Phase I and II ischemic heart failure trial data and previous clinical data on CD34+ mononuclear cells in this indication.

 

The CardiAMP Cell Therapy Chronic Myocardial Ischemia Trial is a Phase III, multi-center, randomized, double-blinded, controlled study of up to 343 patients at up to 40 clinical sites. The Phase III pivotal trial is designed to provide the primary support for the safety and efficacy of the CardiAMP Cell Therapy System for patients with no option chronic myocardial ischemia with refractory angina (BCDA-02). These patients experience frequent angina (i.e., chest pain) attacks that are uncontrolled by optimal drug therapy, and these patients are not suitable candidates for stent placement or bypass surgery, leaving them few therapeutic options. Our therapeutic approach uses many of the same novel aspects used in the CardiAMP Heart Failure Trial and is expected to leverage our experience and investment in the heart failure trial. The Company intends to introduce an adaptive statistical analysis plan with an initial assessment for efficacy when 100 patients reach their primary endpoint, although aspects of this statistical analysis plan remain the subject of study considerations with the FDA.

 

Results from the open label roll-in cohort of patients having chronic myocardial ischemia with refractory angina showed an average 107 second increase in exercise tolerance and an 82% average reduction in angina episodes at the primary six-month follow-up endpoint compared to before receiving the study treatment.

 

CardiALLO Allogeneic MSC for Ischemic Heart Failure with HFrEF (BCDA-03)

 

The FDA approval of the IND application for a Phase I/II trial to deliver our allogeneic MSC for the treatment of HFrEF was secured in December 2022. This trial includes a 3+3 roll-in dose escalation cohort followed by a 60-patient randomized double-blind controlled study and utilizes the Finkelstein Schoenfeld three tier primary composite endpoint of mortality, MACCE, and functional capacity as measured by six-minute walk distance. The cohort receiving the lowest dose of 20 million cells was initiated in December 2023. There have been no treatment-emergent adverse events, arrhythmias, rejection, or allergic response, consistent with our presentation at the Technology and Heart Failure Therapeutics meeting on March 4, 2024.

 

We intend to fund later development through nondilutive grant applications and partnering. With such funding, it is possible to complete enrollment in the Phase I as early as the end of 2024. Phase II development is anticipated to be advanced in both the United States and Japan and would also enroll in approximately one year.

 

 

Helix™ Biotherapeutic Delivery System

 

The Helix transendocardial biotherapeutic delivery system is a therapeutic-enabling platform for minimally invasive targeted delivery of biologic agents to the heart. Helix empowers a seamless transition from bench to commercialization for partners. Our biotherapeutic delivery partnerships are expected to enhance future treatment options for millions of people suffering from heart disease, offset the costs of biotherapeutic delivery for our own programs, and provide our investors with meaningful revenue sharing should our partnering efforts contribute successful therapeutic development.

 

In September 2023, our partner CellProthera announced completion of enrollment in the Excellent Phase 1/2b cell therapy study in post-myocardial infarction and the results are expected to be presented during the next European Society of Cardiology Heart Failure Congress in Lisbon, Portugal, May 14 to 16, 2024.

 

In March 2024, we announced a biotherapeutic delivery partnership with StemCardia through a Phase I/II Clinical Study. Under the partnership, BioCardia is the exclusive biotherapeutic delivery partner for StemCardia’s cell therapy candidate through studies expected to result in FDA approval of an investigational new drug application (IND) and the anticipated Phase I/II clinical development to follow.

 

Morph® Access Innovations

 

All procedures using our Helix transendocardial delivery system include the use of a Morph steerable introducer. We are actively transitioning all procedures using our Helix transendocardial delivery system to our new FDA cleared Morph DNA platform as it has performed well in the CardiAMP CMI Trial. The Morph-DNA for Helix is in a 5 French equivalent. French is a catheter size equal to one-third of a millimeter. We secured approval of an 8 French equivalent for transseptal cardiac procedures, under the name AVANCE. One of the device’s features is that its tendons are designed to enable deflection rotation around the catheter shaft, providing uniform bending in all directions and a substantial reduction of what is called catheter “whip.”

 

Our planned Morph-DNA submission to the FDA for approval of a product family from 5 French to 8 French diameters is on track for submission in the second quarter of 2024 with an expected approval in the third quarter of 2024. This product family was designed for the treatment of lower risk aorto-ostial disease, including renal procedures, superior femoral artery procedures, below the knee procedures and mesenteric artery procedures. After selling approximately 12,000 units of an earlier product design, we believe the new design has the potential to become a leader for aorto-ostial applications. A number of leading vascular surgeons have expressed interest in using these new devices after we secure FDA approval. We anticipate they will prepare case report write ups on the performance of this new platform to share with the broader physician community.

 

Financial Overview

 

Revenue

 

We currently have a portfolio of enabling and delivery products, from which we have generated modest revenue. Net product revenues include commercial sales of our AVANCE steerable introducer and collaboration agreement revenues include revenue from partnering agreements with corporate and academic institutions. Under these partnering agreements, we provide our Helix biotherapeutic delivery system and customer training and support for use in preclinical and clinical studies, and participate in future revenue sharing.

 

Research and Development Expenses

 

Our research and development expenses consist primarily of:

 

•

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.

 

We expense all research and development costs in the periods in which they are incurred. Costs for certain development activities are recognized based on an evaluation of the progress of completion of specific tasks using information and data provided to us by our vendors and clinical sites. Nonrefundable advance payments for goods or services to be received in future periods for use in research and development activities are deferred and capitalized. The capitalized amounts are then expensed as the related goods are delivered and the services are received. 

 

We plan to increase our research and development expenses as we continue the pivotal CardiAMP autologous cell therapy trials in heart failure and chronic myocardial ischemia, and in our CardiALLO allogeneic cell therapy trial in heart failure. We typically use our employee and infrastructure resources across multiple research and development programs, and accordingly, we have not historically allocated resources specifically to our individual programs. There are also significant synergies between these programs.

 

Selling, General and Administrative Expenses

 

Selling, general and administrative expenses consist primarily of salaries and related costs for employees in executive, finance and administration, sales, corporate development and administrative support functions, including share-based compensation expenses and benefits. Other selling, general and administrative expenses include sales commissions, rent, accounting and legal services, obtaining and maintaining patents, the cost of consultants, occupancy costs, insurance premiums and information systems costs.

 

Other Income (Expense)

 

Other income and expense consist primarily of interest income we earn on our cash and cash equivalents. 

 

Critical Accounting Policies and Estimates

 

Our management’s discussion and analysis of our financial condition and results of operations is based on our financial statements, which we have prepared in accordance with U.S. GAAP. The preparation of our financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities. We evaluate these estimates and judgments on an ongoing basis. We base our estimates on historical experience and on various judgements that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not clear from other sources. Actual results may differ from these estimates under different assumptions or conditions. 

 

We define our critical accounting policies as those that require us to make subjective estimates and judgments about matters that are uncertain and are likely to have a material impact on our financial condition and results of operations as well as the specific manner in which we apply those principles. Our critical accounting policies are described in Item 7 in our Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on March 27, 2024, which is incorporated by reference herein. 

 

 

Results of Operations

 

Comparison of Three Months Ended March 31, 2024 and 2023

 

The following table shows our results of operations for the three months ended March 31, 2024 and 2023 (in thousands): 

 

		Three months ended March 31,
		2024				2023
Revenue:
Collaboration agreement revenue		$	55			$	64
Costs and expenses:
Research and development			1,241				2,384
Selling, general and administrative			1,089				1,190
Total costs and expenses			2,330				3,574
Operating loss			(2,275	)			(3,510	)
Other income (expense):
Total other income, net			8				9
Net loss		$	(2,267	)		$	(3,501	)

 

Revenue. Revenue decreased to $55,000 in the three months ended March 31, 2024 as compared to $64,000 in the three months ended March 31, 2023. The amount and timing of collaboration revenues is largely dependent on our partners’ development activities and may be inconsistent and create significant variation in our revenues.

 

Research and Development Expenses. Research and development expenses decreased to $1,241,000 in the three months ended March 31, 2024 as compared to $2,384,000 in the three months ended March 31, 2023, primarily due to clinical staff reductions and reduced personnel related expenses following the completion of enrollment in the CardiAMP Cell Therapy Heart Failure Trial in the second half of 2023.  

 

Selling, General and Administrative Expenses. Selling, general and administrative expenses decreased to $1,089,000 in the three months ended March 31, 2024 as compared to $1,190,000 in three months ended March 31, 2023, primarily due to realignment of personnel roles following staff reductions in the fourth quarter of 2023.

 

Liquidity and Capital Resources

 

We have incurred net losses each year since our inception and as of March 31, 2024, we had an accumulated deficit of approximately $154.4 million. We anticipate that we will continue to incur net losses for the next several years.

 

We have funded our operations principally through the sales of equity and convertible debt securities. As of March 31, 2024, we had cash and cash equivalents of $949,000. 

 

The following table shows a summary of our cash flows for the periods indicated (in thousands): 

 

		Three months ended March 31,
		2024				2023
Net cash provided by (used in):
Operating activities		$	(1,530	)		$	(2,560	)
Investing activities			—				(10	)
Financing activities			1,376				64
Net decrease in cash and cash equivalents		$	(154	)		$	(2,506	)

 

Cash Flows from Operating Activities. Cash flow from operating activities for any period is subject to many variables including the timing of cash receipts, payments to suppliers, and vendor payment terms. Cash flow used in operating activities decreased from $2.6 million in during the three months ended March 31, 2023 to $1.5 million during the three months ended March 31, 2024, due primarily to reductions in research and development expense following completion of enrollment in the CardiAMP Cell Therapy Heart Failure Trial in the second half of 2023.

 

Cash Flows from Investing Activities. Net cash used in investing activities of $0 and $10,000 during the three months ended March 31, 2024 and 2023, respectively, consisted of purchases of property and equipment, primarily lab and office equipment.

 

 

Cash Flows from Financing Activities. Net cash provided by financing activities of $1,376,000 and $64,000 during the three months ended March 31, 2024 and 2023, respectively, related primarily to proceeds from the sale of common stock and warrants. 

 

February 2024 Financing - On February 13, 2024, we sold to certain qualified institutional buyers and institutional accredited investors, as well as Peter Altman, our President and Chief Executive Officer, (i) an aggregate of 2,012,978 shares of our common stock at an offering price of $0.4331 per share and (ii) warrants to purchase an aggregate of 1,006,488 shares of common stock in a private placement, which warrants were immediately exercisable upon issuance at $0.4423 per warrant share (the February 2024 Private Placement). Of such securities, Dr. Altman agreed to purchase (i) 108,108 shares of our common stock and (ii) warrants to purchase 54,054 shares of our common stock. The gross proceeds of the February 2024 Private Placement were$875,000, with associated issuance costs of $43,000.

 

ATM Offerings

 

On April 12, 2022, we entered into a sales agreement (Cantor Sales Agreement) with Cantor Fitzgerald & Co. (Cantor) as the sales agent, pursuant to which we may offer and sell, from time to time, through Cantor, shares of common stock having an aggregate offering price of up to $10.5 million (ATM Offering). Under the terms of the Cantor Sales Agreement, Cantor was paid a commission of 3% of the aggregate proceeds from the sale of shares and reimbursed certain legal fees. The prospectus supplement expired in conjunction with the expiration of the corresponding registration statement on October 20, 2023. On June 20, 2023, we agreed with Cantor to indefinitely suspend sales under the ATM Offering, and on November 14, 2023, we agreed to terminate the Cantor Sales Agreement.

 

On December 6, 2023, we entered into an At-The-Market Offering Agreement (the HCW Sales Agreement) with H.C. Wainwright & Co., LLC (HCW). Under the HCW Sales Agreement, we may offer and sell our common stock, from time to time having an aggregate offering price of up to $2.75 million during the term of the HCW Sales Agreement through or to HCW as sales agent or principal (the HCW ATM Offering and, together with the Cantor ATM Offering, the ATM Offerings). Pursuant to the terms of the HCW Sales Agreement, we have agreed to pay HCW a commission equal to 3.0% of the gross proceeds from the sales of shares.

 

During the three months ended March 31, 2024 and 2023, we sold 1,156,877 and 106,241 and shares of common stock under the ATM Offerings at then-market prices for total gross proceeds of $591,000 and $244,000, with associated issuance costs of $32,000 and $13,000, respectively. During the period from April 1, 2024 to May 13, 2024 we sold 467,727 shares of common stock, respectively, under the ATM Offerings at then-market prices for total gross proceeds of $184,000.

 

Future Funding Requirements

 

To date, we have generated modest revenues. We do not know when, or if, we will generate any revenue from our development stage biotherapeutic programs. We do not expect to generate any revenue from sales of our autologous and allogeneic cell therapy candidates unless and until we obtain regulatory approval. At the same time, we expect our expenses to increase in connection with our ongoing development activities, particularly as we continue the research, development and clinical trials of, and seek regulatory approval for, our therapeutic candidates. In addition, subject to obtaining regulatory approval for any of our therapeutic candidates and companion diagnostic, we expect to incur significant commercialization expenses for product sales, marketing, manufacturing and distribution. We anticipate that we will need additional funding in connection with our continuing operations.      

 

Based upon our current operating plan, we believe that the cash and cash equivalents of $949,000 as of March 31, 2024 are not sufficient to fund our planned expenditures and meet our obligations beyond the second quarter of 2024. In order to continue development of our therapeutic candidates beyond the second quarter of 2024 and to become compliant with the Nasdaq continued listing standards prior to our compliance deadline of September 2, 2024 (as described below), we plan to raise additional capital, potentially including non-dilutive collaboration and licensing arrangements, debt or equity financing, or a combination from these sources. We may be unsuccessful in raising funds from any or all such sources, and to the extent we raise any funds, they may be on highly dilutive terms. We have based our estimates on assumptions that may prove to be wrong, and we may use our available capital resources sooner than we currently expect. Because of the numerous risks and uncertainties associated with the development and commercialization of our therapeutic candidates, we are unable to estimate the amounts of increased capital outlays and operating expenditures necessary to complete the development of our therapeutic candidates.

 

Our future capital requirements will depend on many factors, including:

 

•

the progress, costs, results and timing of our autologous CardiAMP Cell Therapy System and allogeneic Neurokinin-1 Receptor Positive clinical trials and related development programs;

 

•

FDA acceptance of our autologous CardiAMP Cell Therapy System and allogeneic Neurokinin-1 Receptor Positive therapies for heart failure and for other potential indications;

 

•

the outcome, costs and timing of seeking and obtaining FDA and any other regulatory approvals;

 

•

the costs associated with securing, establishing and maintaining commercialization and manufacturing capabilities;

 

 

•

the number and characteristics of product candidates that we pursue, including our product candidates in preclinical development;

 

•

the ability of our product candidates to progress through clinical development successfully;

 

•

our need to expand our research and development activities;

 

•

the costs of acquiring, licensing, or investing in businesses, products, product candidates and technologies;

 

•

our ability to maintain, expand and defend the scope of our intellectual property portfolio, including the amount and timing of any payments we may be required to make, or that we may receive, in connection with the licensing, filing, prosecution, defense and enforcement of any patents or other intellectual property rights;

 

•

the general and administrative expenses related to being a public company;

 

•

our need and ability to hire additional management and scientific, medical and sales personnel;

 

•

the effect of competing technological and market developments; and

 

•

our need to implement additional internal systems and infrastructure, including financial and reporting systems.

 

Until such time that we can generate meaningful revenue from our recurring revenue biotherapeutic delivering partnering business model and/or sales of approved therapies and products, if ever, we expect to finance our operating activities through public or private equity or debt financings, government or other third-party funding, marketing and distribution arrangements, and other collaborations, strategic alliances and licensing arrangements or a combination of these approaches. To the extent that we are able to raise additional capital through the sale of equity or convertible debt securities, the ownership interests of our existing common stockholders may be highly diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our existing common stockholders. Debt financing, if available, may involve agreements that include conversion discounts or covenants limiting or restricting our ability to take specific actions, such as incurring debt, making capital expenditures or declaring dividends. If we raise additional funds through government or other third-party funding, marketing and distribution arrangements or other collaborations, or strategic alliances or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs, products, or therapeutic candidates or to grant licenses on terms that may not be favorable to us.

 

We have prepared our condensed consolidated financial statements as of March 31, 2024 on the basis that we will continue as a going concern, which contemplates the realization of assets and satisfaction of liabilities in the ordinary course of business. Due to the factors described above, there is substantial doubt about our ability to continue as a going concern within one year after the date these financial statements are issued. Our ability to continue as a going concern will depend, in a large part, on our ability to raise additional capital. If adequate funds are not available, we may be required to further reduce operating expenses, delay or reduce the scope of our product development programs, obtain funds through arrangements with others that may require us to relinquish rights to certain of our technologies or products that we would otherwise seek to develop or commercialize ourselves, or cease operations. While we believe in the viability of our strategy to raise additional funds, there can be no assurances that we will be able to obtain additional capital on acceptable terms and in the amounts necessary to fully fund our operating needs.

 

The condensed consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty. If we are unable to continue as a going concern, we may be forced to liquidate assets. In such a scenario, the values received for assets in liquidation or dissolution could be significantly lower than the values reflected in our condensed consolidated financial statements. 

 

Off-Balance Sheet Arrangements

 

During the periods presented, we did not have, nor do we currently have, any off-balance sheet arrangements as defined under the rules of the Securities and Exchange Commission.

 

Recent Accounting Pronouncements

 

See Note 2 of our notes to the condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q for information regarding recent accounting pronouncements that are of significance or potential significance to us.

 

 

ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

 

There have been no material changes in our market risks during the three months ended March 31, 2024.

 

Our exposure to market risk is currently limited to our cash and cash equivalents, all of which have maturities of less than three months. The goals of our investment policy are preservation of capital, maintenance of liquidity needs, and fiduciary control of cash and investments. We also seek to maximize income from our investments without assuming significant risk or departing from our investment policy. We currently do not hedge interest rate exposure. Because of the short-term nature of our cash equivalents, we do not believe that an increase in market rates would have a material negative impact on the value of our portfolio.

 

Interest Rate Risk

 

As of March 31, 2024, based on current interest rates and total borrowings outstanding, a hypothetical 100 basis point increase or decrease in interest rates would have an immaterial pre-tax impact on our results of operations.

 

Foreign Currency Exchange Risks

 

We are a U.S. entity and our functional currency is the U.S. dollar. The vast majority of our revenues were derived from sales in the United States. We have business transactions in foreign currencies; however, we believe we do not have significant exposure to risk from changes in foreign currency exchange rates at this time. We do not currently engage in hedging or similar transactions to reduce our foreign currency risks. We will continue to monitor and evaluate our internal processes relating to foreign currency exchange, including the potential use of hedging strategies.

 

 

ITEM 4. CONTROLS AND PROCEDURES

 

Evaluation of Disclosure Controls and Procedures

 

In connection with the preparation of this Quarterly Report on Form 10-Q, as of March 31, 2024, an evaluation was performed under the supervision and with the participation of our management, including the Chief Executive Officer and Chief Financial Officer, of the effectiveness of the design and operation of our disclosure controls and procedures (as defined in Rule 13a-15(e) under the Exchange Act). Based on that evaluation, our Chief Executive Officer and our Chief Financial Officer have concluded that, as of March 31, 2024, our disclosure controls and procedures were, in design and operation, effective at a reasonable assurance level.

 

Changes in Internal Control over Financial Reporting

 

There were no changes to our internal control over financial reporting identified in connection with the evaluation required by rule 13a-15(d) and 15d-15(d) of the Exchange Act that occurred during the three months ended March 31, 2024 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

 

 

PART II. OTHER INFORMATION

 

ITEM 1. LEGAL PROCEEDINGS

 

The Company may be subject to various claims, complaints, and legal actions that arise from time to time in the normal course of business. Management does not believe that the Company is party to any current pending legal proceedings. There can be no assurance that existing or future legal proceedings arising in the ordinary course of business or otherwise will not have a material adverse effect on the Company’s business, financial position, results of operations, or cash flows.

 

ITEM 1A. RISK FACTORS

 

In addition to the risk described below and the other information set forth in this report, you should carefully consider the factors discussed in Part I, Item 1A. Risk Factors in our Annual Report on Form 10-K for the year ended December 31, 2023, which could materially affect our business, financial condition, or future results, are incorporated by reference herein. The risks described in this report, our Annual Report on Form 10-K for the year ended December 31, 2023, and our Quarterly Reports on Form 10-Q filed periodically with the SEC are not the only risks facing our Company. Additional risks and uncertainties not currently known to us or that we currently deem to be immaterial may also materially adversely affect our business, financial condition or future results.

 

If we do not regain compliance with or continue to satisfy the Nasdaq continued listing requirements, our securities could be delisted from the Nasdaq.

 

The listing of our securities on the Nasdaq Capital Market (Nasdaq) is contingent on our compliance with the Nasdaq’s conditions for continued listing. We are currently not in compliance with Nasdaq listing requirements, specifically those that require us to maintain a minimum market value of listed securities of at least $35.0 million (MVLS Requirements) and a minimum $1.00 per share closing bid price for our common stock (Minimum Bid Price Requirement). On March 6, 2024, and March 12, 2024, we received delisting determination letters from the Nasdaq advising us that we did not regain compliance with the MVLS Requirement and the Minimum Bid Price Requirement, respectively, by the initial compliance dates afforded by the Nasdaq. As a result, trading of our securities on the Nasdaq was subject to suspension at the opening of business on March 15, 2024, and a Form 25-NSE would have been filed with the SEC to remove our securities from listing and registration on the Nasdaq unless we requested an appeal of these determinations to a Nasdaq Hearings Panel (Panel). On March 12, 2024, we submitted a hearing request to the Panel to appeal the delisting determinations. Our request for a hearing stayed the suspension of our securities and the filing of a Form 25-NSE pending the Panel’s decision. Following our hearing with the Panel, on May 13, 2024, the Panel granted our request for continued listing on Nasdaq subject to, among other things, (i) us maintaining compliance with the Minimum Bid Price Requirement for ten consecutive trading days on or before June 24, 2024, which we expect to occur following a reverse stock split that is subject to stockholder approval, and (ii) us demonstrating compliance with minimum stockholders’ equity continued listing requirements under Nasdaq rules on or before September 2, 2024.

 

If we fail to demonstrate our compliance with the requirements of the Panel’s order, our securities will be subject to delisting by the Nasdaq. In the event our securities are no longer listed for trading on Nasdaq, our trading volume and share price may decrease and we may experience further difficulties in raising capital, which could materially affect our operations and financial results. Further, delisting from the Nasdaq could also have other negative effects, including potential loss of confidence by partners, lenders, suppliers and employees and could also trigger various defaults under our financing arrangements and other outstanding agreements.

 

ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS

 

None.

 

ITEM 3. DEFAULTS UPON SENIOR SECURITIES

 

None.

 

ITEM 4. MINE SAFETY DISCLOSURES

 

Not applicable.

 

ITEM 5. OTHER INFORMATION

 

During the three months ended March 31, 2024, none of our directors or executive officers adopted or terminated any Rule 10b5-1 trading arrangement or any non-Rule 10b5-1 trading arrangement (as such terms are defined in Item 408 of Regulation S-K)

 

ITEM 6. EXHIBIT INDEX

 

Exhibit Number	Exhibit Description
3.1(1)	Amended and Restated Certificate of Incorporation, as amended May 6, 2019
3.2(2)	Amended and Restated Bylaws
4.1(3)	Form of Securities Purchase and Registration Rights Agreement, dated February 9, 2024, by and among the Company and the investors named therein
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+	Inline XBRL Instance Document
101.SCH+	Inline XBRL Taxonomy Extension Schema Document
101.CAL+	Inline XBRL Taxonomy Extension Calculation Linkbase Document
101.DEF+	Inline XBRL Taxonomy Extension Definition Linkbase Document
101.LAB+	Inline XBRL Taxonomy Extension Label Linkbase Document
101.PRE+	Inline XBRL Taxonomy Extension Presentation Linkbase Document
104	Cover Page Interactive Data File (formatted as inline XBRL with applicable taxonomy extension information contained in Exhibits 101)

 

*	Filed herewith.
**	Furnished herewith.
(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 May 1, 2023.
(3)	Previously filed as Exhibit 4.1 to the Current Report on Form 8-K filed by us on February 9, 2024.

 

 

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 thereunto duly authorized.

 

	BIOCARDIA, INC. (Registrant)
Date:        May 14, 2024	By:	/s/ Peter Altman
		Peter Altman
		President and Chief Executive Officer
		(Principal Executive Officer)
Date:        May 14, 2024	By:	/s/ David McClung
		David McClung
		Chief Financial Officer
		(Principal Financial and Accounting Officer)

 

Exhibit 31.1

 

Certification of Principal Executive Officer

Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

 

I, Peter Altman, certify that:

 

1.         I have reviewed this Quarterly Report on Form 10-Q of BioCardia, Inc.;

 

2.         Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

 

3.         Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

 

4.        The registrant's other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

 

(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

 

5.        The registrant's other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions):

 

(a)

All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and

 

(b)

Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting.

 

Date: May 14, 2024

	/s/ Peter Altman
	Name: Peter Altman
	Title: President and Chief Executive Officer (Principal Executive Officer)

 

Exhibit 31.2

 

Certification of Principal Financial Officer

Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

 

I, David McClung, certify that:

 

1.         I have reviewed this Quarterly Report on Form 10-Q of BioCardia, Inc.;

 

2.         Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

 

3.         Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

 

4.        The registrant's other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

 

(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

 

5.        The registrant's other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions):

 

(a)

All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and

 

(b)

Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting.

 

Date:  May 14, 2024

	/s/ David McClung
	Name: David McClung
	Title: Chief Financial Officer (Principal Financial Officer)

 

Exhibit 32.1

 

Certification of Principal Executive Officer

 

Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

 

Pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, I, Peter Altman, the President and Chief Executive Officer of BioCardia, Inc. (the "Company"), hereby certify, that, to my knowledge:

 

1.       The Quarterly Report on Form 10-Q for the period ended March 31, 2024 (the "Report") of the Company fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

 

2.       The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

 

 

Date:  May 14, 2024

	/s/ Peter Altman
	Name: Peter Altman
	Title: President and Chief Executive Officer (Principal Executive Officer)

 

Exhibit 32.2

 

Certification of Principal Financial Officer

 

Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

 

Pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, I, David McClung, the Chief Financial Officer of BioCardia, Inc. (the “Company”), hereby certify, that, to my knowledge:

 

1.       The Quarterly Report on Form 10-Q for the period ended March 31, 2024 (the “Report”) of the Company fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

 

2.       The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

 

 

Date:  May 14, 2024

	/s/ David McClung
	Name: David McClung
	Title: Chief Financial Officer (Principal Financial Officer)

 

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	Mar. 31, 2024	May 13, 2024
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Document Type	10-Q
Document Quarterly Report	true
Document Period End Date	Mar. 31, 2024
Document Transition Report	false
Entity File Number	001-38999
Entity Registrant Name	BioCardia, Inc
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	23-2753988
Entity Address, Address Line One	320 Soquel Way
Entity Address, City or Town	Sunnyvale
Entity Address, State or Province	CA
Entity Address, Postal Zip Code	94085
City Area Code	650
Local Phone Number	226-0120
Entity Current Reporting Status	Yes
Entity Interactive Data Current	Yes
Entity Filer Category	Non-accelerated Filer
Entity Small Business	true
Entity Emerging Growth Company	false
Entity Shell Company	false
Entity Common Stock, Shares Outstanding (in shares)		27,304,116
Entity Central Index Key	0000925741
Current Fiscal Year End Date	--12-31
Document Fiscal Year Focus	2024
Document Fiscal Period Focus	Q1
Amendment Flag	false
Common Stock [Member]
Document Information [Line Items]
Title of 12(b) Security	Common Stock, par value $0.001
Trading Symbol	BCDA
Security Exchange Name	NASDAQ
Warrant [Member]
Document Information [Line Items]
Title of 12(b) Security	Warrant to Purchase Common Stock
Trading Symbol	BCDAW
Security Exchange Name	NASDAQ

v3.24.1.1.u2

Condensed Consolidated Balance Sheets (Current Period Unaudited) - USD ($)	Mar. 31, 2024	Dec. 31, 2023
Cash and cash equivalents	$ 949,000	$ 1,103,000
Accounts receivable, net of allowance for doubtful accounts of $22 and $11 as of September 30, 2023 and December 31, 2022, respectively	58,000	63,000
Prepaid expenses and other current assets	252,000	295,000
Total current assets	1,259,000	1,461,000
Property and equipment, net	75,000	94,000
Operating lease right-of-use asset, net	1,174,000	1,261,000
Other assets	171,000	171,000
Total assets	2,679,000	2,987,000
Accounts payable	1,030,000	890,000
Accrued expenses and other current liabilities	2,696,000	2,385,000
Operating lease liability - current	345,000	333,000
Total current liabilities	4,071,000	3,608,000
Operating lease liability - noncurrent	883,000	982,000
Total liabilities	4,954,000	4,590,000
Commitments and Contingencies
Preferred stock, $0.001 par value, 25,000,000 shares authorized and no shares issued and outstanding as of March 31, 2024 and December 31, 2023	0	0
Common stock, $0.001 par value, 100,000,000 shares authorized, 26,836,389 and 23,666,534 shares issued and outstanding as of March 31, 2024 and December 31, 2023, respectively	27,000	24,000
Additional paid-in capital	152,140,000	150,548,000
Accumulated deficit	(154,442,000)	(152,175,000)
Total stockholders’ equity (deficit)	(2,275,000)	(1,603,000)
Total liabilities and stockholders’ equity (deficit)	$ 2,679,000	$ 2,987,000

v3.24.1.1.u2

Condensed Consolidated Balance Sheets (Current Period Unaudited) (Parentheticals) - USD ($) $ in Thousands	Mar. 31, 2024	Dec. 31, 2023
Accounts Receivable, Allowance for Credit Loss, Current	$ 10	$ 34
Preferred Stock, Par or Stated Value Per Share (in dollars per share)	$ 0.001	$ 0.001
Preferred Stock, Shares Authorized (in shares)	25,000,000	25,000,000
Preferred Stock, Shares Issued (in shares)	0	0
Preferred Stock, Shares Outstanding (in shares)	0	0
Common Stock, Par or Stated Value Per Share (in dollars per share)	$ 0.001	$ 0.001
Common Stock, Shares Authorized (in shares)	100,000,000	100,000,000
Common Stock, Shares, Outstanding (in shares)	26,836,389	23,666,534
Common Stock, Shares, Issued (in shares)	26,836,389	23,666,534

v3.24.1.1.u2

Condensed Consolidated Statements of Operations (Unaudited) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2024	Mar. 31, 2023
Revenue, Product and Service [Extensible Enumeration]	Collaboration Agreement [Member]	Collaboration Agreement [Member]
Total revenue	$ 55	$ 64
Research and development	1,241	2,384
Selling, general and administrative	1,089	1,190
Total costs and expenses	2,330	3,574
Operating loss	(2,275)	(3,510)
Total other income, net	8	9
Net loss	$ (2,267)	$ (3,501)
Net loss per share, basic and diluted (in dollars per share)	$ (0.09)	$ (0.17)
Weighted-average shares used in computing net loss per share, basic and diluted (in shares)	25,133,093	20,177,167

v3.24.1.1.u2

Condensed Consolidated Statements of Stockholders' Equity (Unaudited) - USD ($) $ in Thousands	Common Stock [Member] ATM [Member]	Common Stock [Member]	Additional Paid-in Capital [Member] ATM [Member]	Additional Paid-in Capital [Member]	Retained Earnings [Member] ATM [Member]	Retained Earnings [Member]	ATM [Member]	Total
Balance (in shares) at Dec. 31, 2022		20,076,773
Balance at Dec. 31, 2022		$ 20		$ 145,476		$ (140,604)		$ 4,892
Sale of common stock, net of issuance costs (in shares)	106,241
Sale of common stock, net of issuance costs	$ 0		$ 231		$ 0		$ 231
Exercise of common stock options (in shares)		199
Exercise of common stock options				0				0
Stock Issued During Period, Shares, Restricted Stock Award, Gross (in shares)		18,792
Share-based compensation				278				278
Net loss						(3,501)	(3,501)	(3,501)
Share-based compensation				278				278
Balance (in shares) at Mar. 31, 2023		20,202,005
Balance at Mar. 31, 2023		$ 20		145,985		(144,105)		1,900
Balance (in shares) at Dec. 31, 2023		23,666,534
Balance at Dec. 31, 2023		$ 24		150,548		(152,175)		(1,603)
Sale of common stock, net of issuance costs (in shares)	1,156,877	2,012,978
Sale of common stock, net of issuance costs	$ 1	$ 2	$ 558	830	$ 0	0	559	832
Share-based compensation		0		204		0		204
Net loss		0		0		(2,267)	$ (2,267)	(2,267)
Share-based compensation		$ 0		204		0		204
Balance (in shares) at Mar. 31, 2024		26,836,389
Balance at Mar. 31, 2024		$ 27		$ 152,140		$ (154,442)		$ (2,275)

v3.24.1.1.u2

Condensed Consolidated Statements of Stockholders' Equity (Unaudited) (Parentheticals) - USD ($) $ in Thousands	3 Months Ended		6 Months Ended
	Mar. 31, 2024	Mar. 31, 2023	Sep. 30, 2022
ATM [Member]
Adjustments to Additional Paid in Capital, Stock Issued, Issuance Costs		$ 32	$ 13
Adjustments to Additional Paid in Capital, Stock Issued, Issuance Costs	$ 43

v3.24.1.1.u2

Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2024	Mar. 31, 2023
Net loss	$ (2,267)	$ (3,501)
Depreciation	19	22
Reduction in the carrying amount of right-of-use assets	87	79
Share-based compensation	204	278
Allowance for doubtful accounts	(24)	0
Accounts receivable	29	48
Prepaid expenses and other current assets	43	20
Accounts payable	155	345
Accrued expenses and other current liabilities	311	226
Deferred revenue	0	(1)
Operating lease liability	(87)	(76)
Net cash used in operating activities	(1,530)	(2,560)
Purchase of property and equipment	0	(10)
Net cash used in investing activities	0	(10)
Proceeds from sales of common stock	1,466	244
Issuance costs of sale of common stock	(90)	(180)
Net cash provided by financing activities	1,376	64
Net change in cash and cash equivalents	(154)	(2,506)
Cash and cash equivalents at beginning of period	1,103	7,363
Cash and cash equivalents at end of period	949	4,857
Unpaid issuance costs of common stock	$ 181	$ 6

v3.24.1.1.u2

Note 1 - Summary of Business and Basis of Presentation	3 Months Ended
	Mar. 31, 2024
Notes to Financial Statements
Business Description and Basis of Presentation [Text Block]	(1) Summary of Business and Basis of Presentation   Description of Business   BioCardia, Inc. (we, us, our, BioCardia or the Company), is a clinical-stage company focused on developing cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases with significant unmet medical needs. We are advancing two cell therapy platforms derived from bone marrow in clinical trials today. Our CardiAMP® autologous mononuclear cell therapy platform is being advanced for two clinical indications: ischemic heart failure with reduced ejection fraction (HFrEF) and refractory angina resulting from chronic myocardial ischemia (CMI). Our allogeneic mesenchymal stem cell (MSC) therapy platform is being advanced as an “off the shelf” cell therapy for two clinical indications: the treatment of ischemic HFrEF and for acute respiratory distress syndrome (ARDS). Our autologous and our allogeneic cell therapies intended for cardiac indications of HFrEF and CMI are enabled by our Helix™ minimally invasive intramyocardial therapeutic delivery platform. We partner this therapeutic delivery platform selectively with others seeking to develop biotherapeutic interventions for local delivery to the heart. To date, we have devoted substantially all our resources to research and development efforts relating to our 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 our intellectual property.   We manage our operations as a single segment for the purposes of assessing performance and making operating decisions.

v3.24.1.1.u2

Note 2 - Significant Accounting Policies	3 Months Ended
	Mar. 31, 2024
Notes to Financial Statements
Significant Accounting Policies [Text Block]	(2) Significant Accounting Policies     (a) Basis of Preparation   The accompanying condensed consolidated balance sheets, statements of operations, stockholders’ equity (deficit), and cash flows as of March 31, 2024, and for the three months ended March 31, 2024 and 2023 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 our financial position as of March 31, 2024, results of operations for the three months ended March 31, 2024 and 2023, and cash flows for the three months ended March 31, 2024 and 2023. The results for the three months ended March 31, 2024 are not necessarily indicative of the results to be expected for the year ended December 31, 2024 or for any other interim period or for any other future year.   These condensed consolidated financial statements should be read in conjunction with the audited financial statements and related notes included in our Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on March 27, 2024.     (b) Liquidity – Going Concern   We have incurred net losses and negative cash flows from operations since our inception and had an accumulated deficit of approximately $154.4 million as of March 31, 2024. Management expects operating losses and negative cash flows to continue through at least the next several years. We expect to incur increasing costs as we advance our trials and development activities. Therefore, absent additional funding, management believes cash and cash equivalents of $949,000 as of March 31, 2024 are not sufficient to fund our planned expenditures and meet our obligations beyond June 2024. These factors raise substantial doubt about our 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.     Our ability to continue as a going concern and to continue further development of our therapeutic candidates beyond June 2024 will require us to raise additional capital. We plan to raise additional capital, potentially including debt and equity arrangements, to finance our 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, we may be required to reduce operating expenses, delay or reduce the scope of our product development programs, obtain funds through arrangements with others that may require us to relinquish rights to certain of our technologies or products that we would otherwise seek to develop or commercialize, 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 clinical accruals, share-based compensation, right-of-use assets and related liabilities, incremental borrowing rate, the useful lives of property and equipment, allowances for doubtful accounts and sales returns, 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, BioCardia Lifesciences, Inc. All intercompany accounts and transactions have been eliminated during the consolidation process.     (e) Concentration of Credit Risk   Financial instruments that potentially subject us to a concentration of credit risk consist of cash and cash equivalents. Our cash at times exceeds federally insured limits of $250,000 per customer. On March 31, 2024, approximately 95% of our cash and cash equivalents were held by one financial institution and total amounts on deposit were $652,000 in excess of FDIC insurance limits. We have not recognized any losses from credit risks on such accounts since inception.     (f) Changes to Significant Accounting Policies   Our significant accounting policies are described in Note 2 of the notes to the consolidated financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on March 27, 2024. There have been no changes to those policies.     (g) 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 our financial statement presentation or disclosures.

v3.24.1.1.u2

Note 3 - Fair Value Measurement	3 Months Ended
	Mar. 31, 2024
Notes to Financial Statements
Fair Value Disclosures [Text Block]	(3) Fair Value Measurement   The fair value of financial instruments reflects the amounts that we estimate to receive in connection with the sale of an asset or paid in connection with the transfer of a liability in an orderly transaction between market participants at the measurement date (exit price). We follow a fair value hierarchy that prioritizes the use of inputs used in valuation techniques into the following three levels:   Level 1 – quoted prices in active markets for identical assets and liabilities.   Level 2 – observable inputs other than quoted prices in active markets for identical assets and liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities.   Level 3 – unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.     The following table sets forth the fair value of our financial assets measured on a recurring basis and indicates the fair value hierarchy utilized to determine such fair value (in thousands):       As of March 31, 2024                                         Level 1     Level 2     Level 3     Total   Assets:                                 Money market funds   $ 2     $ —     $ —     $ 2   Cash in savings account     —       —       —       580   Cash in checking account     —       —       —       367   Total cash and cash equivalents   $ 2     $ —     $ —     $ 949         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 equivalents   $ 2     $ —     $ —     $ 1,103

v3.24.1.1.u2

Note 4 - Property and Equipment, Net	3 Months Ended
	Mar. 31, 2024
Notes to Financial Statements
Property, Plant and Equipment Disclosure [Text Block]	(4) Property and Equipment, Net   Property and equipment, net consisted of the following (in thousands):       March 31,     December 31,       2024     2023   Computer equipment and software   $ 161     $ 161   Laboratory and manufacturing equipment     574       574   Furniture and fixtures     27       27   Leasehold improvements     26       26   Property and equipment, gross     788       788   Less accumulated depreciation     (713 )     (694 ) Property and equipment, net   $ 75     $ 94   Depreciation expense totaled $19,000 and $22,000 for the three months ended March 31, 2024 and 2023, respectively.

v3.24.1.1.u2

Note 5 - Operating Lease Right-of-use Asset, Net	3 Months Ended
	Mar. 31, 2024
Notes to Financial Statements
Lessee, Operating Leases [Text Block]	(5) Operating Lease Right-of-Use (ROU) Asset, Net   We determine if an arrangement is a lease at inception by assessing whether it conveys the right to control the use of an identified asset for a period of time in exchange for consideration. Our operating lease relates to a property lease for its laboratory and corporate offices which expires in January 2027. BioCardia’s lease agreement does not contain any material residual guarantees or material restrictive covenants.   ROU assets and lease liabilities are recognized at the lease commencement date based on the present value of lease payments over the lease term. Our lease does not provide an implicit rate. We used an adjusted historical incremental borrowing rate, based on the information available at the approximate lease commencement date, to determine the present value of lease payments. Variable rent expense is made up of expenses for common area maintenance and shared utilities and were not included in the determination of the present value of lease payments. We have no finance leases.   Our lease expense was $121,000 for each of the three months ended March 31, 2024 and 2023. The cash paid under the operating lease for base rent for the three months ended March 31, 2024 and 2023 was $121,000 and $118,000, respectively. On March 31, 2024, the weighted average remaining lease term was 2.84 years, and the weighted average discount rate was 10.74%.     Future minimum lease payments under the operating lease as of March 31, 2024 were as follows (in thousands):   Remainder of 2024   $ 364   2025     499   2026     514   2027     44   Total undiscounted lease payments     1,421   Less imputed interest     193   Total operating lease liabilities   $ 1,228

v3.24.1.1.u2

Note 6 - Accrued Expenses and Other Current Liabilities	3 Months Ended
	Mar. 31, 2024
Notes to Financial Statements
Accrued Liabilities and Other Current Liabilities Disclosure [Text Block]	(6) Accrued Expenses and Other Current Liabilities   Accrued expenses and other current liabilities consisted of the following (in thousands):                    March 31,     December 31,       2024     2023   Accrued expenses   $ 116     $ 75   Accrued salaries and employee benefits     837       661   Accrued clinical trial costs     1,140       1,017   Grant liability     471       471   Customer deposits     90       90   Payable to related party     42       71   Total   $ 2,696     $ 2,385

v3.24.1.1.u2

Note 7 - Stockholders' Equity	3 Months Ended
	Mar. 31, 2024
Notes to Financial Statements
Equity [Text Block]	(7) Stockholders’ Equity   Warrants - Set forth below is a table of activity of warrants for common stock and the related weighted average exercise price per warrant.       Number of     Weighted       Common Stock     Average       Warrants     Exercise Price   Balance as of December 31, 2023     2,128,429     $ 6.30   Warrants for common stock sold     1,006,488       0.44   Balance as of March 31, 2024     3,134,917     $ 4.42     February 2024 Financing - On February 9, 2024, we entered into a Securities Purchase and Registration Rights Agreement relating to a private placement with certain qualified institutional buyers and institutional accredited investors, which closed on February 13, 2024. Pursuant to the agreement, we sold 2,012,978 shares of our common stock, and warrants to purchase 1,006,488 shares of our common stock at an exercise price equal to $0.4423 per warrant share, subject to certain adjustments, as provided under the terms of the warrant, which are exercisable at any time before February 13, 2026. The gross proceeds of the Offering were $875,000, with associated issuance costs of $43,000.   At-the-Market (ATM) Offerings - On April 12, 2022, we entered into a sales agreement (Cantor Sales Agreement) with Cantor Fitzgerald & Co. (Cantor) as the sales agent, pursuant to which we may offer and sell, from time to time, through Cantor, shares of common stock having an aggregate offering price of up to $10.5 million (ATM Offering). Under the terms of the Cantor Sales Agreement, Cantor was paid a commission of 3% of the aggregate proceeds from the sale of shares and reimbursed certain legal fees. The prospectus supplement expired in conjunction with the expiration of the corresponding registration statement on October 20, 2023. On June 20, 2023, we agreed with Cantor to indefinitely suspend sales under the ATM Offering, and on November 14, 2023, we agreed to terminate the Cantor Sales Agreement.   On December 6, 2023, we entered into an At The Market Offering Agreement (the Sales Agreement) with H.C. Wainwright & Co., LLC (HCW). Under the Sales Agreement, we may offer and sell our common stock, from time to time having an aggregate offering price of up to $2.75 million during the term of the Sales Agreement through or to HCW as sales agent or principal. We have filed a prospectus supplement relating to the offer and sale of the shares pursuant to the Sales Agreement. The offering and sale of the shares will be made pursuant to the Company’s previously filed and effective Registration Statement on Form S-3 (File No. 333-275099), which was initially filed with the Securities and Exchange Commission (the “SEC”) on October 19, 2023 and declared effective on December 5, 2023. We have agreed to pay HCW a commission equal to 3% of the gross proceeds from the sales of shares and have agreed to provide HCW with customary indemnification and contribution rights.     During the three months ended March 31, 2024 and 2023, we sold an aggregate of 1,156,877 and 106,241 shares of common stock under the ATM Offerings at then-market prices for total gross proceeds of $591,000 and $244,000, with associated issuance costs of $32,000 and $13,000, respectively.

v3.24.1.1.u2

Note 8 - Share-based Compensation	3 Months Ended
	Mar. 31, 2024
Notes to Financial Statements
Share-Based Payment Arrangement [Text Block]	(8) Share-Based Compensation   The share-based compensation expense is recorded in research and development, and selling, general and administrative expenses based on the employee's or non-employee’s respective function. No share-based compensation was capitalized during the periods presented. Share-based compensation expense for the three months ended March 31, 2024 and 2023 was recorded as follows (in thousands):       Three months ended       March 31,       2024     2023   Research and development   $ 115     $ 139   Selling, general and administrative     89       139   Total share-based compensation   $ 204     $ 278     The following table summarizes the activity of stock options and related information:       Number of shares     Weighted average exercise price     Weighted average remaining contractual term (years)     Aggregate intrinsic value (in thousands)                                     Balance, December 31, 2023     2,486,767     $ 3.51       6.8     $ 43   Stock options forfeited     (47,657 )     2.26                   Balance, March 31, 2024     2,439,110     $ 3.54       6.6     $ 1   Exercisable, March 31, 2024     1,601,718     $ 4.49       5.6     $ —     Unrecognized share-based compensation for employee and nonemployee options granted through March 31, 2024 is approximately $1.2 million to be recognized over a remaining weighted average service period of 2.1 years.   Share-Based Compensation (RSUs)   There were no RSUs outstanding and hence there is no unrecognized share-based compensation at March 31, 2024 and December 31, 2023.

v3.24.1.1.u2

Note 9 - Net Loss Per Share	3 Months Ended
	Mar. 31, 2024
Notes to Financial Statements
Earnings Per Share [Text Block]	(9) Net Loss per Share   Basic net loss per share is calculated by dividing the net loss by the weighted average number of shares of common stock outstanding and fully vested restricted stock units. Diluted net loss per share is computed by dividing the net loss by the weighted-average number of common share equivalents outstanding for the period determined using the treasury-stock method. Common stock equivalents are comprised of unvested restricted stock units, warrants to purchase common stock and options outstanding under the stock option plans. For all periods presented, there is no difference in the number of shares used to calculate basic and diluted shares outstanding since the effects of potentially dilutive securities are antidilutive due to the net loss position.     The following outstanding common stock equivalents were excluded from the computation of diluted net loss per share for the periods presented because including them would have been antidilutive:        March 31,       2024     2023                     Stock options to purchase common stock     2,439,110       2,168,450   Unvested restricted stock units     —       2,734   Common stock warrants     3,134,917       2,424,724   Total     5,574,027       4,595,908

v3.24.1.1.u2

Note 10 - Income Taxes	3 Months Ended
	Mar. 31, 2024
Notes to Financial Statements
Income Tax Disclosure [Text Block]	(10) Income Taxes   During the three months ended March 31, 2024 and 2023, there was no income tax expense or benefit for federal or state income taxes in the accompanying condensed consolidated statements of operations due to our net loss and a full valuation allowance on the resulting deferred tax assets.   As of March 31, 2024, we retain a full valuation allowance on our deferred tax assets in all jurisdictions. The realization of our deferred tax assets depends primarily on our ability to generate future taxable income which is uncertain. We do not believe that our 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.

v3.24.1.1.u2

Note 11 - Related Party Transactions	3 Months Ended
	Mar. 31, 2024
Notes to Financial Statements
Related Party Transactions Disclosure [Text Block]	(11) Related Party Transactions   On April 9, 2020, we entered into a Litigation Funding Agreement (Funding Agreement) with BSLF, L.L.C. (Funder), an entity owned and controlled by Andrew Blank, Chair of BioCardia’s board of directors, for the purpose of funding our 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). On April 12, 2021, all parties to the Litigation entered into a confidential settlement agreement and all claims were dismissed.   In March 2022, we entered into confidential settlement agreements with our litigation service providers and the Funder to terminate the Funding Agreement and conclude all remaining matters thereunder (the Litigation Funding Settlement). Under the terms of the Litigation Funding Settlement, litigation and corporate counsel provided credits and refunds of legal fees totaling $688,000, which offset the amounts owed to us by the Funder under the Funding Agreement, and provided up to $300,000 in future discounts on legal services. As a result of the Litigation Funding Settlement, we will remit the discounts, as received, to the Funder on a quarterly basis. During the three months ended March 31, 2024 and 2023, we received discounts totaling $110,000 and $33,000, respectively. As of March 31, 2024 and December 31, 2023, we recorded a related party payable for discounts owed to the Funder in accrued expenses and other current liabilities of $42,000 and $71,000, respectively. With the accrual of $42,000 as of March 31, 2024, all of the future potential discounts have been collected on behalf of the Funder.

v3.24.1.1.u2

Note 12 - Contingencies and Uncertainties	3 Months Ended
	Mar. 31, 2024
Notes to Financial Statements
Contingencies Disclosure [Text Block]	(12) Contingencies   We may be subject to various claims, complaints, and legal actions that arise from time to time in the normal course of business. Management is not aware of any current legal or administrative proceedings that are likely to have an adverse effect on our business, financial position, results of operations, or cash flows.

v3.24.1.1.u2

Insider Trading Arrangements	3 Months Ended
	Mar. 31, 2024
Insider Trading Arr Line Items
Material Terms of Trading Arrangement [Text Block]	ITEM 5. OTHER INFORMATION   During the three months ended March 31, 2024, none of our directors or executive officers adopted or terminated any Rule 10b5-1 trading arrangement or any non-Rule 10b5-1 trading arrangement (as such terms are defined in Item 408 of Regulation S-K)
Rule 10b5-1 Arrangement Adopted [Flag]	false
Non-Rule 10b5-1 Arrangement Adopted [Flag]	false
Rule 10b5-1 Arrangement Terminated [Flag]	false
Non-Rule 10b5-1 Arrangement Terminated [Flag]	false

v3.24.1.1.u2

Significant Accounting Policies (Policies)	3 Months Ended
	Mar. 31, 2024
Accounting Policies [Abstract]
Basis of Accounting, Policy [Policy Text Block]	(a) Basis of Preparation   The accompanying condensed consolidated balance sheets, statements of operations, stockholders’ equity (deficit), and cash flows as of March 31, 2024, and for the three months ended March 31, 2024 and 2023 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 our financial position as of March 31, 2024, results of operations for the three months ended March 31, 2024 and 2023, and cash flows for the three months ended March 31, 2024 and 2023. The results for the three months ended March 31, 2024 are not necessarily indicative of the results to be expected for the year ended December 31, 2024 or for any other interim period or for any other future year.   These condensed consolidated financial statements should be read in conjunction with the audited financial statements and related notes included in our Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on March 27, 2024.
Going Concern and Liquidity [Policy Text Block]	(b) Liquidity – Going Concern   We have incurred net losses and negative cash flows from operations since our inception and had an accumulated deficit of approximately $154.4 million as of March 31, 2024. Management expects operating losses and negative cash flows to continue through at least the next several years. We expect to incur increasing costs as we advance our trials and development activities. Therefore, absent additional funding, management believes cash and cash equivalents of $949,000 as of March 31, 2024 are not sufficient to fund our planned expenditures and meet our obligations beyond June 2024. These factors raise substantial doubt about our 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.     Our ability to continue as a going concern and to continue further development of our therapeutic candidates beyond June 2024 will require us to raise additional capital. We plan to raise additional capital, potentially including debt and equity arrangements, to finance our 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, we may be required to reduce operating expenses, delay or reduce the scope of our product development programs, obtain funds through arrangements with others that may require us to relinquish rights to certain of our technologies or products that we would otherwise seek to develop or commercialize, or cease operations.
Use of Estimates, Policy [Policy Text Block]	(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 clinical accruals, share-based compensation, right-of-use assets and related liabilities, incremental borrowing rate, the useful lives of property and equipment, allowances for doubtful accounts and sales returns, and assumptions used for revenue recognition.
Consolidation, Policy [Policy Text Block]	(d) Principles of Consolidation   The condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiary, BioCardia Lifesciences, Inc. All intercompany accounts and transactions have been eliminated during the consolidation process.
Concentration Risk, Credit Risk, Policy [Policy Text Block]	(e) Concentration of Credit Risk   Financial instruments that potentially subject us to a concentration of credit risk consist of cash and cash equivalents. Our cash at times exceeds federally insured limits of $250,000 per customer. On March 31, 2024, approximately 95% of our cash and cash equivalents were held by one financial institution and total amounts on deposit were $652,000 in excess of FDIC insurance limits. We have not recognized any losses from credit risks on such accounts since inception.
Change to Significant Accounting Policies [Policy Text Block]	(f) Changes to Significant Accounting Policies   Our significant accounting policies are described in Note 2 of the notes to the consolidated financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on March 27, 2024. There have been no changes to those policies.
New Accounting Pronouncements, Policy [Policy Text Block]	(g) 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 our financial statement presentation or disclosures.

v3.24.1.1.u2

Note 3 - Fair Value Measurement (Tables)	3 Months Ended
	Mar. 31, 2024
Notes Tables
Schedule of Fair Value, Assets and Liabilities Measured on Recurring Basis [Table Text Block]	As of March 31, 2024                                         Level 1     Level 2     Level 3     Total   Assets:                                 Money market funds   $ 2     $ —     $ —     $ 2   Cash in savings account     —       —       —       580   Cash in checking account     —       —       —       367   Total cash and cash equivalents   $ 2     $ —     $ —     $ 949       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 equivalents   $ 2     $ —     $ —     $ 1,103

v3.24.1.1.u2

Note 4 - Property and Equipment, Net (Tables)	3 Months Ended
	Mar. 31, 2024
Notes Tables
Property, Plant and Equipment [Table Text Block]	March 31,     December 31,       2024     2023   Computer equipment and software   $ 161     $ 161   Laboratory and manufacturing equipment     574       574   Furniture and fixtures     27       27   Leasehold improvements     26       26   Property and equipment, gross     788       788   Less accumulated depreciation     (713 )     (694 ) Property and equipment, net   $ 75     $ 94

v3.24.1.1.u2

Note 5 - Operating Lease Right-of-use Asset, Net (Tables)	3 Months Ended
	Mar. 31, 2024
Notes Tables
Lessee, Operating Lease, Liability, to be Paid, Maturity [Table Text Block]	Remainder of 2024   $ 364   2025     499   2026     514   2027     44   Total undiscounted lease payments     1,421   Less imputed interest     193   Total operating lease liabilities   $ 1,228

v3.24.1.1.u2

Note 6 - Accrued Expenses and Other Current Liabilities (Tables)	3 Months Ended
	Mar. 31, 2024
Notes Tables
Schedule of Accrued Liabilities and Other Current Liabilities [Table Text Block]	March 31,     December 31,       2024     2023   Accrued expenses   $ 116     $ 75   Accrued salaries and employee benefits     837       661   Accrued clinical trial costs     1,140       1,017   Grant liability     471       471   Customer deposits     90       90   Payable to related party     42       71   Total   $ 2,696     $ 2,385

v3.24.1.1.u2

Note 7 - Stockholders' Equity (Tables)	3 Months Ended
	Mar. 31, 2024
Notes Tables
Schedule of Stockholders' Equity Note, Warrants or Rights [Table Text Block]	Number of     Weighted       Common Stock     Average       Warrants     Exercise Price   Balance as of December 31, 2023     2,128,429     $ 6.30   Warrants for common stock sold     1,006,488       0.44   Balance as of March 31, 2024     3,134,917     $ 4.42

v3.24.1.1.u2

Note 8 - Share-based Compensation (Tables)	3 Months Ended
	Mar. 31, 2024
Notes Tables
Schedule of Share-based Compensation, Expense [Table Text Block]	Three months ended       March 31,       2024     2023   Research and development   $ 115     $ 139   Selling, general and administrative     89       139   Total share-based compensation   $ 204     $ 278
Share-Based Payment Arrangement, Option, Activity [Table Text Block]	Number of shares     Weighted average exercise price     Weighted average remaining contractual term (years)     Aggregate intrinsic value (in thousands)                                     Balance, December 31, 2023     2,486,767     $ 3.51       6.8     $ 43   Stock options forfeited     (47,657 )     2.26                   Balance, March 31, 2024     2,439,110     $ 3.54       6.6     $ 1   Exercisable, March 31, 2024     1,601,718     $ 4.49       5.6     $ —

v3.24.1.1.u2

Note 9 - Net Loss Per Share (Tables)	3 Months Ended
	Mar. 31, 2024
Notes Tables
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share [Table Text Block]	March 31,       2024     2023                     Stock options to purchase common stock     2,439,110       2,168,450   Unvested restricted stock units     —       2,734   Common stock warrants     3,134,917       2,424,724   Total     5,574,027       4,595,908

v3.24.1.1.u2

Note 2 - Significant Accounting Policies (Details Textual) - USD ($)	Mar. 31, 2024	Dec. 31, 2023
Retained Earnings (Accumulated Deficit), Total	$ (154,442,000)	$ (152,175,000)
Cash and Cash Equivalents, at Carrying Value, Total	$ 949,000	$ 1,103,000
Cash, Percentage Held in One Financial Institution	95.00%
Cash, Uninsured Amount	$ 652,000

v3.24.1.1.u2

Note 3 - Fair Value Measurement - Fair Value of Assets Measured on a Recurring Basis (Details) - Fair Value, Recurring [Member] - USD ($) $ in Thousands	Mar. 31, 2024	Dec. 31, 2023
Total cash and cash equivalents	$ 949	$ 1,103
Fair Value, Inputs, Level 1 [Member]
Total cash and cash equivalents	2	2
Fair Value, Inputs, Level 2 [Member]
Total cash and cash equivalents	0	0
Fair Value, Inputs, Level 3 [Member]
Total cash and cash equivalents	0	0
Money Market Funds [Member]
Total cash and cash equivalents	2	2
Money Market Funds [Member] | Fair Value, Inputs, Level 1 [Member]
Total cash and cash equivalents	2	2
Money Market Funds [Member] | Fair Value, Inputs, Level 2 [Member]
Total cash and cash equivalents	0	0
Money Market Funds [Member] | Fair Value, Inputs, Level 3 [Member]
Total cash and cash equivalents	0	0
Savings Account [Member]
Total cash and cash equivalents	580	1,072
Savings Account [Member] | Fair Value, Inputs, Level 1 [Member]
Total cash and cash equivalents	0	0
Savings Account [Member] | Fair Value, Inputs, Level 2 [Member]
Total cash and cash equivalents	0	0
Savings Account [Member] | Fair Value, Inputs, Level 3 [Member]
Total cash and cash equivalents	0	0
Demand Deposits [Member]
Total cash and cash equivalents	367	29
Demand Deposits [Member] | Fair Value, Inputs, Level 1 [Member]
Total cash and cash equivalents	0	0
Demand Deposits [Member] | Fair Value, Inputs, Level 2 [Member]
Total cash and cash equivalents	0	0
Demand Deposits [Member] | Fair Value, Inputs, Level 3 [Member]
Total cash and cash equivalents	$ 0	$ 0

v3.24.1.1.u2

Note 4 - Property and Equipment, Net (Details Textual) - USD ($)	3 Months Ended
	Mar. 31, 2024	Mar. 31, 2023
Depreciation	$ 19,000	$ 22,000

v3.24.1.1.u2

Note 4 - Property and Equipment, Net - Summary of Property and Equipment, Net (Details) - USD ($) $ in Thousands	Mar. 31, 2024	Dec. 31, 2023
Property and equipment, gross	$ 788	$ 788
Less accumulated depreciation	(713)	(694)
Property and equipment, net	75	94
Computer Equipment and Software [Member]
Property and equipment, gross	161	161
Laboratory and Manufacturing Equipment [Member]
Property and equipment, gross	574	574
Furniture and Fixtures [Member]
Property and equipment, gross	27	27
Leasehold Improvements [Member]
Property and equipment, gross	$ 26	$ 26

v3.24.1.1.u2

Note 5 - Operating Lease Right-of-use Asset, Net (Details Textual) - USD ($)	3 Months Ended
	Mar. 31, 2024	Mar. 31, 2023
Operating Lease, Expense	$ 121,000	$ 121,000
Operating Lease, Payments	$ 121,000	$ 118,000
Operating Lease, Weighted Average Remaining Lease Term	2 years 10 months 2 days
Operating Lease, Weighted Average Discount Rate, Percent	10.74%

v3.24.1.1.u2

Note 5 - Operating Lease Right-of-use Asset, Net - Future Minimum Lease Payments Under Operating Lease (Details) $ in Thousands	Mar. 31, 2024 USD ($)
Remainder of 2023	$ 364
2025	499
2026	514
2027	44
Total undiscounted lease payments	1,421
Less imputed interest	193
Total operating lease liabilities	$ 1,228

v3.24.1.1.u2

Note 6 - Accrued Expenses and Other Current Liabilities - Summary of Accrued Expenses and Other Current Liabilities (Details) - USD ($) $ in Thousands	Mar. 31, 2024	Dec. 31, 2023
Accrued expenses	$ 116	$ 75
Accrued salaries and employee benefits	837	661
Accrued clinical trial costs	1,140	1,017
Grant liability	471	471
Customer deposits	90	90
Total	2,696	2,385
Related Party [Member]
Payable to related party	$ 42	$ 71

v3.24.1.1.u2

Note 7 - Stockholders' Equity (Details Textual) - USD ($)			3 Months Ended		12 Months Ended
	Feb. 09, 2024	Apr. 12, 2022	Mar. 31, 2024	Mar. 31, 2023	Dec. 31, 2023	Dec. 06, 2023	Sep. 30, 2023	Dec. 31, 2022
Class of Warrant or Right, Exercise Price of Warrants or Rights							$ 4.42	$ 6.3
Payments of Stock Issuance Costs			$ 90,000	$ 180,000
Proceeds from Issuance of Common Stock			$ 1,466,000	$ 244,000
February 2024 Financing [Member]
Stock Issued During Period, Shares, New Issues (in shares)	2,012,978
Class of Warrant or Right, Number of Securities Called by Warrants or Rights	1,006,488
Class of Warrant or Right, Exercise Price of Warrants or Rights	$ 0.4423
Proceeds from Issuance of Common Stock	$ 875,000
Payments of Stock Issuance Costs	$ 43,000
Sales Agreement with Cantor Fitzgerald Co (Cantor) [Member]
Stock Issued During Period, Shares, New Issues (in shares)			1,156,877	106,241
Payments of Stock Issuance Costs			$ 32,000	$ 13,000
Sale of Stock, Aggregate Value, Maximum		$ 10,500,000
Accrued Sales Commission, Current, Percentage		3.00%
Proceeds from Issuance of Common Stock			$ 591,000	$ 244,000
Sales Agreement With H.C. Wainwright & Co., LLC [Member]
Sale of Stock, Aggregate Value, Maximum					$ 2,750,000
Accrued Sales Commission, Current, Percentage						3.00%

v3.24.1.1.u2

Note 7 - Stockholders' Equity - Warrants (Details)	9 Months Ended
	Sep. 30, 2023 $ / shares shares
Balance , number of common stock warrants (in shares) | shares	2,128,429
Balance, weighted average exercise price (in dollars per share) | $ / shares	$ 6.3
Warrants for common stock sold , number of common stock warrants (in shares) | shares	1,006,488
Warrants for common stock sold, weighted average exercise price (in dollars per share) | $ / shares	$ 0.44
Balance , number of common stock warrants (in shares) | shares	3,134,917
Balance as, weighted average exercise price (in dollars per share) | $ / shares	$ 4.42

v3.24.1.1.u2

Note 8 - Share-based Compensation (Details Textual) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2024	Dec. 31, 2023
Restricted Stock Units (RSUs) [Member]
Share-Based Payment Arrangement, Nonvested Award, Excluding Option, Cost Not yet Recognized, Amount	$ 0	$ 0
Employees, Non-employees and Non-employee Directors [Member]
Share-Based Payment Arrangement, Nonvested Award, Option, Cost Not yet Recognized, Amount	$ 1,200
Share-Based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Period for Recognition	2 years 1 month 6 days

v3.24.1.1.u2

Note 8 - Share-based Compensation - Share-based Compensation Expense (Details) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2024	Mar. 31, 2023
Total share-based compensation	$ 204	$ 278
Research and Development Expense [Member]
Total share-based compensation	115	139
Selling, General and Administrative Expenses [Member]
Total share-based compensation	$ 89	$ 139

v3.24.1.1.u2

Note 8 - Share-based Compensation - Stock Option Activity (Details) - USD ($) $ / shares in Units, $ in Thousands	3 Months Ended	9 Months Ended	12 Months Ended
	Mar. 31, 2024	Sep. 30, 2023	Dec. 31, 2022
Balance, number of shares (in shares)		2,486,767
Balance, weighted average exercise price (in dollars per share)		$ 3.51
Balance, weighted average remaining contractual term (Year)	6 years 7 months 6 days		6 years 9 months 18 days
Balance, aggregate intrinsic value	$ 1		$ 43
Stock options granted, number of shares (in shares)		47,657
Stock options granted, weighted average exercise price (in dollars per share)		$ 2.26
Balance, March 31, 2024 (in shares)	2,439,110		2,486,767
Balance, March 31, 2024 (in dollars per share)	$ 3.54		$ 3.51
Exercisable, March 31, 2024 (in shares)	1,601,718
Exercisable, March 31, 2024 (in dollars per share)	$ 4.49
Exercisable, March 31, 2024 (Year)	5 years 7 months 6 days
Exercisable, March 31, 2024	$ 0

v3.24.1.1.u2

Note 9 - Net Loss Per Share - Anti-dilutive Securities (Details) - shares	3 Months Ended
	Mar. 31, 2024	Mar. 31, 2023
Antidilutive securities (in shares)	5,574,027	4,595,908
Share-Based Payment Arrangement, Option [Member]
Antidilutive securities (in shares)	2,439,110	2,168,450
Restricted Stock Units (RSUs) [Member]
Antidilutive securities (in shares)	0	2,734
Warrant [Member]
Antidilutive securities (in shares)	3,134,917	2,424,724

v3.24.1.1.u2

Note 10 - Income Taxes (Details Textual) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2024	Mar. 31, 2023
Income Tax Expense (Benefit)	$ 0	$ 0

v3.24.1.1.u2

Note 11 - Related Party Transactions (Details Textual) - Funding Agreement [Member] - BSLF, L.L.C. [Member] - USD ($)	1 Months Ended		3 Months Ended
	Mar. 31, 2022	Mar. 29, 2022	Mar. 31, 2024	Mar. 31, 2023	Dec. 31, 2023
Legal Fees	$ 688,000
Maximum Discount on Legal Service		$ 300,000
Litigation Service, Expense			$ 110,000	$ 33,000
Other Liabilities, Current			42,000		$ 71,000
Loss Contingency Accrual			$ 42,000

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