Document And Entity Information
Document And Entity Information - shares | 3 Months Ended | |
Mar. 31, 2024 | May 13, 2024 | |
Document Information [Line Items] | ||
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 $0.001 | |
Trading Symbol | BCDA | |
Security Exchange Name | NASDAQ | |
Warrant [Member] | ||
Document Information [Line Items] | ||
Title of 12(b) Security | Warrant to Purchase Common Stock | |
Trading Symbol | BCDAW | |
Security Exchange Name | NASDAQ |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets (Current Period Unaudited) - USD ($) | 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 |
Condensed Consolidated Balanc_2
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 |
Condensed Consolidated Statemen
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 |
Condensed Consolidated Statem_2
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) |
Condensed Consolidated Statem_3
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 |
Condensed Consolidated Statem_4
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 |
Note 1 - Summary of Business an
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. |
Note 2 - Significant Accounting
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. |
Note 3 - Fair Value Measurement
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 |
Note 4 - Property and Equipment
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 |
Note 5 - Operating Lease Right-
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 |
Note 6 - Accrued Expenses and O
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 |
Note 7 - Stockholders' Equity
Note 7 - Stockholders' Equity | 3 Months Ended |
Mar. 31, 2024 | |
Notes to Financial Statements | |
Equity [Text Block] | (7) Stockholders’ Equity Warrants 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 - At-the-Market (ATM) Offerings - 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. |
Note 8 - Share-based Compensati
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 |
Note 9 - Net Loss Per Share
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 |
Note 10 - Income Taxes
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 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. |
Note 11 - Related Party Transac
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. |
Note 12 - Contingencies and Unc
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. |
Insider Trading Arrangements
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 |
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 |
Significant Accounting Policies
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. |
Note 3 - Fair Value Measureme_2
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 |
Note 4 - Property and Equipme_2
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 |
Note 5 - Operating Lease Righ_2
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 |
Note 6 - Accrued Expenses and_2
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 |
Note 7 - Stockholders' Equity (
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 |
Note 8 - Share-based Compensa_2
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 $ — |
Note 9 - Net Loss Per Share (Ta
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 |
Note 2 - Significant Accounti_2
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% | |
Cash, Uninsured Amount | $ 652,000 |
Note 3 - Fair Value Measureme_3
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 |
Note 4 - Property and Equipme_3
Note 4 - Property and Equipment, Net (Details Textual) - USD ($) | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Depreciation | $ 19,000 | $ 22,000 |
Note 4 - Property and Equipme_4
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 |
Note 5 - Operating Lease Righ_3
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% |
Note 5 - Operating Lease Righ_4
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 |
Note 6 - Accrued Expenses and_3
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 |
Note 7 - Stockholders' Equity_2
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% | |||||||
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% |
Note 7 - Stockholders' Equity -
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 |
Note 8 - Share-based Compensa_3
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 |
Note 8 - Share-based Compensa_4
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 |
Note 8 - Share-based Compensa_5
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 |
Note 9 - Net Loss Per Share - A
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 |
Note 10 - Income Taxes (Details
Note 10 - Income Taxes (Details Textual) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Income Tax Expense (Benefit) | $ 0 | $ 0 |
Note 11 - Related Party Trans_2
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 |