Document And Entity Information
Document And Entity Information - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2023 | Mar. 27, 2024 | Jun. 30, 2023 | |
Document Information [Line Items] | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Period End Date | Dec. 31, 2023 | ||
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 Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
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 | ||
ICFR Auditor Attestation Flag | false | ||
Document Financial Statement Error Correction [Flag] | false | ||
Entity Shell Company | false | ||
Entity Public Float | $ 48 | ||
Entity Common Stock, Shares Outstanding (in shares) | 26,732,542 | ||
Auditor Firm ID | 27 | ||
Auditor Name | PKF San Diego, LLP | ||
Auditor Location | San Diego, California | ||
Entity Central Index Key | 0000925741 | ||
Current Fiscal Year End Date | --12-31 | ||
Document Fiscal Year Focus | 2023 | ||
Document Fiscal Period Focus | FY | ||
Amendment Flag | false | ||
Common Stock [Member] | |||
Document Information [Line Items] | |||
Title of 12(b) Security | Common Stock, par value $0.001 | ||
Trading Symbol | BCDA | ||
Security Exchange Name | NASDAQ | ||
Warrant [Member] | |||
Document Information [Line Items] | |||
Title of 12(b) Security | Warrant to Purchase Common Stock | ||
Trading Symbol | BCDAW | ||
Security Exchange Name | NASDAQ |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 1,103 | $ 7,363 |
Accounts receivable, net of allowance for doubtful accounts of $34 and $11 as of December 31, 2023 and 2022 | 63 | 201 |
Prepaid expenses and other current assets | 295 | 300 |
Total current assets | 1,461 | 7,864 |
Property and equipment, net | 94 | 170 |
Operating lease right-of-use asset, net | 1,261 | 1,588 |
Other assets | 171 | 171 |
Total assets | 2,987 | 9,793 |
Current liabilities: | ||
Accounts payable | 890 | 683 |
Accrued expenses and other current liabilities | 2,385 | 2,246 |
Deferred revenue | 0 | 341 |
Operating lease liability - current | 333 | 315 |
Total current liabilities | 3,608 | 3,585 |
Operating lease liability - noncurrent | 982 | 1,316 |
Total liabilities | 4,590 | 4,901 |
Commitments and Contingencies | ||
Stockholders’ equity: | ||
Preferred stock, $0.001 par value, 25,000,000 shares authorized and no shares issued and outstanding as of December 31, 2023 and 2022 | 0 | 0 |
Common stock, $0.001 par value, 100,000,000 shares authorized, 23,666,534 and 20,076,773 shares issued and outstanding as of December 31, 2023 and 2022, respectively | 24 | 20 |
Additional paid-in capital | 150,548 | 145,476 |
Accumulated deficit | (152,175) | (140,604) |
Total stockholders’ equity | (1,603) | 4,892 |
Total liabilities and stockholders’ equity | $ 2,987 | $ 9,793 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parentheticals) - USD ($) | Dec. 31, 2023 | Dec. 31, 2022 |
Accounts Receivable, Allowance for Credit Loss, Current | $ 34,000 | $ 11,000 |
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, Ending Balance (in shares) | 23,666,534 | |
Common Stock, Shares, Issued (in shares) | 20,076,773 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Revenue: | ||
Net product revenue | $ 477 | $ 1,352 |
Costs and expenses: | ||
Research and development | 7,726 | 8,834 |
Selling, general and administrative | 4,395 | 4,419 |
Total costs and expenses | 12,121 | 13,253 |
Operating loss | (11,644) | (11,901) |
Other income (expense): | ||
Total other income (expense), net | 73 | (6) |
Net loss | $ (11,571) | $ (11,907) |
Net loss per share, basic and diluted (in dollars per share) | $ (0.55) | $ (0.67) |
Weighted-average shares used in computing net loss per share, basic and diluted (in shares) | 21,179,974 | 17,720,972 |
Product [Member] | ||
Revenue: | ||
Net product revenue | $ 0 | $ 3 |
Collaboration Agreement [Member] | ||
Revenue: | ||
Net product revenue | $ 477 | $ 1,349 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Stockholders' Equity (Unaudited) - USD ($) $ in Thousands | Common Stock [Member] Restricted Stock Units (RSUs) [Member] Management [Member] | Common Stock [Member] Restricted Stock Units (RSUs) [Member] | Common Stock [Member] ATM [Member] | Common Stock [Member] June 2023 Financing [Member] | Common Stock [Member] November 2023 Financing [Member] | Common Stock [Member] | Additional Paid-in Capital [Member] Restricted Stock Units (RSUs) [Member] Management [Member] | Additional Paid-in Capital [Member] ATM [Member] | Additional Paid-in Capital [Member] June 2023 Financing [Member] | Additional Paid-in Capital [Member] November 2023 Financing [Member] | Additional Paid-in Capital [Member] | Retained Earnings [Member] Restricted Stock Units (RSUs) [Member] Management [Member] | Retained Earnings [Member] ATM [Member] | Retained Earnings [Member] June 2023 Financing [Member] | Retained Earnings [Member] November 2023 Financing [Member] | Retained Earnings [Member] | Restricted Stock Units (RSUs) [Member] Management [Member] | ATM [Member] | June 2023 Financing [Member] | November 2023 Financing [Member] | Total |
Balance (in shares) at Dec. 31, 2021 | 16,871,265 | ||||||||||||||||||||
Balance at Dec. 31, 2021 | $ 17 | $ 139,055 | $ (128,697) | $ 10,375 | |||||||||||||||||
Restricted stock units vested and issued (in shares) | 0 | 371,980 | |||||||||||||||||||
Sale of common stock (in shares) | 711,511 | 2,122,017 | |||||||||||||||||||
Sale of common stock | $ 1 | $ 2 | $ 1,546 | 3,401 | 0 | $ 1,547 | 3,403 | ||||||||||||||
Restricted stock units issued to settle management bonus obligations (in shares) | 0 | 371,980 | |||||||||||||||||||
Restricted stock units issued to settle management bonus obligations | $ 0 | $ 291 | $ 0 | $ 291 | |||||||||||||||||
Share-based compensation | 1,183 | 1,183 | |||||||||||||||||||
Net loss | (11,907) | (11,907) | |||||||||||||||||||
Balance (in shares) at Dec. 31, 2022 | 20,076,773 | ||||||||||||||||||||
Balance at Dec. 31, 2022 | $ 20 | 145,476 | (140,604) | 4,892 | |||||||||||||||||
Restricted stock units vested and issued (in shares) | 0 | 241,197 | |||||||||||||||||||
Sale of common stock (in shares) | 215,224 | 1,133,141 | 2,000,000 | ||||||||||||||||||
Sale of common stock | $ 0 | $ 1 | $ 2 | $ 262 | $ 2,452 | $ 986 | $ 0 | $ 0 | $ 0 | $ 262 | $ 2,453 | $ 988 | |||||||||
Restricted stock units issued to settle management bonus obligations (in shares) | 0 | 241,197 | |||||||||||||||||||
Restricted stock units issued to settle management bonus obligations | $ 0 | $ 342 | $ 0 | $ 342 | |||||||||||||||||
Share-based compensation | 0 | 1,030 | 0 | 1,030 | |||||||||||||||||
Net loss | $ 0 | 0 | (11,571) | $ (11,571) | |||||||||||||||||
Exercise of common stock options (in shares) | 199 | 199 | |||||||||||||||||||
Exercise of common stock options | 0 | 0 | $ 0 | ||||||||||||||||||
Balance (in shares) at Dec. 31, 2023 | 23,666,534 | ||||||||||||||||||||
Balance at Dec. 31, 2023 | $ 24 | $ 150,548 | $ (152,175) | $ (1,603) |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Stockholders' Equity (Unaudited) (Parentheticals) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
ATM [Member] | ||
Issuance costs | $ 179 | $ 256 |
June 2023 Financing [Member] | ||
Issuance costs | 194 | |
November 2023 Financing [Member] | ||
Issuance costs | $ 312 | |
Issuance costs | $ 162 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Operating activities: | ||
Net loss | $ (11,571) | $ (11,907) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation | 84 | 82 |
Reduction in the carrying amount of right-of-use assets | 327 | 295 |
Share-based compensation | 1,030 | 1,183 |
Loss on disposal of property and equipment | (4) | 0 |
Changes in operating assets and liabilities: | ||
Accounts receivable | (138) | 54 |
Prepaid expenses and other current assets | (5) | (163) |
Accounts payable | 184 | 4 |
Accrued expenses and other current liabilities | 482 | 416 |
Deferred revenue | (341) | (506) |
Operating lease liability | (316) | (237) |
Net cash used in operating activities | (9,974) | (10,561) |
Net Cash Provided by (Used in) Investing Activities [Abstract] | ||
Purchase of property and equipment | (12) | (70) |
Net cash used in investing activities | (12) | (70) |
Net Cash Provided by (Used in) Financing Activities [Abstract] | ||
Proceeds from sales of common stock | 4,388 | 5,540 |
Issuance costs of sale of common stock | 662 | 418 |
Net cash provided by financing activities | 3,726 | 5,122 |
Net change in cash and cash equivalents | (6,260) | (5,509) |
Cash and cash equivalents at beginning of year | 7,363 | 12,872 |
Cash and cash equivalents at end of year | 1,103 | 7,363 |
Supplemental disclosure of noncash investing and financing activities: | ||
Unpaid issuance costs of common stock | 195 | 172 |
Issuance of restricted stock units in lieu of cash bonus obligations | $ 564 | $ 401 |
Note 1 - Summary Of Business
Note 1 - Summary Of Business | 12 Months Ended |
Dec. 31, 2023 | |
Notes to Financial Statements | |
Business Description and Basis of Presentation [Text Block] | (1) Summary of Business (a) Organization and 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 | 12 Months Ended |
Dec. 31, 2023 | |
Notes to Financial Statements | |
Significant Accounting Policies [Text Block] | (2) Significant Accounting Policies (a) Basis of Presentation and Consolidation These consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States (U.S. GAAP) and include all adjustments necessary for the fair presentation of our financial position for the periods presented. The consolidated financial statements include the accounts of the Company and its wholly owned subsidiary, BioCardia Lifesciences, Inc. All material intercompany accounts and transactions have been eliminated during the consolidation process. (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 $152.2 million as of December 31, 2023. 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 $1.1 million as of December 31, 2023 are not sufficient to fund our planned expenditures and meet our obligations beyond the second quarter of 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 the second quarter of 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 share-based compensation, the useful lives of property and equipment, right-of-use assets and related liabilities, incremental borrowing rate, allowances for doubtful accounts and sales returns, clinical accruals and assumptions used for revenue recognition. (d) Cash Equivalents The Company classifies all highly liquid investments with an original maturity date of 90 days or less at the date of purchase as cash equivalents. (e) Concentration of Credit Risk Financial instruments that potentially subject the Company 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 December 31, 2023, approximately 99% of our cash and cash equivalents were held by one financial institution and total amounts on deposit were approximately $0.8 million in excess of FDIC insurance limits. We have not recognized any losses from credit risks on such accounts since inception. (f) Accounts Receivable and Allowance for Doubtful Accounts Accounts receivable are recorded at the invoiced amount and do not bear interest. We consider the creditworthiness of our customers but do not require collateral in advance of a sale. Each reporting period, we evaluate the collectability of outstanding receivable balances and record an allowance for doubtful accounts representing an estimate of current expected credit loss. The estimate is based on our historical write-off experience, customer creditworthiness, facts, and circumstances specific to outstanding balances and payment terms. Account balances are charged off against the allowance after all means of collection have been exhausted and the potential for recovery is considered remote. The allowance for doubtful accounts was $34,000 and $11,000 as of December 31, 2023 and 2022, respectively. (g) Property and Equipment, Net Property and equipment, net, are carried at cost less accumulated depreciation. Depreciation is calculated using the straight-line method over the estimated useful lives of the related assets, as described in the table below. Maintenance and repairs are expensed as incurred. When assets are retired or otherwise disposed of, the cost and the related accumulated depreciation and amortization are removed from the accounts and any resulting gain or loss is reflected in the accompanying consolidated statements of operations. Asset Estimated useful lives (in years) Computer equipment and software 3 Laboratory and manufacturing equipment 3 Furniture and fixtures 3 Leasehold improvements 5 or lease term, if shorter (h) Right-of-Use Assets Operating lease right-of-use asset and liabilities We recognize lease liabilities at the applicable lease commencement date based on the present value of the lease payments required to be paid over the lease term. Variable lease payments are expensed as incurred and are not included in the computation of the lease liability. The lease liability discount rate is generally our incremental borrowing rate unless the lessor’s rate implicit in the lease is readily determinable, in which case the lessor’s implicit rate is used. We recognize our ROU assets at the applicable lease commencement date. The ROU asset equals the carrying amount of the related lease liability, adjusted for any lease payments made prior to lease commencement and lease incentives provided by the lessor, if any. We reduce a ROU asset, and the periodic reduction is the difference between the straight-line total lease cost for the period (including reduction of initial direct costs) and the periodic accretion of the lease liability using the effective interest method. Our lease terms may include options to extend or terminate the lease when it is reasonably certain that it will exercise any such options. Operating lease cost for lease payments is recognized on a straight-line basis over the lease term. Our lease contracts often include lease and non-lease components. We have elected the practical expedient offered by the standard to not separate lease from non-lease components and account for them as a single lease component. We have elected not to recognize ROU assets and lease liabilities for leases with a term of twelve months or less. Lease cost for short-term leases is recognized on a straight-line basis over the lease term. (i) Long-lived Assets Impairment assessment of long-lived assets (j) Clinical Trial Accruals As part of the process of preparing its consolidated financial statements, we are required to estimate our expenses resulting from its obligations under contracts with vendors and consultants and clinical site agreements in connection with conducting clinical trials. The financial terms of these contracts are subject to negotiation and may result in payment flows that do not match the periods over which materials or services are provided by the vendor under the contracts. Our objective is to reflect the clinical trial expenses in our consolidated financial statements by matching those expenses with the period in which the services and efforts are expended. Our accounts for these expenses according to the progress of the trial as measured by patient progression and the timing of various aspects of the trial. We make estimates of our accrued expenses as of each balance sheet date in our consolidated financial statements based on the facts and circumstances known at that time. Although, we do not expect our estimates to be materially different from amounts actually incurred, our understanding of the status and timing of services relative to the actual status and timing of services performed may vary and may result in reported amounts that differ from the actual amounts incurred. (k) Revenue Recognition Net product revenue Collaboration agreement revenue In determining the appropriate amount of revenue to be recognized as it fulfills its obligations under each of our agreements, we perform the following steps: (i) identification of the promised goods or services in the contract; (ii) determination of whether the promised goods or services are performance obligations, including whether they are distinct in the context of the contract; (iii) measurement of the transaction price, including the constraint on variable consideration; (iv) allocation of the transaction price to the performance obligations; and (v) recognition of revenue when (or as) we satisfy each performance obligation. As part of the accounting for these arrangements, we must develop assumptions that require judgment to determine the stand-alone selling price for each performance obligation identified in the contract. We use key assumptions to determine the stand-alone selling price, which may include forecasted revenues, development timelines, reimbursement rates for personnel costs, discount rates and probabilities of technical and regulatory success. This evaluation is subjective and requires us to make judgments about the promised goods and services and whether those goods and services are separable from other aspects of the contract. Further, determining the stand-alone selling price for performance obligations requires significant judgment, and when an observable price of a promised good or service is not readily available, we consider relevant assumptions to estimate the stand-alone selling price, including, as applicable, market conditions, development timelines, probabilities of technical and regulatory success, reimbursement rates for personnel costs, forecasted revenues, potential limitations to the selling price of the product and discount rates. We apply judgment in determining whether a combined performance obligation is satisfied at a point in time or over time, and, if over time, concluding upon the appropriate method of measuring progress to be applied for purposes of recognizing revenue. We evaluate the measure of progress each reporting period and, as estimates related to the measure of progress change, related revenue recognition is adjusted accordingly. Changes in our estimated measure of progress are accounted for prospectively as a change in accounting estimate. We recognize collaboration revenue by measuring the progress toward complete satisfaction of the performance obligation using an input measure. We will re-evaluate the estimate of expected costs to satisfy the performance obligation each reporting period and make adjustments for any significant changes. Amounts received prior to satisfying the revenue recognition criteria are recorded as deferred revenue in our consolidated balance sheets. If the related performance obligation is expected to be satisfied within the next twelve Multiple contracts with the same customer - Contract costs - Contract modifications - (l) Product Warranties We provide a standard warranty of serviceability on all our products for the duration of the product’s shelf life, which is two not (m) Research and Development We expense our research and development costs as incurred. Research and development expense include the costs of basic research activities as well as other research, engineering, and technical effort required to develop new products or services or make significant improvement to an existing product or manufacturing process. Research and development costs also include pre-approval regulatory and clinical trial expenses and support costs for collaborative partnering programs wherein we provide biotherapeutic delivery systems and customer training and support for their use in clinical trials and studies. Our research and development costs consist primarily of: • Salaries, benefits and other personnel-related expenses, including share-based compensation; • Fees paid for services provided by clinical research organizations, research institutions, consultants and other outside service providers; • Costs to acquire and manufacture materials used in research and development activities and clinical trials; • Laboratory consumables and supplies; • Facility-related expenses allocated to research and development activities; • Fees to collaborators to license technology; and • Depreciation expense for equipment used for research and development and clinical purposes. (n) Share-Based Compensation We measure and recognize share-based compensation expense for equity awards to employees, directors and consultants based on fair value at the grant date. We use the Black-Scholes-Merton (BSM) option pricing model to calculate fair value of our stock option grants. The compensation cost for restricted stock awards is based on the closing price of our common stock on the date of grant. Share-based compensation expense recognized in the consolidated statements of operations is based on the period the services are performed and recognized as compensation expense on a straight-line basis over the requisite service period. We account for forfeitures as they occur. Measurement of non-employee awards - The measurement of equity-classified non-employee awards is fixed at the grant date, and we may use the expected term to measure non-employee options or elect to use the contractual term as the expected term, on an award-by-award basis. This differs from the guidance in Accounting Standards Codification (ASC) 505-50 that requires the use of the contractual term. We recognize forfeitures of non-employee awards as they occur. The BSM option pricing model requires the input of subjective assumptions, including the risk-free interest rate, the expected volatility in the value of our common stock, dividend yield, and the expected term of the option. These estimates involve inherent uncertainties and the application of management’s judgment. If factors change and different assumptions are used, the share-based compensation expense could be materially different in the future. These assumptions are estimated as follows: Risk-free Interest Rate The risk-free interest rate assumption is based on the zero-coupon U.S. Treasury instruments appropriate for the expected term of the stock option grants. Expected Volatility Beginning in 2022, we base the volatility assumption on our own historical data. Prior to 2022, we had limited historical data of our own to determine expected volatility, and as such, based the volatility assumption on a combined weighted average of our own historical data and that of a selected peer group. The peer group was developed based on companies in the biotechnology and medical device industries whose shares are publicly traded. Expected Term The expected term represents the period of time that options are expected to be outstanding. As we do not have sufficient historical experience for determining the expected term of the stock options awards granted, the expected life is determined using the simplified method, which is an average of the contractual terms of the option and our ordinary vesting period. Dividend Yield We have no history or expectation of paying cash dividends on our common stock, hence dividend yield is zero for all periods presented. (o) Income Taxes We account for income taxes based on the asset and liability method whereby deferred tax asset and liability account balances are determined based on differences between the financial reporting and tax bases of assets, liabilities, operating loss and tax credit carryforwards. We measure deferred tax assets and liabilities using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. A valuation allowance is provided when it is more likely than not that some portion or all of the deferred tax assets will not be realized. In evaluating the ability to recover our deferred income tax assets, we consider all available positive and negative evidence, including our operating results, forecasts of future taxable income, and ongoing tax planning. In the event we were to determine that we would be able to realize our deferred tax assets in the future in excess of their net recorded amount, we would make an adjustment to the valuation allowance, which would reduce the provision for income taxes. Conversely, in the event that all or part of the net deferred tax assets are determined not to be realizable in the future, an adjustment to the valuation allowance would be charged to earnings in the period such determination is made. We recognize and measure benefits for uncertain tax positions using a two-step approach. The first step is to evaluate the tax position taken or expected to be taken in a tax return by determining if the weight of available evidence indicates that it is more likely than not that the tax position will be sustained upon audit, including resolution of any related appeals or litigation processes. For tax positions that are more likely than not to be sustained upon audit, the second step is to measure the tax benefit as the largest amount that is more than 50% likely to be realized upon settlement. Significant judgment is required to evaluate uncertain tax positions. We evaluate our uncertain tax positions quarterly. Evaluations are based upon a number of factors, including the technical merits of the tax position, changes in facts or circumstances, changes in tax law, interactions with tax authorities during the course of audits, and effective settlement of audit issues. Our policy is to recognize interest and penalties related to unrecognized tax benefits as a component of income tax expense in the consolidated statements of operations and accrued interest and penalties within accrued expenses and other current liabilities in the consolidated balance sheets. No such interest and penalties have been recorded to date. (p) Fair Value of Financial Instruments We apply fair value accounting for all financial assets and liabilities and nonfinancial assets and liabilities that are required to be recognized or disclosed at fair value in the consolidated financial statements. We define fair value as the price that would be received from selling an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. Where observable prices or inputs are not available, valuation models are applied. These valuation techniques involve some level of management estimation and judgment, the degree of which is dependent on the price transparency for the instruments or market and the instruments complexity. Our financial assets and liabilities consist principally of cash and cash equivalents, accounts receivable, accounts payable and accrued expenses and other current liabilities. The fair value of our cash equivalents is determined based on quoted prices in active markets for identical assets. Cash in our operating bank accounts represents the difference between cash in the money market accounts and total cash and cash equivalents reported on the consolidated balance sheets. The recorded values of our accounts receivable, accounts payable and accrued expenses and other current liabilities approximate their current fair values due to the relatively short-term nature of these accounts. (q) Net Loss per Share We calculate basic net loss per share by dividing the net loss by the weighted average number of shares of common stock outstanding. 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 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. (r) Recent Accounting Pronouncements Recent accounting pronouncements issued by the Financial Accounting Standards Board, including its Emerging Issues Task Force, and the American Institute of Certified Public Accountants 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 | 12 Months Ended |
Dec. 31, 2023 | |
Notes to Financial Statements | |
Fair Value Disclosures [Text Block] | (3) Fair Value Measurements 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 the financial assets measured on a recurring basis and indicates the fair value hierarchy utilized to determine such fair value (in thousands). As of December 31, 2023 Level 1 Level 2 Level 3 Total Assets: Money market funds $ 2 $ — $ — $ 2 Cash in savings account — — — 1,072 Cash in checking account — — — 29 Total cash and cash equivalent $ 2 $ — $ — $ 1,103 As of December 31, 2022 Level 1 Level 2 Level 3 Total Assets: Money market funds $ 6,893 $ — $ — $ 6,893 Cash in checking account — — — 470 Total cash and cash equivalent $ 6,893 $ — $ — $ 7,363 |
Note 4 - Property and Equipment
Note 4 - Property and Equipment, Net | 12 Months Ended |
Dec. 31, 2023 | |
Notes to Financial Statements | |
Property, Plant and Equipment Disclosure [Text Block] | (4) Property and Equipment, Net Property and equipment, net consisted of the following as December 31, 2023 and 2022 (in thousands): 2023 2022 Computer equipment and software $ 161 $ 161 Laboratory and manufacturing equipment 574 575 Furniture and fixtures 27 27 Leasehold improvements 26 26 Property and equipment, gross 788 789 Less accumulated depreciation (694 ) (619 ) Property and equipment, net $ 94 $ 170 Depreciation expense totaled approximately $84,000 and $82,000 for the years ended December 31, 2023 and 2022, respectively. All of our property and equipment is located in the United States. |
Note 5 - Operating Lease Right-
Note 5 - Operating Lease Right-of-use Asset, Net | 12 Months Ended |
Dec. 31, 2023 | |
Notes to Financial Statements | |
Lessee, Operating Leases [Text Block] | (5) Operating Lease Right-of-Use Assets, 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. The components of lease expense for the years ended December 31, 2023 and 2022 were as follows (in thousands, except years and percentages): 2023 2022 Straight-line rent expense recognized for operating lease $ 482 $ 482 Variable rent expense recognized for operating lease 69 62 Total rent expense $ 551 $ 544 Weighted average remaining lease term (in years) 3.1 4.1 Weighted average discount rate 10.74 % 10.74 % Supplemental cash flow information related to the operating lease for the years ended December 31, 2023 and 2022 was as follows (in thousands): 2023 2022 Cash paid for amounts included in the measurement of lease liabilities $ 315 $ 237 Cash lease expense (imputed interest expense component of net loss) 156 187 Total rent expense $ 471 $ 424 Future minimum lease payments under the operating lease as of December 31, 2023 are as follows (in thousands): 2024 $ 485 2025 499 2026 514 2027 44 Total undiscounted lease payments $ 1,542 Less imputed interest 227 Total operating lease liabilities $ 1,315 |
Note 6 - Collaborative Agreemen
Note 6 - Collaborative Agreements | 12 Months Ended |
Dec. 31, 2023 | |
Notes to Financial Statements | |
Collaborative Arrangement Disclosure [Text Block] | (6) Collaborative Agreements We have entered into various biotherapeutic delivery partnering collaborations related to preclinical and clinical development. These agreements provide support to partners and utilize our enabling biotherapeutic delivery systems, including training and support during clinical and preclinical delivery of biotherapeutics. Under the terms of these agreements, we typically receive fees for services and products, milestone payments, and participation in future therapeutic revenues. We gain access to certain data generated by our partners for use in our own product development efforts and also receive patent rights to biotherapeutic delivery inventions. Revenue from collaborative agreements is recognized in the consolidated statements of operations in the line “Collaboration agreement revenue.” |
Note 7 - Accrued Expenses and O
Note 7 - Accrued Expenses and Other Current Liabilities | 12 Months Ended |
Dec. 31, 2023 | |
Notes to Financial Statements | |
Accrued Liabilities and Other Current Liabilities Disclosure [Text Block] | (7) Accrued Expenses and Other Current Liabilities Accrued expenses and other current liabilities consisted of the following (in thousands): December 31, December 31, 2023 2022 Accrued expenses $ 75 $ 157 Accrued salaries and employee benefits 661 899 Accrued clinical trial costs 1,017 548 Grant liability 471 534 Customer deposits 90 90 Payable to related party 71 18 Total $ 2,385 $ 2,246 |
Note 8 - Stockholders' Equity
Note 8 - Stockholders' Equity | 12 Months Ended |
Dec. 31, 2023 | |
Notes to Financial Statements | |
Equity [Text Block] | (8) Stockholders Equity Warrants Number of Weighted Common Stock Average Warrants Exercise Price Balance, December 31, 2022 2,424,724 $ 6.36 Warrants expired (296,295 ) 6.75 Balance, December 31, 2023 2,128,429 $ 6.30 November 2023 Financing - June 2023 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 years ended December 31, 2023 and 2022, we sold an aggregate of 215,224 and 711,511 shares of common stock under the ATM Offerings at then-market prices for total gross proceeds of $441,000 and $1,803,000, with associated issuance costs of $179,000 and $256,000, respectively. December 2022 - |
Note 9 - Share-based Compensati
Note 9 - Share-based Compensation | 12 Months Ended |
Dec. 31, 2023 | |
Notes to Financial Statements | |
Share-Based Payment Arrangement [Text Block] | (9) Share-Based Compensation BioCardia Lifesciences adopted, and the BioCardia Lifesciences shareholders approved, the 2002 Stock Plan in 2002 (2002 Plan), and the Company assumed the 2002 Plan in the Merger. We have not granted or do not intend to grant any additional awards under the 2002 Plan following the Merger. In 2016, BioCardia Lifesciences adopted, and the BioCardia Lifesciences shareholders approved, the 2016 Equity Incentive Plan (2016 Plan), and the Company assumed the 2016 Plan in the Merger. BioCardia has granted awards, including incentive stock options and non-qualified stock options, under the 2016 Plan following the Merger. Under the 2002 Plan and the 2016 Plan, the number of shares, terms, and vesting periods are determined by the Company’s board of directors or a committee thereof on an option-by-option basis. Options generally vest ratably over service periods of four ten The Company recognizes in the consolidated statements of operations the grant-date fair value of stock options and other equity-based compensation. Share-based compensation expense for the years ended December 31, 2023 and 2022 was recorded as follows (in thousands): Years ended December 31, 2023 2022 Research and development $ 465 $ 528 Selling, general and administrative 565 655 Total share-based compensation $ 1,030 $ 1,183 The following table summarizes activity under our stock option plans, including the 2002 Plan and the 2016 Plan and related information (in thousands, except share and per share amounts and term): Options outstanding Number of shares Weighted average exercise price Weighted average remaining contractual term (years) Aggregate intrinsic value Balance, December 31, 2022 2,182,708 $ 4.04 7.5 $ 343 Stock options granted 708,284 1.39 Stock options exercised (199 ) 1.49 Stock options forfeited (397,677 ) 2.42 Stock options expired (6,349 ) 16.09 Balance, December 31, 2023 2,486,767 $ 3.51 6.8 $ 43 Exercisable, December 31, 2023 1,552,294 $ 4.56 5.5 $ — Options vested and expected to vest 2,486,767 $ 3.51 6.8 $ 43 The aggregate intrinsic value represents the difference between the total pre-tax value (i.e., the difference between the Company’s stock price and the exercise price) of stock options outstanding as of December 31, 2023, based on our common stock closing price of $0.66 per share, which would have been received by the option holders had all their in-the-money options been exercised as of that date. The total intrinsic value of options exercised was $161 and zero Employee, Director and Non-employee Share-Based Compensation During the years ended December 31, 2023 and 2022, we granted stock options to certain employees, non-employee directors and non-employees to purchase 708,284 and 644,853 shares of common stock, respectively. The fair value of each option grant was estimated on the date of the grant using the BSM option pricing model with the following assumptions: Years ended December 31, 2023 2022 Risk-free interest rate 3.7 - 4.9% 1.8 - 3.8% Volatility 110 - 120% 116 - 122% Dividend yield None None Expected term (in years) 6.25 - 10.0 6.25 - 10.0 Unrecognized share-based compensation for employees, non-employee directors and non-employee options granted through December 31, 2023 is approximately $1.4 million to be recognized over a remaining weighted average service period of 2.3 years. Share-Based Compensation (RSUs) During the years ended December 31, 2023 and 2022, respectively, we granted to certain members of management 331,552 and 287,839 restricted stock units, or RSUs in lieu of paying bonuses. The fair value of each RSU is estimated on the closing market price of our common stock on the grant date. The following table summarizes the activity for RSUs during the year ended December 31, 2023: Weighted average grant date Number of fair value shares per share Balance, December 31, 2022 21,526 $ 4.33 RSUs granted 331,552 1.70 RSUs released (241,197 ) 1.93 RSUs forfeited (111,881 ) 1.70 Balance, December 31, 2023 — $ n/a RSUs vested and settled are converted into our common stock on a one-for-one basis. RSUs are generally subject to forfeiture if employment terminates prior to the release of vesting restrictions. The related compensation expense, which is based on the grant date fair value of our common stock multiplied by the number of units granted, is recognized ratably over the period during which the vesting restrictions lapse. Unrecognized share-based compensation for employee and non-employee RSUs granted through December 31, 2023 was $0. |
Note 10 - Concentrations
Note 10 - Concentrations | 12 Months Ended |
Dec. 31, 2023 | |
Notes to Financial Statements | |
Concentration Risk Disclosure [Text Block] | (10) Concentrations Two Four Two three Three |
Note 11 - Net Loss Per Share
Note 11 - Net Loss Per Share | 12 Months Ended |
Dec. 31, 2023 | |
Notes to Financial Statements | |
Earnings Per Share [Text Block] | (11) Net Loss per Share The following table sets forth the computation of the basic and diluted net loss per share for the years ended December 31, 2023 and 2022 (in thousands, except share and per share data): 2023 2022 Net loss $ (11,571 ) $ (11,907 ) Weighted average shares used to compute net loss per share, basic and diluted 21,179,974 17,720,972 Net loss per share, basic and diluted $ (0.55 ) $ (0.67 ) The following weighted-average outstanding common stock equivalents were excluded from the computation of diluted net loss per share for the years presented because including them would have been antidilutive: December 31, 2023 2022 Stock options to purchase common stock 2,486,767 2,182,708 Unvested restricted stock units — 2,734 Common stock warrants 2,128,429 2,424,724 Total 4,615,196 4,610,166 |
Note 12 - Income Taxes
Note 12 - Income Taxes | 12 Months Ended |
Dec. 31, 2023 | |
Notes to Financial Statements | |
Income Tax Disclosure [Text Block] | (12) Income Taxes Our provision for income taxes for the years ended December 31, 2023 and 2022 was $0 for both years. The provision for income taxes differs from the amount which would result by applying the federal statutory income tax rate to pre-tax loss for the years ended December 31, 2023 and 2022. The reconciliation of the provision computed at the federal statutory rate to the Company’s provision (benefit) for income taxes was as follows (in thousands): Years ended December 31, 2023 2022 Tax at federal statutory rate $ (2,430 ) $ (2,500 ) State, net of federal benefit (342 ) (190 ) Research and development credit (267 ) (291 ) Share-based compensation 178 101 Net operating loss expiration 130 — Other 3 — Change in valuation allowance 2,728 2,880 Total provision for income taxes $ — $ — Deferred income taxes reflect the net tax effects of temporary differences between carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes as well as net operating loss and tax credit carryforwards, net of any adjustment for unrecognized tax benefits. The components of the net deferred income tax assets as of December 31, 2023 and 2022 were as follows (in thousands): Years ended December 31, 2023 2022 Accrued compensation $ 147 $ 189 Inventory adjustments 33 24 Depreciation and amortization 13 17 Share-based compensation 806 569 Net operating loss and tax credit carryforwards 32,910 31,499 Research and development capitalization 2,784 1,674 Other 19 12 Gross Deferred Tax Asset 36,712 33,984 Valuation Allowance (36,712 ) (33,984 ) Net deferred tax asset $ — $ — We had approximately $113.5 million and $65.2 million of federal and state net operating loss (NOL) carryforwards, respectively, as of December 31, 2023. For tax reporting purposes, operating loss carryforwards are available to offset future taxable income; such carryforwards expire in varying amounts beginning in 2023 and 2029 for federal and state purposes, respectively, with 2018-2023 federal NOLs having no expiration date. Under current federal and California law, the amounts of and benefits from net operating losses carried forward may be impaired or limited in certain circumstances. Events which may cause limitations in the amount of net operating losses that we may utilize in any one year include, but are not limited to, a cumulative ownership change of more than 50% over a three-year period. Generally, utilization of the net operating loss carryforwards and credits may be subject to a substantial annual limitation due to the ownership change limitations provided by Section 382 of the Code, which discusses limitations on NOL carryforwards and certain built-in losses following ownership changes, and Section 383 of the Code, which discusses, special limitations on certain excess credits, etc., and similar state provisions. Accordingly, our ability to utilize net operating loss carryforwards and tax credit carryforwards may be limited, potentially significantly, as the result of such an “ownership change.” We have not yet performed a comprehensive study to determine if it has undergone any ownership changes. If we are able to potentially utilize our net operating loss carryforwards and tax credit carryforwards, we will perform a comprehensive Section 382 and 383 study to determine what, if any, limitation on its ability to utilize our NOLs exists. As of December 31, 2023, we had federal and state research and development credits of approximately $3.9 million and $2.8 million available to offset future federal and state income taxes, respectively. The federal tax credit carryforward expires beginning in 2029. The state credit carryforwards have no expiration. We do not believe that these assets are realizable on a more likely than not basis; therefore, the net deferred tax assets have been fully offset by a valuation allowance. We did not The aggregate changes in the balance of gross unrecognized tax benefits were as follows (in thousands): Years ended December 31, 2023 2022 Balance, beginning of year $ 1,519 $ 1,368 Additions based on tax positions related to the current year 158 151 Balance, end of year $ 1,677 $ 1,519 Recognition of approximately $1.2 million and $1.1 million of unrecognized tax benefits would impact the effective rate at December 31, 2023 and 2022, respectively, if recognized. Increases in 2023 relate to increased research and development activity. |
Note 13 - Contingencies and Con
Note 13 - Contingencies and Contingencies | 12 Months Ended |
Dec. 31, 2023 | |
Notes to Financial Statements | |
Contingencies Disclosure [Text Block] | (13) Commitments and Contingencies Contingencies |
Note 14 - Grant Funding
Note 14 - Grant Funding | 12 Months Ended |
Dec. 31, 2023 | |
Notes to Financial Statements | |
Grant Funding [Text Block] | (14) Grant Funding In June 2016, we entered into a grant agreement with Maryland Technology Development Corporation (TEDCO). TEDCO was created by the Maryland State Legislature in 1998 to facilitate the transfer and commercialization of technology from Maryland’s research universities and federal labs into the marketplace. TEDCO administers the Maryland Stem Cell Research Fund to promote State funded stem cell research and cures through financial assistance to public and private entities operating within the State. Under the agreement, TEDCO has agreed to provide the Company an amount not to exceed $750,000 to be used solely to finance the costs to conduct the research project entitled “Heart Failure Trial” over a period of three years. As of December 31, 2023, we have received approximately $750,000 under the grant which is accounted for as a reduction to research and development expenses as the related qualifying costs are incurred. Approximately $279,000 of the qualifying costs had been incurred as of December 31, 2023. The remaining $471,000 was recorded as grant liability in accrued expenses and other current liabilities on the consolidated balance sheet at December 31, 2023. The amount is recorded as a liability as the amounts are refundable, should a default by us, as defined in the agreement, occur prior to incurring the qualifying costs. |
Note 15 - Related Party Transac
Note 15 - Related Party Transactions | 12 Months Ended |
Dec. 31, 2023 | |
Notes to Financial Statements | |
Related Party Transactions Disclosure [Text Block] | (15) 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 years ended December 31, 2023 and 2022, we received discounts totaling $179,000 and $79,000, respectively. As of December 31, 2023 and 2022, we recorded a related party payable for discounts owed to the Funder in accrued expenses and other current liabilities of $79,000 and $18,000, respectively. As of December 31 2023, up to $42,000 of future potential discounts are due to the Funder. |
Note 16 - Employee Benefit Plan
Note 16 - Employee Benefit Plans | 12 Months Ended |
Dec. 31, 2023 | |
Notes to Financial Statements | |
Retirement Benefits [Text Block] | (16) Employee Benefit Plans Our U.S. employees are eligible to participate in a retirement and savings plan that qualifies under Section 401(k) of the IRC. Participating employees may contribute up to 75% of their pretax salary, but not more than statutory limits. We made matching contributions of $28,000 and $30,000 during the years ended December 31, 2023 and 2022, respectively. |
Note 17 - Subsequent Events
Note 17 - Subsequent Events | 12 Months Ended |
Dec. 31, 2023 | |
Notes to Financial Statements | |
Subsequent Events [Text Block] | (17) Subsequent Events 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, as well as Peter Altman, our President and Chief Executive Officer. Pursuant to the agreement, we agreed to sell an aggregate of 2,012,978 shares of our common stock, and warrants to purchase an aggregate of 1,006,488 shares of our common stock, including 108,108 and 54,054, respectively, to Dr. Altman. The shares of common stock were sold at an offering price of $0.4331 per share, except that Dr. Altman agreed to pay $0.4625 per share in compliance with Nasdaq rules. The warrants are exercisable at an exercise price equal to $0.4423 per warrant share, subject to certain adjustments, as provided under the terms of the warrant, and will be exercisable at any time before February 13, 2026. The gross proceeds were $875,000, before deducting transaction expenses. |
Insider Trading Arrangements
Insider Trading Arrangements | 12 Months Ended |
Dec. 31, 2023 | |
Insider Trading Arr Line Items | |
Material Terms of Trading Arrangement [Text Block] | ITEM 9B. OTHER INFORMATION Insider Trading Arrangements During the quarter ended December 31, 2023, 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) | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Policies [Abstract] | |
Basis of Accounting, Policy [Policy Text Block] | (a) Basis of Presentation and Consolidation These consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States (U.S. GAAP) and include all adjustments necessary for the fair presentation of our financial position for the periods presented. The consolidated financial statements include the accounts of the Company and its wholly owned subsidiary, BioCardia Lifesciences, Inc. All material intercompany accounts and transactions have been eliminated during the consolidation process. |
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 $152.2 million as of December 31, 2023. 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 $1.1 million as of December 31, 2023 are not sufficient to fund our planned expenditures and meet our obligations beyond the second quarter of 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 the second quarter of 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 share-based compensation, the useful lives of property and equipment, right-of-use assets and related liabilities, incremental borrowing rate, allowances for doubtful accounts and sales returns, clinical accruals and assumptions used for revenue recognition. |
Concentration Risk, Credit Risk, Policy [Policy Text Block] | (e) Concentration of Credit Risk Financial instruments that potentially subject the Company 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 December 31, 2023, approximately 99% of our cash and cash equivalents were held by one financial institution and total amounts on deposit were approximately $0.8 million in excess of FDIC insurance limits. We have not recognized any losses from credit risks on such accounts since inception. |
Accounts Receivable [Policy Text Block] | (f) Accounts Receivable and Allowance for Doubtful Accounts Accounts receivable are recorded at the invoiced amount and do not bear interest. We consider the creditworthiness of our customers but do not require collateral in advance of a sale. Each reporting period, we evaluate the collectability of outstanding receivable balances and record an allowance for doubtful accounts representing an estimate of current expected credit loss. The estimate is based on our historical write-off experience, customer creditworthiness, facts, and circumstances specific to outstanding balances and payment terms. Account balances are charged off against the allowance after all means of collection have been exhausted and the potential for recovery is considered remote. The allowance for doubtful accounts was $34,000 and $11,000 as of December 31, 2023 and 2022, respectively. |
Property, Plant and Equipment, Policy [Policy Text Block] | (g) Property and Equipment, Net Property and equipment, net, are carried at cost less accumulated depreciation. Depreciation is calculated using the straight-line method over the estimated useful lives of the related assets, as described in the table below. Maintenance and repairs are expensed as incurred. When assets are retired or otherwise disposed of, the cost and the related accumulated depreciation and amortization are removed from the accounts and any resulting gain or loss is reflected in the accompanying consolidated statements of operations. Asset Estimated useful lives (in years) Computer equipment and software 3 Laboratory and manufacturing equipment 3 Furniture and fixtures 3 Leasehold improvements 5 or lease term, if shorter |
Lessee, Leases [Policy Text Block] | (h) Right-of-Use Assets Operating lease right-of-use asset and liabilities We recognize lease liabilities at the applicable lease commencement date based on the present value of the lease payments required to be paid over the lease term. Variable lease payments are expensed as incurred and are not included in the computation of the lease liability. The lease liability discount rate is generally our incremental borrowing rate unless the lessor’s rate implicit in the lease is readily determinable, in which case the lessor’s implicit rate is used. We recognize our ROU assets at the applicable lease commencement date. The ROU asset equals the carrying amount of the related lease liability, adjusted for any lease payments made prior to lease commencement and lease incentives provided by the lessor, if any. We reduce a ROU asset, and the periodic reduction is the difference between the straight-line total lease cost for the period (including reduction of initial direct costs) and the periodic accretion of the lease liability using the effective interest method. Our lease terms may include options to extend or terminate the lease when it is reasonably certain that it will exercise any such options. Operating lease cost for lease payments is recognized on a straight-line basis over the lease term. Our lease contracts often include lease and non-lease components. We have elected the practical expedient offered by the standard to not separate lease from non-lease components and account for them as a single lease component. We have elected not to recognize ROU assets and lease liabilities for leases with a term of twelve months or less. Lease cost for short-term leases is recognized on a straight-line basis over the lease term. |
Property, Plant and Equipment, Impairment [Policy Text Block] | (i) Long-lived Assets Impairment assessment of long-lived assets |
Clinical Trial Accruals, Policy [Policy Text Block] | (j) Clinical Trial Accruals As part of the process of preparing its consolidated financial statements, we are required to estimate our expenses resulting from its obligations under contracts with vendors and consultants and clinical site agreements in connection with conducting clinical trials. The financial terms of these contracts are subject to negotiation and may result in payment flows that do not match the periods over which materials or services are provided by the vendor under the contracts. Our objective is to reflect the clinical trial expenses in our consolidated financial statements by matching those expenses with the period in which the services and efforts are expended. Our accounts for these expenses according to the progress of the trial as measured by patient progression and the timing of various aspects of the trial. We make estimates of our accrued expenses as of each balance sheet date in our consolidated financial statements based on the facts and circumstances known at that time. Although, we do not expect our estimates to be materially different from amounts actually incurred, our understanding of the status and timing of services relative to the actual status and timing of services performed may vary and may result in reported amounts that differ from the actual amounts incurred. |
Revenue [Policy Text Block] | (k) Revenue Recognition Net product revenue Collaboration agreement revenue In determining the appropriate amount of revenue to be recognized as it fulfills its obligations under each of our agreements, we perform the following steps: (i) identification of the promised goods or services in the contract; (ii) determination of whether the promised goods or services are performance obligations, including whether they are distinct in the context of the contract; (iii) measurement of the transaction price, including the constraint on variable consideration; (iv) allocation of the transaction price to the performance obligations; and (v) recognition of revenue when (or as) we satisfy each performance obligation. As part of the accounting for these arrangements, we must develop assumptions that require judgment to determine the stand-alone selling price for each performance obligation identified in the contract. We use key assumptions to determine the stand-alone selling price, which may include forecasted revenues, development timelines, reimbursement rates for personnel costs, discount rates and probabilities of technical and regulatory success. This evaluation is subjective and requires us to make judgments about the promised goods and services and whether those goods and services are separable from other aspects of the contract. Further, determining the stand-alone selling price for performance obligations requires significant judgment, and when an observable price of a promised good or service is not readily available, we consider relevant assumptions to estimate the stand-alone selling price, including, as applicable, market conditions, development timelines, probabilities of technical and regulatory success, reimbursement rates for personnel costs, forecasted revenues, potential limitations to the selling price of the product and discount rates. We apply judgment in determining whether a combined performance obligation is satisfied at a point in time or over time, and, if over time, concluding upon the appropriate method of measuring progress to be applied for purposes of recognizing revenue. We evaluate the measure of progress each reporting period and, as estimates related to the measure of progress change, related revenue recognition is adjusted accordingly. Changes in our estimated measure of progress are accounted for prospectively as a change in accounting estimate. We recognize collaboration revenue by measuring the progress toward complete satisfaction of the performance obligation using an input measure. We will re-evaluate the estimate of expected costs to satisfy the performance obligation each reporting period and make adjustments for any significant changes. Amounts received prior to satisfying the revenue recognition criteria are recorded as deferred revenue in our consolidated balance sheets. If the related performance obligation is expected to be satisfied within the next twelve Multiple contracts with the same customer - Contract costs - Contract modifications - |
Standard Product Warranty, Policy [Policy Text Block] | (l) Product Warranties We provide a standard warranty of serviceability on all our products for the duration of the product’s shelf life, which is two not |
Research and Development Expense, Policy [Policy Text Block] | (m) Research and Development We expense our research and development costs as incurred. Research and development expense include the costs of basic research activities as well as other research, engineering, and technical effort required to develop new products or services or make significant improvement to an existing product or manufacturing process. Research and development costs also include pre-approval regulatory and clinical trial expenses and support costs for collaborative partnering programs wherein we provide biotherapeutic delivery systems and customer training and support for their use in clinical trials and studies. Our research and development costs consist primarily of: • Salaries, benefits and other personnel-related expenses, including share-based compensation; • Fees paid for services provided by clinical research organizations, research institutions, consultants and other outside service providers; • Costs to acquire and manufacture materials used in research and development activities and clinical trials; • Laboratory consumables and supplies; • Facility-related expenses allocated to research and development activities; • Fees to collaborators to license technology; and • Depreciation expense for equipment used for research and development and clinical purposes. |
Compensation Related Costs, Policy [Policy Text Block] | (n) Share-Based Compensation We measure and recognize share-based compensation expense for equity awards to employees, directors and consultants based on fair value at the grant date. We use the Black-Scholes-Merton (BSM) option pricing model to calculate fair value of our stock option grants. The compensation cost for restricted stock awards is based on the closing price of our common stock on the date of grant. Share-based compensation expense recognized in the consolidated statements of operations is based on the period the services are performed and recognized as compensation expense on a straight-line basis over the requisite service period. We account for forfeitures as they occur. Measurement of non-employee awards - The measurement of equity-classified non-employee awards is fixed at the grant date, and we may use the expected term to measure non-employee options or elect to use the contractual term as the expected term, on an award-by-award basis. This differs from the guidance in Accounting Standards Codification (ASC) 505-50 that requires the use of the contractual term. We recognize forfeitures of non-employee awards as they occur. The BSM option pricing model requires the input of subjective assumptions, including the risk-free interest rate, the expected volatility in the value of our common stock, dividend yield, and the expected term of the option. These estimates involve inherent uncertainties and the application of management’s judgment. If factors change and different assumptions are used, the share-based compensation expense could be materially different in the future. These assumptions are estimated as follows: Risk-free Interest Rate The risk-free interest rate assumption is based on the zero-coupon U.S. Treasury instruments appropriate for the expected term of the stock option grants. Expected Volatility Beginning in 2022, we base the volatility assumption on our own historical data. Prior to 2022, we had limited historical data of our own to determine expected volatility, and as such, based the volatility assumption on a combined weighted average of our own historical data and that of a selected peer group. The peer group was developed based on companies in the biotechnology and medical device industries whose shares are publicly traded. Expected Term The expected term represents the period of time that options are expected to be outstanding. As we do not have sufficient historical experience for determining the expected term of the stock options awards granted, the expected life is determined using the simplified method, which is an average of the contractual terms of the option and our ordinary vesting period. Dividend Yield We have no history or expectation of paying cash dividends on our common stock, hence dividend yield is zero for all periods presented. |
Income Tax, Policy [Policy Text Block] | (o) Income Taxes We account for income taxes based on the asset and liability method whereby deferred tax asset and liability account balances are determined based on differences between the financial reporting and tax bases of assets, liabilities, operating loss and tax credit carryforwards. We measure deferred tax assets and liabilities using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. A valuation allowance is provided when it is more likely than not that some portion or all of the deferred tax assets will not be realized. In evaluating the ability to recover our deferred income tax assets, we consider all available positive and negative evidence, including our operating results, forecasts of future taxable income, and ongoing tax planning. In the event we were to determine that we would be able to realize our deferred tax assets in the future in excess of their net recorded amount, we would make an adjustment to the valuation allowance, which would reduce the provision for income taxes. Conversely, in the event that all or part of the net deferred tax assets are determined not to be realizable in the future, an adjustment to the valuation allowance would be charged to earnings in the period such determination is made. We recognize and measure benefits for uncertain tax positions using a two-step approach. The first step is to evaluate the tax position taken or expected to be taken in a tax return by determining if the weight of available evidence indicates that it is more likely than not that the tax position will be sustained upon audit, including resolution of any related appeals or litigation processes. For tax positions that are more likely than not to be sustained upon audit, the second step is to measure the tax benefit as the largest amount that is more than 50% likely to be realized upon settlement. Significant judgment is required to evaluate uncertain tax positions. We evaluate our uncertain tax positions quarterly. Evaluations are based upon a number of factors, including the technical merits of the tax position, changes in facts or circumstances, changes in tax law, interactions with tax authorities during the course of audits, and effective settlement of audit issues. Our policy is to recognize interest and penalties related to unrecognized tax benefits as a component of income tax expense in the consolidated statements of operations and accrued interest and penalties within accrued expenses and other current liabilities in the consolidated balance sheets. No such interest and penalties have been recorded to date. |
Fair Value of Financial Instruments, Policy [Policy Text Block] | (p) Fair Value of Financial Instruments We apply fair value accounting for all financial assets and liabilities and nonfinancial assets and liabilities that are required to be recognized or disclosed at fair value in the consolidated financial statements. We define fair value as the price that would be received from selling an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. Where observable prices or inputs are not available, valuation models are applied. These valuation techniques involve some level of management estimation and judgment, the degree of which is dependent on the price transparency for the instruments or market and the instruments complexity. Our financial assets and liabilities consist principally of cash and cash equivalents, accounts receivable, accounts payable and accrued expenses and other current liabilities. The fair value of our cash equivalents is determined based on quoted prices in active markets for identical assets. Cash in our operating bank accounts represents the difference between cash in the money market accounts and total cash and cash equivalents reported on the consolidated balance sheets. The recorded values of our accounts receivable, accounts payable and accrued expenses and other current liabilities approximate their current fair values due to the relatively short-term nature of these accounts. |
Earnings Per Share, Policy [Policy Text Block] | (q) Net Loss per Share We calculate basic net loss per share by dividing the net loss by the weighted average number of shares of common stock outstanding. 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 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. |
New Accounting Pronouncements, Policy [Policy Text Block] | (r) Recent Accounting Pronouncements Recent accounting pronouncements issued by the Financial Accounting Standards Board, including its Emerging Issues Task Force, and the American Institute of Certified Public Accountants did not or are not believed by management to have a material impact on our financial statement presentation or disclosures. |
Note 2 - Significant Accounti_2
Note 2 - Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Notes Tables | |
Property, Plant and Equipment, Useful Life [Table Text Block] | Asset Estimated useful lives (in years) Computer equipment and software 3 Laboratory and manufacturing equipment 3 Furniture and fixtures 3 Leasehold improvements 5 or lease term, if shorter |
Note 3 - Fair Value Measureme_2
Note 3 - Fair Value Measurement (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Notes Tables | |
Schedule of Fair Value, Assets and Liabilities Measured on Recurring Basis [Table Text Block] | As of December 31, 2023 Level 1 Level 2 Level 3 Total Assets: Money market funds $ 2 $ — $ — $ 2 Cash in savings account — — — 1,072 Cash in checking account — — — 29 Total cash and cash equivalent $ 2 $ — $ — $ 1,103 As of December 31, 2022 Level 1 Level 2 Level 3 Total Assets: Money market funds $ 6,893 $ — $ — $ 6,893 Cash in checking account — — — 470 Total cash and cash equivalent $ 6,893 $ — $ — $ 7,363 |
Note 4 - Property and Equipme_2
Note 4 - Property and Equipment, Net (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Notes Tables | |
Property, Plant and Equipment [Table Text Block] | 2023 2022 Computer equipment and software $ 161 $ 161 Laboratory and manufacturing equipment 574 575 Furniture and fixtures 27 27 Leasehold improvements 26 26 Property and equipment, gross 788 789 Less accumulated depreciation (694 ) (619 ) Property and equipment, net $ 94 $ 170 |
Note 5 - Operating Lease Righ_2
Note 5 - Operating Lease Right-of-use Asset, Net (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Notes Tables | |
Lease, Cost [Table Text Block] | 2023 2022 Straight-line rent expense recognized for operating lease $ 482 $ 482 Variable rent expense recognized for operating lease 69 62 Total rent expense $ 551 $ 544 Weighted average remaining lease term (in years) 3.1 4.1 Weighted average discount rate 10.74 % 10.74 % |
Schedule of Operating Leases Cash Flow Information [Table Text Block] | 2023 2022 Cash paid for amounts included in the measurement of lease liabilities $ 315 $ 237 Cash lease expense (imputed interest expense component of net loss) 156 187 Total rent expense $ 471 $ 424 |
Lessee, Operating Lease, Liability, to be Paid, Maturity [Table Text Block] | 2024 $ 485 2025 499 2026 514 2027 44 Total undiscounted lease payments $ 1,542 Less imputed interest 227 Total operating lease liabilities $ 1,315 |
Note 7 - Accrued Expenses and_2
Note 7 - Accrued Expenses and Other Current Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Notes Tables | |
Schedule of Accrued Liabilities and Other Current Liabilities [Table Text Block] | December 31, December 31, 2023 2022 Accrued expenses $ 75 $ 157 Accrued salaries and employee benefits 661 899 Accrued clinical trial costs 1,017 548 Grant liability 471 534 Customer deposits 90 90 Payable to related party 71 18 Total $ 2,385 $ 2,246 |
Note 8 - Stockholders' Equity (
Note 8 - Stockholders' Equity (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Notes Tables | |
Schedule of Stockholders' Equity Note, Warrants or Rights [Table Text Block] | Number of Weighted Common Stock Average Warrants Exercise Price Balance, December 31, 2022 2,424,724 $ 6.36 Warrants expired (296,295 ) 6.75 Balance, December 31, 2023 2,128,429 $ 6.30 |
Note 9 - Share-based Compensa_2
Note 9 - Share-based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Notes Tables | |
Schedule of Share-based Compensation, Expense [Table Text Block] | Years ended December 31, 2023 2022 Research and development $ 465 $ 528 Selling, general and administrative 565 655 Total share-based compensation $ 1,030 $ 1,183 |
Share-Based Payment Arrangement, Option, Activity [Table Text Block] | Options outstanding Number of shares Weighted average exercise price Weighted average remaining contractual term (years) Aggregate intrinsic value Balance, December 31, 2022 2,182,708 $ 4.04 7.5 $ 343 Stock options granted 708,284 1.39 Stock options exercised (199 ) 1.49 Stock options forfeited (397,677 ) 2.42 Stock options expired (6,349 ) 16.09 Balance, December 31, 2023 2,486,767 $ 3.51 6.8 $ 43 Exercisable, December 31, 2023 1,552,294 $ 4.56 5.5 $ — Options vested and expected to vest 2,486,767 $ 3.51 6.8 $ 43 |
Schedule of Share-Based Payment Award, Stock Options, Valuation Assumptions [Table Text Block] | Years ended December 31, 2023 2022 Risk-free interest rate 3.7 - 4.9% 1.8 - 3.8% Volatility 110 - 120% 116 - 122% Dividend yield None None Expected term (in years) 6.25 - 10.0 6.25 - 10.0 |
Schedule of Nonvested Restricted Stock Units Activity [Table Text Block] | Weighted average grant date Number of fair value shares per share Balance, December 31, 2022 21,526 $ 4.33 RSUs granted 331,552 1.70 RSUs released (241,197 ) 1.93 RSUs forfeited (111,881 ) 1.70 Balance, December 31, 2023 — $ n/a |
Note 11 - Net Loss Per Share (T
Note 11 - Net Loss Per Share (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Notes Tables | |
Schedule of Earnings Per Share, Basic and Diluted [Table Text Block] | 2023 2022 Net loss $ (11,571 ) $ (11,907 ) Weighted average shares used to compute net loss per share, basic and diluted 21,179,974 17,720,972 Net loss per share, basic and diluted $ (0.55 ) $ (0.67 ) |
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share [Table Text Block] | December 31, 2023 2022 Stock options to purchase common stock 2,486,767 2,182,708 Unvested restricted stock units — 2,734 Common stock warrants 2,128,429 2,424,724 Total 4,615,196 4,610,166 |
Note 12 - Income Taxes (Tables)
Note 12 - Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Notes Tables | |
Schedule of Effective Income Tax Rate Reconciliation [Table Text Block] | Years ended December 31, 2023 2022 Tax at federal statutory rate $ (2,430 ) $ (2,500 ) State, net of federal benefit (342 ) (190 ) Research and development credit (267 ) (291 ) Share-based compensation 178 101 Net operating loss expiration 130 — Other 3 — Change in valuation allowance 2,728 2,880 Total provision for income taxes $ — $ — |
Schedule of Deferred Tax Assets and Liabilities [Table Text Block] | Years ended December 31, 2023 2022 Accrued compensation $ 147 $ 189 Inventory adjustments 33 24 Depreciation and amortization 13 17 Share-based compensation 806 569 Net operating loss and tax credit carryforwards 32,910 31,499 Research and development capitalization 2,784 1,674 Other 19 12 Gross Deferred Tax Asset 36,712 33,984 Valuation Allowance (36,712 ) (33,984 ) Net deferred tax asset $ — $ — |
Schedule of Unrecognized Tax Benefits Roll Forward [Table Text Block] | Years ended December 31, 2023 2022 Balance, beginning of year $ 1,519 $ 1,368 Additions based on tax positions related to the current year 158 151 Balance, end of year $ 1,677 $ 1,519 |
Note 2 - Significant Accounti_3
Note 2 - Significant Accounting Policies 1 (Details Textual) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Retained Earnings (Accumulated Deficit), Total | $ (152,175,000) | $ (140,604,000) |
Cash and Cash Equivalents, at Carrying Value, Total | 1,103,000 | 7,363,000 |
Cash, Uninsured Amount | 800,000 | |
Accounts Receivable, Allowance for Credit Loss, Current | 34,000 | 11,000 |
Revenue, Remaining Performance Obligation, Amount | $ 0 | 341,000 |
Standard Product Warranty, Term (Year) | 2 years | |
Standard Product Warranty Accrual, Ending Balance | $ 0 | $ 0 |
Note 2 - Significant Accounti_4
Note 2 - Significant Accounting Policies 2 (Details Textual) | Dec. 31, 2023 |
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date [Axis]: 2023-01-01 | |
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Period | 12 months |
Note 2 - Significant Accounti_5
Note 2 - Significant Accounting Policies - Estimated Useful Lives of Property and Equipment (Details) | Dec. 31, 2023 |
Computer Equipment and Software [Member] | |
Property, plant and equipment useful life (Year) | 3 years |
Laboratory and Manufacturing Equipment [Member] | |
Property, plant and equipment useful life (Year) | 3 years |
Furniture and Fixtures [Member] | |
Property, plant and equipment useful life (Year) | 3 years |
Leasehold Improvements [Member] | |
Property, plant and equipment useful life (Year) | 5 years |
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 | Dec. 31, 2023 | Dec. 31, 2022 |
Money market funds | $ 1,103 | $ 7,363 |
Money market funds | 1,103 | 7,363 |
Fair Value, Inputs, Level 1 [Member] | ||
Money market funds | 2 | 6,893 |
Money market funds | 2 | 6,893 |
Fair Value, Inputs, Level 2 [Member] | ||
Money market funds | 0 | 0 |
Money market funds | 0 | 0 |
Fair Value, Inputs, Level 3 [Member] | ||
Money market funds | 0 | 0 |
Money market funds | 0 | 0 |
Money Market Funds [Member] | ||
Money market funds | 2 | 6,893 |
Money market funds | 2 | 6,893 |
Money Market Funds [Member] | Fair Value, Inputs, Level 1 [Member] | ||
Money market funds | 2 | 6,893 |
Money market funds | 2 | 6,893 |
Money Market Funds [Member] | Fair Value, Inputs, Level 2 [Member] | ||
Money market funds | 0 | 0 |
Money market funds | 0 | 0 |
Money Market Funds [Member] | Fair Value, Inputs, Level 3 [Member] | ||
Money market funds | 0 | 0 |
Money market funds | 0 | 0 |
Demand Deposits [Member] | ||
Money market funds | 29 | 45 |
Money market funds | 29 | 45 |
Demand Deposits [Member] | Fair Value, Inputs, Level 1 [Member] | ||
Money market funds | 0 | 0 |
Money market funds | 0 | 0 |
Demand Deposits [Member] | Fair Value, Inputs, Level 2 [Member] | ||
Money market funds | 0 | 0 |
Money market funds | 0 | 0 |
Demand Deposits [Member] | Fair Value, Inputs, Level 3 [Member] | ||
Money market funds | 0 | 0 |
Money market funds | 0 | $ 0 |
Savings Account [Member] | ||
Money market funds | 1,072 | |
Money market funds | 1,072 | |
Savings Account [Member] | Fair Value, Inputs, Level 1 [Member] | ||
Money market funds | 0 | |
Money market funds | 0 | |
Savings Account [Member] | Fair Value, Inputs, Level 2 [Member] | ||
Money market funds | 0 | |
Money market funds | 0 | |
Savings Account [Member] | Fair Value, Inputs, Level 3 [Member] | ||
Money market funds | 0 | |
Money market funds | $ 0 |
Note 4 - Property and Equipme_3
Note 4 - Property and Equipment, Net (Details Textual) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Depreciation | $ 84,000 | $ 82,000 |
Note 4 - Property and Equipme_4
Note 4 - Property and Equipment, Net - Summary of Property and Equipment, Net (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Property and equipment, gross | $ 788 | $ 789 |
Less accumulated depreciation | (694) | (619) |
Property and equipment, net | 94 | 170 |
Computer Equipment and Software [Member] | ||
Property and equipment, gross | 161 | 161 |
Laboratory and Manufacturing Equipment [Member] | ||
Property and equipment, gross | 574 | 575 |
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 - Impact of New Lease Standard (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Straight-line rent expense recognized for operating lease | $ 482 | $ 482 |
Variable rent expense recognized for operating lease | 69 | 62 |
Total rent expense | $ 551 | $ 544 |
Weighted average remaining lease term (in years) (Year) | 3 years 1 month 6 days | 4 years 1 month 6 days |
Weighted average discount rate | 10.74% | 10.74% |
Note 5 - Operating Lease Righ_4
Note 5 - Operating Lease Right-of-use Asset, Net - Supplement Cash Flow Information (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Cash paid for amounts included in the measurement of lease liabilities | $ 315 | $ 237 |
Cash lease expense (imputed interest expense component of net income) | 156 | 187 |
Total rent expense | $ 471 | $ 424 |
Note 5 - Operating Lease Righ_5
Note 5 - Operating Lease Right-of-use Asset, Net - Future Minimum Lease Payments Under Operating Lease (Details) $ in Thousands | Dec. 31, 2023 USD ($) |
2024 | $ 485 |
2025 | 499 |
2026 | 514 |
2027 | 44 |
Total undiscounted lease payments | 1,542 |
Less imputed interest | 227 |
Total operating lease liabilities | $ 1,315 |
Note 7 - Accrued Expenses and_3
Note 7 - Accrued Expenses and Other Current Liabilities - Summary of Accrued Expenses and Other Current Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Accrued expenses | $ 75 | $ 157 |
Accrued salaries and employee benefits | 661 | 899 |
Accrued clinical trial costs | 1,017 | 548 |
Grant liability | 471 | 534 |
Customer deposits | 90 | 90 |
Total | 2,385 | 2,246 |
Related Party [Member] | ||
Payable to related party | $ 71 | $ 18 |
Note 8 - Stockholders' Equity_2
Note 8 - Stockholders' Equity (Details Textual) - USD ($) | 12 Months Ended | ||||||
Nov. 16, 2023 | Jun. 21, 2023 | Dec. 16, 2022 | Apr. 12, 2022 | Dec. 31, 2023 | Dec. 31, 2022 | Dec. 06, 2023 | |
Proceeds from Issuance of Common Stock | $ 4,388,000 | $ 5,540,000 | |||||
Payments of Stock Issuance Costs | $ 662,000 | $ 418,000 | |||||
November 2023 Financing [Member] | |||||||
Stock Issued During Period, Shares, New Issues (in shares) | 2,000,000 | ||||||
Shares Issued, Price Per Share (in dollars per share) | $ 0.65 | ||||||
Proceeds from Issuance of Common Stock | $ 1,300,000 | ||||||
Payments of Stock Issuance Costs | $ 312,000 | ||||||
June 2023 Financing [Member] | |||||||
Stock Issued During Period, Shares, New Issues (in shares) | 1,133,141 | ||||||
Shares Issued, Price Per Share (in dollars per share) | $ 2.336 | ||||||
Proceeds from Issuance of Common Stock | $ 2,600,000 | ||||||
Payments of Stock Issuance Costs | $ 194,000 | ||||||
June 2023 Financing [Member] | Company’s Directors and Executive Officers [Member] | |||||||
Stock Issued During Period, Shares, New Issues (in shares) | 203,337 | ||||||
Sales Agreement with Cantor Fitzgerald Co (Cantor) [Member] | |||||||
Stock Issued During Period, Shares, New Issues (in shares) | 215,224 | 711,511 | |||||
Proceeds from Issuance of Common Stock | $ 441,000 | $ 1,803,000 | |||||
Payments of Stock Issuance Costs | 179,000 | $ 256,000 | |||||
Sale of Stock, Aggregate Value, Maximum | $ 10,500,000 | ||||||
Accrued Sales Commission, Current, Percentage | 3% | ||||||
Sales Agreement With H.C. Wainwright & Co., LLC [Member] | |||||||
Sale of Stock, Aggregate Value, Maximum | $ 2,750,000 | ||||||
Accrued Sales Commission, Current, Percentage | 3% | ||||||
Private Placement [Member] | Qualified Institutional Buyers and Institutional Accredited Investors [Member] | |||||||
Stock Issued During Period, Shares, New Issues (in shares) | 2,122,017 | ||||||
Shares Issued, Price Per Share (in dollars per share) | $ 1.68 | ||||||
Proceeds from Issuance of Common Stock | $ 3,400,000 | ||||||
Payments of Stock Issuance Costs | $ 162,000 | ||||||
Private Placement [Member] | Company’s Directors and Executive Officers [Member] | |||||||
Stock Issued During Period, Shares, New Issues (in shares) | 499,997 |
Note 8 - Stockholders' Equity -
Note 8 - Stockholders' Equity - Warrants (Details) | 12 Months Ended |
Dec. 31, 2023 $ / shares shares | |
Balance, December 31, 2021 (in shares) | shares | 2,424,724 |
Balance, December 31, 2021 (in dollars per share) | $ / shares | $ 6.36 |
Warrants for common stock sold (in shares) | shares | (296,295) |
Warrants for common stock sold (in dollars per share) | $ / shares | $ 6.75 |
Balance, December 31, 2022 (in shares) | shares | 2,128,429 |
Balance, December 31, 2022 (in dollars per share) | $ / shares | $ 6.3 |
Note 9 - Share-based Compensa_3
Note 9 - Share-based Compensation (Details Textual) - USD ($) | 12 Months Ended | ||
Jan. 01, 2022 | Dec. 31, 2023 | Dec. 31, 2022 | |
Share Price | $ 0.66 | ||
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Exercises in Period, Intrinsic Value | $ 161 | $ 0 | |
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Grants in Period, Weighted Average Grant Date Fair Value | $ 1.18 | $ 1.37 | |
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Grants in Period, Gross | 708,284 | ||
Employees, Non-employees and Non-employee Directors [Member] | |||
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Grants in Period, Gross | 708,284 | 644,853 | |
Share-Based Payment Arrangement, Nonvested Award, Option, Cost Not yet Recognized, Amount | $ 1,400,000 | ||
Share-Based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Period for Recognition | 2 years 3 months 18 days | ||
The 2016 Plan [Member] | |||
Annual Increase, Percentage of Common Shares Outstanding | 4% | ||
Annual Increase, Number of Common Shares | 1,000,000 | ||
Share-Based Payment Arrangement, Option [Member] | |||
Share-Based Compensation Arrangement by Share-Based Payment Award, Award Vesting Period | 4 years | ||
Share-Based Compensation Arrangement by Share-Based Payment Award, Expiration Period | 10 years | ||
Share-Based Payment Arrangement, Option [Member] | The 2016 Plan [Member] | |||
Share-Based Compensation Arrangement by Share-Based Payment Award, Number of Shares Authorized | 361,064 | ||
Restricted Stock Units (RSUs) [Member] | |||
Share-Based Compensation Arrangement by Share-Based Payment Award, Equity Instruments Other than Options, Grants in Period | 331,552 | ||
Share-Based Payment Arrangement, Nonvested Award, Excluding Option, Cost Not yet Recognized, Amount | $ 0 | ||
Restricted Stock Units (RSUs) [Member] | Management [Member] | |||
Share-Based Compensation Arrangement by Share-Based Payment Award, Equity Instruments Other than Options, Grants in Period | 331,552 | 287,839 |
Note 9 - Share-based Compensa_4
Note 9 - Share-based Compensation - Share-based Compensation Expense (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Research and development | $ 1,030 | $ 1,183 |
Research and Development Expense [Member] | ||
Research and development | 465 | 528 |
Selling, General and Administrative Expenses [Member] | ||
Research and development | $ 565 | $ 655 |
Note 9 - Share-based Compensa_5
Note 9 - Share-based Compensation - Stock Option Activity (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Stock options outstanding, beginning of period (in shares) | 2,182,708 | ||
Balance, weighted average exercise price, beginning of period (in dollars per share) | $ 4.04 | ||
Stock options outstanding, weighted average remaining contractual term (Year) | 6 years 9 months 18 days | 7 years 6 months | |
Stock options outstanding, aggregate intrinsic value | $ 43 | $ 343 | |
Stock options granted (in shares) | 708,284 | ||
Stock options granted, weighted average exercise price (in dollars per share) | $ 1.39 | ||
Stock options exercised (in shares) | (199) | ||
Stock options exercised, weighted average exercise price (in dollars per share) | $ 1.49 | ||
Stock options forfeited (in shares) | (397,677) | ||
Stock options forfeited, weighted average exercise price (in dollars per share) | $ 2.42 | ||
Stock options expired (in shares) | (6,349) | ||
Stock options expired, weighted average exercise price (in dollars per share) | $ 16.09 | ||
Stock options outstanding, end of period (in shares) | 2,486,767 | ||
Balance, weighted average exercise price, end of period (in dollars per share) | $ 3.51 | ||
Exercisable, December 31, 2022 (in shares) | 1,552,294 | ||
Options exercisable, weighted average exercise price (in dollars per share) | $ 4.56 | ||
Options exercisable, weighted average remaining contractual term (Year) | 5 years 6 months | ||
Options exercisable, aggregate intrinsic value | $ 0 | ||
Options vested and expected to vest (in shares) | 2,486,767 | ||
Options vested and expected to vest, weighted average exercise price (in dollars per share) | $ 3.51 | ||
Options vested and expected to vest, weighted average remaining contractual term (Year) | 6 years 9 months 18 days | ||
Options vested and expected to vest, aggregate intrinsic value | $ 43 |
Note 9 - Share-based Compensa_6
Note 9 - Share-based Compensation - Valuation Assumptions for Employee Stock Options (Details) - Share-Based Payment Arrangement, Option [Member] | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Minimum [Member] | ||
Risk-free interest rate | 3.70% | 1.80% |
Volatility | 110% | 116% |
Expected term (in years) (Year) | 6 years 3 months | 6 years 3 months |
Maximum [Member] | ||
Risk-free interest rate | 4.90% | 3.80% |
Volatility | 120% | 122% |
Expected term (in years) (Year) | 10 years | 10 years |
Note 9 - Share-based Compensa_7
Note 9 - Share-based Compensation - Summary of Non-vested RSUs (Details) - Restricted Stock Units (RSUs) [Member] | 12 Months Ended |
Dec. 31, 2023 $ / shares shares | |
Balance, shares (in shares) | 21,526 |
Balance, weighted average grant date fair value per share (in dollars per share) | $ / shares | $ 4.33 |
RSUs granted, shares (in shares) | 331,552 |
RSUs granted, weighted average grant date fair value per share (in dollars per share) | $ / shares | $ 1.7 |
RSUs released, shares (in shares) | (241,197) |
RSUs released, weighted average grant date fair value per share (in dollars per share) | $ / shares | $ 1.93 |
RSUs forfeited, shares (in shares) | (111,881) |
RSUs forfeited, weighted average grant date fair value per share (in dollars per share) | $ / shares | $ 1.7 |
Balance, shares (in shares) | 0 |
Note 10 - Concentrations (Detai
Note 10 - Concentrations (Details Textual) - Customer Concentration Risk [Member] | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Revenue Benchmark [Member] | ||
Number of Customers | 2 | 4 |
Revenue Benchmark [Member] | Customer One [Member] | ||
Concentration Risk, Percentage | 71% | 44% |
Revenue Benchmark [Member] | Customer Two [Member] | ||
Concentration Risk, Percentage | 21% | 27% |
Revenue Benchmark [Member] | Customer Three [Member] | ||
Concentration Risk, Percentage | 12% | |
Revenue Benchmark [Member] | Customer Four [Member] | ||
Concentration Risk, Percentage | 12% | |
Revenue Benchmark [Member] | Three Customers Each [Member] | ||
Number of Customers | 3 | |
Concentration Risk, Percentage | 10% | |
Accounts Receivable [Member] | ||
Number of Customers | 3 | |
Accounts Receivable [Member] | Customer One [Member] | ||
Concentration Risk, Percentage | 58% | 39% |
Accounts Receivable [Member] | Customer Two [Member] | ||
Concentration Risk, Percentage | 11% | 11% |
Accounts Receivable [Member] | Customer Three [Member] | ||
Concentration Risk, Percentage | 10% | |
Accounts Receivable [Member] | Two Customers [Member] | ||
Number of Customers | 2 |
Note 11 - Net Loss Per Share -
Note 11 - Net Loss Per Share - Basic and Diluted Net Income (Loss) Per Share (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Net loss | $ (11,571) | $ (11,907) |
Weighted-average shares used in computing net loss per share, basic and diluted (in shares) | 21,179,974 | 17,720,972 |
Net loss per share, basic and diluted (in dollars per share) | $ (0.55) | $ (0.67) |
Note 11 - Net Loss Per Share _2
Note 11 - Net Loss Per Share - Anti-dilutive Securities (Details) - shares | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Stock options to purchase common stock (in shares) | 4,615,196 | 4,610,166 |
Share-Based Payment Arrangement, Option [Member] | ||
Stock options to purchase common stock (in shares) | 2,486,767 | 2,182,708 |
Restricted Stock Units (RSUs) [Member] | ||
Stock options to purchase common stock (in shares) | 0 | 2,734 |
Warrant [Member] | ||
Stock options to purchase common stock (in shares) | 2,128,429 | 2,424,724 |
Note 12 - Income Taxes (Details
Note 12 - Income Taxes (Details Textual) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Income Tax Expense (Benefit) | $ 0 | $ 0 |
Deferred Tax Liabilities, Net, Total | 0 | 0 |
Valuation Allowance, Deferred Tax Asset, Increase (Decrease), Amount | 2,700 | 2,900 |
Unrecognized Tax Benefits that Would Impact Effective Tax Rate | 1,200 | $ 1,100 |
Domestic Tax Authority [Member] | Internal Revenue Service (IRS) [Member] | ||
Operating Loss Carryforwards | 113,500 | |
Domestic Tax Authority [Member] | Internal Revenue Service (IRS) [Member] | Research Tax Credit Carryforward [Member] | ||
Tax Credit Carryforward, Amount | 3,900 | |
State and Local Jurisdiction [Member] | ||
Operating Loss Carryforwards | 65,200 | |
State and Local Jurisdiction [Member] | Research Tax Credit Carryforward [Member] | ||
Tax Credit Carryforward, Amount | $ 2,800 |
Note 12 - Income Taxes - Effect
Note 12 - Income Taxes - Effective Income Tax Reconciliation (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Tax at federal statutory rate | $ (2,430) | $ (2,500) |
State, net of federal benefit | (342) | (190) |
Research and development credit | (267) | (291) |
Share-based compensation | 178 | 101 |
Net operating loss expiration | (130) | 0 |
Other | 3 | 0 |
Change in valuation allowance | 2,728 | 2,880 |
Total provision for income taxes | $ 0 | $ 0 |
Note 12 - Income Taxes - Compon
Note 12 - Income Taxes - Components of the Net Deferred Income Tax Assets (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Accrued compensation | $ 147 | $ 189 |
Inventory adjustments | 33 | 24 |
Depreciation and amortization | 13 | 17 |
Share-based compensation | 806 | 569 |
Net operating loss and tax credit carryforwards | 32,910 | 31,499 |
Research and development capitalization | 2,784 | 1,674 |
Other | 19 | 12 |
Gross Deferred Tax Asset | 36,712 | 33,984 |
Valuation Allowance | (36,712) | (33,984) |
Net deferred tax asset | $ 0 | $ 0 |
Note 12 - Income Taxes - Aggreg
Note 12 - Income Taxes - Aggregate Changes in the Balance of Gross Unrecognized Tax Benefits (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Balance, beginning of year | $ 1,519 | $ 1,368 |
Additions based on tax positions related to the current year | 158 | 151 |
Balance, end of year | $ 1,677 | $ 1,519 |
Note 14 - Grant Funding (Detail
Note 14 - Grant Funding (Details Textual) - Grant Agreement [Member] - TEDCO [Member] - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Jun. 30, 2016 | |
Grant Funding Available | $ 750,000 | |
Proceeds from Grant Funding | $ 750,000 | |
Research and Development Expense Reduction from Qualified Grant Funding | 279,000 | |
Deferred Revenue from Grants, Current | $ 471,000 |
Note 15 - Related Party Trans_2
Note 15 - Related Party Transactions (Details Textual) - BSLF, L.L.C. [Member] - Funding Agreement [Member] - USD ($) | 1 Months Ended | 12 Months Ended | |
Mar. 29, 2022 | Dec. 31, 2023 | Dec. 31, 2022 | |
Legal Fees | $ 688,000 | ||
Maximum Discount on Legal Service | $ 300,000 | $ 42,000 | |
Litigation Service, Expense | 179,000 | $ 79,000 | |
Other Liabilities, Current | $ 79,000 | $ 18,000 |
Note 16 - Employee Benefit Pl_2
Note 16 - Employee Benefit Plans (Details Textual) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Defined Contribution Plan, Maximum Annual Contributions Per Employee, Percent | 75% | |
Defined Contribution Plan, Employer Discretionary Contribution Amount | $ 28,000 | $ 30,000 |
Note 17 - Subsequent Events (De
Note 17 - Subsequent Events (Details Textual) - USD ($) | Feb. 09, 2024 | Dec. 31, 2023 | Dec. 31, 2022 |
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 6.3 | $ 6.36 | |
Subsequent Event [Member] | Warrants Issued in Private Placement [Member] | |||
Stock and Warrants Issued During Period, Value, Preferred Stock and Warrants (in shares) | 1,006,488 | ||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 0.4423 | ||
Subsequent Event [Member] | Warrants Issued in Private Placement [Member] | President and Chief Executive Officer [Member] | |||
Stock and Warrants Issued During Period, Value, Preferred Stock and Warrants (in shares) | 54,054 | ||
Securities Purchase and Registration Rights Agreement [Member] | Subsequent Event [Member] | |||
Stock Issued During Period, Shares, New Issues (in shares) | 2,012,978 | ||
Shares Issued, Price Per Share (in dollars per share) | $ 0.4331 | ||
Proceeds from Issuance of Common Stock | $ 875,000 | ||
Securities Purchase and Registration Rights Agreement [Member] | Subsequent Event [Member] | President and Chief Executive Officer [Member] | |||
Stock Issued During Period, Shares, New Issues (in shares) | 108,108 | ||
Shares Issued, Price Per Share (in dollars per share) | $ 0.4625 |