Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2024 | May 06, 2024 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Quarterly Report | true | |
Document Period End Date | Mar. 31, 2024 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2024 | |
Document Fiscal Period Focus | Q1 | |
Document Transition Report | false | |
Entity File Number | 001-35312 | |
Entity Registrant Name | NUWELLIS, INC. | |
Entity Central Index Key | 0001506492 | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 68-0533453 | |
Entity Address, Address Line One | 12988 Valley View Road | |
Entity Address, City or Town | Eden Prairie | |
Entity Address, State or Province | MN | |
Entity Address, Postal Zip Code | 55344 | |
City Area Code | 952 | |
Local Phone Number | 345-4200 | |
Title of 12(b) Security | Common Stock, par value $0.0001 per share | |
Trading Symbol | NUWE | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 18,051,055 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Current assets | ||
Cash and cash equivalents | $ 1,400 | $ 3,800 |
Accounts receivable | 1,226 | 1,951 |
Inventories, net | 2,131 | 1,997 |
Other current assets | 440 | 461 |
Total current assets | 5,197 | 8,209 |
Property, plant and equipment, net | 681 | 728 |
Operating lease right-of-use asset | 664 | 713 |
Other assets | 120 | 120 |
TOTAL ASSETS | 6,662 | 9,770 |
Current liabilities | ||
Accounts payable and accrued liabilities | 3,332 | 2,380 |
Accrued compensation | 725 | 525 |
Current portion of operating lease liability | 221 | 216 |
Other current liabilities | 45 | 51 |
Total current liabilities | 4,323 | 3,172 |
Common stock warrant liability | 964 | 2,843 |
Operating lease liability | 488 | 544 |
Total liabilities | 5,775 | 6,559 |
Commitments and contingencies | ||
Mezzanine Equity | ||
Series J Convertible Preferred Stock as of March 31, 2024 and December 31, 2023, par value $0.0001 per share; authorized 600,000 shares, issued and outstanding 82 and 11,950, respectively | 2 | 221 |
Stockholders' equity | ||
Preferred stock | 0 | 0 |
Common stock as of March 31, 2024 and December 31, 2023, par value $0.0001 per share; authorized 100,000,000 shares, issued and outstanding 6,801,443 and 5,682,461, respectively | 1 | 1 |
Additional paid-in capital | 292,880 | 290,646 |
Accumulated other comprehensive income: | ||
Foreign currency translation adjustment | (40) | (31) |
Accumulated deficit | (291,956) | (287,626) |
Total stockholders' equity | 885 | 2,990 |
TOTAL LIABILITIES, CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS' EQUITY | 6,662 | 9,770 |
Series A Junior Participating Preferred Stock [Member] | ||
Stockholders' equity | ||
Preferred stock | 0 | 0 |
Series F Convertible Preferred Stock [Member] | ||
Stockholders' equity | ||
Preferred stock | $ 0 | $ 0 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Mar. 31, 2024 | Dec. 31, 2023 |
Stockholders' equity | ||
Preferred stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized (in shares) | 39,352,000 | 39,352,000 |
Preferred stock, shares outstanding (in shares) | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized (in shares) | 100,000,000 | 100,000,000 |
Common stock, shares issued (in shares) | 6,801,443 | 5,682,461 |
Common stock, shares outstanding (in shares) | 6,801,443 | 5,682,461 |
Series J Convertible Preferred Stock [Member] | ||
Mezzanine Equity | ||
Mezzanine equity, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Mezzanine equity, shares authorized (in shares) | 600,000 | 600,000 |
Mezzanine equity, shares issued (in shares) | 82 | 11,950 |
Mezzanine equity, shares outstanding (in shares) | 82 | 11,950 |
Series A Junior Participating Preferred Stock [Member] | ||
Stockholders' equity | ||
Preferred stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized (in shares) | 30,000 | 30,000 |
Preferred stock, shares outstanding (in shares) | 0 | 0 |
Series F Convertible Preferred Stock [Member] | ||
Stockholders' equity | ||
Preferred stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized (in shares) | 18,000 | 18,000 |
Preferred stock, shares issued (in shares) | 127 | 127 |
Preferred stock, shares outstanding (in shares) | 127 | 127 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Condensed Consolidated Statements of Operations and Comprehensive Loss [Abstract] | ||
Net sales | $ 1,857 | $ 1,826 |
Cost of goods sold | 666 | 759 |
Gross profit | 1,191 | 1,067 |
Operating expenses: | ||
Selling, general and administrative | 4,606 | 5,490 |
Research and development | 1,334 | 1,428 |
Total operating expenses | 5,940 | 6,918 |
Loss from operations | (4,749) | (5,851) |
Other income (expense), net | (101) | 123 |
Change in fair value of warrant liability | 522 | (755) |
Loss before income taxes | (4,328) | (6,483) |
Income tax expense | (2) | (2) |
Net loss | (4,330) | (6,485) |
Deemed dividend attributable to Series J Convertible Preferred Stock | 541 | 0 |
Net loss attributable to common stockholders | $ (3,789) | $ (6,485) |
Basic loss per share (in dollars per share) | $ (0.6) | $ (5.76) |
Diluted loss per share (in dollars per share) | $ (0.6) | $ (5.76) |
Weighted average shares outstanding - basic (in shares) | 6,286,298 | 1,125,993 |
Weighted average shares outstanding - diluted (in shares) | 6,286,298 | 1,125,993 |
Other comprehensive loss: | ||
Net loss | $ (4,330) | $ (6,485) |
Unrealized gain on marketable securities | 0 | 6 |
Foreign currency translation adjustments | (9) | (7) |
Total comprehensive loss | $ (4,339) | $ (6,486) |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Stockholders' Equity - USD ($) $ in Thousands | Common Stock [Member] | Common Stock [Member] Series I Convertible Preferred Stock [Member] | Common Stock [Member] Series J Convertible Preferred Stock [Member] | Additional Paid in Capital [Member] | Additional Paid in Capital [Member] Series I Convertible Preferred Stock [Member] | Additional Paid in Capital [Member] Series J Convertible Preferred Stock [Member] | Accumulated Other Comprehensive Income [Member] | Accumulated Other Comprehensive Income [Member] Series I Convertible Preferred Stock [Member] | Accumulated Other Comprehensive Income [Member] Series J Convertible Preferred Stock [Member] | Accumulated Deficit [Member] | Accumulated Deficit [Member] Series I Convertible Preferred Stock [Member] | Accumulated Deficit [Member] Series J Convertible Preferred Stock [Member] | Total | Series I Convertible Preferred Stock [Member] | Series J Convertible Preferred Stock [Member] |
Balance at Dec. 31, 2022 | $ 0 | $ 279,736 | $ 38 | $ (267,417) | $ 12,357 | ||||||||||
Balance (in shares) at Dec. 31, 2022 | 536,394 | ||||||||||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||||||||
Net loss | $ 0 | 0 | 0 | (6,485) | (6,485) | ||||||||||
Unrealized foreign currency translation adjustment | 0 | 0 | (7) | 0 | (7) | ||||||||||
Unrealized gain on marketable securities | 0 | 0 | 6 | 0 | 6 | ||||||||||
Stock-based compensation | $ 0 | 181 | 0 | 0 | 181 | ||||||||||
Stock-based compensation (in shares) | 0 | ||||||||||||||
Issuance costs related to common stock offering | $ 0 | (11) | 0 | 0 | (11) | ||||||||||
Issuance of common stock from conversion of Convertible Preferred Stock | $ 0 | $ 0 | $ 0 | $ 0 | $ 0 | ||||||||||
Issuance of common stock from conversion of convertible preferred stock (in shares) | 10,493 | ||||||||||||||
Reclassification of warrants to equity | 0 | 7,623 | 0 | 0 | 7,623 | ||||||||||
Issuance of common stock from exercise of warrants | $ 0 | 0 | 0 | 0 | 0 | ||||||||||
Issuance of common stock from exercise of warrants (in shares) | 660,045 | ||||||||||||||
Balance at Mar. 31, 2023 | $ 0 | 287,529 | 37 | (273,902) | 13,664 | ||||||||||
Balance (in shares) at Mar. 31, 2023 | 1,206,932 | ||||||||||||||
Balance at Dec. 31, 2023 | $ 1 | 290,646 | (31) | (287,626) | 2,990 | ||||||||||
Balance (in shares) at Dec. 31, 2023 | 5,682,461 | ||||||||||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||||||||
Net loss | $ 0 | 0 | 0 | (4,330) | (4,330) | ||||||||||
Unrealized foreign currency translation adjustment | 0 | 0 | (9) | 0 | (9) | ||||||||||
Unrealized gain on marketable securities | 0 | ||||||||||||||
Stock-based compensation | $ 0 | 158 | 0 | 0 | 158 | ||||||||||
Stock-based compensation (in shares) | 0 | ||||||||||||||
Issuance of common stock from conversion of Convertible Preferred Stock | $ 0 | $ 1,535 | $ 0 | $ 0 | $ 1,535 | ||||||||||
Issuance of common stock from conversion of convertible preferred stock (in shares) | 1,118,982 | ||||||||||||||
Series J Convertible Preferred Stock deemed dividend | $ 0 | 541 | 0 | 0 | 541 | ||||||||||
Balance at Mar. 31, 2024 | $ 1 | $ 292,880 | $ (40) | $ (291,956) | $ 885 | ||||||||||
Balance (in shares) at Mar. 31, 2024 | 6,801,443 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Operating Activities: | ||
Net loss | $ (4,330) | $ (6,485) |
Adjustments to reconcile net loss to cash flows used in operating activities: | ||
Depreciation and amortization | 76 | 86 |
Stock-based compensation expense | 158 | 181 |
Change in fair value of warrant liability | (522) | 755 |
Changes in operating assets and liabilities: | ||
Accounts receivable | 725 | 105 |
Inventory, net | (134) | (81) |
Other current assets | 21 | (81) |
Other assets and liabilities | (6) | (16) |
Accounts payable and accrued expenses | 1,150 | (570) |
Net cash used in operating activities | (2,862) | (6,106) |
Investing Activities: | ||
Additions to intangible assets | 0 | (85) |
Purchases of property and equipment | (29) | (13) |
Net cash used in investing activities | (29) | (98) |
Financing Activities: | ||
Issuance costs related to 2022 common stock offering | 0 | (11) |
Proceeds from the exercise of Series J Convertible Preferred Warrants | 500 | 0 |
Net cash provided by (used in) financing activities | 500 | (11) |
Effect of exchange rate changes on cash | (9) | (7) |
Net decrease in cash and cash equivalents | (2,400) | (6,222) |
Cash and cash equivalents - beginning of period | 3,800 | 17,737 |
Cash and cash equivalents - end of period | 1,400 | 11,515 |
Supplemental cash flow information | ||
Issuance of Series J Preferred Stock for exercise of Warrants | 1,857 | 0 |
Issuance of Common Stock for conversion of Series J Preferred Stock | 1,535 | 0 |
Deemed dividend on Series J Preferred Stock | $ 541 | $ 0 |
Nature of Business and Basis of
Nature of Business and Basis of Presentation | 3 Months Ended |
Mar. 31, 2024 | |
Nature of Business and Basis of Presentation [Abstract] | |
Nature of Business and Basis of Presentation | Note 1 — Nature of Business and Basis of Presentation Nature of Business: In August 2016, the Company acquired the business associated with the Aquadex System (the “Aquadex Business”) from a subsidiary of Baxter International, Inc. (“Baxter”), and refocused its strategy to fully devote its resources to the Aquadex Business. On April 27, 2021, the Company announced that it was changing its name from CHF Solutions, Inc. to Nuwellis, Inc. to reflect the expansion of its customer base from treating fluid imbalance resulting from congestive heart failure to also include critical care and pediatric applications. Principles of Consolidation: These condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023. Going Concern: The Company’s consolidated financial statements have been prepared and presented on a basis assuming it continues as a going concern. During the years ended December 31, 2023 and 2022 and through March 31, 2024, the Company incurred losses from operations and net cash outflows from operating activities as disclosed in the consolidated statements of operations and cash flows, respectively. As of March 31 The Company became a revenue-generating company after acquiring the Aquadex Business in August 2016. The Company expects to incur additional losses in the near-term as it grows the Aquadex Business, including investments in its sales and marketing capabilities, product development, purchasing inventory, manufacturing components, generating additional clinical evidence supporting the efficacy of the Aquadex System, On March 3, 2023, we entered into a Sales Agreement with Ladenburg Thalmann & Co. Inc. (“Ladenburg”) to create an at-the-market offering program under which we could offer and sell shares of our common stock having an aggregate offering price of up to $10.0 million. Ladenburg was entitled to a commission at a fixed rate equal to 3% of the gross proceeds. In 2023, the Company issued shares under the at-the-market program for aggregate net proceeds of approximately $2.1 million after deducting the underwriting discounts and commissions and other costs associated with the offering. On October 12, 2023, the Company entered into a Placement Agency Agreement (the “Placement Agency Agreement”) with Lake Street Capital Markets, LLC and Maxim Group LLC, pursuant to which the Company issued and sold, in a best efforts registered public offering by the Company (the “October 2023 Offering”), 150,000 units, with each Unit consisting of (A) one share of the Company’s Series J Convertible Redeemable Preferred Stock, par value $0.0001 per share, and (B) one warrant to purchase one-half of one (0.50) share of Series J Convertible Preferred Stock, at a price to the public of $15.00 per Unit, less placement agent fees and commissions. The public offering price of $15.00 per Unit reflects the issuance of the Series J Convertible Preferred Stock with an original issue discount of 40%. The Company also registered under the Registration Statement (as defined below) an additional 362,933 shares of Series J Convertible Preferred Stock that will be issued, if and when the Company’s board of directors declares such dividends, as paid in-kind dividends and the shares of the Company’s common stock issuable upon conversion of the Series J Convertible Preferred Stock issued as PIK dividends. The Units, the shares of Series J Convertible Preferred Stock, the Warrants, the PIK Dividend Shares, the PIK Conversion Shares as well as the shares of Series J Convertible Preferred Stock issuable upon exercise of the Warrants and the shares of the Company’s common stock, par value $0.0001 per share, issuable upon conversion of the Series J Convertible Preferred Stock, were offered and sold by the Company pursuant to an effective registration statement on Form S-1, as amended (File No. 333-274610), which was initially filed with the SEC on September 21, 2023, as amended on September 29, 2023, and declared effective by the SEC on September 29, 2023 with an additional registration statement on Form S-1 filed on October 6, 2023 pursuant to Rule 462(c). A final prospectus relating to the Offering was filed with the SEC on October 13, 2023. The closing of the October 2023 Offering contemplated by the Placement Agency Agreement occurred on October 17, 2023. On October 17, 2023, the Company also entered into a warrant agency agreement with the Company’s transfer agent, Equiniti Trust Company, LLC, who will act as warrant agent for the Company, setting forth the terms and conditions of the Warrants sold in the October 2023 Offering. Each Warrant has an exercise price of $7.50 per one-half of one (0.5) share of Series J Convertible Preferred Stock, is immediately exercisable and will expire three (3) years from the date of issuance. There is no established trading market for the Series J Convertible Preferred Stock or the Warrants and we do not expect a market to develop. In addition, we do not intend to list the Series J Convertible Preferred Stock or the Warrants on Nasdaq or any other national securities exchange or any other nationally recognized trading system. The gross proceeds to the Company from the October 2023 Offering were $2.25 million. Net proceeds were approximately $1.5 million after deducting placement agent fees and commissions and offering expenses payable by the Company. The Company used the net proceeds from the Offering for working capital and for general corporate purposes. The Series J Convertible Preferred Stock was reflected as mezzanine equity and accreted to reflect its redemption value as of each reporting date. The accretion was be reflected as a deemed dividend adjustment to arrive at net loss attributed to common stockholders for earnings per share calculations. The Warrants were reflected as a liability and re-measured at fair value as of each reporting date with fair value changes being recorded as non-operating income or expense. The Warrants were valued on day 1 and exceeded the gross proceeds of the offering. This resulted in a day 1 financing expense of $2.7 million. Understanding the near-term need to raise capital, the Company has recently undertaken steps to reduce our monthly cash burn rate, balanced against our strategic growth initiatives, which will provide more flexibility in anticipation of tougher capital market conditions for microcap companies like Nuwellis. These reductions include, but are not limited to the following: selected job eliminations, a reduction of the salaries for members of senior management, no merit increases to the base salaries of any named executive officer or employee in 2024 for performance provided during the fiscal year ended December 31, 2023, no cash bonuses to any named executive officer or employee in 2024 for performance provided during the fiscal year ended December 31, 2023, a reduction in Board of Director and committee fees, temporary suspension of company 401k match, travel reductions, and reductions to select professional services. The Company believes that its existing capital resources will be sufficient to support its operating plan through August 31, 2024. However, the Company will seek to raise additional capital to support its growth or other strategic initiatives through debt, equity or a combination thereof. There can be no assurance we will be successful in raising additional capital. Revenue Recognition: March 31 March 31 les. Accounts Receivable: outstanding receivables based upon significant patterns of collectability, historical experience, and management’s evaluation of specific accounts and will provide an allowance for credit losses when collection becomes doubtful. Payment is generally due 30 days from March March Inventories : Inventories represent finished goods purchased from the Company’s suppliers and are recorded as the lower of cost or net realizable value using the first-in, first-out method. Overhead is allocated to manufactured finished goods inventory based on the normal capacity of the Company’s production facilities. Abnormal amounts of overhead, if any, are expensed as incurred. Inventories consisted of the following: (in thousands) March 31, 2024 December 31, 2023 Finished Goods $ 651 $ 393 Work in Process 198 207 Raw Materials 1,342 1,472 Inventory Reserves (60 ) (75 ) Total $ 2,131 $ 1,997 Loss per Share Diluted earnings per share is computed based on the net loss allocable to common stockholders for each period divided by the weighted average number of common shares outstanding, increased by the number of additional shares that would have been outstanding had the potentially dilutive common shares been issued, and reduced by the number of shares the Company could have repurchased from the proceeds from issuance of the potentially dilutive shares. Potentially dilutive shares of common stock include shares underlying outstanding convertible preferred stock, warrants, stock options and other stock-based awards granted under stock-based compensation plans. The following table sets forth the potential shares of common stock that are not included in the calculation of diluted net loss per share because to do so would be anti-dilutive as of the end of each period presented: March 31 2024 2023 Stock options 147,316 105,296 Warrants to purchase common stock 2,137,323 19,190 Series F convertible preferred stock 125,857 5,080 Series J convertible preferred stock 2,030 — Total 2,412,526 129,566 The following table reconciles reported net loss with reported net loss per share for each of the three months ended March 31: Three months ended March 31 2024 2023 (in thousands, except per share amounts) Net loss $ (4,330 ) $ (6,485 ) Deemed dividend attributable to Series J Convertible Preferred Stock 541 — Net loss after deemed dividend (3,789 ) (6,485 ) Weighted average shares outstanding 6,286 1,126 Basic and diluted loss per share $ (0.60 ) $ (5.76 ) Subsequent Events: The Company evaluates events through the date the condensed consolidated financial statements are filed for events requiring adjustment to or disclosure in the condensed consolidated financial statements. See note 9 – Subsequent Events for additional disclosures. |
Revenue Recognition
Revenue Recognition | 3 Months Ended |
Mar. 31, 2024 | |
Revenue Recognition [Abstract] | |
Revenue Recognition | Note 2 – Revenue Recognition Net Sales: International revenue represents 6% and 4% of net sales for the three months ended March 31, 2024 and 2023, respectively. Revenue from product sales is recognized when the customer or distributor obtains control of the product, which occurs at a point in time, most frequently upon shipment of the product or receipt of the product, depending on shipment terms. The Company’s standard shipping terms are FOB shipping point unless the customer requests that control and title to the inventory transfer upon delivery. Revenue is measured as the amount of consideration we expect to receive, adjusted for any applicable estimates of variable consideration and other factors affecting the transaction price, which is based on the invoiced price, in exchange for transferring products. All revenue is recognized when the Company satisfies its performance obligations under the contract. The majority of the Company’s contracts have a single performance obligation and are short term in nature. The Company has entered into extended service plans with customers whose related revenue is recognized over time. This revenue represents less than 1% of net sales for the three months ended March 31, 2024 and 2023. The unfulfilled performance obligations related to these extended service plans are included in deferred revenue, which is included in other current liabilities on the condensed consolidated balance sheets. The majority of the deferred revenue is expected to be recognized within one year. Sales taxes and value added taxes in foreign jurisdictions that are collected from customers and remitted to governmental authorities are accounted for on a net basis and therefore are excluded from net sales. Revenue includes shipment and handling fees charged to customers. Shipping and handling costs associated with outbound freight after control over a product has transferred to a customer are accounted for as a fulfillment cost and are included in cost of goods sold. Product Returns : The Company offers customers a limited right of return for its products in case of non-conformity or performance issues. The Company estimates the amount of its product sales that may be returned by its customers and records this estimate as a reduction of revenue in the period the related product revenue is recognized. The Company currently estimates product return liabilities using available industry data and its own historical sales and returns information. The Company has received minimal returns to date and believes that future returns of its products will be minimal. Therefore, revenue recognized is not currently impacted by variable consideration related to product returns. |
Stockholders' Equity
Stockholders' Equity | 3 Months Ended |
Mar. 31, 2024 | |
Stockholders' Equity [Abstract] | |
Stockholders' Equity | Note 3 – Stockholders’ Equity Series F Convertible Preferred Stock : On November 27, 2017, the Company closed on an underwritten public offering of Series F convertible preferred stock and warrants to purchase shares of common stock for gross proceeds of $18.0 million. Net proceeds totaled approximately $16.2 million after deducting the underwriting discounts and commissions and other costs associated with the offering. The offering was comprised of Series F convertible preferred stock, convertible into shares of the Company’s common stock at a conversion price of $189,000 per share. Each share of Series F convertible preferred stock was accompanied by a Series 1 warrant, which expired on the first anniversary of its issuance, to purchase 16 shares of the Company’s common stock at an exercise price of $189,000 per share, and a Series 2 warrant, which expires on the seventh anniversary of its issuance, to purchase 4 shares of the Company’s common stock at an exercise price of $189,000 per share. The Series F convertible preferred stock has full ratchet price-based anti-dilution protection, subject to customary carve-outs, in the event of a down-round financing at a price per share below the conversion price of the Series F convertible preferred stock (which protection will expire if, during any 20 of 30 consecutive trading days, the volume weighted average price of the Company’s common stock exceeds 300% of the then-effective conversion price of the Series F convertible preferred stock and the daily dollar trading volume for each trading day during such period exceeds $200,000). The exercise price of the warrants is fixed and does not contain any variable pricing features, nor any price-based anti-dilutive features, apart from customary adjustments for stock splits, combinations, reclassifications, stock dividends or fundamental transactions. A total of 18,000 shares of Series F convertible preferred stock convertible into 96 shares of common stock and warrants to purchase 191 shares of common stock were issued in the offering. Effective March 12, 2019, the conversion price of the Series F convertible preferred stock was reduced from $89,040 to $15,750, the per share price to the public of the Series G convertible preferred stock issued in the March 2019 Offering. Effective October 25, 2019, the conversion price of the Series F convertible preferred stock was reduced from $15,750 to $4,230, and on November 6, 2019, from $4,230 to $2,983, the per share price to the public in the October and November 2019 transactions, respectively. Effective January 28, 2020, the conversion price of the Series F convertible preferred stock was reduced from $2,983 to $1,650, the per share price to the public of the Series H convertible preferred stock which closed in an underwritten public offering on January 28, 2020. Effective March 23, 2020, the conversion price of the Series F convertible preferred stock was reduced from $1,650 to $900, the per share price to the public in the March 2020 transaction. In connection with the March 2021 Offering, the conversion price of the Series F convertible preferred stock was reduced from $900 to $550, the per share price to the public in the March 2021 Offering. In addition, the exercise price of the common stock warrants issued in connection with the offering consummated by the Company on January 28, 2020 (the “January 2020 Offering”) was reduced from $900 to $550, the per share price to the public in the March 2021 Offering. As of March 31, 2024, and December 31, 2023, 127 shares of the Series F convertible preferred stock remained outstanding. Market-Based Warrants : On May 30, 2019, the Company granted a market-based warrant to a consultant in exchange for investor relations services. The warrant represents the right to acquire up to 33 shares of the Company’s common stock at an exercise price of $9,540 per share, the closing stock price of the Company’s common shares on May 30, 2019. The warrant is subject to a vesting schedule based on the Company achieving certain market stock prices within a specified period of time. The warrant expires on May 30, 2024. None of these warrants had vested as of March 31, 2024. March 2021 Offering : On March 19, 2021, the Company closed on an underwritten public offering of 37,958 shares of common stock, for gross proceeds of approximately $20.9 million (the “March 2021 Offering”). Net proceeds totaled approximately $18.9 million after deducting the underwriting discounts and commissions and other costs associated with the offering and after giving effect to the underwriters’ full exercise of their overallotment option. In connection with the March 2021 Offering, the conversion price of the Series F convertible preferred stock was reduced from $900 to $550, the per share price to the public in the March 2021 Offering. In addition, the exercise price of the common stock warrants issued in connection with the January 2020 Offering was reduced from $900 to $550, the per share price to the public in the March 2021 Offering. September 2021 Offering : On September 17, 2021, the Company closed on an underwritten public offering of 40,056 shares of common stock, for gross proceeds of approximately $10.0 million (the “September 2021 Offering”). Net proceeds totaled approximately $9.0 million after deducting the underwriting discounts and commissions and other costs associated with the offering and after giving effect to the underwriters’ full exercise of their overallotment option. In connection with the September 2021 Offering, the conversion price of the Series F convertible preferred stock was reduced from $550 to $250, the per share price to the public in the September 2021 Offering. In addition, the exercise price of the common stock warrants issued in connection with the January 2020 Offering was reduced from $550 to $250, the per share price to the public in the September 2021 Offering. October 2022 Offering : On October 18, 2022, the Company closed on an underwritten public offering of 209,940 shares of common stock and 23,157,124 shares of Series I convertible preferred stock, for gross proceeds of approximately $11.0 million (the “October 2022 Offering”). Net proceeds totaled approximately $9.4 million after deducting underwriting discounts and commissions and other costs associated with the offering and after giving effect to the underwriters’ full exercise of their overallotment option. The offering was comprised of (1) 209,940 Class A Units, priced at a public offering price of $25 per Class A Unit, with each Class A Unit consisting of one share of common stock and 1.5 warrants to purchase one share of common stock at an exercise price of $25 per share, and (2) 23,157,124 Class B Units, priced at a public offering price of $0.25 per Class B Unit, with each Class B Unit consisting of one share of Series I convertible preferred stock, convertible into one share of common stock for every one hundred shares of Series I convertible preferred stock, and 1.5 warrants to purchase one share of common stock for every one hundred shares of Series I convertible preferred stock. The warrants included a cashless exercise provision that upon becoming exercisable, the warrant holders could exercise the warrants for common stock at a zero-dollar exercise price. The warrants became exercisable beginning on the effective date of a reverse stock split in an amount sufficient to permit the exercise in full of the warrants, contingent upon stockholder approval of (i) such reverse stock split and (ii) of the exercisability of the warrants under Nasdaq rules, and they expire on the sixth anniversary of the initial exercise date. On December 8, 2022, following a special meeting of stockholders, the Company’s board of directors approved a one-for-one hundred Reverse Stock Split On December 9, 2022, the Company filed with the Secretary of State of the State of Delaware a Certificate of Amendment to its Certificate of Incorporation to effect the Reverse Stock Split. The Reverse Stock Split became effective as of 5:00 p.m. Eastern Time on December 9, 2022, and the Company’s common stock began trading on a split-adjusted basis when the market opened on December 12, 2022. The conversion price of the preferred stock issued in the October 2022 offering was fixed and does not contain any variable pricing feature or any price-based anti-dilutive feature. The preferred stock issued in this transaction includes a beneficial ownership blocker but has no dividend rights (except to the extent that dividends are also paid on the common stock) or liquidation preference and, subject to limited exceptions, has no voting rights. The securities comprising the units are immediately separable and were issued separately. This reverse stock split did not change the par value of the Company’s common stock or the number of common or preferred shares authorized by the Company’s Fourth Amended and Restated Certificate of Incorporation, as amended. All share and per-share amounts in this quarterly report have been retroactively adjusted to reflect the reverse stock splits for all periods presented. On January 4, 2023, the Company secured stockholder approval for the exercisability of the common stock warrants issued in the October 2022 Offering. The warrants were subsequently determined to be equity-classified warrants and were marked to market, then reclassified to the equity section of the consolidated balance sheet. Through June 30, 2023, 660,046 common stock warrants had converted into 660,046 shares of common stock at a zero-dollar exercise price, with no proceeds received by the Company. In connection with the October 2022 Offering, the conversion price of the Series F convertible preferred stock was reduced from $250 to $25, the per share price to the public in the October 2022 Offering. In addition, the exercise price of the common stock warrants issued in connection with the January 2020 Offering was reduced from $250 to $25, the per share price to the public in the October 2022 Offering. 2023 At-the-Market Program: Supply Agreement Warrants “Supply Agreement” “DaVita” “Pilot” “Ultrafiltration Services Approval” In conjunction with the Supply Agreement, the Company issued DaVita a warrant to purchase up to an aggregate of 1,289,081 shares of common stock of the Company, par value $0.0001 per share, at an exercise price of $3.2996 per share (the “DaVita Warrant” The Company evaluated the accounting treatment for the DaVita Warrant pursuant to ASC 718, “Stock Compensation,” and ASC 480, “Distinguishing Liabilities from Equity,” and concluded that the DaVita Warrant should be classified as an equity instrument on the balance sheet as of March 31, 2024. In accordance with this treatment, the Company’s management concluded none of the performance-based vesting conditions of the DaVita warrant were probable of vesting as of March 31, 2024, and therefore, no expense associated with the DaVita Warrant was recognized in the Company’s financial statements as of that date. The Company will continue to evaluate the probability of achieving the performance milestones associated with the DaVita Supply Agreement and will record the related equity-based expense in its financial statements based on the grant date fair value of the DaVita Warrant when management deems it is probable that the performance-based vesting conditions will be achieved. October 2023 Offering : On October 12, 2023, Nuwellis, Inc. entered into a Placement Agency Agreement with Lake Street Capital Markets, LLC and Maxim Group LLC, pursuant to which the Company issued and sold, in a best efforts registered public offering by the Company, 150,000 units, with each Unit consisting of (A) one share of the Company’s Series J Convertible Redeemable Preferred Stock, par value $0.0001 per share, and (B) one warrant to purchase one-half of one (0.50) share of Series J Convertible Preferred Stock, at a price to the public of $15.00 per Unit, less placement agent fees and commissions. The public offering price of $15.00 per Unit reflects the issuance of the Series J Convertible Preferred Stock with an original issue discount of 40%. The Company is also registering under the Registration Statement (as defined below) an additional 362,933 shares of Series J Convertible Preferred Stock that will be issued, if and when the Company’s Board of Directors declares such dividends, as paid in-kind dividends and the shares of Common Stock issuable upon conversion of the Series J Convertible Preferred Stock issued as PIK dividends. The Units, the shares of Series J Convertible Preferred Stock, the Warrants, the PIK Dividend Shares, the PIK Conversion Shares as well as the shares of Series J Convertible Preferred Stock issuable upon exercise of the Warrants and the shares of the Company’s common stock, par value $0.0001 per share, issuable upon conversion of the Series J Convertible Preferred Stock, were offered and sold by the Company pursuant to an effective registration statement on Form S-1, as amended (File No. 333-274610), which was initially filed with the Securities Exchange Commission on September 21, 2023, as amended on September 29, 2023, and declared effective by the SEC on September 29, 2023 with an additional registration statement on Form S-1 filed on October 6, 2023 pursuant to Rule 462(c). A final prospectus relating to the Offering was filed with the SEC on October 13, 2023. The closing of the Offering contemplated by the Placement Agency Agreement occurred on October 17, 2023. On October 17, 2023, the Company also entered into a warrant agency agreement with the Company’s transfer agent, Equiniti Trust Company, LLC, who will act as warrant agent for the Company, setting forth the terms and conditions of the Warrants sold in this Offering. Each Warrant has an exercise price of $7.50 per one-half of one (0.5) share of Series J Convertible Preferred Stock, is immediately exercisable and will expire three (3) years from the date of issuance. There is no established trading market for the Series J Convertible Preferred Stock or the Warrants and we do not expect a market to develop. In addition, we do not intend to list the Series J Convertible Preferred Stock or the Warrants on The Nasdaq Capital Market or any other national securities exchange or any other nationally recognized trading system. The gross proceeds to the Company from the October 17, 2023, Offering were $2.25 million. Net proceeds were approximately $1.5 million after deducting placement agent fees and commissions and Offering expenses payable by the Company. The Company used the net proceeds from the Offering for working capital and for general corporate purposes. The Series J Convertible Preferred Stock is classified as mezzanine equity and accreted to reflect its redemption value as of each reporting date. The accretion will be reflected as a deemed dividend adjustment to arrive at net loss attributed to common stockholders for earnings per share calculations. The Warrants are recorded as a liability and re-measured at fair value as of each reporting date with fair value changes being recorded as non-operating income or expense. The Warrants were valued on day 1 and exceeded the gross proceeds of the offering. This resulted in a day 1 financing expense of $2.7 million. In connection with the October 2023 offering, the conversion price of the Series F convertible preferred stock was reduced from $25 to $1.01, the per share price to the public in the October 2023 offering. Underwriter and Placement Agent Fees : In connection with the offerings described above, the Company paid the underwriter or placement agent, as applicable, an aggregate cash fee equal to 8% of the aggregate gross proceeds raised in each of the offerings, except with respect to the issuances made pursuant to the At-the-Market Program, for which the placement fee was equal to 3% of the aggregate gross proceeds. |
Stock-Based Compensation
Stock-Based Compensation | 3 Months Ended |
Mar. 31, 2024 | |
Stock-Based Compensation [Abstract] | |
Stock-Based Compensation | Note 4 - Stock-Based Compensation Under the fair value recognition provisions of U.S. GAAP for accounting for stock-based compensation, the Company measures stock-based compensation expense at the grant date based on the fair value of the award and recognizes the compensation expense over the requisite service period, which is generally the vesting period. The following table presents the classification of stock-based compensation expense recognized for the periods below: Three months ended March 31 (in thousands) 2024 2023 Selling, general and administrative expense $ 157 $ 172 Research and development expense 1 9 Total stock-based compensation expense $ 158 $ 181 During the three months ended March 31, 2024 and 2023, under the 2017 Equity Incentive Plan, the 2021 Inducement Plan, and the 2013 Non-Employee Directors’ Equity Incentive Plan, the Company granted 44,330 and 95,113 stock options, respectively, to its directors, officers and employees. Vesting generally occurs over an immediate to 48-month period based on a time-of-service condition. The weighted-average grant date fair value of the stock-options issued during the three months ended March 31, 2024 and 2023 was $0.63 and $7.50 per share, respectively. The total number of stock options outstanding as of March 31, 2024 and March 31, 2023 was 147,316 and 105,296, respectively. The weighted-average assumptions used in the Black-Scholes option-pricing model are as follows for the stock options granted during the three months ended March 31, 2024 and 2023: Three months ended March 31 2024 2023 Expected volatility 138.71 % 159.32 % Expected Life of options (years) 5.51 6.25 Expected dividend yield 0 % 0 % Risk-free interest rate 3.94 % 4.18 % During the three months ended March 31, 2024 and 2023, 31,520 and 1,268 stock options vested, respectively, and 7,930 and 302 stock options were expired or forfeited during these periods, respectively. During the three months ended March 31, 2024 and 2023, no options were exercised. |
Fair Value of Financial Instrum
Fair Value of Financial Instruments | 3 Months Ended |
Mar. 31, 2024 | |
Fair Value of Financial Instruments [Abstract] | |
Fair Value of Financial Instruments | Note 5—Fair Value of Financial Instruments The Company’s financial instruments consist of cash and cash equivalents and warrants. Pursuant to the requirements of Accounting Standards Codification (“ASC”) Topic 820 “Fair Value Measurement,” the Company’s financial assets and liabilities measured at fair value on a recurring basis are classified and disclosed in one of the following three categories: ● Level 1 — Financial instruments with unadjusted quoted prices listed on active market exchanges. ● Level 2 — Financial instruments lacking unadjusted, quoted prices from active market exchanges, including over-the-counter traded financial instruments. The prices for the financial instruments are determined using prices for recently traded financial instruments with similar underlying terms as well as directly or indirectly observable inputs, such as interest rates and yield curves that are observable at commonly quoted intervals. ● Level 3 — Financial instruments that are not actively traded on a market exchange. This category includes situations where there is little, if any, market activity for the financial instrument. The prices are determined using significant unobservable inputs or valuation techniques. The fair value of the Company’s common stock warrant liability related to the investor warrants issued in the October 2023 and October 2022 public offerings was calculated using a Monte Carlo valuation model and was classified as Level 3 in the fair value hierarchy. The following is a roll-forward of the fair value of the Level 3 warrants: (in thousands) Balance at December 31, 2022 $ 6,868 Change in fair value 755 Issuance of Common Stock for exercise of Series I warrants (7,623 ) October 17, 2023, issuance of Series J warrants 4,965 Exercise of Series J warrants (536 ) Change in fair value (1,586 ) Balance at December 31, 2023 2,843 Exercise of Series J warrants (1,357 ) Change in fair value (522 ) Balance at March 31, 2024 $ 964 |
Income Taxes
Income Taxes | 3 Months Ended |
Mar. 31, 2024 | |
Income Taxes [Abstract] | |
Income Taxes | Note 6 – Income Taxes The Company provides for a valuation allowance when it is more likely than not that it will not realize a portion of its deferred tax assets. The Company has established a full valuation allowance for its U.S. and foreign deferred tax assets due to the uncertainty that enough taxable income will be generated in those taxing jurisdictions to utilize the assets. Therefore, the Company has not reflected any benefit of such deferred tax assets in the accompanying condensed consolidated financial statements. As of March 31, 2024, there were no material changes to what the Company disclosed regarding tax uncertainties or penalties in its Annual Report on Form 10-K for the year ended December 31, 2023. |
Operating Leases
Operating Leases | 3 Months Ended |
Mar. 31, 2024 | |
Operating Leases [Abstract] | |
Operating Leases | Note 7—Operating Leases The Company leases a 23,000 square foot facility located in Eden Prairie, Minnesota for |
Commitments and Contingencies
Commitments and Contingencies | 3 Months Ended |
Mar. 31, 2024 | |
Commitments and Contingencies [Abstract] | |
Commitments and Contingencies | Note 8—Commitments and Contingencies Employee Retirement Plan: Milestone Payment: on vital organs, is appointing As of March 31, 2024, the milestone payment has not been paid. |
Subsequent Events
Subsequent Events | 3 Months Ended |
Mar. 31, 2024 | |
Subsequent Events [Abstract] | |
Subsequent Events | Note 9- Subsequent Events Public Offering: On April 30, Nuwellis closed on an underwritten public offering of 11,250,000 shares of its common stock (or pre-funded warrants in lieu thereof) and warrants to purchase up to an aggregate of 16,875,000 shares of its common stock at a combined public offering price $0.24 per share (or pre-funded warrant in lieu thereof) and associated warrant. Each share of common stock (or prefunded warrant in lieu thereof) was sold together with one warrant to purchase one and a half The common warrants contain a reset of the exercise price, effective upon the Warrant Stockholder Approval, to a price equal to the lesser of (i) the then exercise price, (ii) the lowest volume weighted average price for the five The gross proceeds to Nuwellis from the offering, before deducting the placement agent fees and other offering expenses were approximately $2.7 million. Net proceeds totaled approximately $2.1 million after deducting the underwriting discounts and commissions and other costs associated with the offering. |
Insider Trading Arrangement
Insider Trading Arrangement | 3 Months Ended |
Mar. 31, 2024 | |
Insider Trading Arrangements [Line Items] | |
Rule 10b5-1 Arrangement Adopted | false |
Non-Rule 10b5-1 Arrangement Adopted | false |
Rule 10b5-1 Arrangement Terminated | false |
Non-Rule 10b5-1 Arrangement Terminated | false |
Nature of Business and Basis _2
Nature of Business and Basis of Presentation (Policies) | 3 Months Ended |
Mar. 31, 2024 | |
Nature of Business and Basis of Presentation [Abstract] | |
Principles of Consolidation | Principles of Consolidation: These condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023. |
Going Concern | Going Concern: The Company’s consolidated financial statements have been prepared and presented on a basis assuming it continues as a going concern. During the years ended December 31, 2023 and 2022 and through March 31, 2024, the Company incurred losses from operations and net cash outflows from operating activities as disclosed in the consolidated statements of operations and cash flows, respectively. As of March 31 The Company became a revenue-generating company after acquiring the Aquadex Business in August 2016. The Company expects to incur additional losses in the near-term as it grows the Aquadex Business, including investments in its sales and marketing capabilities, product development, purchasing inventory, manufacturing components, generating additional clinical evidence supporting the efficacy of the Aquadex System, On March 3, 2023, we entered into a Sales Agreement with Ladenburg Thalmann & Co. Inc. (“Ladenburg”) to create an at-the-market offering program under which we could offer and sell shares of our common stock having an aggregate offering price of up to $10.0 million. Ladenburg was entitled to a commission at a fixed rate equal to 3% of the gross proceeds. In 2023, the Company issued shares under the at-the-market program for aggregate net proceeds of approximately $2.1 million after deducting the underwriting discounts and commissions and other costs associated with the offering. On October 12, 2023, the Company entered into a Placement Agency Agreement (the “Placement Agency Agreement”) with Lake Street Capital Markets, LLC and Maxim Group LLC, pursuant to which the Company issued and sold, in a best efforts registered public offering by the Company (the “October 2023 Offering”), 150,000 units, with each Unit consisting of (A) one share of the Company’s Series J Convertible Redeemable Preferred Stock, par value $0.0001 per share, and (B) one warrant to purchase one-half of one (0.50) share of Series J Convertible Preferred Stock, at a price to the public of $15.00 per Unit, less placement agent fees and commissions. The public offering price of $15.00 per Unit reflects the issuance of the Series J Convertible Preferred Stock with an original issue discount of 40%. The Company also registered under the Registration Statement (as defined below) an additional 362,933 shares of Series J Convertible Preferred Stock that will be issued, if and when the Company’s board of directors declares such dividends, as paid in-kind dividends and the shares of the Company’s common stock issuable upon conversion of the Series J Convertible Preferred Stock issued as PIK dividends. The Units, the shares of Series J Convertible Preferred Stock, the Warrants, the PIK Dividend Shares, the PIK Conversion Shares as well as the shares of Series J Convertible Preferred Stock issuable upon exercise of the Warrants and the shares of the Company’s common stock, par value $0.0001 per share, issuable upon conversion of the Series J Convertible Preferred Stock, were offered and sold by the Company pursuant to an effective registration statement on Form S-1, as amended (File No. 333-274610), which was initially filed with the SEC on September 21, 2023, as amended on September 29, 2023, and declared effective by the SEC on September 29, 2023 with an additional registration statement on Form S-1 filed on October 6, 2023 pursuant to Rule 462(c). A final prospectus relating to the Offering was filed with the SEC on October 13, 2023. The closing of the October 2023 Offering contemplated by the Placement Agency Agreement occurred on October 17, 2023. On October 17, 2023, the Company also entered into a warrant agency agreement with the Company’s transfer agent, Equiniti Trust Company, LLC, who will act as warrant agent for the Company, setting forth the terms and conditions of the Warrants sold in the October 2023 Offering. Each Warrant has an exercise price of $7.50 per one-half of one (0.5) share of Series J Convertible Preferred Stock, is immediately exercisable and will expire three (3) years from the date of issuance. There is no established trading market for the Series J Convertible Preferred Stock or the Warrants and we do not expect a market to develop. In addition, we do not intend to list the Series J Convertible Preferred Stock or the Warrants on Nasdaq or any other national securities exchange or any other nationally recognized trading system. The gross proceeds to the Company from the October 2023 Offering were $2.25 million. Net proceeds were approximately $1.5 million after deducting placement agent fees and commissions and offering expenses payable by the Company. The Company used the net proceeds from the Offering for working capital and for general corporate purposes. The Series J Convertible Preferred Stock was reflected as mezzanine equity and accreted to reflect its redemption value as of each reporting date. The accretion was be reflected as a deemed dividend adjustment to arrive at net loss attributed to common stockholders for earnings per share calculations. The Warrants were reflected as a liability and re-measured at fair value as of each reporting date with fair value changes being recorded as non-operating income or expense. The Warrants were valued on day 1 and exceeded the gross proceeds of the offering. This resulted in a day 1 financing expense of $2.7 million. Understanding the near-term need to raise capital, the Company has recently undertaken steps to reduce our monthly cash burn rate, balanced against our strategic growth initiatives, which will provide more flexibility in anticipation of tougher capital market conditions for microcap companies like Nuwellis. These reductions include, but are not limited to the following: selected job eliminations, a reduction of the salaries for members of senior management, no merit increases to the base salaries of any named executive officer or employee in 2024 for performance provided during the fiscal year ended December 31, 2023, no cash bonuses to any named executive officer or employee in 2024 for performance provided during the fiscal year ended December 31, 2023, a reduction in Board of Director and committee fees, temporary suspension of company 401k match, travel reductions, and reductions to select professional services. The Company believes that its existing capital resources will be sufficient to support its operating plan through August 31, 2024. However, the Company will seek to raise additional capital to support its growth or other strategic initiatives through debt, equity or a combination thereof. There can be no assurance we will be successful in raising additional capital. |
Revenue Recognition | Revenue Recognition: March 31 March 31 les. |
Accounts Receivable | Accounts Receivable: outstanding receivables based upon significant patterns of collectability, historical experience, and management’s evaluation of specific accounts and will provide an allowance for credit losses when collection becomes doubtful. Payment is generally due 30 days from March March |
Inventories | Inventories : Inventories represent finished goods purchased from the Company’s suppliers and are recorded as the lower of cost or net realizable value using the first-in, first-out method. Overhead is allocated to manufactured finished goods inventory based on the normal capacity of the Company’s production facilities. Abnormal amounts of overhead, if any, are expensed as incurred. Inventories consisted of the following: (in thousands) March 31, 2024 December 31, 2023 Finished Goods $ 651 $ 393 Work in Process 198 207 Raw Materials 1,342 1,472 Inventory Reserves (60 ) (75 ) Total $ 2,131 $ 1,997 |
Loss per Share | Loss per Share Diluted earnings per share is computed based on the net loss allocable to common stockholders for each period divided by the weighted average number of common shares outstanding, increased by the number of additional shares that would have been outstanding had the potentially dilutive common shares been issued, and reduced by the number of shares the Company could have repurchased from the proceeds from issuance of the potentially dilutive shares. Potentially dilutive shares of common stock include shares underlying outstanding convertible preferred stock, warrants, stock options and other stock-based awards granted under stock-based compensation plans. The following table sets forth the potential shares of common stock that are not included in the calculation of diluted net loss per share because to do so would be anti-dilutive as of the end of each period presented: March 31 2024 2023 Stock options 147,316 105,296 Warrants to purchase common stock 2,137,323 19,190 Series F convertible preferred stock 125,857 5,080 Series J convertible preferred stock 2,030 — Total 2,412,526 129,566 The following table reconciles reported net loss with reported net loss per share for each of the three months ended March 31: Three months ended March 31 2024 2023 (in thousands, except per share amounts) Net loss $ (4,330 ) $ (6,485 ) Deemed dividend attributable to Series J Convertible Preferred Stock 541 — Net loss after deemed dividend (3,789 ) (6,485 ) Weighted average shares outstanding 6,286 1,126 Basic and diluted loss per share $ (0.60 ) $ (5.76 ) |
Subsequent Events | Subsequent Events: The Company evaluates events through the date the condensed consolidated financial statements are filed for events requiring adjustment to or disclosure in the condensed consolidated financial statements. See note 9 – Subsequent Events for additional disclosures. |
Nature of Business and Basis _3
Nature of Business and Basis of Presentation (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Nature of Business and Basis of Presentation [Abstract] | |
Inventories | Inventories consisted of the following: (in thousands) March 31, 2024 December 31, 2023 Finished Goods $ 651 $ 393 Work in Process 198 207 Raw Materials 1,342 1,472 Inventory Reserves (60 ) (75 ) Total $ 2,131 $ 1,997 |
Potential Shares of Common Stock not Included in Diluted Net Loss Per Share | The following table sets forth the potential shares of common stock that are not included in the calculation of diluted net loss per share because to do so would be anti-dilutive as of the end of each period presented: March 31 2024 2023 Stock options 147,316 105,296 Warrants to purchase common stock 2,137,323 19,190 Series F convertible preferred stock 125,857 5,080 Series J convertible preferred stock 2,030 — Total 2,412,526 129,566 |
Reconciliation of Reported Net Loss with Reported Net Loss Per Share | The following table reconciles reported net loss with reported net loss per share for each of the three months ended March 31: Three months ended March 31 2024 2023 (in thousands, except per share amounts) Net loss $ (4,330 ) $ (6,485 ) Deemed dividend attributable to Series J Convertible Preferred Stock 541 — Net loss after deemed dividend (3,789 ) (6,485 ) Weighted average shares outstanding 6,286 1,126 Basic and diluted loss per share $ (0.60 ) $ (5.76 ) |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Stock-Based Compensation [Abstract] | |
Classification of Stock-Based Compensation Expense | The following table presents the classification of stock-based compensation expense recognized for the periods below: Three months ended March 31 (in thousands) 2024 2023 Selling, general and administrative expense $ 157 $ 172 Research and development expense 1 9 Total stock-based compensation expense $ 158 $ 181 |
Weighted Average Assumptions used in Black-Scholes Option Pricing Model | The weighted-average assumptions used in the Black-Scholes option-pricing model are as follows for the stock options granted during the three months ended March 31, 2024 and 2023: Three months ended March 31 2024 2023 Expected volatility 138.71 % 159.32 % Expected Life of options (years) 5.51 6.25 Expected dividend yield 0 % 0 % Risk-free interest rate 3.94 % 4.18 % |
Fair Value of Financial Instr_2
Fair Value of Financial Instruments (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Fair Value of Financial Instruments [Abstract] | |
Roll-Forward of Fair Value of Level 3 Warrants | The following is a roll-forward of the fair value of the Level 3 warrants: (in thousands) Balance at December 31, 2022 $ 6,868 Change in fair value 755 Issuance of Common Stock for exercise of Series I warrants (7,623 ) October 17, 2023, issuance of Series J warrants 4,965 Exercise of Series J warrants (536 ) Change in fair value (1,586 ) Balance at December 31, 2023 2,843 Exercise of Series J warrants (1,357 ) Change in fair value (522 ) Balance at March 31, 2024 $ 964 |
Nature of Business and Basis _4
Nature of Business and Basis of Presentation, Nature of Business, Going Concern, Accounts Receivable and Inventories (Details) $ / shares in Units, $ in Thousands, $ in Millions | 3 Months Ended | 12 Months Ended | ||||||
Oct. 17, 2023 USD ($) $ / shares shares | Oct. 17, 2023 AUD ($) | Oct. 12, 2023 shares $ / shares | Mar. 31, 2024 USD ($) Customer $ / shares | Mar. 31, 2023 Customer | Dec. 31, 2023 USD ($) Customer $ / shares | Jun. 30, 2023 $ / shares | Mar. 03, 2023 USD ($) | |
Going Concern [Abstract] | ||||||||
Accumulated deficit | $ (291,956) | $ (287,626) | ||||||
Preferred stock, par value (in dollars per share) | $ / shares | $ 0.0001 | $ 0.0001 | ||||||
Common stock, par value (in dollars per share) | $ / shares | $ 0.0001 | $ 0.0001 | ||||||
Exercise price of warrants (in dollars per share) | $ / shares | $ 0 | |||||||
Merit increases to base salaries of named executive officer or employee | $ 0 | |||||||
Cash bonuses to named executive officer or employee | $ 0 | |||||||
Revenue Recognition [Abstract] | ||||||||
Accounts receivables maximum credit period from invoice date | 30 days | |||||||
Allowance for doubtful accounts | $ 0 | $ 0 | ||||||
Inventories [Abstract] | ||||||||
Finished Goods | 651 | 393 | ||||||
Work in Process | 198 | 207 | ||||||
Raw Materials | 1,342 | 1,472 | ||||||
Inventory Reserves | (60) | (75) | ||||||
Total | $ 2,131 | $ 1,997 | ||||||
Warrants [Member] | October 2023 Offering [Member] | ||||||||
Going Concern [Abstract] | ||||||||
Gross proceeds before deducting placement agent fees and commissions and offering expenses | $ 2,250 | |||||||
Net proceeds after deducting placement agent fees and commissions and offering expenses | $ 1,500 | |||||||
Financing expense | $ 2.7 | |||||||
Series F Convertible Preferred Stock [Member] | ||||||||
Going Concern [Abstract] | ||||||||
Preferred stock, par value (in dollars per share) | $ / shares | $ 0.0001 | $ 0.0001 | ||||||
Series J Convertible Preferred Stock [Member] | October 2023 Offering [Member] | ||||||||
Going Concern [Abstract] | ||||||||
Issuance of common stock, net (in shares) | shares | 150,000 | |||||||
Number of shares in one unit (in shares) | shares | 1 | |||||||
Preferred stock, par value (in dollars per share) | $ / shares | $ 0.0001 | |||||||
Number of warrants included in each unit | shares | 1 | |||||||
Warrants to purchase shares of common stock (in shares) | shares | 0.5 | |||||||
Common stock offering price per share (in dollars per share) | $ / shares | $ 15 | |||||||
Original issue discount percentage | 40% | |||||||
Additional shares issuable upon declaration of dividends (in shares) | shares | 362,933 | |||||||
Series J Convertible Preferred Stock [Member] | Warrants [Member] | October 2023 Offering [Member] | ||||||||
Going Concern [Abstract] | ||||||||
Warrants to purchase shares of common stock (in shares) | shares | 0.5 | |||||||
Exercise price of warrants (in dollars per share) | $ / shares | $ 7.5 | |||||||
Warrants term | 3 years | |||||||
Series J Convertible Preferred Stock [Member] | Common Stock [Member] | October 2023 Offering [Member] | ||||||||
Going Concern [Abstract] | ||||||||
Common stock, par value (in dollars per share) | $ / shares | $ 0.0001 | |||||||
Ladenburg Thalmann & Co. [Member] | ||||||||
Going Concern [Abstract] | ||||||||
Percentage of fixed commission rate | 3% | |||||||
Net proceeds from public stock offering | $ 2,100 | |||||||
Ladenburg Thalmann & Co. [Member] | Maximum [Member] | ||||||||
Going Concern [Abstract] | ||||||||
Aggregate offering price | $ 10,000 | |||||||
Net Sales [Member] | ||||||||
Revenue Recognition [Abstract] | ||||||||
Number of major customers | Customer | 1 | 2 | ||||||
Accounts Receivable [Member] | ||||||||
Revenue Recognition [Abstract] | ||||||||
Number of major customers | Customer | 1 | 2 | ||||||
Customer One [Member] | Net Sales [Member] | Customer Concentration Risk [Member] | ||||||||
Revenue Recognition [Abstract] | ||||||||
Concentration risk percentage | 22% | 14% | ||||||
Customer One [Member] | Accounts Receivable [Member] | Customer Concentration Risk [Member] | ||||||||
Revenue Recognition [Abstract] | ||||||||
Concentration risk percentage | 29% | 14% | ||||||
Customer Two [Member] | Net Sales [Member] | Customer Concentration Risk [Member] | ||||||||
Revenue Recognition [Abstract] | ||||||||
Concentration risk percentage | 13% | |||||||
Customer Two [Member] | Accounts Receivable [Member] | Customer Concentration Risk [Member] | ||||||||
Revenue Recognition [Abstract] | ||||||||
Concentration risk percentage | 15% |
Nature of Business and Basis _5
Nature of Business and Basis of Presentation, Loss Per Share (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Potential shares of common stock that are not included in the calculation of diluted net loss per share [Abstract] | ||
Potential shares of common stock that are not included in the calculation of diluted net loss per share (in shares) | 2,412,526 | 129,566 |
Reported net loss with reported net loss per share [Abstract] | ||
Net loss | $ (4,330) | $ (6,485) |
Deemed dividend attributable to Series J Convertible Preferred Stock | 541 | 0 |
Net loss after deemed dividend | $ (3,789) | $ (6,485) |
Weighted average shares outstanding - basic (in shares) | 6,286,298 | 1,125,993 |
Weighted average shares outstanding - diluted (in shares) | 6,286,298 | 1,125,993 |
Basic loss per share (in dollars per share) | $ (0.6) | $ (5.76) |
Diluted loss per share (in dollars per share) | $ (0.6) | $ (5.76) |
Stock Options [Member] | ||
Potential shares of common stock that are not included in the calculation of diluted net loss per share [Abstract] | ||
Potential shares of common stock that are not included in the calculation of diluted net loss per share (in shares) | 147,316 | 105,296 |
Warrants to Purchase Common Stock [Member] | ||
Potential shares of common stock that are not included in the calculation of diluted net loss per share [Abstract] | ||
Potential shares of common stock that are not included in the calculation of diluted net loss per share (in shares) | 2,137,323 | 19,190 |
Series F Convertible Preferred Stock [Member] | ||
Potential shares of common stock that are not included in the calculation of diluted net loss per share [Abstract] | ||
Potential shares of common stock that are not included in the calculation of diluted net loss per share (in shares) | 125,857 | 5,080 |
Series J Convertible Preferred Stock [Member] | ||
Potential shares of common stock that are not included in the calculation of diluted net loss per share [Abstract] | ||
Potential shares of common stock that are not included in the calculation of diluted net loss per share (in shares) | 2,030 | 0 |
Revenue Recognition (Details)
Revenue Recognition (Details) | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date [Axis]: 2024-04-01 | ||
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction [Abstract] | ||
Expected timing of satisfaction, period | 1 year | |
Sales Revenue [Member] | Customer Concentration Risk [Member] | Revenue Recognized over Time [Member] | Maximum [Member] | ||
Revenue, Performance Obligation [Abstract] | ||
Percentage of net sales | 1% | 1% |
Sales Revenue [Member] | Customer Concentration Risk [Member] | International [Member] | Revenue Recognized over Time [Member] | Maximum [Member] | ||
Revenue, Performance Obligation [Abstract] | ||
Percentage of net sales | 6% | 4% |
Stockholders' Equity (Details)
Stockholders' Equity (Details) $ / shares in Units, $ in Thousands, $ in Millions | 3 Months Ended | 6 Months Ended | 12 Months Ended | ||||||||||||||||||
Oct. 17, 2023 USD ($) $ / shares shares | Oct. 17, 2023 AUD ($) | Oct. 12, 2023 shares $ / shares | Jun. 19, 2023 Tranches $ / shares shares | Dec. 08, 2022 | Oct. 18, 2022 USD ($) $ / shares shares | Sep. 17, 2021 USD ($) $ / shares shares | Mar. 19, 2021 USD ($) $ / shares shares | Mar. 12, 2019 $ / shares | Nov. 27, 2017 USD ($) $ / shares shares | Mar. 31, 2024 $ / shares shares | Jun. 30, 2023 $ / shares shares | Dec. 31, 2023 USD ($) $ / shares shares | Oct. 31, 2022 $ / shares | Sep. 30, 2022 $ / shares | Mar. 23, 2020 $ / shares | Jan. 28, 2020 $ / shares | Nov. 06, 2019 $ / shares | Oct. 25, 2019 $ / shares | May 30, 2019 $ / shares shares | Jul. 03, 2018 $ / shares | |
Class of Stock Disclosures [Abstract] | |||||||||||||||||||||
Common stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 | |||||||||||||||||||
Exercise price of warrants (in dollars per share) | $ 0 | ||||||||||||||||||||
Preferred stock, shares outstanding (in shares) | shares | 0 | 0 | |||||||||||||||||||
Reverse stock split | 0.01 | ||||||||||||||||||||
Number of common stock warrants converted into common stock (in shares) | shares | 660,046 | ||||||||||||||||||||
Number of shares of common stock issued upon conversion of common stock warrants (in shares) | shares | 660,046 | ||||||||||||||||||||
Period of warrants expected to vest | 48 months | ||||||||||||||||||||
Preferred stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 | |||||||||||||||||||
January 2020 Offering [Member] | |||||||||||||||||||||
Class of Stock Disclosures [Abstract] | |||||||||||||||||||||
Exercise price of warrants (in dollars per share) | $ 25 | $ 250 | |||||||||||||||||||
March 2021 Offering [Member] | |||||||||||||||||||||
Class of Stock Disclosures [Abstract] | |||||||||||||||||||||
Issuance of common stock, net (in shares) | shares | 37,958 | ||||||||||||||||||||
Gross proceeds from public stock offering | $ | $ 20,900 | ||||||||||||||||||||
Net proceeds from public stock offering | $ | $ 18,900 | ||||||||||||||||||||
September 2021 Offering [Member] | |||||||||||||||||||||
Class of Stock Disclosures [Abstract] | |||||||||||||||||||||
Issuance of common stock, net (in shares) | shares | 40,056 | ||||||||||||||||||||
Gross proceeds from public stock offering | $ | $ 10,000 | ||||||||||||||||||||
Net proceeds from public stock offering | $ | $ 9,000 | ||||||||||||||||||||
October 2022 Offering [Member] | |||||||||||||||||||||
Class of Stock Disclosures [Abstract] | |||||||||||||||||||||
Gross proceeds from public stock offering | $ | $ 11,000 | ||||||||||||||||||||
Net proceeds from public stock offering | $ | $ 9,400 | ||||||||||||||||||||
At-the-Market Program [Member] | |||||||||||||||||||||
Class of Stock Disclosures [Abstract] | |||||||||||||||||||||
Issuance of common stock, net (in shares) | shares | 657,333 | ||||||||||||||||||||
Gross proceeds from public stock offering | $ | $ 2,300 | ||||||||||||||||||||
Net proceeds from public stock offering | $ | $ 2,100 | ||||||||||||||||||||
Aggregate cash fee paid to underwriter or placement agent | 3% | ||||||||||||||||||||
Warrants to Purchase Common Stock [Member] | |||||||||||||||||||||
Class of Stock Disclosures [Abstract] | |||||||||||||||||||||
Number of warrants vested (in shares) | shares | 0 | ||||||||||||||||||||
Warrants to Purchase Common Stock [Member] | Consultant [Member] | |||||||||||||||||||||
Class of Stock Disclosures [Abstract] | |||||||||||||||||||||
Warrants to purchase shares of common stock (in shares) | shares | 33 | ||||||||||||||||||||
Exercise price of warrants (in dollars per share) | $ 9,540 | ||||||||||||||||||||
Supply Agreement [Member] | Maximum [Member] | |||||||||||||||||||||
Class of Stock Disclosures [Abstract] | |||||||||||||||||||||
Period for ultrafiltration services | 10 years | ||||||||||||||||||||
Supply Agreement [Member] | DaVita Warrant [Member] | |||||||||||||||||||||
Class of Stock Disclosures [Abstract] | |||||||||||||||||||||
Common stock, par value (in dollars per share) | $ 0.0001 | ||||||||||||||||||||
Warrants to purchase shares of common stock (in shares) | shares | 1,289,081 | ||||||||||||||||||||
Exercise price of warrants (in dollars per share) | $ 3.2996 | ||||||||||||||||||||
Number of warrants vested (in shares) | shares | 0 | ||||||||||||||||||||
Number of tranches | Tranches | 4 | ||||||||||||||||||||
Supply Agreement [Member] | DaVita Warrant [Member] | Tranche One [Member] | |||||||||||||||||||||
Class of Stock Disclosures [Abstract] | |||||||||||||||||||||
Percentage of warrants expected to vest | 25% | ||||||||||||||||||||
Supply Agreement [Member] | DaVita Warrant [Member] | Tranche Two [Member] | |||||||||||||||||||||
Class of Stock Disclosures [Abstract] | |||||||||||||||||||||
Percentage of warrants expected to vest | 25% | ||||||||||||||||||||
Period of warrants expected to vest | 12 months | ||||||||||||||||||||
Supply Agreement [Member] | DaVita Warrant [Member] | Tranche Three [Member] | |||||||||||||||||||||
Class of Stock Disclosures [Abstract] | |||||||||||||||||||||
Percentage of warrants expected to vest | 25% | ||||||||||||||||||||
Period of warrants expected to vest | 24 months | ||||||||||||||||||||
Supply Agreement [Member] | DaVita Warrant [Member] | Tranche Four [Member] | |||||||||||||||||||||
Class of Stock Disclosures [Abstract] | |||||||||||||||||||||
Percentage of warrants expected to vest | 25% | ||||||||||||||||||||
Period of warrants expected to vest | 36 months | ||||||||||||||||||||
Supply Agreement [Member] | DaVita Warrant [Member] | Maximum [Member] | |||||||||||||||||||||
Class of Stock Disclosures [Abstract] | |||||||||||||||||||||
Warrants to be exercised for amount of shares ownership percentage in entity | 19.90% | ||||||||||||||||||||
Series F Convertible Preferred Stock [Member] | |||||||||||||||||||||
Class of Stock Disclosures [Abstract] | |||||||||||||||||||||
Gross proceeds from issuance of convertible preferred stock | $ | $ 18,000 | ||||||||||||||||||||
Net proceeds from issuance of convertible preferred stock | $ | $ 16,200 | ||||||||||||||||||||
Conversion price (in dollars per share) | $ 189,000 | $ 89,040 | |||||||||||||||||||
Number of consecutive trading days considered for expiration | 20 days | ||||||||||||||||||||
Number of consecutive trading days | 30 days | ||||||||||||||||||||
Percentage of volume weighted average price of common stock | 300% | ||||||||||||||||||||
Trading volume for each trading day | $ | $ 200 | ||||||||||||||||||||
Preferred stock issued (in shares) | shares | 18,000 | 127 | 127 | ||||||||||||||||||
Number of shares issuable on conversion of preferred stock (in shares) | shares | 96 | ||||||||||||||||||||
Preferred stock, shares outstanding (in shares) | shares | 127 | 127 | |||||||||||||||||||
Preferred stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 | |||||||||||||||||||
Aggregate cash fee paid to underwriter or placement agent | 8% | ||||||||||||||||||||
Series F Convertible Preferred Stock [Member] | March 2019 Offering [Member] | |||||||||||||||||||||
Class of Stock Disclosures [Abstract] | |||||||||||||||||||||
Conversion price (in dollars per share) | $ 15,750 | ||||||||||||||||||||
Series F Convertible Preferred Stock [Member] | October 2019 Offering [Member] | |||||||||||||||||||||
Class of Stock Disclosures [Abstract] | |||||||||||||||||||||
Conversion price (in dollars per share) | $ 4,230 | ||||||||||||||||||||
Series F Convertible Preferred Stock [Member] | November 2019 Offering [Member] | |||||||||||||||||||||
Class of Stock Disclosures [Abstract] | |||||||||||||||||||||
Conversion price (in dollars per share) | $ 2,983 | ||||||||||||||||||||
Series F Convertible Preferred Stock [Member] | January 2020 Offering [Member] | |||||||||||||||||||||
Class of Stock Disclosures [Abstract] | |||||||||||||||||||||
Conversion price (in dollars per share) | $ 1,650 | ||||||||||||||||||||
Exercise price of warrants (in dollars per share) | $ 900 | ||||||||||||||||||||
Series F Convertible Preferred Stock [Member] | March 2020 Offering [Member] | |||||||||||||||||||||
Class of Stock Disclosures [Abstract] | |||||||||||||||||||||
Conversion price (in dollars per share) | $ 900 | ||||||||||||||||||||
Series F Convertible Preferred Stock [Member] | March 2021 Offering [Member] | |||||||||||||||||||||
Class of Stock Disclosures [Abstract] | |||||||||||||||||||||
Conversion price (in dollars per share) | $ 550 | ||||||||||||||||||||
Exercise price of warrants (in dollars per share) | $ 550 | ||||||||||||||||||||
Series F Convertible Preferred Stock [Member] | September 2021 Offering [Member] | |||||||||||||||||||||
Class of Stock Disclosures [Abstract] | |||||||||||||||||||||
Conversion price (in dollars per share) | $ 250 | ||||||||||||||||||||
Exercise price of warrants (in dollars per share) | $ 250 | ||||||||||||||||||||
Series F Convertible Preferred Stock [Member] | October 2020 Offering [Member] | |||||||||||||||||||||
Class of Stock Disclosures [Abstract] | |||||||||||||||||||||
Conversion price (in dollars per share) | $ 250 | ||||||||||||||||||||
Series F Convertible Preferred Stock [Member] | October 2022 Offering [Member] | |||||||||||||||||||||
Class of Stock Disclosures [Abstract] | |||||||||||||||||||||
Conversion price (in dollars per share) | $ 25 | $ 25 | $ 250 | ||||||||||||||||||
Series F Convertible Preferred Stock [Member] | October 2023 Offering [Member] | |||||||||||||||||||||
Class of Stock Disclosures [Abstract] | |||||||||||||||||||||
Conversion price (in dollars per share) | $ 1.01 | ||||||||||||||||||||
Series F Convertible Preferred Stock [Member] | Warrants to Purchase Common Stock [Member] | |||||||||||||||||||||
Class of Stock Disclosures [Abstract] | |||||||||||||||||||||
Warrants to purchase shares of common stock (in shares) | shares | 191 | ||||||||||||||||||||
Series F Convertible Preferred Stock [Member] | Warrant Series 1 [Member] | |||||||||||||||||||||
Class of Stock Disclosures [Abstract] | |||||||||||||||||||||
Warrants to purchase shares of common stock (in shares) | shares | 16 | ||||||||||||||||||||
Exercise price of warrants (in dollars per share) | $ 189,000 | ||||||||||||||||||||
Series F Convertible Preferred Stock [Member] | Warrant Series 2 [Member] | |||||||||||||||||||||
Class of Stock Disclosures [Abstract] | |||||||||||||||||||||
Warrants to purchase shares of common stock (in shares) | shares | 4 | ||||||||||||||||||||
Exercise price of warrants (in dollars per share) | $ 189,000 | ||||||||||||||||||||
Series I Preferred Stock [Member] | October 2022 Offering [Member] | |||||||||||||||||||||
Class of Stock Disclosures [Abstract] | |||||||||||||||||||||
Issuance of common stock, net (in shares) | shares | 23,157,124 | ||||||||||||||||||||
Number of shares in one unit (in shares) | shares | 1 | ||||||||||||||||||||
Class A Unit [Member] | October 2022 Offering [Member] | |||||||||||||||||||||
Class of Stock Disclosures [Abstract] | |||||||||||||||||||||
Issuance of common stock, net (in shares) | shares | 209,940 | ||||||||||||||||||||
Common stock offering price per share (in dollars per share) | $ 25 | ||||||||||||||||||||
Common stock exercise price per share (in dollars per share) | $ 25 | ||||||||||||||||||||
Class B Unit [Member] | October 2022 Offering [Member] | |||||||||||||||||||||
Class of Stock Disclosures [Abstract] | |||||||||||||||||||||
Issuance of common stock, net (in shares) | shares | 23,157,124 | ||||||||||||||||||||
Common stock offering price per share (in dollars per share) | $ 0.25 | ||||||||||||||||||||
Common stock exercise price per share (in dollars per share) | $ 0 | ||||||||||||||||||||
Series J Convertible Preferred Stock [Member] | October 2023 Offering [Member] | |||||||||||||||||||||
Class of Stock Disclosures [Abstract] | |||||||||||||||||||||
Warrants to purchase shares of common stock (in shares) | shares | 0.5 | ||||||||||||||||||||
Issuance of common stock, net (in shares) | shares | 150,000 | ||||||||||||||||||||
Common stock offering price per share (in dollars per share) | $ 15 | ||||||||||||||||||||
Number of shares in one unit (in shares) | shares | 1 | ||||||||||||||||||||
Preferred stock, par value (in dollars per share) | $ 0.0001 | ||||||||||||||||||||
Number of warrants included in each unit | shares | 1 | ||||||||||||||||||||
Original issue discount percentage | 40% | ||||||||||||||||||||
Additional shares issuable upon declaration of dividends (in shares) | shares | 362,933 | ||||||||||||||||||||
Common Stock [Member] | October 2022 Offering [Member] | |||||||||||||||||||||
Class of Stock Disclosures [Abstract] | |||||||||||||||||||||
Issuance of common stock, net (in shares) | shares | 209,940 | ||||||||||||||||||||
Number of shares in one unit (in shares) | shares | 1 | ||||||||||||||||||||
Common Stock [Member] | Series J Convertible Preferred Stock [Member] | October 2023 Offering [Member] | |||||||||||||||||||||
Class of Stock Disclosures [Abstract] | |||||||||||||||||||||
Common stock, par value (in dollars per share) | $ 0.0001 | ||||||||||||||||||||
Warrants [Member] | October 2023 Offering [Member] | |||||||||||||||||||||
Class of Stock Disclosures [Abstract] | |||||||||||||||||||||
Gross proceeds before deducting placement agent fees and commissions and offering expenses | $ | $ 2,250 | ||||||||||||||||||||
Net proceeds after deducting placement agent fees and commissions and offering expenses | $ | $ 1,500 | ||||||||||||||||||||
Financing expense | $ | $ 2.7 | ||||||||||||||||||||
Warrants [Member] | Class A Unit [Member] | October 2022 Offering [Member] | |||||||||||||||||||||
Class of Stock Disclosures [Abstract] | |||||||||||||||||||||
Number of shares in one unit (in shares) | shares | 1.5 | ||||||||||||||||||||
Warrants [Member] | Class B Unit [Member] | October 2022 Offering [Member] | |||||||||||||||||||||
Class of Stock Disclosures [Abstract] | |||||||||||||||||||||
Number of shares in one unit (in shares) | shares | 1.5 | ||||||||||||||||||||
Warrants [Member] | Series J Convertible Preferred Stock [Member] | October 2023 Offering [Member] | |||||||||||||||||||||
Class of Stock Disclosures [Abstract] | |||||||||||||||||||||
Warrants to purchase shares of common stock (in shares) | shares | 0.5 | ||||||||||||||||||||
Exercise price of warrants (in dollars per share) | $ 7.5 | ||||||||||||||||||||
Warrants term | 3 years |
Stock-Based Compensation (Detai
Stock-Based Compensation (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Stock-Based Compensation Expense Items [Abstract] | ||
Stock-based compensation expense | $ 158 | $ 181 |
Additional Disclosures [Abstract] | ||
Vesting period | 48 months | |
Outstanding stock options (in shares) | 147,316 | 105,296 |
Selling, General and Administrative Expense [Member] | ||
Stock-Based Compensation Expense Items [Abstract] | ||
Stock-based compensation expense | $ 157 | $ 172 |
Research and Development Expense [Member] | ||
Stock-Based Compensation Expense Items [Abstract] | ||
Stock-based compensation expense | $ 1 | $ 9 |
Stock Options [Member] | ||
Additional Disclosures [Abstract] | ||
Stock options granted (in shares) | 44,330 | 95,113 |
Weighted average grant date fair value of stock options issued (in dollars per share) | $ 0.63 | $ 7.5 |
Stock options vested (in shares) | 31,520 | 1,268 |
Stock options expired or forfeited (in shares) | 7,930 | 302 |
Exercise of stock options (in shares) | 0 | 0 |
Weighted Average Assumptions used in Black-Scholes Option Pricing Model [Abstract] | ||
Expected volatility | 138.71% | 159.32% |
Expected Life of options (years) | 5 years 6 months 3 days | 6 years 3 months |
Expected dividend yield | 0% | 0% |
Risk-free interest rate | 3.94% | 4.18% |
Fair Value of Financial Instr_3
Fair Value of Financial Instruments (Details) - Warrants [Member] - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended |
Mar. 31, 2024 | Dec. 31, 2023 | |
Roll-Forward of Fair Value of Level 3 Warrants [Roll Forward] | ||
Beginning balance | $ 2,843 | $ 6,868 |
Exercise of warrants | (1,357) | |
Change in fair value | (522) | |
Ending balance | $ 964 | 2,843 |
October 18, 2022 Series I Warrants Issuance [Member] | ||
Roll-Forward of Fair Value of Level 3 Warrants [Roll Forward] | ||
Issuance of Common Stock for exercise of warrants | (7,623) | |
Change in fair value | 755 | |
October 17, 2023 Series J Warrants Issuance [Member] | ||
Roll-Forward of Fair Value of Level 3 Warrants [Roll Forward] | ||
Issuance | 4,965 | |
Exercise of warrants | (536) | |
Change in fair value | $ (1,586) |
Operating Leases (Details)
Operating Leases (Details) $ in Thousands | 3 Months Ended |
Mar. 31, 2024 USD ($) ft² $ / ft² | |
Operating Leases [Abstract] | |
Area of property leased under operating lease | ft² | 23,000 |
Monthly rent and common area maintenance charges | $ | $ 34 |
Annual base rent (per square foot) | 10.5 |
Minimum [Member] | |
Operating Leases [Abstract] | |
Annual increase per square foot (in dollars per square foot) | 0.32 |
Maximum [Member] | |
Operating Leases [Abstract] | |
Annual increase per square foot (in dollars per square foot) | 0.34 |
Commitments and Contingencies (
Commitments and Contingencies (Details) - SeaStar Medical Holding Corporation [Member] - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Dec. 27, 2022 | |
Commitments and Contingencies [Abstract] | ||
Milestone payment due | $ 450 | |
Payment period after achievement of milestone event | 30 days | |
Milestone payment made | $ 0 |
Subsequent Events (Details)
Subsequent Events (Details) $ / shares in Units, $ in Millions | Apr. 30, 2024 USD ($) Warrant $ / shares shares | Jun. 30, 2023 $ / shares |
Stockholders' equity [Abstract] | ||
Warrant exercise price per share (in dollars per share) | $ / shares | $ 0 | |
Subsequent Event [Member] | ||
Stockholders' equity [Abstract] | ||
Issuance of stock (in shares) | shares | 11,250,000 | |
Aggregate purchase of warrants (in shares) | shares | 16,875,000 | |
Common stock offering price per share (in dollars per share) | $ / shares | $ 0.24 | |
Number of warrants included in each unit | Warrant | 1 | |
Warrants to purchase common shares (in shares) | shares | 1.50 | |
Warrant exercise price per share (in dollars per share) | $ / shares | $ 0.4 | |
Warrant expiry period | 5 years | |
Gross proceeds before deducting the placement agent fees and other offering expenses | $ | $ 2.7 | |
Net proceeds from Public Offering | $ | $ 2.1 | |
Subsequent Event [Member] | Common Warrants [Member] | ||
Stockholders' equity [Abstract] | ||
Warrants to purchase common shares (in shares) | shares | 1 | |
Number of trading days | 5 days | |
Floor price per share (in dollars per share) | $ / shares | $ 0.06 |