Document and Entity Information
Document and Entity Information | 9 Months Ended |
Sep. 30, 2023 | |
Cover [Abstract] | |
Document Type | S-1 |
Amendment Flag | false |
Entity Registrant Name | Nuwellis, Inc. |
Entity Central Index Key | 0001506492 |
Entity Filer Category | Non-accelerated Filer |
Entity Small Business | true |
Entity Emerging Growth Company | false |
Consolidated Balance Sheets (FY
Consolidated Balance Sheets (FY) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Current assets | ||
Cash and cash equivalents | $ 17,737 | $ 8,742 |
Marketable securities | 569 | 15,463 |
Accounts receivable | 1,406 | 750 |
Inventories, net | 2,661 | 2,843 |
Other current assets | 396 | 328 |
Total current assets | 22,769 | 28,126 |
Property, plant and equipment, net | 980 | 1,188 |
Operating lease right-of-use asset | 903 | 1,082 |
Other assets | 21 | 21 |
TOTAL ASSETS | 24,673 | 30,417 |
Current liabilities | ||
Accounts payable and accrued liabilities | 2,245 | 1,414 |
Accrued compensation | 2,161 | 1,664 |
Current portion of operating lease liability | 196 | 167 |
Current portion of finance lease liability | 28 | 26 |
Other current liabilities | 58 | 36 |
Total current liabilities | 4,688 | 3,307 |
Common stock warrant liability | 6,868 | 0 |
Operating lease liability | 760 | 956 |
Finance lease liability | 0 | 28 |
Other long-term liability | 0 | 179 |
Total liabilities | 12,316 | 4,470 |
Commitments and contingencies | ||
Stockholders' equity | ||
Preferred stock | 0 | 0 |
Common stock as of December 31, 2022 and December 31, 2021, par value $0.0001 per share; authorized 100,000,000 shares, issued and outstanding 536,394 and 105,376, respectively | 0 | 0 |
Additional paid-in capital | 279,736 | 278,874 |
Accumulated other comprehensive income: | ||
Foreign currency translation adjustment | (18) | (11) |
Unrealized gain (loss) on marketable securities | 56 | (24) |
Accumulated deficit | (267,417) | (252,892) |
Total stockholders' equity | 12,357 | 25,947 |
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | 24,673 | 30,417 |
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 |
Series I Convertible Preferred Stock [Member] | ||
Stockholders' equity | ||
Preferred stock | $ 0 | $ 0 |
Consolidated Balance Sheets (_2
Consolidated Balance Sheets (FY) (Parenthetical) - $ / shares | Sep. 30, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | Nov. 27, 2017 |
Stockholders' equity | ||||
Preferred stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 | $ 0.0001 | |
Preferred stock, shares authorized (in shares) | 39,969,873 | 39,969,873 | 39,969,873 | |
Preferred stock, shares outstanding (in shares) | 0 | 0 | 0 | |
Common stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 | $ 0.0001 | |
Common stock, shares authorized (in shares) | 100,000,000 | 100,000,000 | 100,000,000 | |
Common stock, shares issued (in shares) | 1,864,265 | 536,394 | 105,376 | |
Common stock, shares outstanding (in shares) | 1,864,265 | 536,394 | 105,376 | |
Series A Junior Participating Preferred Stock [Member] | ||||
Stockholders' equity | ||||
Preferred stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 | $ 0.0001 | |
Preferred stock, shares authorized (in shares) | 30,000 | 30,000 | 30,000 | |
Preferred stock, shares outstanding (in shares) | 0 | 0 | 0 | |
Series F Convertible Preferred Stock [Member] | ||||
Stockholders' equity | ||||
Preferred stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 | $ 0.0001 | |
Preferred stock, shares authorized (in shares) | 127 | 127 | 127 | |
Preferred stock, shares issued (in shares) | 127 | 127 | 127 | 18,000 |
Preferred stock, shares outstanding (in shares) | 127 | 127 | 127 | |
Series I Convertible Preferred Stock [Member] | ||||
Stockholders' equity | ||||
Preferred stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 | $ 0.0001 | |
Preferred stock, shares authorized (in shares) | 1,049,280 | 1,049,280 | 0 | |
Preferred stock, shares issued (in shares) | 0 | 1,049,280 | 0 | |
Preferred stock, shares outstanding (in shares) | 0 | 1,049,280 | 0 |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive Loss (FY) - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||||||
Sep. 30, 2023 | Jun. 30, 2023 | Mar. 31, 2023 | Sep. 30, 2022 | Jun. 30, 2022 | Mar. 31, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | |
Consolidated Statements of Operations and Comprehensive Loss [Abstract] | ||||||||||
Net sales | $ 2,412 | $ 2,065 | $ 6,313 | $ 6,204 | $ 8,543 | $ 7,921 | ||||
Cost of goods sold | 1,031 | 806 | 2,718 | 2,780 | 3,788 | 3,430 | ||||
Gross profit | 1,381 | 1,259 | 3,595 | 3,424 | 4,755 | 4,491 | ||||
Operating expenses: | ||||||||||
Selling, general and administrative | 3,428 | 4,251 | 13,582 | 12,920 | 17,584 | 19,039 | ||||
Research and development | 1,117 | 928 | 4,050 | 3,141 | 4,342 | 4,978 | ||||
Total operating expenses | 4,545 | 5,179 | 17,632 | 16,061 | 21,926 | 24,017 | ||||
Loss from operations | (3,164) | (3,920) | (14,037) | (12,637) | (17,171) | (19,526) | ||||
Other income (expense), net | ||||||||||
Other income (expense), net | (204) | 52 | 98 | 14 | 75 | (19) | ||||
Financing expense | (9,247) | 0 | ||||||||
Change in fair value of warrant liability | 0 | 0 | (755) | 0 | 11,827 | 0 | ||||
Loss before income taxes | (3,368) | (3,868) | (14,694) | (12,623) | (14,516) | (19,545) | ||||
Income tax expense | (2) | (2) | (6) | (6) | (9) | (9) | ||||
Net loss | $ (3,370) | $ (4,845) | $ (6,485) | $ (3,870) | $ (4,286) | $ (4,473) | $ (14,700) | $ (12,629) | $ (14,525) | $ (19,554) |
Basic loss per share (in dollars per share) | $ (1.81) | $ (36.72) | $ (10.21) | $ (119.85) | $ (83.55) | $ (285.36) | ||||
Diluted loss per share (in dollars per share) | $ (1.81) | $ (36.72) | $ (10.21) | $ (119.85) | $ (83.55) | $ (285.36) | ||||
Weighted average shares outstanding - basic (in shares) | 1,864 | 105 | 1,439 | 105 | 174 | 69 | ||||
Weighted average shares outstanding - diluted (in shares) | 1,864 | 105 | 1,439 | 105 | 174 | 69 | ||||
Other comprehensive loss: | ||||||||||
Unrealized gain (loss) on marketable securities | $ 0 | (61) | 6 | $ 80 | $ (24) | |||||
Unrealized foreign currency translation adjustment | 0 | $ 0 | $ (7) | $ 2 | $ 1 | $ (2) | (7) | (4) | ||
Total comprehensive loss | $ (3,370) | $ (3,868) | $ (14,706) | $ (12,628) | $ (14,452) | $ (19,582) |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Equity (FY) - USD ($) $ in Thousands | Common Stock [Member] | Additional Paid in Capital [Member] | Accumulated Other Comprehensive Income [Member] | Accumulated Deficit [Member] | Total |
Balance at Dec. 31, 2020 | $ 0 | $ 249,663 | $ (7) | $ (233,338) | $ 16,318 |
Balance (in shares) at Dec. 31, 2020 | 27,360 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | $ 0 | 0 | 0 | (19,554) | (19,554) |
Unrealized foreign currency translation adjustment | 0 | 0 | (4) | 0 | (4) |
Unrealized gain (loss) on marketable securities | 0 | 0 | (24) | 0 | (24) |
Stock-based compensation, net | $ 0 | 1,314 | 0 | 0 | 1,314 |
Stock-based compensation, net (in shares) | 0 | ||||
Issuance of common stock, net | $ 0 | 27,896 | 0 | 0 | 27,896 |
Issuance of common stock, net (in shares) | 78,014 | ||||
Exercise of warrants | $ 0 | 1 | 0 | 0 | 1 |
Exercise of warrants (in shares) | 2 | ||||
Balance at Dec. 31, 2021 | $ 0 | 278,874 | (35) | (252,892) | 25,947 |
Balance (in shares) at Dec. 31, 2021 | 105,376 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | $ 0 | 0 | 0 | (4,473) | (4,473) |
Unrealized foreign currency translation adjustment | 0 | 0 | (2) | 0 | (2) |
Stock-based compensation, net | $ 0 | 241 | 0 | 0 | 241 |
Stock-based compensation, net (in shares) | 0 | ||||
Balance at Mar. 31, 2022 | $ 0 | 279,115 | (37) | (257,365) | 21,713 |
Balance (in shares) at Mar. 31, 2022 | 105,376 | ||||
Balance at Dec. 31, 2021 | $ 0 | 278,874 | (35) | (252,892) | 25,947 |
Balance (in shares) at Dec. 31, 2021 | 105,376 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | (12,629) | ||||
Balance at Sep. 30, 2022 | $ 0 | 279,571 | (34) | (265,521) | 14,016 |
Balance (in shares) at Sep. 30, 2022 | 105,376 | ||||
Balance at Dec. 31, 2021 | $ 0 | 278,874 | (35) | (252,892) | 25,947 |
Balance (in shares) at Dec. 31, 2021 | 105,376 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | $ 0 | 0 | 0 | (14,525) | (14,525) |
Unrealized foreign currency translation adjustment | 0 | 0 | (7) | 0 | (7) |
Unrealized gain (loss) on marketable securities | 0 | 0 | 80 | 0 | 80 |
Stock-based compensation, net | $ 0 | 862 | 0 | 0 | 862 |
Stock-based compensation, net (in shares) | 0 | ||||
Issuance of common stock, net | $ 0 | 0 | 0 | 0 | 0 |
Issuance of common stock, net (in shares) | 209,940 | ||||
Conversion of preferred stock into common stock | $ 0 | 0 | 0 | 0 | 0 |
Conversion of preferred stock into common stock (in shares) | 221,078 | ||||
Balance at Dec. 31, 2022 | $ 0 | 279,736 | 38 | (267,417) | 12,357 |
Balance (in shares) at Dec. 31, 2022 | 536,394 | ||||
Balance at Mar. 31, 2022 | $ 0 | 279,115 | (37) | (257,365) | 21,713 |
Balance (in shares) at Mar. 31, 2022 | 105,376 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | $ 0 | 0 | 0 | (4,286) | (4,286) |
Unrealized foreign currency translation adjustment | 0 | 0 | 1 | 0 | 1 |
Stock-based compensation, net | $ 0 | 236 | 0 | 0 | 236 |
Stock-based compensation, net (in shares) | 0 | ||||
Balance at Jun. 30, 2022 | $ 0 | 279,351 | (36) | (261,651) | 17,664 |
Balance (in shares) at Jun. 30, 2022 | 105,376 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | $ 0 | 0 | 0 | (3,870) | (3,870) |
Unrealized foreign currency translation adjustment | 0 | 0 | 2 | 0 | 2 |
Stock-based compensation, net | $ 0 | 220 | 0 | 0 | 220 |
Stock-based compensation, net (in shares) | 0 | ||||
Balance at Sep. 30, 2022 | $ 0 | 279,571 | (34) | (265,521) | 14,016 |
Balance (in shares) at Sep. 30, 2022 | 105,376 | ||||
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 (loss) on marketable securities | 0 | 0 | 6 | 0 | 6 |
Stock-based compensation, net | $ 0 | 181 | 0 | 0 | 181 |
Stock-based compensation, net (in shares) | 0 | ||||
Issuance of common stock, net | $ 0 | 11 | 0 | 0 | 11 |
Conversion of preferred stock into common stock | $ 0 | 0 | 0 | 0 | 0 |
Conversion of preferred stock into common stock (in shares) | 10,493 | ||||
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, 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 | (14,700) | ||||
Balance at Sep. 30, 2023 | $ 0 | 289,980 | (24) | (282,117) | 7,839 |
Balance (in shares) at Sep. 30, 2023 | 1,864,265 | ||||
Balance at Mar. 31, 2023 | $ 0 | 287,529 | 37 | (273,902) | 13,664 |
Balance (in shares) at Mar. 31, 2023 | 1,206,932 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | $ 0 | 0 | 0 | (4,845) | (4,845) |
Unrealized foreign currency translation adjustment | 0 | 0 | 0 | 0 | 0 |
Unrealized gain (loss) on marketable securities | 0 | 0 | (61) | 0 | (61) |
Stock-based compensation, net | $ 0 | 197 | 0 | 0 | 197 |
Stock-based compensation, net (in shares) | 0 | ||||
Issuance of common stock, net | $ 0 | 98 | 0 | 0 | 98 |
Issuance of common stock, net (in shares) | 657,333 | ||||
Balance at Jun. 30, 2023 | $ 0 | 289,845 | (24) | (278,747) | 11,074 |
Balance (in shares) at Jun. 30, 2023 | 1,864,265 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | $ 0 | 0 | 0 | (3,370) | (3,370) |
Unrealized foreign currency translation adjustment | 0 | 0 | 0 | 0 | 0 |
Unrealized gain (loss) on marketable securities | 0 | 0 | 0 | 0 | 0 |
Stock-based compensation, net | $ 0 | 135 | 0 | 0 | 135 |
Stock-based compensation, net (in shares) | 0 | ||||
Issuance of common stock, net | $ 0 | 0 | 0 | 0 | 0 |
Issuance of common stock, net (in shares) | 0 | ||||
Balance at Sep. 30, 2023 | $ 0 | $ 289,980 | $ (24) | $ (282,117) | $ 7,839 |
Balance (in shares) at Sep. 30, 2023 | 1,864,265 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows (FY) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Operating Activities | ||
Net loss | $ (14,525) | $ (19,554) |
Adjustments to reconcile net loss to cash flows from operating activities: | ||
Depreciation and amortization | 372 | 488 |
Stock-based compensation expense, net | 862 | 1,314 |
Change in fair value of warrant liability | (11,827) | 0 |
Financing expense | 9,247 | 0 |
Net realized and unrealized gains on marketable securities | 124 | 13 |
Changes in operating assets and liabilities: | ||
Accounts receivable | (656) | 155 |
Inventory | 140 | (143) |
Other current assets | (68) | (91) |
Other assets and liabilities | (96) | 186 |
Accounts payable and accrued expenses | 1,278 | (211) |
Net cash used in operating activities | (15,149) | (17,843) |
Investing activities: | ||
Purchases of marketable securities | 0 | (18,850) |
Proceeds from sales of marketable securities | 14,850 | 3,350 |
Purchase of property and equipment | (122) | (219) |
Net cash provided by (used in) investing activities | 14,728 | (15,719) |
Financing activities: | ||
Proceeds from public stock offerings, net | 9,449 | 27,896 |
Proceeds from warrant exercises | 0 | 1 |
Payments on finance lease liability | (26) | (26) |
Net cash provided by (used in) financing activities | 9,423 | 27,871 |
Effect of exchange rate changes on cash | (7) | (4) |
Net increase (decrease) in cash and cash equivalents | 8,995 | (5,695) |
Cash and cash equivalents - beginning of period | 8,742 | 14,437 |
Cash and cash equivalents - end of period | 17,737 | 8,742 |
Supplemental schedule of non-cash activities | ||
Inventory transferred to property, plant and equipment | 42 | 257 |
Operating right-of-use asset recorded as an operating lease liability | 0 | 901 |
Supplemental cash flow information | ||
Cash paid for income taxes | $ 9 | $ 11 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets (Q3) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 | Dec. 31, 2021 |
Current assets | |||
Cash and cash equivalents | $ 4,930 | $ 17,737 | $ 8,742 |
Marketable securities | 0 | 569 | 15,463 |
Accounts receivable | 1,425 | 1,406 | 750 |
Inventories, net | 2,336 | 2,661 | 2,843 |
Other current assets | 947 | 396 | 328 |
Total current assets | 9,638 | 22,769 | 28,126 |
Property, plant and equipment, net | 912 | 980 | 1,188 |
Operating lease right-of-use asset | 762 | 903 | 1,082 |
Other assets | 120 | 21 | 21 |
TOTAL ASSETS | 11,432 | 24,673 | 30,417 |
Current liabilities | |||
Accounts payable and accrued liabilities | 1,707 | 2,245 | 1,414 |
Accrued compensation | 1,021 | 2,161 | 1,664 |
Current portion of operating lease liability | 211 | 196 | 167 |
Current portion of finance lease liability | 8 | 28 | 26 |
Other current liabilities | 45 | 58 | 36 |
Total current liabilities | 2,992 | 4,688 | 3,307 |
Common stock warrant liability | 0 | 6,868 | 0 |
Operating lease liability | 601 | 760 | 956 |
Total liabilities | 3,593 | 12,316 | 4,470 |
Commitments and contingencies | |||
Stockholders' equity | |||
Preferred stock | 0 | 0 | 0 |
Common stock as of September 30, 2023 and December 31, 2022, par value $0.0001 per share; authorized 100,000,000 shares, issued and outstanding 1,864,265 and 536,394 shares, respectively | 0 | 0 | 0 |
Additional paid-in capital | 289,980 | 279,736 | 278,874 |
Accumulated other comprehensive income: | |||
Foreign currency translation adjustment | (24) | (18) | (11) |
Unrealized gain on marketable securities | 0 | 56 | (24) |
Accumulated deficit | (282,117) | (267,417) | (252,892) |
Total stockholders' equity | 7,839 | 12,357 | 25,947 |
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | 11,432 | 24,673 | 30,417 |
Series A Junior Participating Preferred Stock [Member] | |||
Stockholders' equity | |||
Preferred stock | 0 | 0 | 0 |
Series F Convertible Preferred Stock [Member] | |||
Stockholders' equity | |||
Preferred stock | 0 | 0 | 0 |
Series I Convertible Preferred Stock [Member] | |||
Stockholders' equity | |||
Preferred stock | $ 0 | $ 0 | $ 0 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Q3) (Parenthetical) - $ / shares | Sep. 30, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | Nov. 27, 2017 |
Stockholders' equity | ||||
Preferred stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 | $ 0.0001 | |
Preferred stock, shares authorized (in shares) | 39,969,873 | 39,969,873 | 39,969,873 | |
Preferred stock, shares outstanding (in shares) | 0 | 0 | 0 | |
Common stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 | $ 0.0001 | |
Common stock, shares authorized (in shares) | 100,000,000 | 100,000,000 | 100,000,000 | |
Common stock, shares issued (in shares) | 1,864,265 | 536,394 | 105,376 | |
Common stock, shares outstanding (in shares) | 1,864,265 | 536,394 | 105,376 | |
Series A Junior Participating Preferred Stock [Member] | ||||
Stockholders' equity | ||||
Preferred stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 | $ 0.0001 | |
Preferred stock, shares authorized (in shares) | 30,000 | 30,000 | 30,000 | |
Preferred stock, shares outstanding (in shares) | 0 | 0 | 0 | |
Series F Convertible Preferred Stock [Member] | ||||
Stockholders' equity | ||||
Preferred stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 | $ 0.0001 | |
Preferred stock, shares authorized (in shares) | 127 | 127 | 127 | |
Preferred stock, shares issued (in shares) | 127 | 127 | 127 | 18,000 |
Preferred stock, shares outstanding (in shares) | 127 | 127 | 127 | |
Series I Convertible Preferred Stock [Member] | ||||
Stockholders' equity | ||||
Preferred stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 | $ 0.0001 | |
Preferred stock, shares authorized (in shares) | 1,049,280 | 1,049,280 | 0 | |
Preferred stock, shares issued (in shares) | 0 | 1,049,280 | 0 | |
Preferred stock, shares outstanding (in shares) | 0 | 1,049,280 | 0 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss (Q3) - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Consolidated Statements of Operations and Comprehensive Loss [Abstract] | ||||
Net sales | $ 2,412 | $ 2,065 | $ 6,313 | $ 6,204 |
Cost of goods sold | 1,031 | 806 | 2,718 | 2,780 |
Gross profit | 1,381 | 1,259 | 3,595 | 3,424 |
Operating expenses: | ||||
Selling, general and administrative | 3,428 | 4,251 | 13,582 | 12,920 |
Research and development | 1,117 | 928 | 4,050 | 3,141 |
Total operating expenses | 4,545 | 5,179 | 17,632 | 16,061 |
Loss from operations | (3,164) | (3,920) | (14,037) | (12,637) |
Other income (expense), net | (204) | 52 | 98 | 14 |
Change in fair value of warrant liability | 0 | 0 | (755) | 0 |
Loss before income taxes | (3,368) | (3,868) | (14,694) | (12,623) |
Income tax expense | (2) | (2) | (6) | (6) |
Net loss | $ (3,370) | $ (3,870) | $ (14,700) | $ (12,629) |
Basic loss per share (in dollars per share) | $ (1.81) | $ (36.72) | $ (10.21) | $ (119.85) |
Diluted loss per share (in dollars per share) | $ (1.81) | $ (36.72) | $ (10.21) | $ (119.85) |
Weighted average shares outstanding - basic (in shares) | 1,864 | 105 | 1,439 | 105 |
Weighted average shares outstanding - diluted (in shares) | 1,864 | 105 | 1,439 | 105 |
Other comprehensive loss: | ||||
Foreign currency translation adjustments | $ 0 | $ 2 | $ (6) | $ 1 |
Total comprehensive loss | $ (3,370) | $ (3,868) | $ (14,706) | $ (12,628) |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Stockholders' Equity (Q3) - USD ($) $ in Thousands | Common Stock [Member] | Additional Paid in Capital [Member] | Accumulated Other Comprehensive Income [Member] | Accumulated Deficit [Member] | Total |
Balance at Dec. 31, 2020 | $ 0 | $ 249,663 | $ (7) | $ (233,338) | $ 16,318 |
Balance (in shares) at Dec. 31, 2020 | 27,360 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | $ 0 | 0 | 0 | (19,554) | (19,554) |
Unrealized foreign currency translation adjustment | 0 | 0 | (4) | 0 | (4) |
Unrealized gain on marketable securities | 0 | 0 | (24) | 0 | (24) |
Stock-based compensation, net | $ 0 | 1,314 | 0 | 0 | 1,314 |
Stock-based compensation, net (in shares) | 0 | ||||
Issuance costs related to common stock offering | $ 0 | (27,896) | 0 | 0 | (27,896) |
Issuance of common stock from ATM offering (in shares) | 78,014 | ||||
Balance at Dec. 31, 2021 | $ 0 | 278,874 | (35) | (252,892) | 25,947 |
Balance (in shares) at Dec. 31, 2021 | 105,376 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | $ 0 | 0 | 0 | (4,473) | (4,473) |
Unrealized foreign currency translation adjustment | 0 | 0 | (2) | 0 | (2) |
Stock-based compensation, net | $ 0 | 241 | 0 | 0 | 241 |
Stock-based compensation, net (in shares) | 0 | ||||
Balance at Mar. 31, 2022 | $ 0 | 279,115 | (37) | (257,365) | 21,713 |
Balance (in shares) at Mar. 31, 2022 | 105,376 | ||||
Balance at Dec. 31, 2021 | $ 0 | 278,874 | (35) | (252,892) | 25,947 |
Balance (in shares) at Dec. 31, 2021 | 105,376 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | (12,629) | ||||
Balance at Sep. 30, 2022 | $ 0 | 279,571 | (34) | (265,521) | 14,016 |
Balance (in shares) at Sep. 30, 2022 | 105,376 | ||||
Balance at Dec. 31, 2021 | $ 0 | 278,874 | (35) | (252,892) | 25,947 |
Balance (in shares) at Dec. 31, 2021 | 105,376 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | $ 0 | 0 | 0 | (14,525) | (14,525) |
Unrealized foreign currency translation adjustment | 0 | 0 | (7) | 0 | (7) |
Unrealized gain on marketable securities | 0 | 0 | 80 | 0 | 80 |
Stock-based compensation, net | $ 0 | 862 | 0 | 0 | 862 |
Stock-based compensation, net (in shares) | 0 | ||||
Issuance costs related to common stock offering | $ 0 | 0 | 0 | 0 | 0 |
Conversion of preferred stock into common stock | $ 0 | 0 | 0 | 0 | 0 |
Conversion of preferred stock into common stock (in shares) | 221,078 | ||||
Issuance of common stock from ATM offering (in shares) | 209,940 | ||||
Balance at Dec. 31, 2022 | $ 0 | 279,736 | 38 | (267,417) | 12,357 |
Balance (in shares) at Dec. 31, 2022 | 536,394 | ||||
Balance at Mar. 31, 2022 | $ 0 | 279,115 | (37) | (257,365) | 21,713 |
Balance (in shares) at Mar. 31, 2022 | 105,376 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | $ 0 | 0 | 0 | (4,286) | (4,286) |
Unrealized foreign currency translation adjustment | 0 | 0 | 1 | 0 | 1 |
Stock-based compensation, net | $ 0 | 236 | 0 | 0 | 236 |
Stock-based compensation, net (in shares) | 0 | ||||
Balance at Jun. 30, 2022 | $ 0 | 279,351 | (36) | (261,651) | 17,664 |
Balance (in shares) at Jun. 30, 2022 | 105,376 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | $ 0 | 0 | 0 | (3,870) | (3,870) |
Unrealized foreign currency translation adjustment | 0 | 0 | 2 | 0 | 2 |
Stock-based compensation, net | $ 0 | 220 | 0 | 0 | 220 |
Stock-based compensation, net (in shares) | 0 | ||||
Balance at Sep. 30, 2022 | $ 0 | 279,571 | (34) | (265,521) | 14,016 |
Balance (in shares) at Sep. 30, 2022 | 105,376 | ||||
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, net | $ 0 | 181 | 0 | 0 | 181 |
Stock-based compensation, net (in shares) | 0 | ||||
Issuance costs related to common stock offering | $ 0 | (11) | 0 | 0 | (11) |
Conversion of preferred stock into common stock | $ 0 | 0 | 0 | 0 | 0 |
Conversion of preferred stock into common stock (in shares) | 10,493 | ||||
Reclassification of warrants to equity | $ 0 | 7,623 | 0 | 0 | 7,623 |
Conversion of warrants into common stock | $ 0 | 0 | 0 | 0 | 0 |
Conversion of warrants into common stock (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, 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 | (14,700) | ||||
Balance at Sep. 30, 2023 | $ 0 | 289,980 | (24) | (282,117) | 7,839 |
Balance (in shares) at Sep. 30, 2023 | 1,864,265 | ||||
Balance at Mar. 31, 2023 | $ 0 | 287,529 | 37 | (273,902) | 13,664 |
Balance (in shares) at Mar. 31, 2023 | 1,206,932 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | $ 0 | 0 | 0 | (4,845) | (4,845) |
Unrealized foreign currency translation adjustment | 0 | 0 | 0 | 0 | 0 |
Unrealized gain on marketable securities | 0 | 0 | (61) | 0 | (61) |
Stock-based compensation, net | $ 0 | 197 | 0 | 0 | 197 |
Stock-based compensation, net (in shares) | 0 | ||||
Issuance costs related to common stock offering | $ 0 | (98) | 0 | 0 | (98) |
Issuance of common stock from ATM offering | $ 0 | 2,217 | 0 | 0 | 2,217 |
Issuance of common stock from ATM offering (in shares) | 657,333 | ||||
Balance at Jun. 30, 2023 | $ 0 | 289,845 | (24) | (278,747) | 11,074 |
Balance (in shares) at Jun. 30, 2023 | 1,864,265 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | $ 0 | 0 | 0 | (3,370) | (3,370) |
Unrealized foreign currency translation adjustment | 0 | 0 | 0 | 0 | 0 |
Unrealized gain on marketable securities | 0 | 0 | 0 | 0 | 0 |
Stock-based compensation, net | $ 0 | 135 | 0 | 0 | 135 |
Stock-based compensation, net (in shares) | 0 | ||||
Issuance costs related to common stock offering | $ 0 | 0 | 0 | 0 | 0 |
Issuance of common stock from ATM offering | $ 0 | 0 | 0 | 0 | 0 |
Issuance of common stock from ATM offering (in shares) | 0 | ||||
Balance at Sep. 30, 2023 | $ 0 | $ 289,980 | $ (24) | $ (282,117) | $ 7,839 |
Balance (in shares) at Sep. 30, 2023 | 1,864,265 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows (Q3) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Operating Activities: | ||
Net loss | $ (14,700) | $ (12,629) |
Adjustments to reconcile net loss to cash flows used in operating activities: | ||
Depreciation and amortization | 253 | 301 |
Stock-based compensation expense, net | 513 | 697 |
Change in fair value of warrant liability | 755 | 0 |
Net realized gain on marketable securities | (65) | 0 |
Changes in operating assets and liabilities: | ||
Accounts receivable | (19) | (350) |
Inventory, net | 325 | (113) |
Other current assets | (551) | (40) |
Other assets and liabilities | (16) | (142) |
Accounts payable and accrued expenses | (1,678) | 254 |
Net cash used in operating activities | (15,183) | (12,022) |
Investing Activities: | ||
Proceeds from sale of marketable securities | 578 | 0 |
Additions to intangible assets | (99) | 0 |
Purchases of property and equipment | (185) | (103) |
Net cash provided by (used in) investing activities | 294 | (103) |
Financing Activities: | ||
Proceeds from ATM stock offerings, net | 2,108 | 0 |
Payments on finance lease liability | (20) | (28) |
Net cash provided by (used in) financing activities | 2,088 | (28) |
Effect of exchange rate changes on cash | (6) | 1 |
Net increase (decrease) in cash and cash equivalents | (12,807) | (12,152) |
Cash and cash equivalents - beginning of period | 17,737 | 8,742 |
Cash and cash equivalents - end of period | 4,930 | 12,053 |
Supplemental cash flow information | ||
Inventory transferred to property, plant and equipment | 0 | 37 |
Non-cash impact of conversion of warrants to common stock | $ 6,868 | 0 |
As Reported [Member] | ||
Financing Activities: | ||
Cash and cash equivalents - beginning of period | $ 24,205 |
Nature of Business and Signific
Nature of Business and Significant Accounting Policies (FY) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Nature of Business, Basis of Presentation and Significant Accounting Policies [Abstract] | ||
Nature of Business and Significant Accounting Policies | Note 1 — Nature of Business and Basis of Presentation Nature of Business: Nuwellis, Inc. (the “Company”) is a medical technology company focused on developing, manufacturing, and commercializing the Aquadex FlexFlow® and Aquadex SmartFlow® systems (collectively, the “Aquadex System”) for ultrafiltration therapy. The Aquadex System is indicated for temporary (up to eight hours) or extended (longer than 8 hours in patients who require hospitalization) use in adult and pediatric patients weighing 20 kg. or more whose fluid overload is unresponsive to medical management, including diuretics. Nuwellis, Inc. is a Delaware corporation headquartered in Minneapolis with a wholly owned subsidiary in Ireland. The Company’s common stock began trading on the Nasdaq Capital Market in February 2012. 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: The accompanying condensed consolidated balance sheet as of December 31, 2022, which has been derived from the consolidated audited financial statements, and the unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information and with the instructions to Form 10-Q and Article 8 of Regulation S-X. Certain information and note disclosures normally included in the audited annual consolidated financial statements have been condensed or omitted pursuant to those rules and regulations. Accordingly, they do not include all of the information necessary for a fair presentation of results of operations, comprehensive loss, financial condition, and cash flows in conformity with U.S. GAAP. In the opinion of management, the condensed consolidated financial statements reflect all adjustments (consisting of normal recurring adjustments) considered necessary for a fair presentation of the results of the Company for the periods presented. Operating results for interim periods are not necessarily indicative of results that may be expected for the year as a whole. The preparation of the consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenues, expenses, and the related disclosures at the date of the consolidated financial statements and during the reporting period. Actual results could differ materially from these estimates. 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, 2022. 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, 2022 and 2021 and through September 30, 2023, 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 September 30, 2023, the Company had an accumulated deficit of $282.1 million and it expects to incur losses for the immediate future. To date, the Company has been funded by equity financings, and although the Company believes that it will be able to successfully fund its operations, there can be no assurance that it will be able to do so or that it will ever operate profitably. These factors raise substantial doubt about the Company’s ability to continue as a going concern through the next twelve months. 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, and complying with the requirements related to being a U.S. public company. To become and remain profitable, the Company must succeed in expanding the adoption and market acceptance of the Aquadex System. This will require the Company to succeed in training personnel at hospitals and in outpatient care settings, and effectively and efficiently manufacturing, marketing, and distributing the Aquadex System and related components. There can be no assurance that the Company will succeed in these activities, and it may never generate revenues sufficient to achieve profitability. During 2022, the Company closed on an underwritten public equity offering for aggregate net proceeds of approximately $9.4 million after deducting the underwriting discounts and commissions and other costs associated with the offering. See Note 3 — Stockholders’ Equity for additional related disclosures. The Company will require additional funding to grow its Aquadex Business, which may not be available on terms favorable to the Company, or at all. The Company may receive those funds from the proceeds from future warrant exercises, issuances of equity securities, or other financing transactions. 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. For the three and nine months ending September 30, 2023, the Company issued shares under the at-the-market program for aggregate net proceeds of none and approximately $2.1 million after deducting the underwriting discounts and commissions and other costs associated with the offering. The Company believes that its existing capital resources will be sufficient to support its operating plan through February 28, 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: The Company recognizes revenue in accordance with Accounting Standards Codification, Topic 606, Revenue from Contracts with Customers, which the Company adopted effective January 1, 2018. Accordingly, the Company recognizes revenue when its customers obtain control of its products or services, in an amount that reflects the consideration that the Company expects to receive in exchange for those goods and services. See Note 2 – Revenue Recognition below for additional disclosures. For the three months ended September 30, 2023, two customers represented 21% and 11% of net sales. For the nine months ended September 30, 2023, two customers each represented 17% and 12% of net sales. For the three months ended September 30, 2022, one customer represented 12% of net sales. For the nine months ended September 30, 2022, two customers each represented 13% and 10% of net sales. Accounts Receivable: Accounts receivable are unsecured, are recorded at net realizable value, and do not bear interest. The Company makes judgments as to its ability to collect 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. The Company performs credit evaluations of its customers’ financial condition on an as-needed basis. Payment is generally due 30 days from the invoice date and accounts past 30 days are individually analyzed for collectability. When all collection efforts have been exhausted, the account is written off against the related allowance. To date, the Company has not experienced any write-offs or significant deterioration of the aging of its accounts receivable, and therefore, no allowance for doubtful accounts was considered necessary as of September 30, 2023, or December 31, 2022. As of September 30, 2023, three customers represented 17%, 17% and 11% of the accounts receivable balance. As of December 31, 2022, two customers represented 15% and 10% of the total accounts receivable balance. 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) September 30, 2023 December 31, 2022 Finished Goods $ 811 $ 993 Work in Process 170 204 Raw Materials 1,659 1,609 Inventory Reserves (304 ) (145 ) Total $2,336 $2,661 Loss per Share : Basic loss per share is computed based on the net loss for each period divided by the weighted average number of common shares outstanding. See Note 3 – Stockholders’ Equity below for additional disclosures. 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: September 30 2023 2022 Stock options 111,275 11,910 Warrants to purchase common stock 1,308,271 16,970 Series F convertible preferred stock 5,080 508 Total 1,424,626 29,388 The following table reconciles reported net loss with reported net loss per share for each of the three and nine months ended September 30: Three months ended September 30 Nine months ended September 30 (in thousands, except per share amounts) 2023 2022 2023 2022 Net loss $(3,370) $(3,870) $(14,700) $(12,629) Weighted average shares outstanding 1,864 105 1,439 105 Basic and diluted loss per share $ (1.81 ) $(36.72 ) $ (10.21 ) $ (119.85 ) Subsequent Events: The Company evaluates events through the date the consolidated financial statements are filed for events requiring adjustment to or disclosure in the consolidated financial statements. See note 10 – Subsequent Events for additional disclosures. | Note 1—Nature of Business and Significant Accounting Policies Nature of Business Nuwellis, Inc. (the “Company”) is a medical technology company focused on developing, manufacturing and commercializing the Aquadex FlexFlow® and Aquadex SmartFlow® systems (collectively, the “Aquadex System”) for ultrafiltration therapy. The Aquadex SmartFlow® system is indicated for temporary (up to eight hours) or extended (longer than 8 hours in patients who require hospitalization) use in adult and pediatric patients weighing 20 kg or more, whose fluid overload is unresponsive to medical management, including diuretics. Nuwellis, Inc. is a Delaware corporation headquartered in Minneapolis with a wholly owned subsidiary in Ireland. The Company has been listed on Nasdaq since February 2012. 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 pediatrics applications. Going Concern The Company’s financial statements have been prepared and presented on a basis assuming it continues as a going concern. During the years ended December 31, 2022 and 2021, 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 December 31, 2022, the Company had an accumulated deficit of $267.4 million, and it expects to incur losses for the immediate future. To date, the Company has been funded by equity financings, and although the Company believes that it will be able to successfully fund its operations, there can be no assurance that it will be able to do so or that it will ever operate profitably. These factors raise substantial doubt about the Company’s ability to continue as a going concern through at least twelve months from the report date. 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 expanding its sales and marketing capabilities, purchasing inventory, manufacturing components, investing in clinical research and new product development, and complying with the requirements related to being a U.S. public company. To become and remain profitable, the Company must succeed in expanding the adoption and market acceptance of the Aquadex System. This will require the Company to succeed in training personnel at hospitals and effectively and efficiently manufacturing, marketing, and distributing the Aquadex System and related components. There can be no assurance that the Company will succeed in these activities, and it may never generate revenues sufficient to achieve profitability. During 2021 and through December 31, 2022, the Company closed on underwritten public equity offerings for aggregate net proceeds of approximately $37.3 million after deducting the underwriting discounts and commissions and other costs associated with the offerings. See Note 4—Stockholders’ Equity for additional related disclosure. The Company will require additional funding to grow its Aquadex Business, which may not be available on terms favorable to the Company, or at all. The Company may receive those funds from the proceeds from future warrant exercises, issuances of equity securities, or other financing transactions. The Company believes that its existing capital resources will be sufficient to support its operating plan through December 31, 2023. However, the Company may 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. Basis of Presentation The accompanying consolidated financial statements include the accounts of Nuwellis, Inc. and its wholly owned subsidiary, Sunshine Heart Ireland Limited. All intercompany accounts and transactions between consolidated entities have been eliminated. Use of Estimates The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the reported amounts and disclosures in the consolidated financial statements and accompanying notes. Actual results could differ materially from those estimates. Cash and Cash Equivalents Cash and cash equivalents consist of cash and term deposits with original maturities of three months or less. The carrying value of these instruments approximates fair value. The balances, at times, may exceed federally insured limits. The Company has not experienced any losses on its cash and cash equivalents. Marketable securities The Company’s marketable securities typically consist of investment-grade, U.S. dollar-denominated fixed and floating-rate debt, which are classified as available-for-sale and included in current assets. Most marketable securities mature within twelve months from their date of purchase and generally are intended to fund current operations. Securities are valued based on market prices for similar assets using third party certified pricing sources. Available-for-sale securities are carried at fair value with unrealized gains and losses reported as a component of shareholders’ equity in accumulated other comprehensive income (loss). Available-for-sale securities are reviewed for possible impairment at least quarterly, or more frequently if circumstances arise that may indicate impairment. When the fair value of the securities declines below the amortized cost basis and impairment is indicated, it must be determined whether the impairment is other than temporary. Impairment is considered to be other than temporary if the Company: (i) intends to sell the security, (ii) will more likely than not be forced to sell the security before recovering its cost, or (iii) does not expect to recover the security’s amortized cost basis. If the decline in fair value is considered other than temporary, the cost basis of the security is adjusted to its fair market value and the realized loss is reported in earnings. Subsequent increases or decreases in fair value are reported as a component of shareholders’ equity in accumulated other comprehensive gain (loss). There were no other than temporary unrealized losses as of December 31, 2022. Accounts Receivable Accounts receivables are unsecured, recorded at net realizable value, and do not bear interest. The Company makes judgments as to its ability to collect outstanding receivables based upon significant patterns of collectability, historical experience, and management’s evaluation of specific accounts, and it will provide an allowance for credit losses when collection becomes doubtful. The Company performs credit evaluations of its customers’ financial condition on an as-needed basis. Payment is generally due 30 days from the invoice date and accounts past 30 days are individually analyzed for collectability. When all collection efforts have been exhausted, the account is written off against the related allowance. To date the Company has not experienced any write-offs or significant deterioration in the aging of its accounts receivable, and therefore, no allowance for doubtful accounts was considered necessary as of December 31, 2022 or December 31, 2021. As of December 31, 2022, two customers represented 15% and 10% of the total accounts receivable balance. As of December 31, 2021, two customers represented 12% and 11% of the total accounts receivable balance. Inventories Inventories are recorded at 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. On a regular basis, the Company reviews its inventory and identifies that which is excess, slow moving, and obsolete by considering factors such as inventory levels and expected product life. A reserve is established for any identified excess, slow moving, and obsolete inventory through a charge to cost of goods sold. Inventories consisted of the following as of December 31: (Dollars in thousands) 2022 2021 Finished Goods $ 993 $1,527 Work in Process 204 276 Raw Materials 1,609 1,281 Inventory Reserves (145) (241) Total $2,661 $2,843 Other Current Assets Other current assets represent prepayments and deposits made by the Company. Property, Plant and Equipment Property, plant and equipment is stated at cost less accumulated depreciation. Depreciation is computed based upon the estimated useful life of the respective asset. Leasehold improvements are amortized using the straight-line method over the shorter of the lease term or the estimated useful life of the assets. Repairs and maintenance cost is expensed as incurred. The cost and accumulated depreciation of property, plant and equipment retired or otherwise disposed of is removed from the related accounts, and any residual values are charged to expense. Depreciation expense has been calculated using the following estimated useful lives: Production Equipment 3-7 years Office Furniture and Fixtures 3-5 years Computer Software and Equipment 3-4 years Loaners and demo equipment 1-5 years Leasehold improvements 3-5 years Depreciation expense was $372,000 and $488,000 for the years ended December 31, 2022 and 2021, respectively. Property, plant and equipment is reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset or asset group may not be recoverable. If the impairment tests indicate that the carrying value of the asset or asset group is greater than the expected undiscounted cash flows to be generated by such asset or asset group, further analysis is performed to determine the fair value of the asset or asset group. To the extent the fair value of the asset or asset group is less than its carrying value, an impairment loss is recognized equal to the amount the fair value of the asset or asset group is exceeded by its carrying amount. Assets to be disposed of are carried at the lower of their carrying value or fair value less costs to sell. Considerable management judgment is necessary to estimate the fair value of assets or asset groups, and accordingly, actual results could vary significantly from such estimates. The Company continues to report operating losses and negative cash flows from operations, both of which it considers to be indicators of potential impairment. Therefore, the Company evaluates its long-lived assets for potential impairment at each reporting period. The Company has concluded that its cash flows from the various long-lived assets are highly interrelated and, as a result, the Company consists of a single asset group. As the Company expects to continue incurring losses in the foreseeable future, the undiscounted cash flow step was bypassed, and the Company proceeded to fair value the asset group. The Company has determined the fair value of the asset group using a combination of expected discounted cash flows and other fair value indicators related to the asset grouping. There have been no impairment losses recognized for the years ended December 31, 2022 or 2021. Accounts Payable and Accrued Liabilities Accrued liabilities includes amounts accrued but not invoiced related to payments owed for licensing agreements, director fees, and others. Revenue Recognition The Company recognizes revenue in accordance with Accounting Standards Codification (“ASC”) Topic 606, Revenue from Contracts with Customers Foreign Currency Translation Sales and expenses denominated in foreign currencies are translated at average exchange rates in effect throughout the year. Assets and liabilities of foreign operations are translated at period-end exchange rates with the impacts of foreign currency translation recorded in cumulative translation adjustment, a component of accumulated other comprehensive income. Foreign currency transactions gains and losses are included in other expense, net in the consolidated statements of operations and other comprehensive loss. Stock-Based Compensation The Company recognizes all share-based payments to employees, directors, and consultants, including grants of stock options and common stock awards, in the consolidated statement of operations and comprehensive loss as an operating expense based on their fair values as established at the grant date. Equity instruments issued to non-employees include common stock awards or warrants to purchase shares of our common stock. These common stock awards or warrants are either fully vested and exercisable at the date of grant or vest over a certain period during which services are provided. The Company expenses the fair market value of fully vested awards at the time of grant, and of unvested awards over the period in which the related services are received. The Company computes the estimated fair values of stock options using the Black-Scholes option pricing model. Market price at the date of grant is used to calculate the fair value of common stock awards. Stock-based compensation expense is based on awards ultimately expected to vest and is reduced for forfeitures. See Note 5—Stock-Based Compensation, for further information regarding the assumptions used to calculate the fair value of stock-based compensation. Income Taxes Deferred income taxes are provided on a liability method, whereby deferred tax assets are recognized for deductible temporary differences and operating loss and tax credit carryforwards. Deferred tax liabilities are recognized for taxable temporary differences, which are the differences between the reported amounts of assets and liabilities and their tax bases. Deferred tax assets are reduced by a valuation allowance when, in the opinion of management, it is more likely than not that some portion or all of the deferred tax assets will not be realized. Deferred tax assets and liabilities are adjusted for the effects of changes in tax laws and rates on the date of enactment. The Company recognizes the financial statement benefit of a tax position only after determining that the relevant tax authority would more likely than not sustain the position following an audit. For tax positions meeting the more-likely-than-not threshold, the amount recognized in the consolidated financial statements is the largest benefit that has a greater than 50 percent likelihood of being realized upon ultimate settlement with the relevant tax authority. Loss per share Basic loss per share is computed based on the net loss for each period divided by the weighted average number of common shares outstanding. The net loss allocable to common stockholders for the year ended December 31, 2021, includes a deemed dividend of $75,000 that resulted from the change in the exercise price of warrants as a result of the March 2021 and September 2021 public offerings. (see Note 4 — Stockholders’ Equity). 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 year presented: December 31, 2022 2021 Stock options 10,485 7,481 Warrants to purchase common stock 679,244 16,299 Series F convertible preferred stock 5,080 50,800 Series I convertible preferred stock 10,493 — Total 705,302 74,580 The following table reconciles reported net loss with reported net loss per share for the years ended December 31: (in thousands, except per share amounts) 2022 2021 Net loss $(14,525) $(19,545) Deemed dividend to preferred stockholders (see Note 4) — (75) Net loss after deemed dividend (14,525) (19,620) Weighted average shares outstanding 174 69 Basic and diluted loss per share $ (83.55 ) $(285.36 ) Research and Development Research and development (R&D) costs include activities related to development, design, and testing improvements of the Aquadex System and potential related new products. These R&D costs also include expenses related to clinical research that the Company may sponsor or conduct to enhance understanding of the product and its use. R&D costs are expensed as incurred. Recent Accounting Pronouncements In June 2016, the FASB issued Accounting Standards Update (ASU) 2016-13, “Financial Instruments – Credit Losses.” This ASU added a new impairment model (known as the current expected credit loss (“CECL”) model) that is based on expected losses rather than incurred losses. Under the new guidance, an entity recognizes as an allowance its estimate of expected credit losses. The CECL model applies to most debt instruments, trade receivables, lease receivables, financial guarantee contracts, and other loan commitments. The CECL model does not have a minimum threshold for recognition of impairment losses, and entities will need to measure expected credit losses on assets that have a low risk of loss. As a smaller reporting company pursuant to Rule 12b-2 of the Securities Exchange Act of 1934, as amended, these changes become effective for the Company on January 1, 2023. Management has evaluated the potential impact of these changes on the consolidated financial statements of the Company and does not anticipate it will have any impact to the Company’s consolidated financial statements. The Company evaluates subsequent events through the date the consolidated financial statements are filed for events requiring adjustment to or disclosure in the consolidated financial statements. |
Revenue Recognition (FY)
Revenue Recognition (FY) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Revenue Recognition [Abstract] | ||
Revenue Recognition | Note 2 — Revenue Recognition Net Sales: The Company sells its products in the United States primarily through a direct salesforce. Customers who purchase the Company’s products include hospitals and clinics throughout the United States. In countries outside the United States, the Company sells its products through a limited number of specialty healthcare distributors in Austria, Brazil, Colombia, The Czech Republic, Germany, Greece, Hong Kong, India, Indonesia, Israel, Italy, Panama, Romania, Singapore, Slovakia, Spain, Switzerland, Thailand, United Arab Emirates, and the United Kingdom. These distributors resell the Company’s products to hospitals and clinics in their respective geographies. International revenue represents 5% of net sales for the three and nine months ended September 30, 2023 and 2022. 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 and nine months ended September 30, 2023 and 2022. The unfulfilled performance obligations related to these extended service plans are included in deferred revenue, which is included in other current liabilities on the 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 not received any 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. | Note 2 – Revenue Recognition Net Sales The Company sells its products in the United States primarily through a direct salesforce. Customers who purchase the Company’s products include hospitals and clinics throughout the United States. In countries outside the United States, the Company sells its products through a limited number of specialty healthcare distributors in Austria, Brazil, Colombia, the Czech Republic, Germany, Greece, Hong Kong, India, Israel, Italy, Panama. Romania, Singapore, Slovakia, Spain, Switzerland, Thailand, United Arab Emirates, and the United Kingdom. These distributors resell the Company’s products to hospitals and clinics in their respective geographies. 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, which are recognized over time. This revenue represents less than 1% of net sales for each of the years ended December 31, 2022 and 2021. The unfulfilled performance obligations related to these extended service plans are included in deferred revenue, which is included in other current liabilities on the 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 product 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 not received any 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. |
Property, Plant and Equipment (
Property, Plant and Equipment (FY) | 12 Months Ended |
Dec. 31, 2022 | |
Property, Plant and Equipment [Abstract] | |
Property, Plant and Equipment | Note 3—Property, Plant and Equipment Property, plant and equipment were as follows: (in thousands) December 31, 2022 December 31, 2021 Production Equipment $ 1,360 $ 1,321 Loaners and Demo Equipment 1,444 1,364 Computer Software and Equipment 719 714 Office Furniture & Fixtures 375 364 Leasehold Improvements 253 245 Total 4,151 4,008 Accumulated Depreciation (3,171 ) (2,820 ) $ 980 $ 1,188 |
Stockholders' Equity (FY)
Stockholders' Equity (FY) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
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. 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, described below. 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, described below. As of September 30, 2023, and December 31, 2022, 127 shares of the Series F convertible preferred stock remained outstanding. 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. 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 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 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 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: In March 2023, the Company filed a Prospectus Supplement to its Registration Statement on Form S-3 with the SEC in connection with a proposed At-the-Market Securities offering (the “At-the-Market Program”). During the three months and nine months ended September 30, 2023, the Company issued none and 657,333 shares of common stock under the At-the-Market Program for gross proceeds of none and approximately $2.3 million, respectively. Net proceeds for the three and nine months ended September 30, 2023, totaled none approximately $2.1 million, respectively, after deducting the underwriting discounts and commissions and other costs associated with the 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. 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, based on 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 and had not vested as of September 30, 2023. Supply Agreement Warrants : On June 19, 2023, we entered into a Supply and Collaboration Agreement (the “Supply Agreement” ) with DaVita Inc., a Delaware corporation ( “DaVita” ), pursuant to which DaVita will pilot the Aquadex ultrafiltration therapy system to treat adult patients with congestive heart failure and related conditions within select U.S. markets. The pilot program is expected to launch by the end of fourth quarter 2023 and extend through May 31, 2024 (the “Pilot” ). Through the Pilot, ultrafiltration therapy using Aquadex will be offered at a combination of DaVita’s hospital customer and outpatient center locations, with both companies collaborating on the roll-out of the therapy, clinician training, and patient support. At the conclusion of the Pilot, DaVita has the option, in its sole discretion, to extend the Supply Agreement with the Company for continued provision of both inpatient and outpatient ultrafiltration services for up to 10 years ( “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 September 30, 2023. 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 September 30, 2023, 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. | Note 4—Stockholders’ Equity Series F Convertible Preferred Stock : On November 27, 2017, the Company closed on an underwritten public offering 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 was to expire 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, described below. 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, described below. 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, described below. 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 2020 offering, described below. As of December 31, 2022, and December 31, 2021, 127 shares of the Series F convertible preferred stock remained outstanding. Series H Convertible Preferred Stock and January 2020 Offering: On January 28, 2020, the Company closed on an underwritten public offering of common stock, Series H convertible preferred stock, and warrants to purchase shares of common stock for gross proceeds of $9.7 million, which included the full exercise of the underwriter’s over-allotment option to purchase additional shares and warrants (“January 2020 Offering”). Net proceeds totaled approximately $8.6 million after deducting the underwriting discounts and commissions and other costs associated with the offering. The Series H convertible preferred stock included a beneficial conversion amount of $1.6 million, representing the intrinsic value of the shares at the time of issuance, and $0.2 million of down-round protection in connection with the re-pricing of the warrants following the March 2020 offering described below. This amount is reflected as an increase to the loss per share allocable to common stockholders in the year ended December 31, 2020. The January 2020 Offering was comprised of 2,015 shares of common stock priced at $1,650 per share and 115,173 shares of Series H convertible preferred stock, convertible into common stock at $1,650 per share, including the full exercise of the over-allotment option. Each share of Series H convertible preferred stock and each share of common stock was accompanied by a warrant to purchase common stock. The warrants are exercisable into 5,855 shares of common stock. The conversion price of the preferred stock issued in the transaction is 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. The warrants were exercisable beginning on the closing date and expire on the fifth anniversary of the closing date and had an initial exercise price per share equal to $1,650 per share, subject to appropriate adjustment in the event of subsequent equity sales of common stock or securities convertible into common stock for an exercise price per share less than the exercise price per share of the warrants then in effect (but in no event lower than 10% of the applicable unit offering price), or in the event of recapitalization events, stock dividends, stock splits, stock combinations, reclassifications, reorganizations or similar events affecting our common stock. Effective March 23, 2020, the exercise price of these warrants was reduced from $1,650 to $900, the per share price to the public in the March 2020 offering, described below. As of December 31, 2020, all 115,173 shares of the Series H convertible preferred stock had been converted into common stock and none remained outstanding. As of December 31, 2020, warrants to purchase 4,552 shares of common stock had been exercised for total cash proceeds of $4.1 million. March 2020 Offering: On March 23, 2020, the Company closed on a registered direct offering of 1,387 shares of its common stock at a price to the public of $900 per share, for gross proceeds of approximately $1.2 million, or $1.0 million net proceeds, after deducting commissions and offering expenses. In a concurrent private placement, the Company agreed to issue to the investors in the registered direct offering warrants to purchase up to 1,387 shares of the Company’s common stock. The warrants to purchase up to 1,387 shares of common stock have an exercise price of $1,118 per share, were exercisable six months from the date of issuance, and will expire five and a half years April 2020 Offering : On April 1, 2020, the Company closed on a registered direct offering of 1,710 shares of its common stock at a price to the public of $1,302 per share, for gross proceeds of approximately $2.2 million, prior to deduction of commissions and offering expenses related to the transaction. In a concurrent private placement, the Company agreed to issue to the investors in the registered direct offering warrants to purchase up to 855 shares of the Company’s common stock. The warrants have an exercise price of $1,115 per share, were exercisable immediately, and will expire five and a half years May 2020 Offering : On May 5, 2020, the Company closed on a registered direct offering of 1,199 shares of its common stock at a price to the public of $1,418 per share, for gross proceeds of approximately $1.7 million, prior to deduction of commissions and offering expenses related to the transaction. In a concurrent private placement, the Company agreed to issue to the investors in the registered direct offering warrants to purchase up to 600 shares of the Company’s common stock. The warrants have an exercise price of $1,230 per share, were exercisable immediately, and will expire five and a half years August 2020 Offering : On August 21, 2020, the Company closed on an underwritten public offering of common stock and warrants to purchase shares of common stock for gross proceeds of approximately $14.4 million, which included the full exercise of the underwriter’s over-allotment option to purchase additional shares and warrants (“August 2020 Offering”). Net proceeds totaled approximately $13.0 million after deducting the underwriting discounts and commissions and other costs associated with the offering. The August 2020 Offering was comprised of 10,647 shares of common stock priced at $1,350 per share. Each share of common stock was accompanied by a warrant to purchase common stock. The warrants are exercisable into 10,647 shares of common stock. The securities comprising the units are immediately separable and were issued separately. The warrants were exercisable beginning on the effective date of our stockholders’ approval of a reverse stock split in an amount sufficient to permit the exercise in full of the warrants, which occurred on October 6, 2020, and will expire on the five-year anniversary of the closing date. 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 for every one hundred shares of Series I convertible preferred 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 at a $0.00 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 such reverse stock split and of the exercisability of the warrants under Nasdaq rules, and will 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” “Certificate of Amendment” 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. Placement Agent Fees : In connection with the offerings described above, the Company paid the placement agents an aggregate cash placement fee equal to 8% of the aggregate gross proceeds raised in each of the offerings. 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 December 31, 2022. Reverse Stock Split : On December 5, 2022, the Company’s stockholders approved the Company’s management to execute a reverse split of its outstanding common stock at a ratio in the range of 1-for-50 1-for-100 1-for-100 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 have been retroactively adjusted to reflect the reverse stock splits for all periods presented. |
Stock-Based Compensation (FY)
Stock-Based Compensation (FY) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
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 September 30 Nine months ended September 30 (in thousands) 2023 2022 2023 2022 Selling, general and administrative expense $133 $199 $484 $624 Research and development expense 2 21 29 73 Total stock-based compensation expense $135 $220 $513 $697 During the three months ended September 30, 2023 and 2022, under the 2017 Equity Incentive Plan, the 2021 Inducement Plan, and the 2013 Non-Employee Directors’ Equity Incentive Plan, the Company granted 18,643 and 369 stock options, respectively, to its directors, officers and employees. During the nine months ended September 30, 2023 and 2022, the Company granted 125,410 and 5,577, respectively, to its directors, officers, employees and consultants. Vesting generally occurs over an immediate to 48-month period based on a time-of-service condition, although vesting acceleration is provided under one grant in the event that a certain milestone is met. The weighted-average grant date fair value of the stock-options issued during the three months ended September 30, 2023 and 2022 was $1.63 and $60.40 per share, respectively. The weighted-average grant date fair value of the stock options issued during the nine months ended September 30, 2023 and 2022 was $6.18 and $79.07 per share, respectively. The total number of stock options outstanding as of September 30, 2023 and September 30, 2022 was 111,275 and 12,003, respectively. The weighted-average assumptions used in the Black-Scholes option-pricing model are as follows for the stock options granted during the three and nine months ended September 30, 2023 and 2022: Three months ended September 30 Nine months ended September 30 2023 2022 2023 2022 Expected volatility 131.06% 132.08% 152.59% 132.48% Expected Life of options (years) 6.25 6.25 6.19 6.15 Expected dividend yield 0% 0% 0% 0% Risk-free interest rate 4.29% 3.02% 4.16% 2.13% During the three months ended September 30, 2023 and 2022, 2,576 and 823 stock options vested, respectively, and 21,372 and 343 stock options were expired or forfeited during these periods, respectively. During the nine months ended September 30, 2023 and 2022, 5,022 and 2,730 stock options vested, respectively, and 24,620 and 1,148 stock options were expired or forfeited during these periods, respectively. During the three and nine months ended September 30, 2023 and 2022, no options were exercised. | Note 5— Stock-Based Compensation Stock Options and Restricted Stock Awards The Company has various share-based compensation plans, including the Third Amended and Restated 2017 Equity Incentive Plan, the 2013 Non-Employee Directors’ Equity Incentive Plan and the 2021 Inducement Plan (collectively, the “Plans” The Company recognized stock-based compensation expense related to grants of stock options and common stock awards to employees, directors and consultants of $862,000 and $1.3 million during the years ended December 31, 2022 and 2021, respectively. The following table summarizes the stock-based compensation expense that was recognized in the consolidated statements of operations for the years ended December 31, (Dollars in thousands) 2022 2021 Selling, general and administrative $784 $1,171 Research and development 78 143 Total $862 $1,314 The majority of the common stock awards and options to purchase common stock vest on the anniversary of the date of grant, which ranges from one Stock Options : The following is a summary of the Plans’ stock option activity during the years ended December 31: 2022 2021 Options Outstanding Weighted Average Exercise Price Options Outstanding Weighted Average Exercise Price Beginning Balance 7,481 $656.05 144 $40,534.00 Granted 5,833 83.96 9,081 444.83 Exercised — — — — Forfeited/expired (2,829) 410.34 (1,744) 2,332.06 Outstanding at December 31 10,485 $404.08 7,481 $ 656.05 Vested at December 31 3,531 $727.26 409 $ 4,218.40 For options outstanding and vested at December 31, 2022 and 2021, the weighted average remaining contractual life was 8.79 years and 8.63 years, respectively. There were no option exercises in 2022 or 2021. The total fair value of options that vested in 2022 and 2021 was $1.1 million, and $0.7 million, respectively, at the fair value of the options as of the date of grant. Valuation Assumptions : The fair value of each stock option is estimated at the grant date using the Black-Scholes option pricing model. The fair value of stock options under the Black-Scholes option pricing model requires management to make assumptions regarding projected employee stock option exercise behaviors, risk-free interest rates, volatility of the Company’s stock price, and expected dividends. The Company has not historically paid cash dividends to its stockholders and currently does not anticipate paying any cash dividends in the foreseeable future. As a result, the Company has assumed a dividend yield of 0%. The risk-free interest rate is based upon the rates of U.S. Treasury bills with a term that approximates the expected life of the option. Since the Company has limited historical exercise data to reasonably estimate the expected life of its option awards, the expected life is calculated using a simplified method. Expected volatility is based on historical volatility of the Company’s stock. The following table provides the weighted average assumptions used in the Black-Scholes option pricing model for the years ended December 31: 2022 2021 Expected dividend yield 0% 0% Risk-free interest rate 2.13% 1.19% Expected volatility 132.48% 131.03% Expected life (in years) 6.15 6.21 The weighted-average fair value of stock options granted in 2022 and 2021 was $76.05 and $396.17, respectively. As of December 31, 2022, the total compensation cost related to all non-vested stock option awards not yet recognized was approximately $1.3 million and is expected to be recognized over the remaining weighted-average life of 2.54 years. Warrants : Warrants to purchase 679,244 and 16,299 shares of common stock were outstanding on December 31, 2022 and 2021, respectively. As of December 31, 2022, warrants outstanding were exercisable at prices ranging from $25 to $189,000 per share and are exercisable over a period ranging from immediately to 5.8 years. |
Fair Value of Financial Instrum
Fair Value of Financial Instruments (FY) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
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, marketable securities, 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. All cash equivalents and marketable securities are considered Level 1 measurements for all periods presented. The available-for-sale marketable securities primarily consist of investment-grade, U.S.-dollar-denominated fixed and floating rate debt, measured at fair value on a recurring basis. September 30, 2023 December 31, 2022 (in thousands) Fair Value Level 1 Fair Value Level 1 Marketable securities $0 $0 $569 $569 The fair value of the Company’s common stock warrant liability related to the investor warrants issued in the October 2022 Offering 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 Balance at January 4, 2023 (revaluation date) 7,623 Warrants reclassified to equity (7,623 ) Balance at September 30, 2023 $ — | Note 6—Fair Value of Financial Instruments The Company’s financial instruments consist of cash and cash equivalents, marketable securities, and warrants. Pursuant to the requirements of ASC Topic 820 “Fair Value Measurement,” • 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. All cash equivalents and marketable securities are considered Level 1 measurements for all periods presented. The available-for-sale marketable securities primarily consist of investment-grade, U.S. dollar-denominated fixed and floating-rate debt, measured at fair value on a recurring basis. 2022 2021 (Dollars in thousands) Fair Value Level 1 Fair Value Level 1 Marketable securities $569 $569 $15,463 $15,463 The fair value of the Company’s common stock warrant liability related to the investor warrants issued in the October 2022 public offering, 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 Level 3 warrants: (in thousands) October 18, 2022 warrant issuance $ 18,695 Change in fair value (11,827) Ending balance December 31, 2022 $ 6,868 Fair values were calculated using the following assumptions: Oct. 18, 2022 Dec. 31, 2022 Risk-free interest rates, adjusted for continuous compounding 4.16% 3.97% Term (years) 6.18 6.11 Expected volatility 141.5% 145.3% Dates and probability of future equity raises various various A significant change in the inputs used for the Monte Carlo and Black Scholes valuation models, such as the expected volatility, risk-free interest rate, or probability of future equity financings, in isolation, would result in significantly higher or lower fair value measurements. In combination, changes in these inputs could result in a significantly higher or lower fair value measurement if the input changes were to be aligned or could result in a minimally higher or lower fair value measurement if the input changes were of a compensating nature. |
Income Taxes (FY)
Income Taxes (FY) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
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 September 30, 2023, 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, 2022. | Note 7—Income Taxes Domestic and foreign income (loss) before income taxes consists of the following for the years ended December 31: (in thousands) 2022 2021 Domestic $(14,551) $(19,582) Foreign 35 37 Loss before income taxes $(14,516 ) $(19,545 ) The components of income tax expense consist of the following for the years ended December 31: (in thousands) 2022 2021 Current: United States and state $— $— Foreign, net (9) (9) Deferred: United States and state — — Foreign — — Total income tax expense $ (9 ) $ (9 ) Actual income tax expense differs from statutory federal income tax expense as follows for the years ended December 31: (in thousands) 2022 2021 Statutory federal income tax benefit $ 3,048 $ 4,109 State tax benefit, net of federal taxes 783 560 Foreign tax (1) (1) Nondeductible/nontaxable items 548 (220) Other (41) 406 Valuation allowance (increase) decrease (4,346) (4,863) Total income tax expense $ (9 ) $ (9 ) Deferred taxes consist of the following as of December 31: (in thousands) 2022 2021 Deferred tax assets: Noncurrent: Accrued leave $ 397 $ 59 Stock based compensation 360 368 Net operating loss carryforward 45,405 42,363 Other 42 131 Intangibles 1,786 723 R&D credit carryforward 531 531 Total deferred tax assets 48,521 44,175 Less: valuation allowance (48,521) (44,175) Total $ — $ — As of December 31, 2022, the Company had federal net operating loss 2024 2038 The Company provides for a valuation allowance when it is more likely than not that it will not realize a portion of the deferred tax assets. The Company has established a valuation allowance for 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 consolidated financial statements. For the years ended December 31, 2022, and 2021, the valuation allowance increased by $4.3 million and $4.9 million, respectively. The current year increase was primarily due to the federal and state net operating losses generated. During 2022 and 2021, the Company believes it experienced an ownership change as defined in Section 382 of the Internal Revenue Code, which will limit the ability to utilize the Company’s net operating losses (NOLs). The Company may have experienced additional ownership changes in earlier years further limiting the NOL carryforwards that may be utilized. The Company has not yet completed a formal Section 382 analysis. The general limitation rules allow the Company to utilize its NOLs subject to an annual limitation that is determined by multiplying the federal long-term tax-exempt rate by the Company’s value immediately before the ownership change. The accounting guidance related to uncertain tax positions prescribes a recognition threshold and measurement attribute for recognition and measurement of a tax position taken or expected to be taken in a tax return. It also provides guidance on de-recognition, classification, interest and penalties, accounting in interim periods, disclosure and transition. The Company had no material uncertain tax positions as of December 31, 2022 or 2021. The Company recognizes interest and penalties on unrecognized tax benefits as well as interest received from favorable tax settlements within income tax expense. At December 31, 2022 and 2021, the Company recorded no accrued interest or penalties related to uncertain tax positions. The tax years ended December 31, 2019 through December 31, 2022 remain open to examination by the Internal Revenue Service and by the various states where the Company is subject to taxation. Additionally, the returns of the Company’s Australian (through November 2020) and Irish subsidiaries are subject to examination by tax authorities of those jurisdictions for the tax years ended and subsequent to June 30, 2017 and December 31, 2017, respectively. |
Operating Leases (FY)
Operating Leases (FY) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Operating Leases [Abstract] | ||
Operating Leases | Note 7 — Operating Leases The Company leases a 23,000 square foot facility located in Eden Prairie, Minnesota for office and manufacturing space under a non-cancelable operating lease that expires in March 2027. In November 2021, the Company entered into a fourth amendment to the lease, extending the term of the lease from March 31, 2022 to March 31, 2027. This facility serves as our corporate headquarters and houses substantially all our functional departments. Monthly rent and common area maintenance charges, including estimated property tax for our headquarters, total approximately $32,000. The lease contains provisions for annual inflationary adjustments. Rent expense is being recorded on a straight-line basis over the term of the lease. Beginning on April 1, 2022, the annual base rent was $10.50 per square foot, subject to future annual increases of $0.32 to $0.34 per square foot. | Note 8—Operating Leases The Company leases a 23,000 square foot facility located in Eden Prairie, Minnesota for office and manufacturing space under a non-cancelable operating lease that expires in March 2027. In November 2021, the Company entered into a fourth amendment to the lease, extending the term of the lease from March 31, 2022 to March 31, 2027. This facility serves as our corporate headquarters and houses substantially all our functional areas. Monthly rent and common area maintenance charges, including estimated property tax for our headquarters, total approximately $31,000. The lease contains provisions for annual inflationary adjustments. Rent expense is being recorded on a straight-line basis over the term of the lease. Beginning on April 1, 2022, the annual base rent was $10.50 per square foot, subject to annual increases of $0.32 to $0.34 per square foot thereafter. The cost components of the Company’s operating lease were as follows for the year ended December 31: (in thousands) 2022 2021 Operating lease cost $238 $219 Variable lease cost 127 123 Total $365 $342 Variable lease costs consist primarily of taxes, insurance, and common area or other maintenance costs for our leased office and manufacturing space. Maturities of our lease liability for the Company’s operating lease are as follows as of December 31: (in thousands) 2022 2023 $ 249 2024 257 2025 264 2026 272 2027 69 Total lease payments 1,111 Less: Interest (155 ) Present value of lease liability $ 956 As of December 31, 2022, and 2021, the remaining lease terms were 4.25 and 5.25 years, respectively, and discount rates were 6.25% and 7.5% respectively. For the years ended December 31, 2022, and 2021, the operating cash outflows from the Company’s operating lease for office and manufacturing space were $238,000 and $219,000, respectively. |
Finance Lease Liability (FY)
Finance Lease Liability (FY) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Finance Lease Liability [Abstract] | ||
Finance Lease Liability | Note 8 — Finance Lease Liability In 2020, the Company entered into lease agreements to finance equipment valued at $98,000. The equipment consisted of computer hardware and audio-visual equipment and is included in Property, Plant and Equipment | Note 9—Finance Lease Liability In 2020, the Company entered into lease agreements to finance equipment valued at $98,000. The equipment consisted of computer hardware and audio-visual equipment and is included in Property, Plant and Equipment |
Commitments and Contingencies (
Commitments and Contingencies (FY) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Commitments and Contingencies [Abstract] | ||
Commitments and Contingencies | Note 9 — Commitments and Contingencies Employee Retirement Plan: The Company has a 401(k) retirement plan that provides retirement benefits to substantially all full-time U.S. employees. Eligible employees may contribute a percentage of their annual compensation, subject to Internal Revenue Service limitations, with the Company matching a portion of the employees’ contributions at the discretion of the Company. Milestone Payment: On December 27, 2022, the Company entered into a license and distribution agreement with SeaStar Medical Holding Corporation, (Nasdaq: ICU), a medical device company developing proprietary solutions to reduce the consequences of dysregulated immune responses including hyperinflammation on vital organs (“SeaStar”), appointing the Company as the exclusive U.S. distributor to promote, advertise, market, distribute and sell certain products. As a part of this agreement, the Company agreed to pay SeaStar, a milestone payment of $450,000, upon its receipt of a Human Device Exemption (HDE) approval from the U.S. Food and Drug Administration’s (FDA). This payment is due within 30 days after achievement of the milestone event. As of September 30, 2023, SeaStar had not obtained such HDE approval, but the Company believes approval is reasonably possible. No liability for this milestone payment has been recorded in the financial statements as of September 30, 2023. | Note 10—Commitments and Contingencies Employee Retirement Plan The Company has a 401(k) plan that provides a retirement benefit to substantially all full-time U.S. employees. Eligible employees may contribute a percentage of their annual compensation, subject to Internal Revenue Service limitations, with the Company matching a portion of the employees’ contributions at the discretion of the Company. Matching contributions totaled $185,000 and $255,000 for the years ended December 31, 2022 and 2021, respectively. Non-refundable Technology License Fee On June 24, 2021, the Company entered into a research and development collaboration agreement with Koronis Biomedical Corporation (KBT) to design and develop an integrated continuous renal replacement therapy device. This agreement became effective on August 5, 2021, when KBT received approval of a $1.7 million grant from the National Institutes of Health (NIH) to support this project. As part of this agreement, the Company will pay KBT a non-refundable technology license fee of $428,160, payable in twelve equal monthly installments commencing on June 1, 2022. The Company has recorded a liability for the non-refundable technology license fee, with $178,400 included in Current Accounts Payable at December 31, 2022. The full amount of $428,160 was expensed and included in the Research and Development Expense line for the year ended December 31, 2021. |
Related Party Transactions (FY)
Related Party Transactions (FY) | 12 Months Ended |
Dec. 31, 2022 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | Note 11—Related Party Transactions There were no related party transactions requiring disclosure during the year ended December 31, 2022 and 2021. |
Segment and Geographic Informat
Segment and Geographic Information (FY) | 12 Months Ended |
Dec. 31, 2022 | |
Segment and Geographic Information [Abstract] | |
Segment and Geographic Information | Note 12—Segment and Geographic Information The Company has one reportable segment, fluid management. At December 31, 2022 and 2021, long-lived assets were located primarily in the United States. |
Revision and Immaterial Correct
Revision and Immaterial Correction of an Error in Previously Issued Financial Statements (FY) | 12 Months Ended |
Dec. 31, 2022 | |
Revision and Immaterial Correction of an Error in Previously Issued Financial Statements [Abstract] | |
Revision and Immaterial Correction of an Error in Previously Issued Financial Statements | Note 13—Revision and Immaterial Correction of an Error in Previously Issued Financial Statements The Company identified an error related to the classification and disclosures of marketable securities in our consolidated financial statements as of and for the year ended December 31, 2021 as reported on Form 10-K. In our December 31, 2021 consolidated financial statements, we incorrectly classified short term marketable securities as a cash and cash equivalents on the consolidated balance sheet. There was no change to the total current assets on the consolidated balance sheet. Additionally, we recorded an unrealized gain in other income on the consolidated statement of operations. This unrealized gain should have been recorded as accumulated other comprehensive income in the consolidated statement of operations and comprehensive loss and the consolidated statements of stockholders’ equity. This correction also impacts the consolidated statement of cash flows, as the purchase of these securities and redemption of these securities would be shown in the investing activities section. In accordance with ASC 250, Accounting Changes and Error Corrections The tables below present the effect of the financial statement adjustments related to the revision discussed above of the Company’s previously reported financial statements as of and for the periods ended December 31, 2021. The effect of the immaterial correction of an error on our previously filed audited consolidated financial statements as of December 31, 2021 and for the year then ended is as follows: (in thousands) December 31, 2021 Consolidated Balance Sheet As reported Adjustment As revised Cash and cash equivalents $24,205 $(15,463) $ 8,742 Marketable securities — 15,463 15,463 Total Current Assets 28,126 — 28,126 Consolidated Statement of Operations and Comprehensive Loss (in thousands) As reported Adjustment As revised Other income (expense) (43) 24 (19) Unrealized gains (losses) on marketable securities — (24) (24) (43) — (43) Consolidated Statement of Cash Flows (in thousands) As reported Adjustment As revised Net realized and unrealized gains on marketable securities — 13 13 Net cash provided in operations — 13 13 Purchases of marketable securities — (18,850) (18,850) Proceeds from sales of marketable securities — 3,350 3,350 Net cash used in investing activities — (15,500) (15,500) Beginning cash and cash equivalents 14,437 — 14,437 Ending cash and cash equivalents $24,205 $(15,463) $ 8,742 |
Subsequent Events (FY)
Subsequent Events (FY) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Subsequent Events [Abstract] | ||
Subsequent Events | Note 10 — Subsequent Events Public Offering: On October 17, 2023, the Company closed on a public offering of 150,000 units (the “Units”), with each Unit consisting of one share of the Company’s Series J Convertible Redeemable Preferred Stock, par value $0.0001 per share, with a liquidation preference of $25.00 per share (the “Series J Convertible Preferred Stock”), and one warrant (the “October 2023 Warrants”) to purchase one-half of one (0.50) share of Series J Convertible Preferred Stock. The purchase price for one Unit was $15.00, which reflects the issuance of the Series J Convertible Preferred Stock with an original issue discount. The Series J Convertible Preferred Stock has a term of three (3) years and is convertible at the option of the holder at any time into shares of the Company’s common stock at a conversion price of $1.01. If any shares of our Series J Convertible Preferred Stock are outstanding at the end of the three-year term, then the Company will promptly redeem all of such outstanding shares of Series J Convertible Preferred Stock on a pro rata basis among all of the holders of Series J Convertible Preferred Stock commencing on the third-year anniversary of the closing date of this offering (the “Mandatory Redemption Date”) in cash, to the extent legally permissible under Delaware law, or, if redemption for cash is not legally permissible in duly authorized, validly issued, fully paid and non-assessable shares of the Company’s common stock equal in number to the quotient obtained by dividing such unpaid amount by the closing price of the Company’s common stock on the Nasdaq on the Mandatory Redemption Date. Dividends on the Series J Convertible Preferred Stock will be paid, if and when declared by the Company’s board of directors, in-kind (“PIK dividends”) in additional shares of Series J Convertible Preferred Stock based on the stated value of $25.00 per share at a dividend rate of 5.0%. The PIK dividends will be paid on a quarterly basis for three (3) years following the closing date to holders of the Series J Convertible Preferred Stock of record at the close of business on October 31, January 31, April 30, and July 31 of each year. The October 2023 Warrants have a term of three (3) years. Each October 2023 Warrant has an exercise price of $7.50 (50.0% of the public offering price per Unit) per one-half of one share (0.5) of Series J Convertible Preferred Stock and is immediately exercisable. The Company is currently evaluating the accounting treatment of the Series J Convertible Preferred Stock and the October 2023 Warrants. The gross proceeds before underwriting discounts and commissions and offering expenses, were approximately $2.25 million. The Company intends to use the net proceeds from the offering for working capital and for general corporate purposes. | Note 14—Subsequent Events On January 4, 2023, shareholder approval was secured by the Company for the issuance of the common stock warrants issued in conjunction with the Company’s October 2022 financing. During 2023, through February 24, 2023, there were 660,046 common stock warrants which had converted into 660,046 shares of common stock at a $0 exercise price with no proceeds received by the Company. At-The-Market Offering 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 may offer and sell shares having an aggregate offering price of up to $10.0 million. Ladenburg is entitled to a commission at a fixed commission rate equal to up to 3% of the gross proceeds. |
Nature of Business and Basis of
Nature of Business and Basis of Presentation (Q3) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Nature of Business, Basis of Presentation and Significant Accounting Policies [Abstract] | ||
Nature of Business and Basis of Presentation | Note 1 — Nature of Business and Basis of Presentation Nature of Business: Nuwellis, Inc. (the “Company”) is a medical technology company focused on developing, manufacturing, and commercializing the Aquadex FlexFlow® and Aquadex SmartFlow® systems (collectively, the “Aquadex System”) for ultrafiltration therapy. The Aquadex System is indicated for temporary (up to eight hours) or extended (longer than 8 hours in patients who require hospitalization) use in adult and pediatric patients weighing 20 kg. or more whose fluid overload is unresponsive to medical management, including diuretics. Nuwellis, Inc. is a Delaware corporation headquartered in Minneapolis with a wholly owned subsidiary in Ireland. The Company’s common stock began trading on the Nasdaq Capital Market in February 2012. 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: The accompanying condensed consolidated balance sheet as of December 31, 2022, which has been derived from the consolidated audited financial statements, and the unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information and with the instructions to Form 10-Q and Article 8 of Regulation S-X. Certain information and note disclosures normally included in the audited annual consolidated financial statements have been condensed or omitted pursuant to those rules and regulations. Accordingly, they do not include all of the information necessary for a fair presentation of results of operations, comprehensive loss, financial condition, and cash flows in conformity with U.S. GAAP. In the opinion of management, the condensed consolidated financial statements reflect all adjustments (consisting of normal recurring adjustments) considered necessary for a fair presentation of the results of the Company for the periods presented. Operating results for interim periods are not necessarily indicative of results that may be expected for the year as a whole. The preparation of the consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenues, expenses, and the related disclosures at the date of the consolidated financial statements and during the reporting period. Actual results could differ materially from these estimates. 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, 2022. 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, 2022 and 2021 and through September 30, 2023, 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 September 30, 2023, the Company had an accumulated deficit of $282.1 million and it expects to incur losses for the immediate future. To date, the Company has been funded by equity financings, and although the Company believes that it will be able to successfully fund its operations, there can be no assurance that it will be able to do so or that it will ever operate profitably. These factors raise substantial doubt about the Company’s ability to continue as a going concern through the next twelve months. 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, and complying with the requirements related to being a U.S. public company. To become and remain profitable, the Company must succeed in expanding the adoption and market acceptance of the Aquadex System. This will require the Company to succeed in training personnel at hospitals and in outpatient care settings, and effectively and efficiently manufacturing, marketing, and distributing the Aquadex System and related components. There can be no assurance that the Company will succeed in these activities, and it may never generate revenues sufficient to achieve profitability. During 2022, the Company closed on an underwritten public equity offering for aggregate net proceeds of approximately $9.4 million after deducting the underwriting discounts and commissions and other costs associated with the offering. See Note 3 — Stockholders’ Equity for additional related disclosures. The Company will require additional funding to grow its Aquadex Business, which may not be available on terms favorable to the Company, or at all. The Company may receive those funds from the proceeds from future warrant exercises, issuances of equity securities, or other financing transactions. 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. For the three and nine months ending September 30, 2023, the Company issued shares under the at-the-market program for aggregate net proceeds of none and approximately $2.1 million after deducting the underwriting discounts and commissions and other costs associated with the offering. The Company believes that its existing capital resources will be sufficient to support its operating plan through February 28, 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: The Company recognizes revenue in accordance with Accounting Standards Codification, Topic 606, Revenue from Contracts with Customers, which the Company adopted effective January 1, 2018. Accordingly, the Company recognizes revenue when its customers obtain control of its products or services, in an amount that reflects the consideration that the Company expects to receive in exchange for those goods and services. See Note 2 – Revenue Recognition below for additional disclosures. For the three months ended September 30, 2023, two customers represented 21% and 11% of net sales. For the nine months ended September 30, 2023, two customers each represented 17% and 12% of net sales. For the three months ended September 30, 2022, one customer represented 12% of net sales. For the nine months ended September 30, 2022, two customers each represented 13% and 10% of net sales. Accounts Receivable: Accounts receivable are unsecured, are recorded at net realizable value, and do not bear interest. The Company makes judgments as to its ability to collect 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. The Company performs credit evaluations of its customers’ financial condition on an as-needed basis. Payment is generally due 30 days from the invoice date and accounts past 30 days are individually analyzed for collectability. When all collection efforts have been exhausted, the account is written off against the related allowance. To date, the Company has not experienced any write-offs or significant deterioration of the aging of its accounts receivable, and therefore, no allowance for doubtful accounts was considered necessary as of September 30, 2023, or December 31, 2022. As of September 30, 2023, three customers represented 17%, 17% and 11% of the accounts receivable balance. As of December 31, 2022, two customers represented 15% and 10% of the total accounts receivable balance. 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) September 30, 2023 December 31, 2022 Finished Goods $ 811 $ 993 Work in Process 170 204 Raw Materials 1,659 1,609 Inventory Reserves (304 ) (145 ) Total $2,336 $2,661 Loss per Share : Basic loss per share is computed based on the net loss for each period divided by the weighted average number of common shares outstanding. See Note 3 – Stockholders’ Equity below for additional disclosures. 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: September 30 2023 2022 Stock options 111,275 11,910 Warrants to purchase common stock 1,308,271 16,970 Series F convertible preferred stock 5,080 508 Total 1,424,626 29,388 The following table reconciles reported net loss with reported net loss per share for each of the three and nine months ended September 30: Three months ended September 30 Nine months ended September 30 (in thousands, except per share amounts) 2023 2022 2023 2022 Net loss $(3,370) $(3,870) $(14,700) $(12,629) Weighted average shares outstanding 1,864 105 1,439 105 Basic and diluted loss per share $ (1.81 ) $(36.72 ) $ (10.21 ) $ (119.85 ) Subsequent Events: The Company evaluates events through the date the consolidated financial statements are filed for events requiring adjustment to or disclosure in the consolidated financial statements. See note 10 – Subsequent Events for additional disclosures. | Note 1—Nature of Business and Significant Accounting Policies Nature of Business Nuwellis, Inc. (the “Company”) is a medical technology company focused on developing, manufacturing and commercializing the Aquadex FlexFlow® and Aquadex SmartFlow® systems (collectively, the “Aquadex System”) for ultrafiltration therapy. The Aquadex SmartFlow® system is indicated for temporary (up to eight hours) or extended (longer than 8 hours in patients who require hospitalization) use in adult and pediatric patients weighing 20 kg or more, whose fluid overload is unresponsive to medical management, including diuretics. Nuwellis, Inc. is a Delaware corporation headquartered in Minneapolis with a wholly owned subsidiary in Ireland. The Company has been listed on Nasdaq since February 2012. 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 pediatrics applications. Going Concern The Company’s financial statements have been prepared and presented on a basis assuming it continues as a going concern. During the years ended December 31, 2022 and 2021, 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 December 31, 2022, the Company had an accumulated deficit of $267.4 million, and it expects to incur losses for the immediate future. To date, the Company has been funded by equity financings, and although the Company believes that it will be able to successfully fund its operations, there can be no assurance that it will be able to do so or that it will ever operate profitably. These factors raise substantial doubt about the Company’s ability to continue as a going concern through at least twelve months from the report date. 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 expanding its sales and marketing capabilities, purchasing inventory, manufacturing components, investing in clinical research and new product development, and complying with the requirements related to being a U.S. public company. To become and remain profitable, the Company must succeed in expanding the adoption and market acceptance of the Aquadex System. This will require the Company to succeed in training personnel at hospitals and effectively and efficiently manufacturing, marketing, and distributing the Aquadex System and related components. There can be no assurance that the Company will succeed in these activities, and it may never generate revenues sufficient to achieve profitability. During 2021 and through December 31, 2022, the Company closed on underwritten public equity offerings for aggregate net proceeds of approximately $37.3 million after deducting the underwriting discounts and commissions and other costs associated with the offerings. See Note 4—Stockholders’ Equity for additional related disclosure. The Company will require additional funding to grow its Aquadex Business, which may not be available on terms favorable to the Company, or at all. The Company may receive those funds from the proceeds from future warrant exercises, issuances of equity securities, or other financing transactions. The Company believes that its existing capital resources will be sufficient to support its operating plan through December 31, 2023. However, the Company may 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. Basis of Presentation The accompanying consolidated financial statements include the accounts of Nuwellis, Inc. and its wholly owned subsidiary, Sunshine Heart Ireland Limited. All intercompany accounts and transactions between consolidated entities have been eliminated. Use of Estimates The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the reported amounts and disclosures in the consolidated financial statements and accompanying notes. Actual results could differ materially from those estimates. Cash and Cash Equivalents Cash and cash equivalents consist of cash and term deposits with original maturities of three months or less. The carrying value of these instruments approximates fair value. The balances, at times, may exceed federally insured limits. The Company has not experienced any losses on its cash and cash equivalents. Marketable securities The Company’s marketable securities typically consist of investment-grade, U.S. dollar-denominated fixed and floating-rate debt, which are classified as available-for-sale and included in current assets. Most marketable securities mature within twelve months from their date of purchase and generally are intended to fund current operations. Securities are valued based on market prices for similar assets using third party certified pricing sources. Available-for-sale securities are carried at fair value with unrealized gains and losses reported as a component of shareholders’ equity in accumulated other comprehensive income (loss). Available-for-sale securities are reviewed for possible impairment at least quarterly, or more frequently if circumstances arise that may indicate impairment. When the fair value of the securities declines below the amortized cost basis and impairment is indicated, it must be determined whether the impairment is other than temporary. Impairment is considered to be other than temporary if the Company: (i) intends to sell the security, (ii) will more likely than not be forced to sell the security before recovering its cost, or (iii) does not expect to recover the security’s amortized cost basis. If the decline in fair value is considered other than temporary, the cost basis of the security is adjusted to its fair market value and the realized loss is reported in earnings. Subsequent increases or decreases in fair value are reported as a component of shareholders’ equity in accumulated other comprehensive gain (loss). There were no other than temporary unrealized losses as of December 31, 2022. Accounts Receivable Accounts receivables are unsecured, recorded at net realizable value, and do not bear interest. The Company makes judgments as to its ability to collect outstanding receivables based upon significant patterns of collectability, historical experience, and management’s evaluation of specific accounts, and it will provide an allowance for credit losses when collection becomes doubtful. The Company performs credit evaluations of its customers’ financial condition on an as-needed basis. Payment is generally due 30 days from the invoice date and accounts past 30 days are individually analyzed for collectability. When all collection efforts have been exhausted, the account is written off against the related allowance. To date the Company has not experienced any write-offs or significant deterioration in the aging of its accounts receivable, and therefore, no allowance for doubtful accounts was considered necessary as of December 31, 2022 or December 31, 2021. As of December 31, 2022, two customers represented 15% and 10% of the total accounts receivable balance. As of December 31, 2021, two customers represented 12% and 11% of the total accounts receivable balance. Inventories Inventories are recorded at 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. On a regular basis, the Company reviews its inventory and identifies that which is excess, slow moving, and obsolete by considering factors such as inventory levels and expected product life. A reserve is established for any identified excess, slow moving, and obsolete inventory through a charge to cost of goods sold. Inventories consisted of the following as of December 31: (Dollars in thousands) 2022 2021 Finished Goods $ 993 $1,527 Work in Process 204 276 Raw Materials 1,609 1,281 Inventory Reserves (145) (241) Total $2,661 $2,843 Other Current Assets Other current assets represent prepayments and deposits made by the Company. Property, Plant and Equipment Property, plant and equipment is stated at cost less accumulated depreciation. Depreciation is computed based upon the estimated useful life of the respective asset. Leasehold improvements are amortized using the straight-line method over the shorter of the lease term or the estimated useful life of the assets. Repairs and maintenance cost is expensed as incurred. The cost and accumulated depreciation of property, plant and equipment retired or otherwise disposed of is removed from the related accounts, and any residual values are charged to expense. Depreciation expense has been calculated using the following estimated useful lives: Production Equipment 3-7 years Office Furniture and Fixtures 3-5 years Computer Software and Equipment 3-4 years Loaners and demo equipment 1-5 years Leasehold improvements 3-5 years Depreciation expense was $372,000 and $488,000 for the years ended December 31, 2022 and 2021, respectively. Property, plant and equipment is reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset or asset group may not be recoverable. If the impairment tests indicate that the carrying value of the asset or asset group is greater than the expected undiscounted cash flows to be generated by such asset or asset group, further analysis is performed to determine the fair value of the asset or asset group. To the extent the fair value of the asset or asset group is less than its carrying value, an impairment loss is recognized equal to the amount the fair value of the asset or asset group is exceeded by its carrying amount. Assets to be disposed of are carried at the lower of their carrying value or fair value less costs to sell. Considerable management judgment is necessary to estimate the fair value of assets or asset groups, and accordingly, actual results could vary significantly from such estimates. The Company continues to report operating losses and negative cash flows from operations, both of which it considers to be indicators of potential impairment. Therefore, the Company evaluates its long-lived assets for potential impairment at each reporting period. The Company has concluded that its cash flows from the various long-lived assets are highly interrelated and, as a result, the Company consists of a single asset group. As the Company expects to continue incurring losses in the foreseeable future, the undiscounted cash flow step was bypassed, and the Company proceeded to fair value the asset group. The Company has determined the fair value of the asset group using a combination of expected discounted cash flows and other fair value indicators related to the asset grouping. There have been no impairment losses recognized for the years ended December 31, 2022 or 2021. Accounts Payable and Accrued Liabilities Accrued liabilities includes amounts accrued but not invoiced related to payments owed for licensing agreements, director fees, and others. Revenue Recognition The Company recognizes revenue in accordance with Accounting Standards Codification (“ASC”) Topic 606, Revenue from Contracts with Customers Foreign Currency Translation Sales and expenses denominated in foreign currencies are translated at average exchange rates in effect throughout the year. Assets and liabilities of foreign operations are translated at period-end exchange rates with the impacts of foreign currency translation recorded in cumulative translation adjustment, a component of accumulated other comprehensive income. Foreign currency transactions gains and losses are included in other expense, net in the consolidated statements of operations and other comprehensive loss. Stock-Based Compensation The Company recognizes all share-based payments to employees, directors, and consultants, including grants of stock options and common stock awards, in the consolidated statement of operations and comprehensive loss as an operating expense based on their fair values as established at the grant date. Equity instruments issued to non-employees include common stock awards or warrants to purchase shares of our common stock. These common stock awards or warrants are either fully vested and exercisable at the date of grant or vest over a certain period during which services are provided. The Company expenses the fair market value of fully vested awards at the time of grant, and of unvested awards over the period in which the related services are received. The Company computes the estimated fair values of stock options using the Black-Scholes option pricing model. Market price at the date of grant is used to calculate the fair value of common stock awards. Stock-based compensation expense is based on awards ultimately expected to vest and is reduced for forfeitures. See Note 5—Stock-Based Compensation, for further information regarding the assumptions used to calculate the fair value of stock-based compensation. Income Taxes Deferred income taxes are provided on a liability method, whereby deferred tax assets are recognized for deductible temporary differences and operating loss and tax credit carryforwards. Deferred tax liabilities are recognized for taxable temporary differences, which are the differences between the reported amounts of assets and liabilities and their tax bases. Deferred tax assets are reduced by a valuation allowance when, in the opinion of management, it is more likely than not that some portion or all of the deferred tax assets will not be realized. Deferred tax assets and liabilities are adjusted for the effects of changes in tax laws and rates on the date of enactment. The Company recognizes the financial statement benefit of a tax position only after determining that the relevant tax authority would more likely than not sustain the position following an audit. For tax positions meeting the more-likely-than-not threshold, the amount recognized in the consolidated financial statements is the largest benefit that has a greater than 50 percent likelihood of being realized upon ultimate settlement with the relevant tax authority. Loss per share Basic loss per share is computed based on the net loss for each period divided by the weighted average number of common shares outstanding. The net loss allocable to common stockholders for the year ended December 31, 2021, includes a deemed dividend of $75,000 that resulted from the change in the exercise price of warrants as a result of the March 2021 and September 2021 public offerings. (see Note 4 — Stockholders’ Equity). 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 year presented: December 31, 2022 2021 Stock options 10,485 7,481 Warrants to purchase common stock 679,244 16,299 Series F convertible preferred stock 5,080 50,800 Series I convertible preferred stock 10,493 — Total 705,302 74,580 The following table reconciles reported net loss with reported net loss per share for the years ended December 31: (in thousands, except per share amounts) 2022 2021 Net loss $(14,525) $(19,545) Deemed dividend to preferred stockholders (see Note 4) — (75) Net loss after deemed dividend (14,525) (19,620) Weighted average shares outstanding 174 69 Basic and diluted loss per share $ (83.55 ) $(285.36 ) Research and Development Research and development (R&D) costs include activities related to development, design, and testing improvements of the Aquadex System and potential related new products. These R&D costs also include expenses related to clinical research that the Company may sponsor or conduct to enhance understanding of the product and its use. R&D costs are expensed as incurred. Recent Accounting Pronouncements In June 2016, the FASB issued Accounting Standards Update (ASU) 2016-13, “Financial Instruments – Credit Losses.” This ASU added a new impairment model (known as the current expected credit loss (“CECL”) model) that is based on expected losses rather than incurred losses. Under the new guidance, an entity recognizes as an allowance its estimate of expected credit losses. The CECL model applies to most debt instruments, trade receivables, lease receivables, financial guarantee contracts, and other loan commitments. The CECL model does not have a minimum threshold for recognition of impairment losses, and entities will need to measure expected credit losses on assets that have a low risk of loss. As a smaller reporting company pursuant to Rule 12b-2 of the Securities Exchange Act of 1934, as amended, these changes become effective for the Company on January 1, 2023. Management has evaluated the potential impact of these changes on the consolidated financial statements of the Company and does not anticipate it will have any impact to the Company’s consolidated financial statements. The Company evaluates subsequent events through the date the consolidated financial statements are filed for events requiring adjustment to or disclosure in the consolidated financial statements. |
Revenue Recognition (Q3)
Revenue Recognition (Q3) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Revenue Recognition [Abstract] | ||
Revenue Recognition | Note 2 — Revenue Recognition Net Sales: The Company sells its products in the United States primarily through a direct salesforce. Customers who purchase the Company’s products include hospitals and clinics throughout the United States. In countries outside the United States, the Company sells its products through a limited number of specialty healthcare distributors in Austria, Brazil, Colombia, The Czech Republic, Germany, Greece, Hong Kong, India, Indonesia, Israel, Italy, Panama, Romania, Singapore, Slovakia, Spain, Switzerland, Thailand, United Arab Emirates, and the United Kingdom. These distributors resell the Company’s products to hospitals and clinics in their respective geographies. International revenue represents 5% of net sales for the three and nine months ended September 30, 2023 and 2022. 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 and nine months ended September 30, 2023 and 2022. The unfulfilled performance obligations related to these extended service plans are included in deferred revenue, which is included in other current liabilities on the 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 not received any 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. | Note 2 – Revenue Recognition Net Sales The Company sells its products in the United States primarily through a direct salesforce. Customers who purchase the Company’s products include hospitals and clinics throughout the United States. In countries outside the United States, the Company sells its products through a limited number of specialty healthcare distributors in Austria, Brazil, Colombia, the Czech Republic, Germany, Greece, Hong Kong, India, Israel, Italy, Panama. Romania, Singapore, Slovakia, Spain, Switzerland, Thailand, United Arab Emirates, and the United Kingdom. These distributors resell the Company’s products to hospitals and clinics in their respective geographies. 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, which are recognized over time. This revenue represents less than 1% of net sales for each of the years ended December 31, 2022 and 2021. The unfulfilled performance obligations related to these extended service plans are included in deferred revenue, which is included in other current liabilities on the 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 product 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 not received any 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 (Q3)
Stockholders' Equity (Q3) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
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. 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, described below. 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, described below. As of September 30, 2023, and December 31, 2022, 127 shares of the Series F convertible preferred stock remained outstanding. 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. 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 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 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 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: In March 2023, the Company filed a Prospectus Supplement to its Registration Statement on Form S-3 with the SEC in connection with a proposed At-the-Market Securities offering (the “At-the-Market Program”). During the three months and nine months ended September 30, 2023, the Company issued none and 657,333 shares of common stock under the At-the-Market Program for gross proceeds of none and approximately $2.3 million, respectively. Net proceeds for the three and nine months ended September 30, 2023, totaled none approximately $2.1 million, respectively, after deducting the underwriting discounts and commissions and other costs associated with the 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. 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, based on 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 and had not vested as of September 30, 2023. Supply Agreement Warrants : On June 19, 2023, we entered into a Supply and Collaboration Agreement (the “Supply Agreement” ) with DaVita Inc., a Delaware corporation ( “DaVita” ), pursuant to which DaVita will pilot the Aquadex ultrafiltration therapy system to treat adult patients with congestive heart failure and related conditions within select U.S. markets. The pilot program is expected to launch by the end of fourth quarter 2023 and extend through May 31, 2024 (the “Pilot” ). Through the Pilot, ultrafiltration therapy using Aquadex will be offered at a combination of DaVita’s hospital customer and outpatient center locations, with both companies collaborating on the roll-out of the therapy, clinician training, and patient support. At the conclusion of the Pilot, DaVita has the option, in its sole discretion, to extend the Supply Agreement with the Company for continued provision of both inpatient and outpatient ultrafiltration services for up to 10 years ( “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 September 30, 2023. 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 September 30, 2023, 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. | Note 4—Stockholders’ Equity Series F Convertible Preferred Stock : On November 27, 2017, the Company closed on an underwritten public offering 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 was to expire 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, described below. 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, described below. 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, described below. 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 2020 offering, described below. As of December 31, 2022, and December 31, 2021, 127 shares of the Series F convertible preferred stock remained outstanding. Series H Convertible Preferred Stock and January 2020 Offering: On January 28, 2020, the Company closed on an underwritten public offering of common stock, Series H convertible preferred stock, and warrants to purchase shares of common stock for gross proceeds of $9.7 million, which included the full exercise of the underwriter’s over-allotment option to purchase additional shares and warrants (“January 2020 Offering”). Net proceeds totaled approximately $8.6 million after deducting the underwriting discounts and commissions and other costs associated with the offering. The Series H convertible preferred stock included a beneficial conversion amount of $1.6 million, representing the intrinsic value of the shares at the time of issuance, and $0.2 million of down-round protection in connection with the re-pricing of the warrants following the March 2020 offering described below. This amount is reflected as an increase to the loss per share allocable to common stockholders in the year ended December 31, 2020. The January 2020 Offering was comprised of 2,015 shares of common stock priced at $1,650 per share and 115,173 shares of Series H convertible preferred stock, convertible into common stock at $1,650 per share, including the full exercise of the over-allotment option. Each share of Series H convertible preferred stock and each share of common stock was accompanied by a warrant to purchase common stock. The warrants are exercisable into 5,855 shares of common stock. The conversion price of the preferred stock issued in the transaction is 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. The warrants were exercisable beginning on the closing date and expire on the fifth anniversary of the closing date and had an initial exercise price per share equal to $1,650 per share, subject to appropriate adjustment in the event of subsequent equity sales of common stock or securities convertible into common stock for an exercise price per share less than the exercise price per share of the warrants then in effect (but in no event lower than 10% of the applicable unit offering price), or in the event of recapitalization events, stock dividends, stock splits, stock combinations, reclassifications, reorganizations or similar events affecting our common stock. Effective March 23, 2020, the exercise price of these warrants was reduced from $1,650 to $900, the per share price to the public in the March 2020 offering, described below. As of December 31, 2020, all 115,173 shares of the Series H convertible preferred stock had been converted into common stock and none remained outstanding. As of December 31, 2020, warrants to purchase 4,552 shares of common stock had been exercised for total cash proceeds of $4.1 million. March 2020 Offering: On March 23, 2020, the Company closed on a registered direct offering of 1,387 shares of its common stock at a price to the public of $900 per share, for gross proceeds of approximately $1.2 million, or $1.0 million net proceeds, after deducting commissions and offering expenses. In a concurrent private placement, the Company agreed to issue to the investors in the registered direct offering warrants to purchase up to 1,387 shares of the Company’s common stock. The warrants to purchase up to 1,387 shares of common stock have an exercise price of $1,118 per share, were exercisable six months from the date of issuance, and will expire five and a half years April 2020 Offering : On April 1, 2020, the Company closed on a registered direct offering of 1,710 shares of its common stock at a price to the public of $1,302 per share, for gross proceeds of approximately $2.2 million, prior to deduction of commissions and offering expenses related to the transaction. In a concurrent private placement, the Company agreed to issue to the investors in the registered direct offering warrants to purchase up to 855 shares of the Company’s common stock. The warrants have an exercise price of $1,115 per share, were exercisable immediately, and will expire five and a half years May 2020 Offering : On May 5, 2020, the Company closed on a registered direct offering of 1,199 shares of its common stock at a price to the public of $1,418 per share, for gross proceeds of approximately $1.7 million, prior to deduction of commissions and offering expenses related to the transaction. In a concurrent private placement, the Company agreed to issue to the investors in the registered direct offering warrants to purchase up to 600 shares of the Company’s common stock. The warrants have an exercise price of $1,230 per share, were exercisable immediately, and will expire five and a half years August 2020 Offering : On August 21, 2020, the Company closed on an underwritten public offering of common stock and warrants to purchase shares of common stock for gross proceeds of approximately $14.4 million, which included the full exercise of the underwriter’s over-allotment option to purchase additional shares and warrants (“August 2020 Offering”). Net proceeds totaled approximately $13.0 million after deducting the underwriting discounts and commissions and other costs associated with the offering. The August 2020 Offering was comprised of 10,647 shares of common stock priced at $1,350 per share. Each share of common stock was accompanied by a warrant to purchase common stock. The warrants are exercisable into 10,647 shares of common stock. The securities comprising the units are immediately separable and were issued separately. The warrants were exercisable beginning on the effective date of our stockholders’ approval of a reverse stock split in an amount sufficient to permit the exercise in full of the warrants, which occurred on October 6, 2020, and will expire on the five-year anniversary of the closing date. 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 for every one hundred shares of Series I convertible preferred 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 at a $0.00 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 such reverse stock split and of the exercisability of the warrants under Nasdaq rules, and will 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” “Certificate of Amendment” 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. Placement Agent Fees : In connection with the offerings described above, the Company paid the placement agents an aggregate cash placement fee equal to 8% of the aggregate gross proceeds raised in each of the offerings. 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 December 31, 2022. Reverse Stock Split : On December 5, 2022, the Company’s stockholders approved the Company’s management to execute a reverse split of its outstanding common stock at a ratio in the range of 1-for-50 1-for-100 1-for-100 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 have been retroactively adjusted to reflect the reverse stock splits for all periods presented. |
Stock-Based Compensation (Q3)
Stock-Based Compensation (Q3) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
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 September 30 Nine months ended September 30 (in thousands) 2023 2022 2023 2022 Selling, general and administrative expense $133 $199 $484 $624 Research and development expense 2 21 29 73 Total stock-based compensation expense $135 $220 $513 $697 During the three months ended September 30, 2023 and 2022, under the 2017 Equity Incentive Plan, the 2021 Inducement Plan, and the 2013 Non-Employee Directors’ Equity Incentive Plan, the Company granted 18,643 and 369 stock options, respectively, to its directors, officers and employees. During the nine months ended September 30, 2023 and 2022, the Company granted 125,410 and 5,577, respectively, to its directors, officers, employees and consultants. Vesting generally occurs over an immediate to 48-month period based on a time-of-service condition, although vesting acceleration is provided under one grant in the event that a certain milestone is met. The weighted-average grant date fair value of the stock-options issued during the three months ended September 30, 2023 and 2022 was $1.63 and $60.40 per share, respectively. The weighted-average grant date fair value of the stock options issued during the nine months ended September 30, 2023 and 2022 was $6.18 and $79.07 per share, respectively. The total number of stock options outstanding as of September 30, 2023 and September 30, 2022 was 111,275 and 12,003, respectively. The weighted-average assumptions used in the Black-Scholes option-pricing model are as follows for the stock options granted during the three and nine months ended September 30, 2023 and 2022: Three months ended September 30 Nine months ended September 30 2023 2022 2023 2022 Expected volatility 131.06% 132.08% 152.59% 132.48% Expected Life of options (years) 6.25 6.25 6.19 6.15 Expected dividend yield 0% 0% 0% 0% Risk-free interest rate 4.29% 3.02% 4.16% 2.13% During the three months ended September 30, 2023 and 2022, 2,576 and 823 stock options vested, respectively, and 21,372 and 343 stock options were expired or forfeited during these periods, respectively. During the nine months ended September 30, 2023 and 2022, 5,022 and 2,730 stock options vested, respectively, and 24,620 and 1,148 stock options were expired or forfeited during these periods, respectively. During the three and nine months ended September 30, 2023 and 2022, no options were exercised. | Note 5— Stock-Based Compensation Stock Options and Restricted Stock Awards The Company has various share-based compensation plans, including the Third Amended and Restated 2017 Equity Incentive Plan, the 2013 Non-Employee Directors’ Equity Incentive Plan and the 2021 Inducement Plan (collectively, the “Plans” The Company recognized stock-based compensation expense related to grants of stock options and common stock awards to employees, directors and consultants of $862,000 and $1.3 million during the years ended December 31, 2022 and 2021, respectively. The following table summarizes the stock-based compensation expense that was recognized in the consolidated statements of operations for the years ended December 31, (Dollars in thousands) 2022 2021 Selling, general and administrative $784 $1,171 Research and development 78 143 Total $862 $1,314 The majority of the common stock awards and options to purchase common stock vest on the anniversary of the date of grant, which ranges from one Stock Options : The following is a summary of the Plans’ stock option activity during the years ended December 31: 2022 2021 Options Outstanding Weighted Average Exercise Price Options Outstanding Weighted Average Exercise Price Beginning Balance 7,481 $656.05 144 $40,534.00 Granted 5,833 83.96 9,081 444.83 Exercised — — — — Forfeited/expired (2,829) 410.34 (1,744) 2,332.06 Outstanding at December 31 10,485 $404.08 7,481 $ 656.05 Vested at December 31 3,531 $727.26 409 $ 4,218.40 For options outstanding and vested at December 31, 2022 and 2021, the weighted average remaining contractual life was 8.79 years and 8.63 years, respectively. There were no option exercises in 2022 or 2021. The total fair value of options that vested in 2022 and 2021 was $1.1 million, and $0.7 million, respectively, at the fair value of the options as of the date of grant. Valuation Assumptions : The fair value of each stock option is estimated at the grant date using the Black-Scholes option pricing model. The fair value of stock options under the Black-Scholes option pricing model requires management to make assumptions regarding projected employee stock option exercise behaviors, risk-free interest rates, volatility of the Company’s stock price, and expected dividends. The Company has not historically paid cash dividends to its stockholders and currently does not anticipate paying any cash dividends in the foreseeable future. As a result, the Company has assumed a dividend yield of 0%. The risk-free interest rate is based upon the rates of U.S. Treasury bills with a term that approximates the expected life of the option. Since the Company has limited historical exercise data to reasonably estimate the expected life of its option awards, the expected life is calculated using a simplified method. Expected volatility is based on historical volatility of the Company’s stock. The following table provides the weighted average assumptions used in the Black-Scholes option pricing model for the years ended December 31: 2022 2021 Expected dividend yield 0% 0% Risk-free interest rate 2.13% 1.19% Expected volatility 132.48% 131.03% Expected life (in years) 6.15 6.21 The weighted-average fair value of stock options granted in 2022 and 2021 was $76.05 and $396.17, respectively. As of December 31, 2022, the total compensation cost related to all non-vested stock option awards not yet recognized was approximately $1.3 million and is expected to be recognized over the remaining weighted-average life of 2.54 years. Warrants : Warrants to purchase 679,244 and 16,299 shares of common stock were outstanding on December 31, 2022 and 2021, respectively. As of December 31, 2022, warrants outstanding were exercisable at prices ranging from $25 to $189,000 per share and are exercisable over a period ranging from immediately to 5.8 years. |
Fair Value of Financial Instr_2
Fair Value of Financial Instruments (Q3) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
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, marketable securities, 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. All cash equivalents and marketable securities are considered Level 1 measurements for all periods presented. The available-for-sale marketable securities primarily consist of investment-grade, U.S.-dollar-denominated fixed and floating rate debt, measured at fair value on a recurring basis. September 30, 2023 December 31, 2022 (in thousands) Fair Value Level 1 Fair Value Level 1 Marketable securities $0 $0 $569 $569 The fair value of the Company’s common stock warrant liability related to the investor warrants issued in the October 2022 Offering 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 Balance at January 4, 2023 (revaluation date) 7,623 Warrants reclassified to equity (7,623 ) Balance at September 30, 2023 $ — | Note 6—Fair Value of Financial Instruments The Company’s financial instruments consist of cash and cash equivalents, marketable securities, and warrants. Pursuant to the requirements of ASC Topic 820 “Fair Value Measurement,” • 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. All cash equivalents and marketable securities are considered Level 1 measurements for all periods presented. The available-for-sale marketable securities primarily consist of investment-grade, U.S. dollar-denominated fixed and floating-rate debt, measured at fair value on a recurring basis. 2022 2021 (Dollars in thousands) Fair Value Level 1 Fair Value Level 1 Marketable securities $569 $569 $15,463 $15,463 The fair value of the Company’s common stock warrant liability related to the investor warrants issued in the October 2022 public offering, 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 Level 3 warrants: (in thousands) October 18, 2022 warrant issuance $ 18,695 Change in fair value (11,827) Ending balance December 31, 2022 $ 6,868 Fair values were calculated using the following assumptions: Oct. 18, 2022 Dec. 31, 2022 Risk-free interest rates, adjusted for continuous compounding 4.16% 3.97% Term (years) 6.18 6.11 Expected volatility 141.5% 145.3% Dates and probability of future equity raises various various A significant change in the inputs used for the Monte Carlo and Black Scholes valuation models, such as the expected volatility, risk-free interest rate, or probability of future equity financings, in isolation, would result in significantly higher or lower fair value measurements. In combination, changes in these inputs could result in a significantly higher or lower fair value measurement if the input changes were to be aligned or could result in a minimally higher or lower fair value measurement if the input changes were of a compensating nature. |
Income Taxes (Q3)
Income Taxes (Q3) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
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 September 30, 2023, 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, 2022. | Note 7—Income Taxes Domestic and foreign income (loss) before income taxes consists of the following for the years ended December 31: (in thousands) 2022 2021 Domestic $(14,551) $(19,582) Foreign 35 37 Loss before income taxes $(14,516 ) $(19,545 ) The components of income tax expense consist of the following for the years ended December 31: (in thousands) 2022 2021 Current: United States and state $— $— Foreign, net (9) (9) Deferred: United States and state — — Foreign — — Total income tax expense $ (9 ) $ (9 ) Actual income tax expense differs from statutory federal income tax expense as follows for the years ended December 31: (in thousands) 2022 2021 Statutory federal income tax benefit $ 3,048 $ 4,109 State tax benefit, net of federal taxes 783 560 Foreign tax (1) (1) Nondeductible/nontaxable items 548 (220) Other (41) 406 Valuation allowance (increase) decrease (4,346) (4,863) Total income tax expense $ (9 ) $ (9 ) Deferred taxes consist of the following as of December 31: (in thousands) 2022 2021 Deferred tax assets: Noncurrent: Accrued leave $ 397 $ 59 Stock based compensation 360 368 Net operating loss carryforward 45,405 42,363 Other 42 131 Intangibles 1,786 723 R&D credit carryforward 531 531 Total deferred tax assets 48,521 44,175 Less: valuation allowance (48,521) (44,175) Total $ — $ — As of December 31, 2022, the Company had federal net operating loss 2024 2038 The Company provides for a valuation allowance when it is more likely than not that it will not realize a portion of the deferred tax assets. The Company has established a valuation allowance for 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 consolidated financial statements. For the years ended December 31, 2022, and 2021, the valuation allowance increased by $4.3 million and $4.9 million, respectively. The current year increase was primarily due to the federal and state net operating losses generated. During 2022 and 2021, the Company believes it experienced an ownership change as defined in Section 382 of the Internal Revenue Code, which will limit the ability to utilize the Company’s net operating losses (NOLs). The Company may have experienced additional ownership changes in earlier years further limiting the NOL carryforwards that may be utilized. The Company has not yet completed a formal Section 382 analysis. The general limitation rules allow the Company to utilize its NOLs subject to an annual limitation that is determined by multiplying the federal long-term tax-exempt rate by the Company’s value immediately before the ownership change. The accounting guidance related to uncertain tax positions prescribes a recognition threshold and measurement attribute for recognition and measurement of a tax position taken or expected to be taken in a tax return. It also provides guidance on de-recognition, classification, interest and penalties, accounting in interim periods, disclosure and transition. The Company had no material uncertain tax positions as of December 31, 2022 or 2021. The Company recognizes interest and penalties on unrecognized tax benefits as well as interest received from favorable tax settlements within income tax expense. At December 31, 2022 and 2021, the Company recorded no accrued interest or penalties related to uncertain tax positions. The tax years ended December 31, 2019 through December 31, 2022 remain open to examination by the Internal Revenue Service and by the various states where the Company is subject to taxation. Additionally, the returns of the Company’s Australian (through November 2020) and Irish subsidiaries are subject to examination by tax authorities of those jurisdictions for the tax years ended and subsequent to June 30, 2017 and December 31, 2017, respectively. |
Operating Leases (Q3)
Operating Leases (Q3) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Operating Leases [Abstract] | ||
Operating Leases | Note 7 — Operating Leases The Company leases a 23,000 square foot facility located in Eden Prairie, Minnesota for office and manufacturing space under a non-cancelable operating lease that expires in March 2027. In November 2021, the Company entered into a fourth amendment to the lease, extending the term of the lease from March 31, 2022 to March 31, 2027. This facility serves as our corporate headquarters and houses substantially all our functional departments. Monthly rent and common area maintenance charges, including estimated property tax for our headquarters, total approximately $32,000. The lease contains provisions for annual inflationary adjustments. Rent expense is being recorded on a straight-line basis over the term of the lease. Beginning on April 1, 2022, the annual base rent was $10.50 per square foot, subject to future annual increases of $0.32 to $0.34 per square foot. | Note 8—Operating Leases The Company leases a 23,000 square foot facility located in Eden Prairie, Minnesota for office and manufacturing space under a non-cancelable operating lease that expires in March 2027. In November 2021, the Company entered into a fourth amendment to the lease, extending the term of the lease from March 31, 2022 to March 31, 2027. This facility serves as our corporate headquarters and houses substantially all our functional areas. Monthly rent and common area maintenance charges, including estimated property tax for our headquarters, total approximately $31,000. The lease contains provisions for annual inflationary adjustments. Rent expense is being recorded on a straight-line basis over the term of the lease. Beginning on April 1, 2022, the annual base rent was $10.50 per square foot, subject to annual increases of $0.32 to $0.34 per square foot thereafter. The cost components of the Company’s operating lease were as follows for the year ended December 31: (in thousands) 2022 2021 Operating lease cost $238 $219 Variable lease cost 127 123 Total $365 $342 Variable lease costs consist primarily of taxes, insurance, and common area or other maintenance costs for our leased office and manufacturing space. Maturities of our lease liability for the Company’s operating lease are as follows as of December 31: (in thousands) 2022 2023 $ 249 2024 257 2025 264 2026 272 2027 69 Total lease payments 1,111 Less: Interest (155 ) Present value of lease liability $ 956 As of December 31, 2022, and 2021, the remaining lease terms were 4.25 and 5.25 years, respectively, and discount rates were 6.25% and 7.5% respectively. For the years ended December 31, 2022, and 2021, the operating cash outflows from the Company’s operating lease for office and manufacturing space were $238,000 and $219,000, respectively. |
Finance Lease Liability (Q3)
Finance Lease Liability (Q3) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Finance Lease Liability [Abstract] | ||
Finance Lease Liability | Note 8 — Finance Lease Liability In 2020, the Company entered into lease agreements to finance equipment valued at $98,000. The equipment consisted of computer hardware and audio-visual equipment and is included in Property, Plant and Equipment | Note 9—Finance Lease Liability In 2020, the Company entered into lease agreements to finance equipment valued at $98,000. The equipment consisted of computer hardware and audio-visual equipment and is included in Property, Plant and Equipment |
Commitments and Contingencies_2
Commitments and Contingencies (Q3) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Commitments and Contingencies [Abstract] | ||
Commitments and Contingencies | Note 9 — Commitments and Contingencies Employee Retirement Plan: The Company has a 401(k) retirement plan that provides retirement benefits to substantially all full-time U.S. employees. Eligible employees may contribute a percentage of their annual compensation, subject to Internal Revenue Service limitations, with the Company matching a portion of the employees’ contributions at the discretion of the Company. Milestone Payment: On December 27, 2022, the Company entered into a license and distribution agreement with SeaStar Medical Holding Corporation, (Nasdaq: ICU), a medical device company developing proprietary solutions to reduce the consequences of dysregulated immune responses including hyperinflammation on vital organs (“SeaStar”), appointing the Company as the exclusive U.S. distributor to promote, advertise, market, distribute and sell certain products. As a part of this agreement, the Company agreed to pay SeaStar, a milestone payment of $450,000, upon its receipt of a Human Device Exemption (HDE) approval from the U.S. Food and Drug Administration’s (FDA). This payment is due within 30 days after achievement of the milestone event. As of September 30, 2023, SeaStar had not obtained such HDE approval, but the Company believes approval is reasonably possible. No liability for this milestone payment has been recorded in the financial statements as of September 30, 2023. | Note 10—Commitments and Contingencies Employee Retirement Plan The Company has a 401(k) plan that provides a retirement benefit to substantially all full-time U.S. employees. Eligible employees may contribute a percentage of their annual compensation, subject to Internal Revenue Service limitations, with the Company matching a portion of the employees’ contributions at the discretion of the Company. Matching contributions totaled $185,000 and $255,000 for the years ended December 31, 2022 and 2021, respectively. Non-refundable Technology License Fee On June 24, 2021, the Company entered into a research and development collaboration agreement with Koronis Biomedical Corporation (KBT) to design and develop an integrated continuous renal replacement therapy device. This agreement became effective on August 5, 2021, when KBT received approval of a $1.7 million grant from the National Institutes of Health (NIH) to support this project. As part of this agreement, the Company will pay KBT a non-refundable technology license fee of $428,160, payable in twelve equal monthly installments commencing on June 1, 2022. The Company has recorded a liability for the non-refundable technology license fee, with $178,400 included in Current Accounts Payable at December 31, 2022. The full amount of $428,160 was expensed and included in the Research and Development Expense line for the year ended December 31, 2021. |
Subsequent Events (Q3)
Subsequent Events (Q3) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Subsequent Events [Abstract] | ||
Subsequent Events | Note 10 — Subsequent Events Public Offering: On October 17, 2023, the Company closed on a public offering of 150,000 units (the “Units”), with each Unit consisting of one share of the Company’s Series J Convertible Redeemable Preferred Stock, par value $0.0001 per share, with a liquidation preference of $25.00 per share (the “Series J Convertible Preferred Stock”), and one warrant (the “October 2023 Warrants”) to purchase one-half of one (0.50) share of Series J Convertible Preferred Stock. The purchase price for one Unit was $15.00, which reflects the issuance of the Series J Convertible Preferred Stock with an original issue discount. The Series J Convertible Preferred Stock has a term of three (3) years and is convertible at the option of the holder at any time into shares of the Company’s common stock at a conversion price of $1.01. If any shares of our Series J Convertible Preferred Stock are outstanding at the end of the three-year term, then the Company will promptly redeem all of such outstanding shares of Series J Convertible Preferred Stock on a pro rata basis among all of the holders of Series J Convertible Preferred Stock commencing on the third-year anniversary of the closing date of this offering (the “Mandatory Redemption Date”) in cash, to the extent legally permissible under Delaware law, or, if redemption for cash is not legally permissible in duly authorized, validly issued, fully paid and non-assessable shares of the Company’s common stock equal in number to the quotient obtained by dividing such unpaid amount by the closing price of the Company’s common stock on the Nasdaq on the Mandatory Redemption Date. Dividends on the Series J Convertible Preferred Stock will be paid, if and when declared by the Company’s board of directors, in-kind (“PIK dividends”) in additional shares of Series J Convertible Preferred Stock based on the stated value of $25.00 per share at a dividend rate of 5.0%. The PIK dividends will be paid on a quarterly basis for three (3) years following the closing date to holders of the Series J Convertible Preferred Stock of record at the close of business on October 31, January 31, April 30, and July 31 of each year. The October 2023 Warrants have a term of three (3) years. Each October 2023 Warrant has an exercise price of $7.50 (50.0% of the public offering price per Unit) per one-half of one share (0.5) of Series J Convertible Preferred Stock and is immediately exercisable. The Company is currently evaluating the accounting treatment of the Series J Convertible Preferred Stock and the October 2023 Warrants. The gross proceeds before underwriting discounts and commissions and offering expenses, were approximately $2.25 million. The Company intends to use the net proceeds from the offering for working capital and for general corporate purposes. | Note 14—Subsequent Events On January 4, 2023, shareholder approval was secured by the Company for the issuance of the common stock warrants issued in conjunction with the Company’s October 2022 financing. During 2023, through February 24, 2023, there were 660,046 common stock warrants which had converted into 660,046 shares of common stock at a $0 exercise price with no proceeds received by the Company. At-The-Market Offering 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 may offer and sell shares having an aggregate offering price of up to $10.0 million. Ladenburg is entitled to a commission at a fixed commission rate equal to up to 3% of the gross proceeds. |
Nature of Business and Signif_2
Nature of Business and Significant Accounting Policies (FY) (Policies) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Nature of Business, Basis of Presentation and Significant Accounting Policies [Abstract] | ||
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, 2022 and 2021 and through September 30, 2023, 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 September 30, 2023, the Company had an accumulated deficit of $282.1 million and it expects to incur losses for the immediate future. To date, the Company has been funded by equity financings, and although the Company believes that it will be able to successfully fund its operations, there can be no assurance that it will be able to do so or that it will ever operate profitably. These factors raise substantial doubt about the Company’s ability to continue as a going concern through the next twelve months. 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, and complying with the requirements related to being a U.S. public company. To become and remain profitable, the Company must succeed in expanding the adoption and market acceptance of the Aquadex System. This will require the Company to succeed in training personnel at hospitals and in outpatient care settings, and effectively and efficiently manufacturing, marketing, and distributing the Aquadex System and related components. There can be no assurance that the Company will succeed in these activities, and it may never generate revenues sufficient to achieve profitability. During 2022, the Company closed on an underwritten public equity offering for aggregate net proceeds of approximately $9.4 million after deducting the underwriting discounts and commissions and other costs associated with the offering. See Note 3 — Stockholders’ Equity for additional related disclosures. The Company will require additional funding to grow its Aquadex Business, which may not be available on terms favorable to the Company, or at all. The Company may receive those funds from the proceeds from future warrant exercises, issuances of equity securities, or other financing transactions. 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. For the three and nine months ending September 30, 2023, the Company issued shares under the at-the-market program for aggregate net proceeds of none and approximately $2.1 million after deducting the underwriting discounts and commissions and other costs associated with the offering. The Company believes that its existing capital resources will be sufficient to support its operating plan through February 28, 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. | Going Concern The Company’s financial statements have been prepared and presented on a basis assuming it continues as a going concern. During the years ended December 31, 2022 and 2021, 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 December 31, 2022, the Company had an accumulated deficit of $267.4 million, and it expects to incur losses for the immediate future. To date, the Company has been funded by equity financings, and although the Company believes that it will be able to successfully fund its operations, there can be no assurance that it will be able to do so or that it will ever operate profitably. These factors raise substantial doubt about the Company’s ability to continue as a going concern through at least twelve months from the report date. 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 expanding its sales and marketing capabilities, purchasing inventory, manufacturing components, investing in clinical research and new product development, and complying with the requirements related to being a U.S. public company. To become and remain profitable, the Company must succeed in expanding the adoption and market acceptance of the Aquadex System. This will require the Company to succeed in training personnel at hospitals and effectively and efficiently manufacturing, marketing, and distributing the Aquadex System and related components. There can be no assurance that the Company will succeed in these activities, and it may never generate revenues sufficient to achieve profitability. During 2021 and through December 31, 2022, the Company closed on underwritten public equity offerings for aggregate net proceeds of approximately $37.3 million after deducting the underwriting discounts and commissions and other costs associated with the offerings. See Note 4—Stockholders’ Equity for additional related disclosure. The Company will require additional funding to grow its Aquadex Business, which may not be available on terms favorable to the Company, or at all. The Company may receive those funds from the proceeds from future warrant exercises, issuances of equity securities, or other financing transactions. The Company believes that its existing capital resources will be sufficient to support its operating plan through December 31, 2023. However, the Company may 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. |
Basis of Presentation | Basis of Presentation The accompanying consolidated financial statements include the accounts of Nuwellis, Inc. and its wholly owned subsidiary, Sunshine Heart Ireland Limited. All intercompany accounts and transactions between consolidated entities have been eliminated. | |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the reported amounts and disclosures in the consolidated financial statements and accompanying notes. Actual results could differ materially from those estimates. | |
Cash and Cash Equivalents | Cash and Cash Equivalents Cash and cash equivalents consist of cash and term deposits with original maturities of three months or less. The carrying value of these instruments approximates fair value. The balances, at times, may exceed federally insured limits. The Company has not experienced any losses on its cash and cash equivalents. | |
Marketable securities | Marketable securities The Company’s marketable securities typically consist of investment-grade, U.S. dollar-denominated fixed and floating-rate debt, which are classified as available-for-sale and included in current assets. Most marketable securities mature within twelve months from their date of purchase and generally are intended to fund current operations. Securities are valued based on market prices for similar assets using third party certified pricing sources. Available-for-sale securities are carried at fair value with unrealized gains and losses reported as a component of shareholders’ equity in accumulated other comprehensive income (loss). Available-for-sale securities are reviewed for possible impairment at least quarterly, or more frequently if circumstances arise that may indicate impairment. When the fair value of the securities declines below the amortized cost basis and impairment is indicated, it must be determined whether the impairment is other than temporary. Impairment is considered to be other than temporary if the Company: (i) intends to sell the security, (ii) will more likely than not be forced to sell the security before recovering its cost, or (iii) does not expect to recover the security’s amortized cost basis. If the decline in fair value is considered other than temporary, the cost basis of the security is adjusted to its fair market value and the realized loss is reported in earnings. Subsequent increases or decreases in fair value are reported as a component of shareholders’ equity in accumulated other comprehensive gain (loss). There were no other than temporary unrealized losses as of December 31, 2022. | |
Accounts Receivable | Accounts Receivable: Accounts receivable are unsecured, are recorded at net realizable value, and do not bear interest. The Company makes judgments as to its ability to collect 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. The Company performs credit evaluations of its customers’ financial condition on an as-needed basis. Payment is generally due 30 days from the invoice date and accounts past 30 days are individually analyzed for collectability. When all collection efforts have been exhausted, the account is written off against the related allowance. To date, the Company has not experienced any write-offs or significant deterioration of the aging of its accounts receivable, and therefore, no allowance for doubtful accounts was considered necessary as of September 30, 2023, or December 31, 2022. As of September 30, 2023, three customers represented 17%, 17% and 11% of the accounts receivable balance. As of December 31, 2022, two customers represented 15% and 10% of the total accounts receivable balance. | Accounts Receivable Accounts receivables are unsecured, recorded at net realizable value, and do not bear interest. The Company makes judgments as to its ability to collect outstanding receivables based upon significant patterns of collectability, historical experience, and management’s evaluation of specific accounts, and it will provide an allowance for credit losses when collection becomes doubtful. The Company performs credit evaluations of its customers’ financial condition on an as-needed basis. Payment is generally due 30 days from the invoice date and accounts past 30 days are individually analyzed for collectability. When all collection efforts have been exhausted, the account is written off against the related allowance. To date the Company has not experienced any write-offs or significant deterioration in the aging of its accounts receivable, and therefore, no allowance for doubtful accounts was considered necessary as of December 31, 2022 or December 31, 2021. As of December 31, 2022, two customers represented 15% and 10% of the total accounts receivable balance. As of December 31, 2021, two customers represented 12% and 11% of the total accounts receivable balance. |
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) September 30, 2023 December 31, 2022 Finished Goods $ 811 $ 993 Work in Process 170 204 Raw Materials 1,659 1,609 Inventory Reserves (304 ) (145 ) Total $2,336 $2,661 | Inventories Inventories are recorded at 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. On a regular basis, the Company reviews its inventory and identifies that which is excess, slow moving, and obsolete by considering factors such as inventory levels and expected product life. A reserve is established for any identified excess, slow moving, and obsolete inventory through a charge to cost of goods sold. Inventories consisted of the following as of December 31: (Dollars in thousands) 2022 2021 Finished Goods $ 993 $1,527 Work in Process 204 276 Raw Materials 1,609 1,281 Inventory Reserves (145) (241) Total $2,661 $2,843 |
Other Current Assets | Other Current Assets Other current assets represent prepayments and deposits made by the Company. | |
Property, Plant and Equipment | Property, Plant and Equipment Property, plant and equipment is stated at cost less accumulated depreciation. Depreciation is computed based upon the estimated useful life of the respective asset. Leasehold improvements are amortized using the straight-line method over the shorter of the lease term or the estimated useful life of the assets. Repairs and maintenance cost is expensed as incurred. The cost and accumulated depreciation of property, plant and equipment retired or otherwise disposed of is removed from the related accounts, and any residual values are charged to expense. Depreciation expense has been calculated using the following estimated useful lives: Production Equipment 3-7 years Office Furniture and Fixtures 3-5 years Computer Software and Equipment 3-4 years Loaners and demo equipment 1-5 years Leasehold improvements 3-5 years Depreciation expense was $372,000 and $488,000 for the years ended December 31, 2022 and 2021, respectively. Property, plant and equipment is reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset or asset group may not be recoverable. If the impairment tests indicate that the carrying value of the asset or asset group is greater than the expected undiscounted cash flows to be generated by such asset or asset group, further analysis is performed to determine the fair value of the asset or asset group. To the extent the fair value of the asset or asset group is less than its carrying value, an impairment loss is recognized equal to the amount the fair value of the asset or asset group is exceeded by its carrying amount. Assets to be disposed of are carried at the lower of their carrying value or fair value less costs to sell. Considerable management judgment is necessary to estimate the fair value of assets or asset groups, and accordingly, actual results could vary significantly from such estimates. The Company continues to report operating losses and negative cash flows from operations, both of which it considers to be indicators of potential impairment. Therefore, the Company evaluates its long-lived assets for potential impairment at each reporting period. The Company has concluded that its cash flows from the various long-lived assets are highly interrelated and, as a result, the Company consists of a single asset group. As the Company expects to continue incurring losses in the foreseeable future, the undiscounted cash flow step was bypassed, and the Company proceeded to fair value the asset group. The Company has determined the fair value of the asset group using a combination of expected discounted cash flows and other fair value indicators related to the asset grouping. There have been no impairment losses recognized for the years ended December 31, 2022 or 2021. | |
Accounts Payable and Accrued Liabilities | Accounts Payable and Accrued Liabilities Accrued liabilities includes amounts accrued but not invoiced related to payments owed for licensing agreements, director fees, and others. | |
Revenue Recognition | Revenue Recognition: The Company recognizes revenue in accordance with Accounting Standards Codification, Topic 606, Revenue from Contracts with Customers, which the Company adopted effective January 1, 2018. Accordingly, the Company recognizes revenue when its customers obtain control of its products or services, in an amount that reflects the consideration that the Company expects to receive in exchange for those goods and services. See Note 2 – Revenue Recognition below for additional disclosures. For the three months ended September 30, 2023, two customers represented 21% and 11% of net sales. For the nine months ended September 30, 2023, two customers each represented 17% and 12% of net sales. For the three months ended September 30, 2022, one customer represented 12% of net sales. For the nine months ended September 30, 2022, two customers each represented 13% and 10% of net sales. | Revenue Recognition The Company recognizes revenue in accordance with Accounting Standards Codification (“ASC”) Topic 606, Revenue from Contracts with Customers |
Foreign Currency Translation | Foreign Currency Translation Sales and expenses denominated in foreign currencies are translated at average exchange rates in effect throughout the year. Assets and liabilities of foreign operations are translated at period-end exchange rates with the impacts of foreign currency translation recorded in cumulative translation adjustment, a component of accumulated other comprehensive income. Foreign currency transactions gains and losses are included in other expense, net in the consolidated statements of operations and other comprehensive loss. | |
Stock-Based Compensation | Stock-Based Compensation The Company recognizes all share-based payments to employees, directors, and consultants, including grants of stock options and common stock awards, in the consolidated statement of operations and comprehensive loss as an operating expense based on their fair values as established at the grant date. Equity instruments issued to non-employees include common stock awards or warrants to purchase shares of our common stock. These common stock awards or warrants are either fully vested and exercisable at the date of grant or vest over a certain period during which services are provided. The Company expenses the fair market value of fully vested awards at the time of grant, and of unvested awards over the period in which the related services are received. The Company computes the estimated fair values of stock options using the Black-Scholes option pricing model. Market price at the date of grant is used to calculate the fair value of common stock awards. Stock-based compensation expense is based on awards ultimately expected to vest and is reduced for forfeitures. See Note 5—Stock-Based Compensation, for further information regarding the assumptions used to calculate the fair value of stock-based compensation. | |
Income Taxes | Income Taxes Deferred income taxes are provided on a liability method, whereby deferred tax assets are recognized for deductible temporary differences and operating loss and tax credit carryforwards. Deferred tax liabilities are recognized for taxable temporary differences, which are the differences between the reported amounts of assets and liabilities and their tax bases. Deferred tax assets are reduced by a valuation allowance when, in the opinion of management, it is more likely than not that some portion or all of the deferred tax assets will not be realized. Deferred tax assets and liabilities are adjusted for the effects of changes in tax laws and rates on the date of enactment. The Company recognizes the financial statement benefit of a tax position only after determining that the relevant tax authority would more likely than not sustain the position following an audit. For tax positions meeting the more-likely-than-not threshold, the amount recognized in the consolidated financial statements is the largest benefit that has a greater than 50 percent likelihood of being realized upon ultimate settlement with the relevant tax authority. | |
Loss per Share | Loss per Share : Basic loss per share is computed based on the net loss for each period divided by the weighted average number of common shares outstanding. See Note 3 – Stockholders’ Equity below for additional disclosures. 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: September 30 2023 2022 Stock options 111,275 11,910 Warrants to purchase common stock 1,308,271 16,970 Series F convertible preferred stock 5,080 508 Total 1,424,626 29,388 The following table reconciles reported net loss with reported net loss per share for each of the three and nine months ended September 30: Three months ended September 30 Nine months ended September 30 (in thousands, except per share amounts) 2023 2022 2023 2022 Net loss $(3,370) $(3,870) $(14,700) $(12,629) Weighted average shares outstanding 1,864 105 1,439 105 Basic and diluted loss per share $ (1.81 ) $(36.72 ) $ (10.21 ) $ (119.85 ) | Loss per share Basic loss per share is computed based on the net loss for each period divided by the weighted average number of common shares outstanding. The net loss allocable to common stockholders for the year ended December 31, 2021, includes a deemed dividend of $75,000 that resulted from the change in the exercise price of warrants as a result of the March 2021 and September 2021 public offerings. (see Note 4 — Stockholders’ Equity). 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 year presented: December 31, 2022 2021 Stock options 10,485 7,481 Warrants to purchase common stock 679,244 16,299 Series F convertible preferred stock 5,080 50,800 Series I convertible preferred stock 10,493 — Total 705,302 74,580 The following table reconciles reported net loss with reported net loss per share for the years ended December 31: (in thousands, except per share amounts) 2022 2021 Net loss $(14,525) $(19,545) Deemed dividend to preferred stockholders (see Note 4) — (75) Net loss after deemed dividend (14,525) (19,620) Weighted average shares outstanding 174 69 Basic and diluted loss per share $ (83.55 ) $(285.36 ) |
Research and Development | Research and Development Research and development (R&D) costs include activities related to development, design, and testing improvements of the Aquadex System and potential related new products. These R&D costs also include expenses related to clinical research that the Company may sponsor or conduct to enhance understanding of the product and its use. R&D costs are expensed as incurred. | |
Recent Accounting Pronouncements | Recent Accounting Pronouncements In June 2016, the FASB issued Accounting Standards Update (ASU) 2016-13, “Financial Instruments – Credit Losses.” This ASU added a new impairment model (known as the current expected credit loss (“CECL”) model) that is based on expected losses rather than incurred losses. Under the new guidance, an entity recognizes as an allowance its estimate of expected credit losses. The CECL model applies to most debt instruments, trade receivables, lease receivables, financial guarantee contracts, and other loan commitments. The CECL model does not have a minimum threshold for recognition of impairment losses, and entities will need to measure expected credit losses on assets that have a low risk of loss. As a smaller reporting company pursuant to Rule 12b-2 of the Securities Exchange Act of 1934, as amended, these changes become effective for the Company on January 1, 2023. Management has evaluated the potential impact of these changes on the consolidated financial statements of the Company and does not anticipate it will have any impact to the Company’s consolidated financial statements. The Company evaluates subsequent events through the date the consolidated financial statements are filed for events requiring adjustment to or disclosure in the consolidated financial statements. |
Nature of Business and Basis _2
Nature of Business and Basis of Presentation (Q3) (Policies) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Nature of Business, Basis of Presentation and Significant Accounting Policies [Abstract] | ||
Principles of Consolidation | Principles of Consolidation: The accompanying condensed consolidated balance sheet as of December 31, 2022, which has been derived from the consolidated audited financial statements, and the unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information and with the instructions to Form 10-Q and Article 8 of Regulation S-X. Certain information and note disclosures normally included in the audited annual consolidated financial statements have been condensed or omitted pursuant to those rules and regulations. Accordingly, they do not include all of the information necessary for a fair presentation of results of operations, comprehensive loss, financial condition, and cash flows in conformity with U.S. GAAP. In the opinion of management, the condensed consolidated financial statements reflect all adjustments (consisting of normal recurring adjustments) considered necessary for a fair presentation of the results of the Company for the periods presented. Operating results for interim periods are not necessarily indicative of results that may be expected for the year as a whole. The preparation of the consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenues, expenses, and the related disclosures at the date of the consolidated financial statements and during the reporting period. Actual results could differ materially from these estimates. 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, 2022. | |
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, 2022 and 2021 and through September 30, 2023, 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 September 30, 2023, the Company had an accumulated deficit of $282.1 million and it expects to incur losses for the immediate future. To date, the Company has been funded by equity financings, and although the Company believes that it will be able to successfully fund its operations, there can be no assurance that it will be able to do so or that it will ever operate profitably. These factors raise substantial doubt about the Company’s ability to continue as a going concern through the next twelve months. 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, and complying with the requirements related to being a U.S. public company. To become and remain profitable, the Company must succeed in expanding the adoption and market acceptance of the Aquadex System. This will require the Company to succeed in training personnel at hospitals and in outpatient care settings, and effectively and efficiently manufacturing, marketing, and distributing the Aquadex System and related components. There can be no assurance that the Company will succeed in these activities, and it may never generate revenues sufficient to achieve profitability. During 2022, the Company closed on an underwritten public equity offering for aggregate net proceeds of approximately $9.4 million after deducting the underwriting discounts and commissions and other costs associated with the offering. See Note 3 — Stockholders’ Equity for additional related disclosures. The Company will require additional funding to grow its Aquadex Business, which may not be available on terms favorable to the Company, or at all. The Company may receive those funds from the proceeds from future warrant exercises, issuances of equity securities, or other financing transactions. 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. For the three and nine months ending September 30, 2023, the Company issued shares under the at-the-market program for aggregate net proceeds of none and approximately $2.1 million after deducting the underwriting discounts and commissions and other costs associated with the offering. The Company believes that its existing capital resources will be sufficient to support its operating plan through February 28, 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. | Going Concern The Company’s financial statements have been prepared and presented on a basis assuming it continues as a going concern. During the years ended December 31, 2022 and 2021, 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 December 31, 2022, the Company had an accumulated deficit of $267.4 million, and it expects to incur losses for the immediate future. To date, the Company has been funded by equity financings, and although the Company believes that it will be able to successfully fund its operations, there can be no assurance that it will be able to do so or that it will ever operate profitably. These factors raise substantial doubt about the Company’s ability to continue as a going concern through at least twelve months from the report date. 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 expanding its sales and marketing capabilities, purchasing inventory, manufacturing components, investing in clinical research and new product development, and complying with the requirements related to being a U.S. public company. To become and remain profitable, the Company must succeed in expanding the adoption and market acceptance of the Aquadex System. This will require the Company to succeed in training personnel at hospitals and effectively and efficiently manufacturing, marketing, and distributing the Aquadex System and related components. There can be no assurance that the Company will succeed in these activities, and it may never generate revenues sufficient to achieve profitability. During 2021 and through December 31, 2022, the Company closed on underwritten public equity offerings for aggregate net proceeds of approximately $37.3 million after deducting the underwriting discounts and commissions and other costs associated with the offerings. See Note 4—Stockholders’ Equity for additional related disclosure. The Company will require additional funding to grow its Aquadex Business, which may not be available on terms favorable to the Company, or at all. The Company may receive those funds from the proceeds from future warrant exercises, issuances of equity securities, or other financing transactions. The Company believes that its existing capital resources will be sufficient to support its operating plan through December 31, 2023. However, the Company may 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: The Company recognizes revenue in accordance with Accounting Standards Codification, Topic 606, Revenue from Contracts with Customers, which the Company adopted effective January 1, 2018. Accordingly, the Company recognizes revenue when its customers obtain control of its products or services, in an amount that reflects the consideration that the Company expects to receive in exchange for those goods and services. See Note 2 – Revenue Recognition below for additional disclosures. For the three months ended September 30, 2023, two customers represented 21% and 11% of net sales. For the nine months ended September 30, 2023, two customers each represented 17% and 12% of net sales. For the three months ended September 30, 2022, one customer represented 12% of net sales. For the nine months ended September 30, 2022, two customers each represented 13% and 10% of net sales. | Revenue Recognition The Company recognizes revenue in accordance with Accounting Standards Codification (“ASC”) Topic 606, Revenue from Contracts with Customers |
Accounts Receivable | Accounts Receivable: Accounts receivable are unsecured, are recorded at net realizable value, and do not bear interest. The Company makes judgments as to its ability to collect 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. The Company performs credit evaluations of its customers’ financial condition on an as-needed basis. Payment is generally due 30 days from the invoice date and accounts past 30 days are individually analyzed for collectability. When all collection efforts have been exhausted, the account is written off against the related allowance. To date, the Company has not experienced any write-offs or significant deterioration of the aging of its accounts receivable, and therefore, no allowance for doubtful accounts was considered necessary as of September 30, 2023, or December 31, 2022. As of September 30, 2023, three customers represented 17%, 17% and 11% of the accounts receivable balance. As of December 31, 2022, two customers represented 15% and 10% of the total accounts receivable balance. | Accounts Receivable Accounts receivables are unsecured, recorded at net realizable value, and do not bear interest. The Company makes judgments as to its ability to collect outstanding receivables based upon significant patterns of collectability, historical experience, and management’s evaluation of specific accounts, and it will provide an allowance for credit losses when collection becomes doubtful. The Company performs credit evaluations of its customers’ financial condition on an as-needed basis. Payment is generally due 30 days from the invoice date and accounts past 30 days are individually analyzed for collectability. When all collection efforts have been exhausted, the account is written off against the related allowance. To date the Company has not experienced any write-offs or significant deterioration in the aging of its accounts receivable, and therefore, no allowance for doubtful accounts was considered necessary as of December 31, 2022 or December 31, 2021. As of December 31, 2022, two customers represented 15% and 10% of the total accounts receivable balance. As of December 31, 2021, two customers represented 12% and 11% of the total accounts receivable balance. |
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) September 30, 2023 December 31, 2022 Finished Goods $ 811 $ 993 Work in Process 170 204 Raw Materials 1,659 1,609 Inventory Reserves (304 ) (145 ) Total $2,336 $2,661 | Inventories Inventories are recorded at 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. On a regular basis, the Company reviews its inventory and identifies that which is excess, slow moving, and obsolete by considering factors such as inventory levels and expected product life. A reserve is established for any identified excess, slow moving, and obsolete inventory through a charge to cost of goods sold. Inventories consisted of the following as of December 31: (Dollars in thousands) 2022 2021 Finished Goods $ 993 $1,527 Work in Process 204 276 Raw Materials 1,609 1,281 Inventory Reserves (145) (241) Total $2,661 $2,843 |
Loss per Share | Loss per Share : Basic loss per share is computed based on the net loss for each period divided by the weighted average number of common shares outstanding. See Note 3 – Stockholders’ Equity below for additional disclosures. 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: September 30 2023 2022 Stock options 111,275 11,910 Warrants to purchase common stock 1,308,271 16,970 Series F convertible preferred stock 5,080 508 Total 1,424,626 29,388 The following table reconciles reported net loss with reported net loss per share for each of the three and nine months ended September 30: Three months ended September 30 Nine months ended September 30 (in thousands, except per share amounts) 2023 2022 2023 2022 Net loss $(3,370) $(3,870) $(14,700) $(12,629) Weighted average shares outstanding 1,864 105 1,439 105 Basic and diluted loss per share $ (1.81 ) $(36.72 ) $ (10.21 ) $ (119.85 ) | Loss per share Basic loss per share is computed based on the net loss for each period divided by the weighted average number of common shares outstanding. The net loss allocable to common stockholders for the year ended December 31, 2021, includes a deemed dividend of $75,000 that resulted from the change in the exercise price of warrants as a result of the March 2021 and September 2021 public offerings. (see Note 4 — Stockholders’ Equity). 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 year presented: December 31, 2022 2021 Stock options 10,485 7,481 Warrants to purchase common stock 679,244 16,299 Series F convertible preferred stock 5,080 50,800 Series I convertible preferred stock 10,493 — Total 705,302 74,580 The following table reconciles reported net loss with reported net loss per share for the years ended December 31: (in thousands, except per share amounts) 2022 2021 Net loss $(14,525) $(19,545) Deemed dividend to preferred stockholders (see Note 4) — (75) Net loss after deemed dividend (14,525) (19,620) Weighted average shares outstanding 174 69 Basic and diluted loss per share $ (83.55 ) $(285.36 ) |
Subsequent Events | Subsequent Events: The Company evaluates events through the date the consolidated financial statements are filed for events requiring adjustment to or disclosure in the consolidated financial statements. See note 10 – Subsequent Events for additional disclosures. |
Nature of Business and Signif_3
Nature of Business and Significant Accounting Policies (FY) (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Nature of Business, Basis of Presentation and Significant Accounting Policies [Abstract] | ||
Inventories | Inventories consisted of the following: (in thousands) September 30, 2023 December 31, 2022 Finished Goods $ 811 $ 993 Work in Process 170 204 Raw Materials 1,659 1,609 Inventory Reserves (304 ) (145 ) Total $2,336 $2,661 | Inventories consisted of the following as of December 31: (Dollars in thousands) 2022 2021 Finished Goods $ 993 $1,527 Work in Process 204 276 Raw Materials 1,609 1,281 Inventory Reserves (145) (241) Total $2,661 $2,843 |
Estimated Useful Lives | Depreciation expense has been calculated using the following estimated useful lives: Production Equipment 3-7 years Office Furniture and Fixtures 3-5 years Computer Software and Equipment 3-4 years Loaners and demo equipment 1-5 years Leasehold improvements 3-5 years | |
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: September 30 2023 2022 Stock options 111,275 11,910 Warrants to purchase common stock 1,308,271 16,970 Series F convertible preferred stock 5,080 508 Total 1,424,626 29,388 | 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 year presented: December 31, 2022 2021 Stock options 10,485 7,481 Warrants to purchase common stock 679,244 16,299 Series F convertible preferred stock 5,080 50,800 Series I convertible preferred stock 10,493 — Total 705,302 74,580 |
Reconciles 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 and nine months ended September 30: Three months ended September 30 Nine months ended September 30 (in thousands, except per share amounts) 2023 2022 2023 2022 Net loss $(3,370) $(3,870) $(14,700) $(12,629) Weighted average shares outstanding 1,864 105 1,439 105 Basic and diluted loss per share $ (1.81 ) $(36.72 ) $ (10.21 ) $ (119.85 ) | The following table reconciles reported net loss with reported net loss per share for the years ended December 31: (in thousands, except per share amounts) 2022 2021 Net loss $(14,525) $(19,545) Deemed dividend to preferred stockholders (see Note 4) — (75) Net loss after deemed dividend (14,525) (19,620) Weighted average shares outstanding 174 69 Basic and diluted loss per share $ (83.55 ) $(285.36 ) |
Property, Plant and Equipment_2
Property, Plant and Equipment (FY) (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Property, Plant and Equipment [Abstract] | |
Property, Plant and Equipment | Property, plant and equipment were as follows: (in thousands) December 31, 2022 December 31, 2021 Production Equipment $ 1,360 $ 1,321 Loaners and Demo Equipment 1,444 1,364 Computer Software and Equipment 719 714 Office Furniture & Fixtures 375 364 Leasehold Improvements 253 245 Total 4,151 4,008 Accumulated Depreciation (3,171 ) (2,820 ) $ 980 $ 1,188 |
Stock-Based Compensation (FY) (
Stock-Based Compensation (FY) (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Stock-Based Compensation [Abstract] | ||
Summary of Stock-Based Compensation Expense | The following table presents the classification of stock-based compensation expense recognized for the periods below: Three months ended September 30 Nine months ended September 30 (in thousands) 2023 2022 2023 2022 Selling, general and administrative expense $133 $199 $484 $624 Research and development expense 2 21 29 73 Total stock-based compensation expense $135 $220 $513 $697 | The following table summarizes the stock-based compensation expense that was recognized in the consolidated statements of operations for the years ended December 31, (Dollars in thousands) 2022 2021 Selling, general and administrative $784 $1,171 Research and development 78 143 Total $862 $1,314 |
Summary of Plan Stock Option Activity | The following is a summary of the Plans’ stock option activity during the years ended December 31: 2022 2021 Options Outstanding Weighted Average Exercise Price Options Outstanding Weighted Average Exercise Price Beginning Balance 7,481 $656.05 144 $40,534.00 Granted 5,833 83.96 9,081 444.83 Exercised — — — — Forfeited/expired (2,829) 410.34 (1,744) 2,332.06 Outstanding at December 31 10,485 $404.08 7,481 $ 656.05 Vested at December 31 3,531 $727.26 409 $ 4,218.40 | |
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 and nine months ended September 30, 2023 and 2022: Three months ended September 30 Nine months ended September 30 2023 2022 2023 2022 Expected volatility 131.06% 132.08% 152.59% 132.48% Expected Life of options (years) 6.25 6.25 6.19 6.15 Expected dividend yield 0% 0% 0% 0% Risk-free interest rate 4.29% 3.02% 4.16% 2.13% | The following table provides the weighted average assumptions used in the Black-Scholes option pricing model for the years ended December 31: 2022 2021 Expected dividend yield 0% 0% Risk-free interest rate 2.13% 1.19% Expected volatility 132.48% 131.03% Expected life (in years) 6.15 6.21 |
Fair Value of Financial Instr_3
Fair Value of Financial Instruments (FY) (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Fair Value of Financial Instruments [Abstract] | ||
Available-for-Sale Marketable Securities Measured at Fair Value on Recurring Basis | The available-for-sale marketable securities primarily consist of investment-grade, U.S.-dollar-denominated fixed and floating rate debt, measured at fair value on a recurring basis. September 30, 2023 December 31, 2022 (in thousands) Fair Value Level 1 Fair Value Level 1 Marketable securities $0 $0 $569 $569 | The available-for-sale marketable securities primarily consist of investment-grade, U.S. dollar-denominated fixed and floating-rate debt, measured at fair value on a recurring basis. 2022 2021 (Dollars in thousands) Fair Value Level 1 Fair Value Level 1 Marketable securities $569 $569 $15,463 $15,463 |
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 Balance at January 4, 2023 (revaluation date) 7,623 Warrants reclassified to equity (7,623 ) Balance at September 30, 2023 $ — | The following is a roll-forward of the fair value of Level 3 warrants: (in thousands) October 18, 2022 warrant issuance $ 18,695 Change in fair value (11,827) Ending balance December 31, 2022 $ 6,868 |
Fair Value Assumptions | Fair values were calculated using the following assumptions: Oct. 18, 2022 Dec. 31, 2022 Risk-free interest rates, adjusted for continuous compounding 4.16% 3.97% Term (years) 6.18 6.11 Expected volatility 141.5% 145.3% Dates and probability of future equity raises various various |
Income Taxes (FY) (Tables)
Income Taxes (FY) (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Income Taxes [Abstract] | |
Domestic and Foreign Income (Loss) Before Income Taxes | Domestic and foreign income (loss) before income taxes consists of the following for the years ended December 31: (in thousands) 2022 2021 Domestic $(14,551) $(19,582) Foreign 35 37 Loss before income taxes $(14,516 ) $(19,545 ) |
Components of Income Tax Expense | The components of income tax expense consist of the following for the years ended December 31: (in thousands) 2022 2021 Current: United States and state $— $— Foreign, net (9) (9) Deferred: United States and state — — Foreign — — Total income tax expense $ (9 ) $ (9 ) |
Actual Income Tax Expense Differs from Statutory Federal Income Tax Expense | Actual income tax expense differs from statutory federal income tax expense as follows for the years ended December 31: (in thousands) 2022 2021 Statutory federal income tax benefit $ 3,048 $ 4,109 State tax benefit, net of federal taxes 783 560 Foreign tax (1) (1) Nondeductible/nontaxable items 548 (220) Other (41) 406 Valuation allowance (increase) decrease (4,346) (4,863) Total income tax expense $ (9 ) $ (9 ) |
Deferred Taxes | Deferred taxes consist of the following as of December 31: (in thousands) 2022 2021 Deferred tax assets: Noncurrent: Accrued leave $ 397 $ 59 Stock based compensation 360 368 Net operating loss carryforward 45,405 42,363 Other 42 131 Intangibles 1,786 723 R&D credit carryforward 531 531 Total deferred tax assets 48,521 44,175 Less: valuation allowance (48,521) (44,175) Total $ — $ — |
Operating Leases (FY) (Tables)
Operating Leases (FY) (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Operating Leases [Abstract] | |
Cost Components of Operating Leases | The cost components of the Company’s operating lease were as follows for the year ended December 31: (in thousands) 2022 2021 Operating lease cost $238 $219 Variable lease cost 127 123 Total $365 $342 |
Maturities of Lease Liability | Maturities of our lease liability for the Company’s operating lease are as follows as of December 31: (in thousands) 2022 2023 $ 249 2024 257 2025 264 2026 272 2027 69 Total lease payments 1,111 Less: Interest (155 ) Present value of lease liability $ 956 |
Revision and Immaterial Corre_2
Revision and Immaterial Correction of an Error in Previously Issued Financial Statements (FY) (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Revision and Immaterial Correction of an Error in Previously Issued Financial Statements [Abstract] | |
Immaterial Correction of Error on Consolidated Financial Statements | The effect of the immaterial correction of an error on our previously filed audited consolidated financial statements as of December 31, 2021 and for the year then ended is as follows: (in thousands) December 31, 2021 Consolidated Balance Sheet As reported Adjustment As revised Cash and cash equivalents $24,205 $(15,463) $ 8,742 Marketable securities — 15,463 15,463 Total Current Assets 28,126 — 28,126 Consolidated Statement of Operations and Comprehensive Loss (in thousands) As reported Adjustment As revised Other income (expense) (43) 24 (19) Unrealized gains (losses) on marketable securities — (24) (24) (43) — (43) Consolidated Statement of Cash Flows (in thousands) As reported Adjustment As revised Net realized and unrealized gains on marketable securities — 13 13 Net cash provided in operations — 13 13 Purchases of marketable securities — (18,850) (18,850) Proceeds from sales of marketable securities — 3,350 3,350 Net cash used in investing activities — (15,500) (15,500) Beginning cash and cash equivalents 14,437 — 14,437 Ending cash and cash equivalents $24,205 $(15,463) $ 8,742 |
Nature of Business and Basis _3
Nature of Business and Basis of Presentation (Q3) (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Nature of Business, Basis of Presentation and Significant Accounting Policies [Abstract] | ||
Inventories | Inventories consisted of the following: (in thousands) September 30, 2023 December 31, 2022 Finished Goods $ 811 $ 993 Work in Process 170 204 Raw Materials 1,659 1,609 Inventory Reserves (304 ) (145 ) Total $2,336 $2,661 | Inventories consisted of the following as of December 31: (Dollars in thousands) 2022 2021 Finished Goods $ 993 $1,527 Work in Process 204 276 Raw Materials 1,609 1,281 Inventory Reserves (145) (241) Total $2,661 $2,843 |
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: September 30 2023 2022 Stock options 111,275 11,910 Warrants to purchase common stock 1,308,271 16,970 Series F convertible preferred stock 5,080 508 Total 1,424,626 29,388 | 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 year presented: December 31, 2022 2021 Stock options 10,485 7,481 Warrants to purchase common stock 679,244 16,299 Series F convertible preferred stock 5,080 50,800 Series I convertible preferred stock 10,493 — Total 705,302 74,580 |
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 and nine months ended September 30: Three months ended September 30 Nine months ended September 30 (in thousands, except per share amounts) 2023 2022 2023 2022 Net loss $(3,370) $(3,870) $(14,700) $(12,629) Weighted average shares outstanding 1,864 105 1,439 105 Basic and diluted loss per share $ (1.81 ) $(36.72 ) $ (10.21 ) $ (119.85 ) | The following table reconciles reported net loss with reported net loss per share for the years ended December 31: (in thousands, except per share amounts) 2022 2021 Net loss $(14,525) $(19,545) Deemed dividend to preferred stockholders (see Note 4) — (75) Net loss after deemed dividend (14,525) (19,620) Weighted average shares outstanding 174 69 Basic and diluted loss per share $ (83.55 ) $(285.36 ) |
Stock-Based Compensation (Q3) (
Stock-Based Compensation (Q3) (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
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 September 30 Nine months ended September 30 (in thousands) 2023 2022 2023 2022 Selling, general and administrative expense $133 $199 $484 $624 Research and development expense 2 21 29 73 Total stock-based compensation expense $135 $220 $513 $697 | The following table summarizes the stock-based compensation expense that was recognized in the consolidated statements of operations for the years ended December 31, (Dollars in thousands) 2022 2021 Selling, general and administrative $784 $1,171 Research and development 78 143 Total $862 $1,314 |
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 and nine months ended September 30, 2023 and 2022: Three months ended September 30 Nine months ended September 30 2023 2022 2023 2022 Expected volatility 131.06% 132.08% 152.59% 132.48% Expected Life of options (years) 6.25 6.25 6.19 6.15 Expected dividend yield 0% 0% 0% 0% Risk-free interest rate 4.29% 3.02% 4.16% 2.13% | The following table provides the weighted average assumptions used in the Black-Scholes option pricing model for the years ended December 31: 2022 2021 Expected dividend yield 0% 0% Risk-free interest rate 2.13% 1.19% Expected volatility 132.48% 131.03% Expected life (in years) 6.15 6.21 |
Fair Value of Financial Instr_4
Fair Value of Financial Instruments (Q3) (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Fair Value of Financial Instruments [Abstract] | ||
Available-for-Sale Marketable Securities Measured at Fair Value on Recurring Basis | The available-for-sale marketable securities primarily consist of investment-grade, U.S.-dollar-denominated fixed and floating rate debt, measured at fair value on a recurring basis. September 30, 2023 December 31, 2022 (in thousands) Fair Value Level 1 Fair Value Level 1 Marketable securities $0 $0 $569 $569 | The available-for-sale marketable securities primarily consist of investment-grade, U.S. dollar-denominated fixed and floating-rate debt, measured at fair value on a recurring basis. 2022 2021 (Dollars in thousands) Fair Value Level 1 Fair Value Level 1 Marketable securities $569 $569 $15,463 $15,463 |
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 Balance at January 4, 2023 (revaluation date) 7,623 Warrants reclassified to equity (7,623 ) Balance at September 30, 2023 $ — | The following is a roll-forward of the fair value of Level 3 warrants: (in thousands) October 18, 2022 warrant issuance $ 18,695 Change in fair value (11,827) Ending balance December 31, 2022 $ 6,868 |
Nature of Business and Signif_4
Nature of Business and Significant Accounting Policies, Going Concern, Accounts Receivable and Inventories (FY) (Details) $ in Thousands | 9 Months Ended | 12 Months Ended | 24 Months Ended | ||
Sep. 30, 2023 USD ($) Customer | Sep. 30, 2022 USD ($) | Dec. 31, 2022 USD ($) Customer | Dec. 31, 2021 USD ($) Customer | Dec. 31, 2022 USD ($) | |
Going Concern [Abstract] | |||||
Accumulated deficit | $ (282,117) | $ (267,417) | $ (252,892) | $ (267,417) | |
Net proceeds from issuance of public offering | $ 9,400 | 37,300 | |||
Accounts Receivable [Abstract] | |||||
Accounts receivables maximum credit period from invoice date | 30 days | 30 days | |||
Allowance for doubtful accounts | $ 0 | $ 0 | 0 | 0 | |
Inventories [Abstract] | |||||
Finished Goods | 811 | 993 | 1,527 | 993 | |
Work in Process | 170 | 204 | 276 | 204 | |
Raw Materials | 1,659 | 1,609 | 1,281 | 1,609 | |
Inventory Reserves | (304) | (145) | (241) | (145) | |
Total | $ 2,336 | $ 2,661 | $ 2,843 | $ 2,661 | |
Accounts Receivable [Member] | |||||
Revenue, Performance Obligation [Abstract] | |||||
Number of major customers | Customer | 3 | 2 | 2 | ||
Accounts Receivable [Member] | Customer Concentration Risk [Member] | Customer One [Member] | |||||
Revenue, Performance Obligation [Abstract] | |||||
Concentration risk percentage | 17% | 15% | 12% | ||
Accounts Receivable [Member] | Customer Concentration Risk [Member] | Customer Two [Member] | |||||
Revenue, Performance Obligation [Abstract] | |||||
Concentration risk percentage | 17% | 10% | 11% |
Nature of Business and Signif_5
Nature of Business and Significant Accounting Policies, Property, Plant and Equipment and Revenue Recognition (FY) (Details) | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2023 Customer | Sep. 30, 2022 Customer | Sep. 30, 2023 Customer | Sep. 30, 2022 Customer | Dec. 31, 2022 USD ($) Customer | Dec. 31, 2021 USD ($) Customer | |
Property, Plant and Equipment [Abstract] | ||||||
Depreciation expense | $ 372,000 | $ 488,000 | ||||
Impairment losses recognized | $ 0 | $ 0 | ||||
Production Equipment [Member] | Minimum [Member] | ||||||
Property, Plant and Equipment [Abstract] | ||||||
Estimated useful lives | 3 years | |||||
Production Equipment [Member] | Maximum [Member] | ||||||
Property, Plant and Equipment [Abstract] | ||||||
Estimated useful lives | 7 years | |||||
Office Furniture and Fixtures [Member] | Minimum [Member] | ||||||
Property, Plant and Equipment [Abstract] | ||||||
Estimated useful lives | 3 years | |||||
Office Furniture and Fixtures [Member] | Maximum [Member] | ||||||
Property, Plant and Equipment [Abstract] | ||||||
Estimated useful lives | 5 years | |||||
Computer Software and Equipment [Member] | Minimum [Member] | ||||||
Property, Plant and Equipment [Abstract] | ||||||
Estimated useful lives | 3 years | |||||
Computer Software and Equipment [Member] | Maximum [Member] | ||||||
Property, Plant and Equipment [Abstract] | ||||||
Estimated useful lives | 4 years | |||||
Loaners and Demo Equipment [Member] | Minimum [Member] | ||||||
Property, Plant and Equipment [Abstract] | ||||||
Estimated useful lives | 1 year | |||||
Loaners and Demo Equipment [Member] | Maximum [Member] | ||||||
Property, Plant and Equipment [Abstract] | ||||||
Estimated useful lives | 5 years | |||||
Leasehold Improvements [Member] | Minimum [Member] | ||||||
Property, Plant and Equipment [Abstract] | ||||||
Estimated useful lives | 3 years | |||||
Leasehold Improvements [Member] | Maximum [Member] | ||||||
Property, Plant and Equipment [Abstract] | ||||||
Estimated useful lives | 5 years | |||||
ASC 606 [Member] | Net Sales [Member] | ||||||
Revenue Recognition [Abstract] | ||||||
Number of major customers | Customer | 2 | 1 | 2 | 2 | 1 | 2 |
ASC 606 [Member] | Customer One [Member] | Net Sales [Member] | Customer Concentration Risk [Member] | ||||||
Revenue Recognition [Abstract] | ||||||
Concentration risk percentage | 21% | 12% | 17% | 13% | 12.50% | 12.30% |
ASC 606 [Member] | Customer Two [Member] | Net Sales [Member] | Customer Concentration Risk [Member] | ||||||
Revenue Recognition [Abstract] | ||||||
Concentration risk percentage | 11% | 12% | 10% | 10.70% |
Nature of Business and Signif_6
Nature of Business and Significant Accounting Policies, Loss Per Share (FY) (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | |
Loss per share [Abstract] | ||||||
Net deemed dividends resulting from subsequent reduction in exercise price of warrants | $ 75,000 | |||||
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) | 1,424,626 | 29,388 | 705,302 | 74,580 | ||
Reported net loss with reported net loss per share [Abstract] | ||||||
Net loss | $ (3,370) | $ (3,870) | $ (14,700) | $ (12,629) | $ (14,525) | $ (19,545) |
Deemed dividend to preferred shareholders (see Note 4) | 0 | (75) | ||||
Net loss after deemed dividend | $ (14,525) | $ (19,620) | ||||
Weighted average shares outstanding - basic (in shares) | 1,864,000 | 105,000 | 1,439,000 | 105,000 | 174,000 | 69,000 |
Weighted average shares outstanding - diluted (in shares) | 1,864,000 | 105,000 | 1,439,000 | 105,000 | 174,000 | 69,000 |
Basic loss per share (in dollars per share) | $ (1.81) | $ (36.72) | $ (10.21) | $ (119.85) | $ (83.55) | $ (285.36) |
Diluted loss per share (in dollars per share) | $ (1.81) | $ (36.72) | $ (10.21) | $ (119.85) | $ (83.55) | $ (285.36) |
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) | 111,275 | 11,910 | 10,485 | 7,481 | ||
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) | 1,308,271 | 16,970 | 679,244 | 16,299 | ||
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) | 5,080 | 508 | 5,080 | 50,800 | ||
Series I 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) | 10,493 | 0 |
Revenue Recognition (FY) (Detai
Revenue Recognition (FY) (Details) | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Sep. 30, 2023 | |
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date [Axis]: 2022-01-01 | |||
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction [Abstract] | |||
Expected timing of satisfaction, period | 1 year | ||
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date [Axis]: 2023-01-01 | |||
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction [Abstract] | |||
Expected timing of satisfaction, period | 1 year | ||
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date [Axis]: 2023-10-01 | |||
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction [Abstract] | |||
Expected timing of satisfaction, period | 1 year | ||
Sales Revenue [Member] | Customer Concentration Risk [Member] | ASC 606 [Member] | Maximum [Member] | |||
Revenue, Performance Obligation [Abstract] | |||
Concentration risk percentage | 1% | 1% |
Property, Plant and Equipment_3
Property, Plant and Equipment (FY) (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 | Dec. 31, 2021 |
Property, Plant and Equipment, Gross [Abstract] | |||
Property, Plant and Equipment, Gross | $ 4,151 | $ 4,008 | |
Accumulated Depreciation | (3,171) | (2,820) | |
Property, Plant and Equipment, Net | $ 912 | 980 | 1,188 |
Production Equipment [Member] | |||
Property, Plant and Equipment, Gross [Abstract] | |||
Property, Plant and Equipment, Gross | 1,360 | 1,321 | |
Loaners and Demo Equipment [Member] | |||
Property, Plant and Equipment, Gross [Abstract] | |||
Property, Plant and Equipment, Gross | 1,444 | 1,364 | |
Computer Software and Equipment [Member] | |||
Property, Plant and Equipment, Gross [Abstract] | |||
Property, Plant and Equipment, Gross | 719 | 714 | |
Office Furniture & Fixtures [Member] | |||
Property, Plant and Equipment, Gross [Abstract] | |||
Property, Plant and Equipment, Gross | 375 | 364 | |
Leasehold Improvements [Member] | |||
Property, Plant and Equipment, Gross [Abstract] | |||
Property, Plant and Equipment, Gross | $ 253 | $ 245 |
Stockholders' Equity (FY) (Deta
Stockholders' Equity (FY) (Details) | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||||||||||||||||||||||
Dec. 08, 2022 | Dec. 05, 2022 | Oct. 18, 2022 USD ($) $ / shares shares | Sep. 17, 2021 USD ($) $ / shares shares | Mar. 19, 2021 USD ($) $ / shares shares | Aug. 21, 2020 USD ($) $ / shares shares | May 05, 2020 USD ($) $ / shares shares | Apr. 01, 2020 USD ($) shares | Mar. 23, 2020 USD ($) $ / shares shares | Jan. 28, 2020 USD ($) $ / shares shares | Mar. 12, 2019 $ / shares | Nov. 27, 2017 USD ($) $ / shares shares | Sep. 30, 2023 shares | Jun. 30, 2023 $ / shares shares | Mar. 31, 2023 shares | Sep. 30, 2023 USD ($) shares | Sep. 30, 2022 USD ($) $ / shares | Dec. 31, 2022 USD ($) shares | Dec. 31, 2021 USD ($) shares | Dec. 31, 2020 USD ($) shares | Oct. 31, 2022 $ / shares | Apr. 02, 2020 $ / shares shares | Nov. 06, 2019 $ / shares | Oct. 25, 2019 $ / shares | May 30, 2019 $ / shares shares | Jul. 03, 2018 $ / shares | |
Class of Stock Disclosures [Abstract] | ||||||||||||||||||||||||||
Warrants exercised to purchase common stock (in shares) | 4,552,000 | |||||||||||||||||||||||||
Proceeds from warrant exercises | $ | $ 0 | $ 1,000 | $ 4,100,000 | |||||||||||||||||||||||
Exercise price of warrants (in dollars per share) | $ / shares | $ 0 | |||||||||||||||||||||||||
Preferred stock, shares outstanding (in shares) | 0 | 0 | 0 | 0 | ||||||||||||||||||||||
Gross proceeds from public stock offering | $ | $ 2,108,000 | $ 0 | ||||||||||||||||||||||||
Reverse stock split | 0.01 | |||||||||||||||||||||||||
Minimum [Member] | ||||||||||||||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||||||||||||||
Reverse stock split | 0.02 | |||||||||||||||||||||||||
Maximum [Member] | ||||||||||||||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||||||||||||||
Reverse stock split | 0.01 | |||||||||||||||||||||||||
January 2020 Offering [Member] | ||||||||||||||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||||||||||||||
Warrants to purchase shares of common stock (in shares) | 5,855,000 | |||||||||||||||||||||||||
Exercise price of warrants (in dollars per share) | $ / shares | $ 25 | $ 900 | $ 1,650 | $ 250 | ||||||||||||||||||||||
Issuance of common stock, net (in shares) | 2,015,000 | |||||||||||||||||||||||||
Public offering price (in dollars per share) | $ / shares | $ 1,650 | |||||||||||||||||||||||||
Gross proceeds from public stock offering | $ | $ 9,700,000 | |||||||||||||||||||||||||
Net proceeds from public stock offering | $ | 8,600,000 | |||||||||||||||||||||||||
Down-round protection in connection with re-pricing of warrants | $ | 200,000 | |||||||||||||||||||||||||
Beneficial conversion amount | $ | $ 1,600,000 | |||||||||||||||||||||||||
March 2020 Offering [Member] | ||||||||||||||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||||||||||||||
Warrants to purchase shares of common stock (in shares) | 1,387,000 | |||||||||||||||||||||||||
Exercise price of warrants (in dollars per share) | $ / shares | $ 1,118 | |||||||||||||||||||||||||
Issuance of common stock, net (in shares) | 1,387,000 | |||||||||||||||||||||||||
Public offering price (in dollars per share) | $ / shares | $ 900 | |||||||||||||||||||||||||
Gross proceeds from public stock offering | $ | $ 1,200,000 | |||||||||||||||||||||||||
Net proceeds from public stock offering | $ | $ 1,000,000 | |||||||||||||||||||||||||
Warrant expiry period | 5 years 6 months | |||||||||||||||||||||||||
Warrants exercisable period | 6 months | |||||||||||||||||||||||||
April 2020 Offering [Member] | ||||||||||||||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||||||||||||||
Warrants to purchase shares of common stock (in shares) | 855,000 | |||||||||||||||||||||||||
Exercise price of warrants (in dollars per share) | $ / shares | $ 1,115 | |||||||||||||||||||||||||
Issuance of common stock, net (in shares) | 1,710,000 | |||||||||||||||||||||||||
Public offering price (in dollars per share) | $ / shares | $ 1,302 | |||||||||||||||||||||||||
Gross proceeds from public stock offering | $ | $ 2,200,000 | |||||||||||||||||||||||||
Warrant expiry period | 5 years 6 months | |||||||||||||||||||||||||
May 2020 Offering [Member] | ||||||||||||||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||||||||||||||
Warrants to purchase shares of common stock (in shares) | 600,000 | |||||||||||||||||||||||||
Exercise price of warrants (in dollars per share) | $ / shares | $ 1,230 | |||||||||||||||||||||||||
Issuance of common stock, net (in shares) | 1,199,000 | |||||||||||||||||||||||||
Public offering price (in dollars per share) | $ / shares | $ 1,418 | |||||||||||||||||||||||||
Gross proceeds from public stock offering | $ | $ 1,700,000 | |||||||||||||||||||||||||
Warrant expiry period | 5 years 6 months | |||||||||||||||||||||||||
August 2020 Offering [Member] | ||||||||||||||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||||||||||||||
Issuance of common stock, net (in shares) | 10,647,000 | |||||||||||||||||||||||||
Public offering price (in dollars per share) | $ / shares | $ 1,350 | |||||||||||||||||||||||||
Gross proceeds from public stock offering | $ | $ 14,400,000 | |||||||||||||||||||||||||
Net proceeds from public stock offering | $ | $ 13,000,000 | |||||||||||||||||||||||||
Number of shares issuable on the exercise of warrants (in shares) | 10,647,000 | |||||||||||||||||||||||||
Warrant expiry period | 5 years | |||||||||||||||||||||||||
March 2021 Offering [Member] | ||||||||||||||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||||||||||||||
Issuance of common stock, net (in shares) | 37,958 | |||||||||||||||||||||||||
Gross proceeds from public stock offering | $ | $ 20,900,000 | |||||||||||||||||||||||||
Net proceeds from public stock offering | $ | $ 18,900,000 | |||||||||||||||||||||||||
September 2021 Offering [Member] | ||||||||||||||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||||||||||||||
Issuance of common stock, net (in shares) | 40,056 | |||||||||||||||||||||||||
Gross proceeds from public stock offering | $ | $ 10,000,000 | |||||||||||||||||||||||||
Net proceeds from public stock offering | $ | $ 9,000,000 | |||||||||||||||||||||||||
October 2022 Offering [Member] | ||||||||||||||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||||||||||||||
Gross proceeds from public stock offering | $ | $ 11,000,000 | |||||||||||||||||||||||||
Net proceeds from public stock offering | $ | $ 9,400,000 | |||||||||||||||||||||||||
Warrants to Purchase Common Stock [Member] | ||||||||||||||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||||||||||||||
Number of warrants vested (in shares) | 0 | 0 | ||||||||||||||||||||||||
Warrants to Purchase Common Stock [Member] | Consultant [Member] | ||||||||||||||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||||||||||||||
Warrants to purchase shares of common stock (in shares) | 33 | |||||||||||||||||||||||||
Exercise price of warrants (in dollars per share) | $ / shares | $ 9,540 | |||||||||||||||||||||||||
Common Stock [Member] | ||||||||||||||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||||||||||||||
Issuance of common stock, net (in shares) | 0 | 657,333 | 209,940 | 78,014 | ||||||||||||||||||||||
Conversion of preferred stock into common stock (in shares) | 10,493 | 221,078 | ||||||||||||||||||||||||
Common Stock [Member] | October 2022 Offering [Member] | ||||||||||||||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||||||||||||||
Issuance of common stock, net (in shares) | 209,940 | |||||||||||||||||||||||||
Number of shares in one unit (in shares) | 1 | |||||||||||||||||||||||||
Series F Convertible Preferred Stock [Member] | ||||||||||||||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||||||||||||||
Gross proceeds from issuance of convertible preferred stock | $ | $ 18,000,000 | |||||||||||||||||||||||||
Net proceeds from issuance of convertible preferred stock | $ | $ 16,200,000 | |||||||||||||||||||||||||
Conversion price (in dollars per share) | $ / shares | $ 189,000 | $ 89,040 | ||||||||||||||||||||||||
Number of consecutive trading days considered for expiration | 20 days | 20 days | ||||||||||||||||||||||||
Number of consecutive trading days | 30 days | 30 days | ||||||||||||||||||||||||
Percentage of volume weighted average price of common stock | 300% | |||||||||||||||||||||||||
Trading volume for each trading day | $ | $ 200,000 | |||||||||||||||||||||||||
Preferred stock issued (in shares) | 18,000 | 127 | 127 | 127 | 127 | |||||||||||||||||||||
Number of shares issuable on conversion of preferred stock (in shares) | 96 | |||||||||||||||||||||||||
Preferred stock, shares outstanding (in shares) | 127 | 127 | 127 | 127 | ||||||||||||||||||||||
Aggregate cash placement fee | 8% | |||||||||||||||||||||||||
Series F Convertible Preferred Stock [Member] | Minimum [Member] | ||||||||||||||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||||||||||||||
Percentage of volume weighted average price of common stock | 300% | |||||||||||||||||||||||||
Trading volume for each trading day | $ | $ 200,000 | |||||||||||||||||||||||||
Series F Convertible Preferred Stock [Member] | March 2019 Offering [Member] | ||||||||||||||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||||||||||||||
Conversion price (in dollars per share) | $ / shares | $ 15,750 | |||||||||||||||||||||||||
Series F Convertible Preferred Stock [Member] | October 2019 Offering [Member] | ||||||||||||||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||||||||||||||
Conversion price (in dollars per share) | $ / shares | $ 4,230 | |||||||||||||||||||||||||
Series F Convertible Preferred Stock [Member] | November 2019 Offering [Member] | ||||||||||||||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||||||||||||||
Conversion price (in dollars per share) | $ / shares | $ 2,983 | |||||||||||||||||||||||||
Series F Convertible Preferred Stock [Member] | January 2020 Offering [Member] | ||||||||||||||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||||||||||||||
Conversion price (in dollars per share) | $ / shares | $ 1,650 | |||||||||||||||||||||||||
Exercise price of warrants (in dollars per share) | $ / shares | 900 | |||||||||||||||||||||||||
Series F Convertible Preferred Stock [Member] | March 2020 Offering [Member] | ||||||||||||||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||||||||||||||
Conversion price (in dollars per share) | $ / shares | $ 900 | |||||||||||||||||||||||||
Series F Convertible Preferred Stock [Member] | March 2021 Offering [Member] | ||||||||||||||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||||||||||||||
Conversion price (in dollars per share) | $ / shares | $ 550 | |||||||||||||||||||||||||
Exercise price of warrants (in dollars per share) | $ / shares | $ 550 | |||||||||||||||||||||||||
Series F Convertible Preferred Stock [Member] | September 2021 Offering [Member] | ||||||||||||||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||||||||||||||
Conversion price (in dollars per share) | $ / shares | $ 250 | |||||||||||||||||||||||||
Exercise price of warrants (in dollars per share) | $ / shares | $ 250 | |||||||||||||||||||||||||
Series F Convertible Preferred Stock [Member] | October 2022 Offering [Member] | ||||||||||||||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||||||||||||||
Conversion price (in dollars per share) | $ / shares | $ 25 | $ 250 | $ 25 | |||||||||||||||||||||||
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) | 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) | 16 | |||||||||||||||||||||||||
Exercise price of warrants (in dollars per share) | $ / shares | $ 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) | 4 | |||||||||||||||||||||||||
Exercise price of warrants (in dollars per share) | $ / shares | $ 189,000 | |||||||||||||||||||||||||
Series H Preferred Stock [Member] | ||||||||||||||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||||||||||||||
Conversion price (in dollars per share) | $ / shares | $ 1,650 | |||||||||||||||||||||||||
Preferred stock, shares outstanding (in shares) | 0 | |||||||||||||||||||||||||
Maximum percentage of the applicable Unit offering price, by which exercise price can be lower than adjustment | 10% | |||||||||||||||||||||||||
Conversion of preferred stock into common stock (in shares) | 115,173 | |||||||||||||||||||||||||
Series H Preferred Stock [Member] | January 2020 Offering [Member] | ||||||||||||||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||||||||||||||
Issuance of common stock, net (in shares) | 115,173,000 | |||||||||||||||||||||||||
Series I Preferred Stock [Member] | ||||||||||||||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||||||||||||||
Preferred stock issued (in shares) | 0 | 0 | 1,049,280 | 0 | ||||||||||||||||||||||
Preferred stock, shares outstanding (in shares) | 0 | 0 | 1,049,280 | 0 | ||||||||||||||||||||||
Series I Preferred Stock [Member] | October 2022 Offering [Member] | ||||||||||||||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||||||||||||||
Issuance of common stock, net (in shares) | 23,157,124 | |||||||||||||||||||||||||
Number of shares in one unit (in shares) | 1 | |||||||||||||||||||||||||
Class A Unit [Member] | October 2022 Offering [Member] | ||||||||||||||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||||||||||||||
Issuance of common stock, net (in shares) | 209,940 | |||||||||||||||||||||||||
Common stock offering price per share (in dollars per share) | $ / shares | $ 25 | |||||||||||||||||||||||||
Number of shares in one unit (in shares) | 1 | |||||||||||||||||||||||||
Common stock exercise price per share (in dollars per share) | $ / shares | $ 25 | |||||||||||||||||||||||||
Class A Unit [Member] | Warrants [Member] | October 2022 Offering [Member] | ||||||||||||||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||||||||||||||
Number of shares in one unit (in shares) | 1.5 | |||||||||||||||||||||||||
Class B Unit [Member] | October 2022 Offering [Member] | ||||||||||||||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||||||||||||||
Issuance of common stock, net (in shares) | 23,157,124 | |||||||||||||||||||||||||
Common stock offering price per share (in dollars per share) | $ / shares | $ 0.25 | |||||||||||||||||||||||||
Common stock exercise price per share (in dollars per share) | $ / shares | $ 0 | |||||||||||||||||||||||||
Class B Unit [Member] | Warrants [Member] | October 2022 Offering [Member] | ||||||||||||||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||||||||||||||
Number of shares in one unit (in shares) | 1.5 |
Stock-Based Compensation, Stock
Stock-Based Compensation, Stock Options (FY) (Details) - USD ($) | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | |
Stock-Based Compensation Expense Items [Abstract] | ||||||
Stock-based compensation expense | $ 135,000 | $ 220,000 | $ 513,000 | $ 697,000 | $ 862,000 | $ 1,314,000 |
Minimum [Member] | ||||||
Additional Disclosures [Abstract] | ||||||
Award vesting period | 1 year | |||||
Maximum [Member] | ||||||
Additional Disclosures [Abstract] | ||||||
Award vesting period | 4 years | |||||
Selling, General and Administrative [Member] | ||||||
Stock-Based Compensation Expense Items [Abstract] | ||||||
Stock-based compensation expense | 133,000 | 199,000 | 484,000 | 624,000 | $ 784,000 | 1,171,000 |
Research and Development [Member] | ||||||
Stock-Based Compensation Expense Items [Abstract] | ||||||
Stock-based compensation expense | $ 2,000 | $ 21,000 | $ 29,000 | $ 73,000 | $ 78,000 | $ 143,000 |
Stock Options [Member] | ||||||
Stock Options Activity [Roll Forward] | ||||||
Outstanding, beginning balance (in shares) | 10,485 | 7,481 | 7,481 | 144 | ||
Granted (in shares) | 18,643 | 369 | 125,410 | 5,577 | 5,833 | 9,081 |
Exercised (in shares) | 0 | 0 | 0 | 0 | 0 | 0 |
Forfeited/expired (in shares) | (21,372) | (343) | (24,620) | (1,148) | (2,829) | (1,744) |
Outstanding, ending balance (in shares) | 111,275 | 12,003 | 111,275 | 12,003 | 10,485 | 7,481 |
Vested at the end of the year (in shares) | 3,531 | 409 | ||||
Weighted Average Exercise Price [Abstract] | ||||||
Outstanding, beginning balance (in dollars per share) | $ 404.08 | $ 656.05 | $ 656.05 | $ 40,534 | ||
Granted (in dollars per share) | 83.96 | 444.83 | ||||
Exercised (in dollars per share) | 0 | 0 | ||||
Forfeited/expired (in dollars per share) | 410.34 | 2,332.06 | ||||
Outstanding, ending balance (in dollars per share) | 404.08 | 656.05 | ||||
Vested at the end of the year (in dollars per share) | $ 727.26 | $ 4,218.4 | ||||
Weighted Average Remaining Contractual Term [Abstract] | ||||||
Options outstanding, weighted average remaining contractual life | 8 years 9 months 14 days | 8 years 9 months 14 days | ||||
Options vested, weighted average remaining contractual life | 8 years 7 months 17 days | 8 years 7 months 17 days | ||||
Aggregate Intrinsic Value [Abstract] | ||||||
Fair value of options, vested | $ 1,100,000 | $ 700,000 | ||||
Weighted Average Assumptions used in Black-Scholes Option Pricing Model [Abstract] | ||||||
Expected dividend yield | 0% | 0% | 0% | 0% | 0% | 0% |
Risk-free interest rate | 4.29% | 3.02% | 4.16% | 2.13% | 2.13% | 1.19% |
Expected volatility | 131.06% | 132.08% | 152.59% | 132.48% | 132.48% | 131.03% |
Expected life | 6 years 3 months | 6 years 3 months | 6 years 2 months 8 days | 6 years 1 month 24 days | 6 years 1 month 24 days | 6 years 2 months 15 days |
Additional Disclosures [Abstract] | ||||||
Award vesting period | 48 months | |||||
Weighted-average fair value of options granted (in dollars per share) | $ 1.63 | $ 60.4 | $ 6.18 | $ 79.07 | $ 76.05 | $ 396.17 |
Total unrecognized compensation costs related to non-vested stock option awards | $ 1,300,000 | |||||
Unrecognized compensation costs related to non-vested stock option awards, recognition life | 2 years 6 months 14 days |
Stock-Based Compensation, Warra
Stock-Based Compensation, Warrants (FY) (Details) - $ / shares shares in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Jun. 30, 2023 | Dec. 31, 2021 | |
Class of Warrant or Right [Abstract] | |||
Exercise price of warrants (in dollars per share) | $ 0 | ||
Warrants [Member] | |||
Class of Warrant or Right [Abstract] | |||
Warrants outstanding (in shares) | 679,244 | 16,299 | |
Warrants [Member] | Minimum [Member] | |||
Class of Warrant or Right [Abstract] | |||
Exercise price of warrants (in dollars per share) | $ 25 | ||
Warrants [Member] | Maximum [Member] | |||
Class of Warrant or Right [Abstract] | |||
Exercise price of warrants (in dollars per share) | $ 189,000 | ||
Warrants exercisable period | 5 years 9 months 18 days |
Fair Value of Financial Instr_5
Fair Value of Financial Instruments, Available-for-Sale Marketable Securities Measured at Fair Value on Recurring Basis (FY) (Details) - Recurring [Member] - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 | Dec. 31, 2021 |
Available-for-sale marketable securities [Abstract] | |||
Marketable securities | $ 0 | $ 569 | $ 15,463 |
Level 1 [Member] | |||
Available-for-sale marketable securities [Abstract] | |||
Marketable securities | $ 0 | $ 569 | $ 15,463 |
Fair Value of Financial Instr_6
Fair Value of Financial Instruments, Roll-Forward of Fair Value of Level 3 Warrants (FY) (Details) - Warrant [Member] - USD ($) $ in Thousands | 2 Months Ended | |
Jan. 04, 2023 | Dec. 31, 2022 | |
Roll-Forward of Fair Value of Level 3 Warrants [Roll Forward] | ||
Beginning balance | $ 6,868 | $ 18,695 |
Change in fair value | 755 | (11,827) |
Ending balance | $ 7,623 | $ 6,868 |
Fair Value of Financial Instr_7
Fair Value of Financial Instruments, Fair Values Assumptions (FY) (Details) | 12 Months Ended | |
Oct. 18, 2022 | Dec. 31, 2022 | |
Valuation Technique and Input, Description [Abstract] | ||
Dates and probability of future equity raises | various | various |
Risk-Free Interest Rate, Adjusted for Continuous Compounding [Member] | ||
Valuation Technique and Input, Description [Abstract] | ||
Measurement input | 0.0416 | 0.0397 |
Term [Member] | ||
Valuation Technique and Input, Description [Abstract] | ||
Term | 6 years 2 months 4 days | 6 years 1 month 9 days |
Expected Volatility [Member] | ||
Valuation Technique and Input, Description [Abstract] | ||
Measurement input | 1.415 | 1.453 |
Income Taxes, Domestic and Fore
Income Taxes, Domestic and Foreign Income (Loss) Before Income Taxes (FY) (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | |
Domestic and foreign income (loss) before income taxes [Abstract] | ||||||
Domestic | $ (14,551) | $ (19,582) | ||||
Foreign | 35 | 37 | ||||
Loss before income taxes | $ (3,368) | $ (3,868) | $ (14,694) | $ (12,623) | $ (14,516) | $ (19,545) |
Income Taxes, Components of Inc
Income Taxes, Components of Income Tax Expense (FY) (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | |
Current [Abstract] | ||||||
United States and state | $ 0 | $ 0 | ||||
Foreign, net | (9) | (9) | ||||
Deferred [Abstract] | ||||||
United States and state | 0 | 0 | ||||
Foreign | 0 | 0 | ||||
Total income tax expense | $ (2) | $ (2) | $ (6) | $ (6) | $ (9) | $ (9) |
Income Taxes, Effective Income
Income Taxes, Effective Income Tax Rate Reconciliation (FY) (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | |
Effective income tax rate reconciliation [Abstract] | ||||||
Statutory federal income tax benefit | $ 3,048 | $ 4,109 | ||||
State tax benefit, net of federal taxes | 783 | 560 | ||||
Foreign tax | (1) | (1) | ||||
Nondeductible/nontaxable items | 548 | (220) | ||||
Other | (41) | 406 | ||||
Valuation allowance (increase) decrease | (4,346) | (4,863) | ||||
Total income tax expense | $ (2) | $ (2) | $ (6) | $ (6) | $ (9) | $ (9) |
Income Taxes, Deferred Taxes an
Income Taxes, Deferred Taxes and Other Information (FY) (Details) $ in Thousands, $ in Millions | 12 Months Ended | ||
Dec. 31, 2022 USD ($) | Dec. 31, 2021 USD ($) | Dec. 31, 2020 AUD ($) | |
Noncurrent [Abstract] | |||
Accrued leave | $ 397 | $ 59 | |
Stock based compensation | 360 | 368 | |
Net operating loss carryforward | 45,405 | 42,363 | |
Other | 42 | 131 | |
Intangibles | 1,786 | 723 | |
R&D credit carryforward | 531 | 531 | |
Total deferred tax assets | 48,521 | 44,175 | |
Less: valuation allowance | (48,521) | (44,175) | |
Total | 0 | 0 | |
Operating Loss Carryforwards [Abstract] | |||
Increase in valuation allowance | 4,300 | 4,900 | |
Unrecognized Tax Benefits [Abstract] | |||
Uncertain tax positions | 0 | 0 | |
Penalties and Interest Accrued [Abstract] | |||
Interest and penalties accrued on uncertain tax positions | $ 0 | $ 0 | |
Earliest Tax Year [Member] | |||
Operating Loss Carryforwards [Abstract] | |||
Net operating loss (NOL) carryforwards, expiration date | Dec. 31, 2024 | ||
Latest Tax Year [Member] | |||
Operating Loss Carryforwards [Abstract] | |||
Net operating loss (NOL) carryforwards, expiration date | Dec. 31, 2038 | ||
Federal [Member] | |||
Operating Loss Carryforwards [Abstract] | |||
Net operating loss (NOL) carryforwards | $ 198,100 | ||
Net operating loss (NOL) carryforwards with expiration date | 120,100 | ||
Net operating loss (NOL) carryforwards with no expiration date | 78,000 | ||
State [Member] | |||
Operating Loss Carryforwards [Abstract] | |||
Net operating loss (NOL) carryforwards | $ 53,800 | ||
Australian [Member] | |||
Operating Loss Carryforwards [Abstract] | |||
Net operating loss (NOL) carryforwards | $ 0 |
Operating Leases (FY) (Details)
Operating Leases (FY) (Details) $ in Thousands | 9 Months Ended | 12 Months Ended | |
Sep. 30, 2023 USD ($) ft² $ / ft² | Dec. 31, 2022 USD ($) $ / ft² ft² | Dec. 31, 2021 USD ($) | |
Operating Leases [Abstract] | |||
Area of property leased under operating lease | ft² | 23,000 | 23,000 | |
Monthly rent and common area maintenance charges | $ 32 | $ 31 | |
Annual base rent (per square foot) | $ / ft² | 10.5 | 10.5 | |
Cost Components of Operating Leases [Abstract] | |||
Operating lease cost | $ 238 | $ 219 | |
Variable lease cost | 127 | 123 | |
Total | 365 | $ 342 | |
Maturities of Lease Liability [Abstract] | |||
2023 | 249 | ||
2024 | 257 | ||
2025 | 264 | ||
2026 | 272 | ||
2027 | 69 | ||
Total lease payments | 1,111 | ||
Less: Interest | (155) | ||
Present value of lease liability | $ 956 | ||
Remaining lease term | 4 years 3 months | 5 years 3 months | |
Discount rate | 6.25% | 7.50% | |
Operating cash outflows from operating lease | $ 238 | $ 219 | |
Minimum [Member] | |||
Operating Leases [Abstract] | |||
Annual increase per square foot (in dollars per square foot) | $ / ft² | 0.32 | 0.32 | |
Maximum [Member] | |||
Operating Leases [Abstract] | |||
Annual increase per square foot (in dollars per square foot) | $ / ft² | 0.34 | 0.34 |
Finance Lease Liability (FY) (D
Finance Lease Liability (FY) (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2020 |
Finance Lease Liability [Abstract] | ||
Value of finance lease equipment | $ 98 | |
Finance Lease, Right-of-Use Asset, Statement of Financial Position [Extensible Enumeration] | Property, Plant and Equipment, Net | |
Principal amount under lease agreement | $ 93 | |
Implied interest rate | 7.50% | |
Finance lease term | 39 months | 39 months |
Commitments and Contingencies_3
Commitments and Contingencies (FY) (Details) | 12 Months Ended | ||
Aug. 05, 2021 USD ($) Installment | Dec. 31, 2022 USD ($) | Dec. 31, 2021 USD ($) | |
Employee Retirement Plan [Abstract] | |||
Employer's matching contribution | $ 185,000 | $ 255,000 | |
Koronis Biomedical Corporation [Member] | |||
Commitments and Contingencies [Abstract] | |||
Amount of grant approval received | $ 1,700,000 | ||
Non-refundable technology license fee | $ 428,160 | ||
Number of equal monthly installments | Installment | 12 | ||
Research and Development Expense [Member] | Koronis Biomedical Corporation [Member] | |||
Commitments and Contingencies [Abstract] | |||
Non-refundable technology license fee expenses | $ 428,160 | ||
Accounts Payable [Member] | Koronis Biomedical Corporation [Member] | |||
Commitments and Contingencies [Abstract] | |||
Non-refundable technology license fee | $ 178,400 |
Related Party Transactions (F_2
Related Party Transactions (FY) (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Related Party Transactions [Abstract] | ||
Amount of related party transactions | $ 0 | $ 0 |
Segment and Geographic Inform_2
Segment and Geographic Information (FY) (Details) | 12 Months Ended |
Dec. 31, 2022 Segment | |
Segment and Geographic Information [Abstract] | |
Number of reportable segments | 1 |
Revision and Immaterial Corre_3
Revision and Immaterial Correction of an Error in Previously Issued Financial Statements (FY) (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||||
Sep. 30, 2023 | Jun. 30, 2023 | Mar. 31, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | |
Consolidated Balance Sheet [Abstract] | ||||||||
Cash and cash equivalents | $ 4,930 | $ 4,930 | $ 17,737 | $ 8,742 | ||||
Marketable securities | 0 | 0 | 569 | 15,463 | ||||
Total current assets | 9,638 | 9,638 | 22,769 | 28,126 | ||||
Consolidated Statement of Operations and Comprehensive Loss [Abstract] | ||||||||
Other income (expense) | (204) | $ 52 | 98 | $ 14 | 75 | (19) | ||
Unrealized gains (losses) on marketable securities | 0 | $ (61) | $ 6 | 80 | (24) | |||
Total comprehensive loss | (43) | |||||||
Consolidated Statement of Cash Flows [Abstract] | ||||||||
Net realized and unrealized gains on marketable securities | 124 | 13 | ||||||
Net cash used in operating activities | 13 | |||||||
Purchases of marketable securities | 0 | (18,850) | ||||||
Proceeds from sale of marketable securities | 578 | 0 | 14,850 | 3,350 | ||||
Net cash provided (used) in investing activities | (15,500) | |||||||
Cash and cash equivalents - beginning of period | $ 17,737 | 17,737 | 8,742 | 8,742 | 14,437 | |||
Cash and cash equivalents - end of period | $ 4,930 | $ 12,053 | $ 4,930 | 12,053 | 17,737 | 8,742 | ||
As Reported [Member] | ||||||||
Consolidated Balance Sheet [Abstract] | ||||||||
Cash and cash equivalents | 24,205 | |||||||
Marketable securities | 0 | |||||||
Total current assets | 28,126 | |||||||
Consolidated Statement of Operations and Comprehensive Loss [Abstract] | ||||||||
Other income (expense) | (43) | |||||||
Unrealized gains (losses) on marketable securities | 0 | |||||||
Total comprehensive loss | (43) | |||||||
Consolidated Statement of Cash Flows [Abstract] | ||||||||
Net realized and unrealized gains on marketable securities | 0 | |||||||
Net cash used in operating activities | 0 | |||||||
Purchases of marketable securities | 0 | |||||||
Proceeds from sale of marketable securities | 0 | |||||||
Net cash provided (used) in investing activities | 0 | |||||||
Cash and cash equivalents - beginning of period | 24,205 | 24,205 | 14,437 | |||||
Cash and cash equivalents - end of period | 24,205 | |||||||
Adjustment [Member] | ||||||||
Consolidated Balance Sheet [Abstract] | ||||||||
Cash and cash equivalents | (15,463) | |||||||
Marketable securities | 15,463 | |||||||
Total current assets | 0 | |||||||
Consolidated Statement of Operations and Comprehensive Loss [Abstract] | ||||||||
Other income (expense) | 24 | |||||||
Unrealized gains (losses) on marketable securities | (24) | |||||||
Total comprehensive loss | 0 | |||||||
Consolidated Statement of Cash Flows [Abstract] | ||||||||
Net realized and unrealized gains on marketable securities | 13 | |||||||
Net cash used in operating activities | 13 | |||||||
Purchases of marketable securities | (18,850) | |||||||
Proceeds from sale of marketable securities | 3,350 | |||||||
Net cash provided (used) in investing activities | (15,500) | |||||||
Cash and cash equivalents - beginning of period | $ (15,463) | $ (15,463) | 0 | |||||
Cash and cash equivalents - end of period | $ (15,463) |
Subsequent Events (FY) (Details
Subsequent Events (FY) (Details) - USD ($) $ / shares in Units, $ in Millions | 2 Months Ended | 6 Months Ended | |
Feb. 24, 2023 | Jun. 30, 2023 | Mar. 03, 2023 | |
Common Stock Warrants Converted [Abstract] | |||
Number of common stock warrants converted into common stock (in shares) | 660,046 | ||
Number of shares of common stock issued upon conversion of common stock warrants (in shares) | 660,046 | ||
Exercise price of warrants (in dollars per share) | $ 0 | ||
Ladenburg Thalmann & Co. [Member] | |||
At-The-Market Offering [Abstract] | |||
Percentage of fixed commission rate | 3% | ||
Ladenburg Thalmann & Co. [Member] | Maximum [Member] | |||
At-The-Market Offering [Abstract] | |||
Aggregate offering price | $ 10 | ||
Subsequent Event [Member] | |||
Common Stock Warrants Converted [Abstract] | |||
Number of common stock warrants converted into common stock (in shares) | 660,046 | ||
Number of shares of common stock issued upon conversion of common stock warrants (in shares) | 660,046 | ||
Exercise price of warrants (in dollars per share) | $ 0 | ||
Subsequent Event [Member] | Ladenburg Thalmann & Co. [Member] | Maximum [Member] | |||
At-The-Market Offering [Abstract] | |||
Aggregate offering price | $ 10 | ||
Percentage of fixed commission rate | 3% |
Nature of Business and Basis _4
Nature of Business and Basis of Presentation, Nature of Business, Going Concern, Accounts Receivable and Inventories (Q3) (Details) $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | 24 Months Ended | ||||
Sep. 30, 2023 USD ($) Customer | Sep. 30, 2022 Customer | Sep. 30, 2023 USD ($) Customer | Sep. 30, 2022 USD ($) Customer | Dec. 31, 2022 USD ($) Customer | Dec. 31, 2021 USD ($) Customer | Dec. 31, 2022 USD ($) | Mar. 03, 2023 USD ($) | |
Going Concern [Abstract] | ||||||||
Accumulated deficit | $ (282,117) | $ (282,117) | $ (267,417) | $ (252,892) | $ (267,417) | |||
Net proceeds from issuance of public offering | $ 9,400 | 37,300 | ||||||
Revenue Recognition [Abstract] | ||||||||
Accounts receivables maximum credit period from invoice date | 30 days | 30 days | ||||||
Allowance for doubtful accounts | 0 | $ 0 | $ 0 | 0 | 0 | |||
Inventories [Abstract] | ||||||||
Finished Goods | 811 | 811 | 993 | 1,527 | 993 | |||
Work in Process | 170 | 170 | 204 | 276 | 204 | |||
Raw Materials | 1,659 | 1,659 | 1,609 | 1,281 | 1,609 | |||
Inventory Reserves | (304) | (304) | (145) | (241) | (145) | |||
Total | 2,336 | 2,336 | $ 2,661 | $ 2,843 | $ 2,661 | |||
Ladenburg Thalmann & Co. [Member] | ||||||||
Going Concern [Abstract] | ||||||||
Percentage of fixed commission rate | 3% | |||||||
Net proceeds from public stock offering | $ 0 | $ 2,100 | ||||||
Ladenburg Thalmann & Co. [Member] | Maximum [Member] | ||||||||
Going Concern [Abstract] | ||||||||
Aggregate offering price | $ 10,000 | |||||||
Accounts Receivable [Member] | ||||||||
Revenue Recognition [Abstract] | ||||||||
Number of major customers | Customer | 3 | 2 | 2 | |||||
Customer One [Member] | Accounts Receivable [Member] | Customer Concentration Risk [Member] | ||||||||
Revenue Recognition [Abstract] | ||||||||
Concentration risk percentage | 17% | 15% | 12% | |||||
Customer Two [Member] | Accounts Receivable [Member] | Customer Concentration Risk [Member] | ||||||||
Revenue Recognition [Abstract] | ||||||||
Concentration risk percentage | 17% | 10% | 11% | |||||
Customer Three [Member] | Accounts Receivable [Member] | Customer Concentration Risk [Member] | ||||||||
Revenue Recognition [Abstract] | ||||||||
Concentration risk percentage | 11% | |||||||
ASC 606 [Member] | Net Sales [Member] | ||||||||
Revenue Recognition [Abstract] | ||||||||
Number of major customers | Customer | 2 | 1 | 2 | 2 | 1 | 2 | ||
ASC 606 [Member] | Customer One [Member] | Net Sales [Member] | Customer Concentration Risk [Member] | ||||||||
Revenue Recognition [Abstract] | ||||||||
Concentration risk percentage | 21% | 12% | 17% | 13% | 12.50% | 12.30% | ||
ASC 606 [Member] | Customer Two [Member] | Net Sales [Member] | Customer Concentration Risk [Member] | ||||||||
Revenue Recognition [Abstract] | ||||||||
Concentration risk percentage | 11% | 12% | 10% | 10.70% |
Nature of Business and Basis _5
Nature of Business and Basis of Presentation, Loss Per Share (Q3) (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | |
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) | 1,424,626 | 29,388 | 705,302 | 74,580 | ||
Reported net loss with reported net loss per share [Abstract] | ||||||
Net loss | $ (3,370) | $ (3,870) | $ (14,700) | $ (12,629) | $ (14,525) | $ (19,545) |
Weighted average shares outstanding - basic (in shares) | 1,864,000 | 105,000 | 1,439,000 | 105,000 | 174,000 | 69,000 |
Weighted average shares outstanding - diluted (in shares) | 1,864,000 | 105,000 | 1,439,000 | 105,000 | 174,000 | 69,000 |
Basic loss per share (in dollars per share) | $ (1.81) | $ (36.72) | $ (10.21) | $ (119.85) | $ (83.55) | $ (285.36) |
Diluted loss per share (in dollars per share) | $ (1.81) | $ (36.72) | $ (10.21) | $ (119.85) | $ (83.55) | $ (285.36) |
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) | 111,275 | 11,910 | 10,485 | 7,481 | ||
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) | 1,308,271 | 16,970 | 679,244 | 16,299 | ||
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) | 5,080 | 508 | 5,080 | 50,800 |
Revenue Recognition (Q3) (Detai
Revenue Recognition (Q3) (Details) | 3 Months Ended | 9 Months Ended | ||||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | |
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date [Axis]: 2022-01-01 | ||||||
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction [Abstract] | ||||||
Expected timing of satisfaction, period | 1 year | |||||
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date [Axis]: 2023-01-01 | ||||||
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction [Abstract] | ||||||
Expected timing of satisfaction, period | 1 year | |||||
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date [Axis]: 2023-10-01 | ||||||
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction [Abstract] | ||||||
Expected timing of satisfaction, period | 1 year | 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% | 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 | 5% | 5% | 5% | 5% |
Stockholders' Equity (Q3) (Deta
Stockholders' Equity (Q3) (Details) $ / shares in Units, $ in Thousands | 3 Months Ended | 6 Months Ended | 9 Months Ended | 12 Months Ended | ||||||||||||||||||
Jun. 19, 2023 Tranches $ / shares shares | Dec. 08, 2022 | Dec. 05, 2022 | Oct. 18, 2022 USD ($) $ / shares shares | Sep. 17, 2021 USD ($) $ / shares shares | Mar. 19, 2021 USD ($) $ / shares shares | Mar. 23, 2020 USD ($) $ / shares shares | Jan. 28, 2020 USD ($) $ / shares shares | Mar. 12, 2019 $ / shares | Nov. 27, 2017 USD ($) $ / shares shares | Sep. 30, 2023 USD ($) $ / shares shares | Jun. 30, 2023 $ / shares shares | Jun. 30, 2023 $ / shares shares | Sep. 30, 2023 USD ($) $ / shares shares | Sep. 30, 2022 USD ($) $ / shares | Dec. 31, 2022 $ / shares shares | Dec. 31, 2021 $ / shares shares | Oct. 31, 2022 $ / 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) | $ / shares | $ 0.0001 | $ 0.0001 | $ 0.0001 | $ 0.0001 | ||||||||||||||||||
Exercise price of warrants (in dollars per share) | $ / shares | $ 0 | $ 0 | ||||||||||||||||||||
Preferred stock, shares outstanding (in shares) | 0 | 0 | 0 | 0 | ||||||||||||||||||
Gross proceeds from public stock offering | $ | $ 2,108 | $ 0 | ||||||||||||||||||||
Reverse stock split | 0.01 | |||||||||||||||||||||
Number of common stock warrants converted into common stock (in shares) | 660,046 | |||||||||||||||||||||
Number of shares of common stock issued upon conversion of common stock warrants (in shares) | 660,046 | |||||||||||||||||||||
Maximum [Member] | ||||||||||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||||||||||
Reverse stock split | 0.01 | |||||||||||||||||||||
Period of warrants expected to vest | 4 years | |||||||||||||||||||||
January 2020 Offering [Member] | ||||||||||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||||||||||
Warrants to purchase shares of common stock (in shares) | 5,855,000 | |||||||||||||||||||||
Exercise price of warrants (in dollars per share) | $ / shares | $ 25 | $ 900 | $ 1,650 | $ 250 | ||||||||||||||||||
Issuance of common stock, net (in shares) | 2,015,000 | |||||||||||||||||||||
Gross proceeds from public stock offering | $ | $ 9,700 | |||||||||||||||||||||
Net proceeds from public stock offering | $ | $ 8,600 | |||||||||||||||||||||
March 2020 Offering [Member] | ||||||||||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||||||||||
Warrants to purchase shares of common stock (in shares) | 1,387,000 | |||||||||||||||||||||
Exercise price of warrants (in dollars per share) | $ / shares | $ 1,118 | |||||||||||||||||||||
Issuance of common stock, net (in shares) | 1,387,000 | |||||||||||||||||||||
Gross proceeds from public stock offering | $ | $ 1,200 | |||||||||||||||||||||
Net proceeds from public stock offering | $ | $ 1,000 | |||||||||||||||||||||
March 2021 Offering [Member] | ||||||||||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||||||||||
Issuance of common stock, net (in 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) | 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) | 0 | 657,333 | ||||||||||||||||||||
Gross proceeds from public stock offering | $ | $ 0 | $ 2,300 | ||||||||||||||||||||
Net proceeds from public stock offering | $ | $ 0 | $ 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) | 0 | 0 | ||||||||||||||||||||
Warrants to Purchase Common Stock [Member] | Consultant [Member] | ||||||||||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||||||||||
Warrants to purchase shares of common stock (in shares) | 33 | |||||||||||||||||||||
Exercise price of warrants (in dollars per share) | $ / shares | $ 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] | ||||||||||||||||||||||
Warrants to purchase shares of common stock (in shares) | 1,289,081 | |||||||||||||||||||||
Common stock, par value (in dollars per share) | $ / shares | $ 0.0001 | |||||||||||||||||||||
Exercise price of warrants (in dollars per share) | $ / shares | $ 3.2996 | |||||||||||||||||||||
Number of warrants vested (in 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) | $ / shares | $ 189,000 | $ 89,040 | ||||||||||||||||||||
Number of consecutive trading days considered for expiration | 20 days | 20 days | ||||||||||||||||||||
Number of consecutive trading days | 30 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) | 18,000 | 127 | 127 | 127 | 127 | |||||||||||||||||
Number of shares issuable on conversion of preferred stock (in shares) | 96 | |||||||||||||||||||||
Preferred stock, shares outstanding (in shares) | 127 | 127 | 127 | 127 | ||||||||||||||||||
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) | $ / shares | $ 15,750 | |||||||||||||||||||||
Series F Convertible Preferred Stock [Member] | October 2019 Offering [Member] | ||||||||||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||||||||||
Conversion price (in dollars per share) | $ / shares | $ 4,230 | |||||||||||||||||||||
Series F Convertible Preferred Stock [Member] | November 2019 Offering [Member] | ||||||||||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||||||||||
Conversion price (in dollars per share) | $ / shares | $ 2,983 | |||||||||||||||||||||
Series F Convertible Preferred Stock [Member] | January 2020 Offering [Member] | ||||||||||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||||||||||
Conversion price (in dollars per share) | $ / shares | $ 1,650 | |||||||||||||||||||||
Exercise price of warrants (in dollars per share) | $ / shares | $ 900 | |||||||||||||||||||||
Series F Convertible Preferred Stock [Member] | March 2020 Offering [Member] | ||||||||||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||||||||||
Conversion price (in dollars per share) | $ / shares | $ 900 | |||||||||||||||||||||
Series F Convertible Preferred Stock [Member] | March 2021 Offering [Member] | ||||||||||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||||||||||
Conversion price (in dollars per share) | $ / shares | $ 550 | |||||||||||||||||||||
Exercise price of warrants (in dollars per share) | $ / shares | $ 550 | |||||||||||||||||||||
Series F Convertible Preferred Stock [Member] | September 2021 Offering [Member] | ||||||||||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||||||||||
Conversion price (in dollars per share) | $ / shares | $ 250 | |||||||||||||||||||||
Exercise price of warrants (in dollars per share) | $ / shares | $ 250 | |||||||||||||||||||||
Series F Convertible Preferred Stock [Member] | October 2020 Offering [Member] | ||||||||||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||||||||||
Conversion price (in dollars per share) | $ / shares | $ 250 | |||||||||||||||||||||
Series F Convertible Preferred Stock [Member] | October 2022 Offering [Member] | ||||||||||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||||||||||
Conversion price (in dollars per share) | $ / shares | $ 25 | $ 250 | $ 25 | |||||||||||||||||||
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) | 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) | 16 | |||||||||||||||||||||
Exercise price of warrants (in dollars per share) | $ / shares | $ 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) | 4 | |||||||||||||||||||||
Exercise price of warrants (in dollars per share) | $ / shares | $ 189,000 | |||||||||||||||||||||
Series I Preferred Stock [Member] | ||||||||||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||||||||||
Preferred stock issued (in shares) | 0 | 0 | 1,049,280 | 0 | ||||||||||||||||||
Preferred stock, shares outstanding (in shares) | 0 | 0 | 1,049,280 | 0 | ||||||||||||||||||
Series I Preferred Stock [Member] | October 2022 Offering [Member] | ||||||||||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||||||||||
Issuance of common stock, net (in shares) | 23,157,124 | |||||||||||||||||||||
Number of shares in one unit (in shares) | 1 | |||||||||||||||||||||
Class A Unit [Member] | October 2022 Offering [Member] | ||||||||||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||||||||||
Issuance of common stock, net (in shares) | 209,940 | |||||||||||||||||||||
Common stock offering price per share (in dollars per share) | $ / shares | $ 25 | |||||||||||||||||||||
Number of shares in one unit (in shares) | 1 | |||||||||||||||||||||
Common stock exercise price per share (in dollars per share) | $ / shares | $ 25 | |||||||||||||||||||||
Class B Unit [Member] | October 2022 Offering [Member] | ||||||||||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||||||||||
Issuance of common stock, net (in shares) | 23,157,124 | |||||||||||||||||||||
Common stock offering price per share (in dollars per share) | $ / shares | $ 0.25 | |||||||||||||||||||||
Common stock exercise price per share (in dollars per share) | $ / shares | $ 0 | |||||||||||||||||||||
Common Stock [Member] | ||||||||||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||||||||||
Issuance of common stock, net (in shares) | 0 | 657,333 | 209,940 | 78,014 | ||||||||||||||||||
Common Stock [Member] | October 2022 Offering [Member] | ||||||||||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||||||||||
Issuance of common stock, net (in shares) | 209,940 | |||||||||||||||||||||
Number of shares in one unit (in shares) | 1 | |||||||||||||||||||||
Warrants [Member] | Class A Unit [Member] | October 2022 Offering [Member] | ||||||||||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||||||||||
Number of shares in one unit (in 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) | 1.5 |
Stock-Based Compensation (Q3)_2
Stock-Based Compensation (Q3) (Details) - USD ($) | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Stock-Based Compensation Expense Items [Abstract] | |||||||
Stock-based compensation expense | $ 135,000 | $ 220,000 | $ 513,000 | $ 697,000 | $ 862,000 | $ 1,314,000 | |
Selling, General and Administrative Expense [Member] | |||||||
Stock-Based Compensation Expense Items [Abstract] | |||||||
Stock-based compensation expense | 133,000 | 199,000 | 484,000 | 624,000 | 784,000 | 1,171,000 | |
Research and Development Expense [Member] | |||||||
Stock-Based Compensation Expense Items [Abstract] | |||||||
Stock-based compensation expense | $ 2,000 | $ 21,000 | $ 29,000 | $ 73,000 | $ 78,000 | $ 143,000 | |
Stock Options [Member] | |||||||
Additional Disclosures [Abstract] | |||||||
Stock options granted (in shares) | 18,643 | 369 | 125,410 | 5,577 | 5,833 | 9,081 | |
Vesting period | 48 months | ||||||
Weighted average grant date fair value of stock options issued (in dollars per share) | $ 1.63 | $ 60.4 | $ 6.18 | $ 79.07 | $ 76.05 | $ 396.17 | |
Outstanding stock options (in shares) | 111,275 | 12,003 | 111,275 | 12,003 | 10,485 | 7,481 | 144 |
Stock options vested (in shares) | 2,576 | 823 | 5,022 | 2,730 | |||
Stock options expired or forfeited (in shares) | 21,372 | 343 | 24,620 | 1,148 | 2,829 | 1,744 | |
Exercise of stock options (in shares) | 0 | 0 | 0 | 0 | 0 | 0 | |
Weighted Average Assumptions used in Black-Scholes Option Pricing Model [Abstract] | |||||||
Expected volatility | 131.06% | 132.08% | 152.59% | 132.48% | 132.48% | 131.03% | |
Expected Life of options (years) | 6 years 3 months | 6 years 3 months | 6 years 2 months 8 days | 6 years 1 month 24 days | 6 years 1 month 24 days | 6 years 2 months 15 days | |
Expected dividend yield | 0% | 0% | 0% | 0% | 0% | 0% | |
Risk-free interest rate | 4.29% | 3.02% | 4.16% | 2.13% | 2.13% | 1.19% |
Fair Value of Financial Instr_8
Fair Value of Financial Instruments, Available-for-Sale Marketable Securities Measured at Fair Value on Recurring Basis (Q3) (Details) - Recurring [Member] - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 | Dec. 31, 2021 |
Available-for-sale marketable securities [Abstract] | |||
Marketable securities | $ 0 | $ 569 | $ 15,463 |
Level 1 [Member] | |||
Available-for-sale marketable securities [Abstract] | |||
Marketable securities | $ 0 | $ 569 | $ 15,463 |
Fair Value of Financial Instr_9
Fair Value of Financial Instruments, Roll-Forward of Fair Value of Level 3 Warrants (Q3) (Details) - Warrant [Member] - USD ($) $ in Thousands | 2 Months Ended | 9 Months Ended | |
Jan. 04, 2023 | Dec. 31, 2022 | Sep. 30, 2023 | |
Roll-Forward of Fair Value of Level 3 Warrants [Roll Forward] | |||
Beginning balance | $ 6,868 | $ 18,695 | $ 7,623 |
Change in fair value | 755 | (11,827) | |
Warrants reclassified to equity | (7,623) | ||
Ending balance | $ 7,623 | $ 6,868 | $ 0 |
Operating Leases (Q3) (Details)
Operating Leases (Q3) (Details) $ in Thousands | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 USD ($) ft² $ / ft² | Dec. 31, 2022 USD ($) $ / ft² ft² | |
Operating Leases [Abstract] | ||
Area of property leased under operating lease | ft² | 23,000 | 23,000 |
Monthly rent and common area maintenance charges | $ | $ 32 | $ 31 |
Annual base rent (per square foot) | 10.5 | 10.5 |
Minimum [Member] | ||
Operating Leases [Abstract] | ||
Annual increase per square foot (in dollars per square foot) | 0.32 | 0.32 |
Maximum [Member] | ||
Operating Leases [Abstract] | ||
Annual increase per square foot (in dollars per square foot) | 0.34 | 0.34 |
Finance Lease Liability (Q3) (D
Finance Lease Liability (Q3) (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2020 |
Finance Lease Liability [Abstract] | ||
Value of finance lease equipment | $ 98 | |
Finance Lease, Right-of-Use Asset, Statement of Financial Position [Extensible Enumeration] | Property, Plant and Equipment, Net | |
Principal amount under lease agreement | $ 93 | |
Implied interest rate | 7.50% | |
Finance lease term | 39 months | 39 months |
Commitments and Contingencies_4
Commitments and Contingencies (Q3) (Details) - SeaStar Medical Holding Corporation [Member] - USD ($) $ in Thousands | 9 Months Ended | |
Dec. 27, 2022 | Sep. 30, 2023 | |
Commitments and Contingencies [Abstract] | ||
Milestone payments | $ 450 | |
Payment period after achievement of milestone event | 30 days |
Subsequent Events (Q3) (Details
Subsequent Events (Q3) (Details) $ / shares in Units, $ in Thousands | Oct. 17, 2023 USD ($) Warrant $ / shares shares | Sep. 30, 2023 $ / shares | Jun. 30, 2023 $ / shares | Feb. 24, 2023 $ / shares | Dec. 31, 2022 $ / shares | Dec. 31, 2021 $ / shares |
Stockholders' equity [Abstract] | ||||||
Preferred stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 | $ 0.0001 | |||
Warrant exercise price per share (in dollars per share) | $ 0 | |||||
Subsequent Event [Member] | ||||||
Stockholders' equity [Abstract] | ||||||
Warrant exercise price per share (in dollars per share) | $ 0 | |||||
Gross proceeds before underwriting discounts and commissions and offering expenses | $ | $ 2,250 | |||||
Subsequent Event [Member] | October 2023 Warrants [Member] | ||||||
Stockholders' equity [Abstract] | ||||||
Purchase price for one unit (in dollars per share) | $ 15 | |||||
Subsequent Event [Member] | Series J Convertible Preferred Stock [Member] | ||||||
Stockholders' equity [Abstract] | ||||||
Issuance of stock (in shares) | shares | 150,000 | |||||
Number of shares in one unit (in shares) | shares | 1 | |||||
Preferred stock, par value (in dollars per share) | $ 0.0001 | |||||
Liquidation preference per share (in dollars per share) | $ 25 | |||||
Stock term | 3 years | |||||
Conversion price (in dollars per share) | $ 1.01 | |||||
Preferred stock, dividend rate | 5% | |||||
Dividend payment period | 3 years | |||||
Subsequent Event [Member] | Series J Convertible Preferred Stock [Member] | October 2023 Warrants [Member] | ||||||
Stockholders' equity [Abstract] | ||||||
Number of warrants included in each unit | Warrant | 1 | |||||
Number of shares to be purchased with each warrant (in shares) | shares | 0.5 | |||||
Warrants term | 3 years | |||||
Warrant exercise price per share (in dollars per share) | $ 7.5 | |||||
Warrant percentage of public offering price per unit | 50% |