| Date of Report (Date of earliest event reported) | |||||
| (Exact name of registrant as specified in its charter) | ||
| (State or other jurisdiction of incorporation) | (Commission File Number) | (IRS Employer Identification No.) | ||||||
| (Address of principal executive offices) | (Zip Code) | ||||||||||
| Registrant’s telephone number, including area code | ||||||||
| N/A | ||
| (Former name or former address, if changed since last report) | ||
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) | |||||
| Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) | |||||
| Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) | |||||
| Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) | |||||
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||||||
| N/A | N/A | N/A | ||||||
Exhibit No. | Description | |||||||
Press Release dated November 8, 2024 | ||||||||
| 104 | Cover Page Interactive Data File--the cover page XBRL tags are embedded within the Inline XBRL document. | |||||||
| SANUWAVE HEALTH, INC. | ||||||||
Dated: November 8, 2024 | By: | /s/ Peter Sorensen | ||||||
| Name: | Peter Sorensen | |||||||
| Title: | Chief Financial Officer | |||||||

| (in thousands) | 2024 | 2023 | |||||||||||||||
| Revenue | $ | 9,360 | $ | 4,953 | |||||||||||||
| Cost of Revenues | 2,293 | 1,412 | |||||||||||||||
| Gross Margin | 7,067 | 3,541 | |||||||||||||||
| Gross Margin % | 75.5 | % | 71.5 | % | |||||||||||||
| Total operating expenses | 5,114 | 4,072 | |||||||||||||||
| Operating Income (Loss) | $ | 1,953 | $ | (531) | |||||||||||||
| Total other expense | (22,610) | (23,169) | |||||||||||||||
| Net Income (Loss) | $ | (20,657) | $ | (23,700) | |||||||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
| (in thousands) | 2024 | 2023 | 2024 | 2023 | |||||||||||||||||||
| Net Income/(Loss) | $ | (20,657) | $ | (23,700) | $ | (18,624) | $ | (44,042) | |||||||||||||||
| Non-GAAP Adjustments: | |||||||||||||||||||||||
| Interest expense | 3,661 | 3,845 | 11,004 | 12,504 | |||||||||||||||||||
| Depreciation and amortization | 256 | 266 | 736 | 780 | |||||||||||||||||||
| EBITDA | (16,740) | (19,589) | (6,884) | (30,758) | |||||||||||||||||||
| Non-GAAP Adjustments for Adjusted EBITDA: | |||||||||||||||||||||||
| Change in fair value of derivative liabilities | 18,849 | 19,325 | 17,633 | 29,943 | |||||||||||||||||||
| Other non-cash or non-recurring charges: | |||||||||||||||||||||||
| Gain on extinguishment of debt | - | - | (5,205) | - | |||||||||||||||||||
| Severance agreement and legal settlement | - | - | 585 | - | |||||||||||||||||||
| Release of historical accrued expenses | - | - | (579) | (1,250) | |||||||||||||||||||
| Shares for services | - | - | - | 224 | |||||||||||||||||||
| License and option agreement | - | - | (2,500) | - | |||||||||||||||||||
| Prepaid legal fees expensed from termination of Merger Agreement | - | - | 457 | - | |||||||||||||||||||
| Adjusted EBITDA | $ | 2,109 | $ | (264) | $ | 3,507 | $ | (1,841) | |||||||||||||||
| (In thousands, except share data) | September 30, 2024 | December 31, 2023 | |||||||||
| ASSETS | |||||||||||
| Current Assets: | |||||||||||
| Cash and cash equivalent | $ | 3,259 | $ | 1,797 | |||||||
Accounts receivable, net of allowance of $1,056 and $1,237, respectively | 2,836 | 3,314 | |||||||||
| Inventory | 3,431 | 2,951 | |||||||||
| Prepaid expenses and other current assets | 378 | 1,722 | |||||||||
| Total Current Assets | 9,904 | 9,784 | |||||||||
| Non-Current Assets: | |||||||||||
| Property, equipment and other, net | 774 | 938 | |||||||||
| Intangible assets, net | 3,906 | 4,434 | |||||||||
| Goodwill | 7,260 | 7,260 | |||||||||
| Total Non-current Assets | 11,940 | 12,632 | |||||||||
| Total Assets | $ | 21,844 | $ | 22,416 | |||||||
| LIABILITIES | |||||||||||
| Current Liabilities: | |||||||||||
| Senior secured debt, in default | $ | 24,426 | $ | 18,278 | |||||||
| Convertible promissory notes payable | 4,817 | 5,404 | |||||||||
| Convertible promissory notes payable, related parties | 2,838 | 1,705 | |||||||||
| Asset-backed secured promissory notes payable | — | 3,117 | |||||||||
| Asset-backed secured promissory notes, related parties | — | 1,458 | |||||||||
| Promissory note payable, related party | 500 | - | |||||||||
| Accounts payable | 4,137 | 5,705 | |||||||||
| Accrued expenses | 5,241 | 5,999 | |||||||||
| Factoring liabilities | 1,938 | 1,490 | |||||||||
| Warrant liability | 35,509 | 14,447 | |||||||||
| Accrued interest | 643 | 5,444 | |||||||||
| Accrued interest, related parties | 952 | 669 | |||||||||
| Current portion of contract liabilities | 137 | 92 | |||||||||
| Other | 375 | 947 | |||||||||
| Total Current Liabilities | 81,513 | 64,755 | |||||||||
| Non-current Liabilities | |||||||||||
| Lease liabilities, less current portion | 236 | 492 | |||||||||
| Contract liabilities, less current portion | 358 | 347 | |||||||||
| Total Non-current Liabilities | 594 | 839 | |||||||||
| Total Liabilities | $ | 82,107 | $ | 65,594 | |||||||
| STOCKHOLDERS’ DEFICIT | |||||||||||
Preferred Stock, par value $0.001, 5,000,000 shares authorized; 6,175 shares Series A, 293 shares Series B, 90 shares Series C and 8 shares Series D authorized; no shares issued and outstanding at September 30, 2024 and December 31, 2023 | $ | - | $ | - | |||||||
Common stock, par value $0.001, 2,500,000,000 shares authorized; 3,150,062 and 3,041,492 issued and outstanding at September 30, 2024 and December 31, 2023, respectively * | 3 | 3 | |||||||||
| Additional paid-in capital | 178,397 | 176,979 | |||||||||
| Accumulated deficit | (238,673) | (220,049) | |||||||||
| Accumulated other comprehensive income (loss) | 10 | (111) | |||||||||
| Total Stockholders’ Deficit | (60,263) | (43,178) | |||||||||
| Total Liabilities and Stockholders’ Deficit | $ | 21,844 | $ | 22,416 | |||||||
| (In thousands, except share data) | Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||||||||
| 2024 | 2023 | 2024 | 2023 | ||||||||||||||||||||
| Revenue | $ | 9,360 | $ | 4,953 | $ | 22,308 | $ | 13,404 | |||||||||||||||
| Cost of Revenues | 2,293 | 1,412 | 5,799 | 3,876 | |||||||||||||||||||
| Gross Margin | 7,067 | 3,541 | 16,509 | 9,528 | |||||||||||||||||||
| Operating Expenses: | |||||||||||||||||||||||
| General and administrative | 2,545 | 2,681 | 8,059 | 6,678 | |||||||||||||||||||
| Selling and marketing | 2,202 | 1,039 | 4,468 | 3,430 | |||||||||||||||||||
| Research and development | 161 | 165 | 519 | 436 | |||||||||||||||||||
| Depreciation and amortization | 206 | 187 | 568 | 563 | |||||||||||||||||||
| Total Operating Expenses | 5,114 | 4,072 | 13,614 | 11,107 | |||||||||||||||||||
| Operating Income (Loss) | 1,953 | (531) | 2,895 | (1,579) | |||||||||||||||||||
| Other Income (Expense): | |||||||||||||||||||||||
| Interest expense | (3,315) | (2,907) | (9,948) | (10,125) | |||||||||||||||||||
| Interest expense, related party | (346) | (938) | (1,056) | (2,379) | |||||||||||||||||||
| Gain on extinguishment of debt | — | - | 5,205 | - | |||||||||||||||||||
| Change in fair value of derivative liabilities | (18,849) | (19,325) | (17,633) | (29,943) | |||||||||||||||||||
| Other expense | (106) | - | (893) | (16) | |||||||||||||||||||
Other income | 6 | 1 | 2,806 | - | |||||||||||||||||||
| Total Other Expense | (22,610) | (23,169) | (21,519) | (42,463) | |||||||||||||||||||
| Net Loss | (20,657) | (23,700) | (18,624) | (44,042) | |||||||||||||||||||
| Other Comprehensive Loss | |||||||||||||||||||||||
| Foreign currency translation adjustments | — | 7 | 121 | (6) | |||||||||||||||||||
| Total Comprehensive Loss | $ | (20,657) | $ | (23,693) | $ | (18,503) | $ | (44,048) | |||||||||||||||
| Net Loss per share: | |||||||||||||||||||||||
| Basic and Diluted * | $ | (6.49) | $ | (9.95) | $ | (5.92) | $ | (24.15) | |||||||||||||||
| Weighted average shares outstanding: | |||||||||||||||||||||||
| Basic and Diluted * | 3,185 | 2,381 | 3,146 | 1,823 | |||||||||||||||||||
| (In thousands, except share data) | ||||||||||||||||||||||||||||||||||||||
| Three Months Ended September 30, 2024 | ||||||||||||||||||||||||||||||||||||||
| Common Stock | ||||||||||||||||||||||||||||||||||||||
| Number of Shares Issued and Outstanding | Par Value | Additional Paid- in Capital | Accumulated Deficit | Accumulated Other Comprehensive Loss | Total | |||||||||||||||||||||||||||||||||
| Balances as of June 30, 2024 | 3,150,062 | $ | 3 | $ | 178,397 | $ | (218,016) | $ | 10 | $ | (39,606) | |||||||||||||||||||||||||||
Net loss | - | - | - | (20,657) | - | (20,657) | ||||||||||||||||||||||||||||||||
| Balances as of September 30, 2024 | 3,150,062 | $ | 3 | $ | 178,397 | $ | (238,673) | $ | 10 | $ | (60,263) | |||||||||||||||||||||||||||
| Three Months Ended September 30, 2023 | ||||||||||||||||||||||||||||||||||||||
| Common Stock | ||||||||||||||||||||||||||||||||||||||
| Number of Shares Issued and Outstanding | Par Value | Additional Paid- in Capital | Accumulated Deficit | Accumulated Other Comprehensive Loss | Total | |||||||||||||||||||||||||||||||||
| Balances as of June 30, 2023 | 1,497,700 | $ | 2 | $ | 153,824 | $ | (214,584) | $ | (80) | $ | (60,838) | |||||||||||||||||||||||||||
| Shares issued for settlement of debt | 1,238,509 | 1 | 18,576 | - | - | $ | 18,577 | |||||||||||||||||||||||||||||||
| Foreign currency translation adjustment | - | - | - | - | 7 | $ | 7 | |||||||||||||||||||||||||||||||
| Net loss | - | - | - | (23,700) | - | $ | (23,700) | |||||||||||||||||||||||||||||||
| Balances as of September 30, 2023 | 2,736,209 | $ | 3 | $ | 172,400 | $ | (238,284) | $ | (73) | $ | (65,954) | |||||||||||||||||||||||||||
| Nine Months Ended September 30, | ||||||||||||||||||||||||||||||||||||||
| Common Stock | ||||||||||||||||||||||||||||||||||||||
| Number of Shares Issued and Outstanding | Par Value | Additional Paid- in Capital | Accumulated Deficit | Accumulated Other Comprehensive Loss | Total | |||||||||||||||||||||||||||||||||
| Balances as of December 31, 2023 | 3,041,492 | $ | 3 | $ | 176,979 | $ | (220,049) | $ | (111) | $ | (43,178) | |||||||||||||||||||||||||||
| Shares issued for settlement of warrants | 14,440 | - | 6 | - | - | 6 | ||||||||||||||||||||||||||||||||
| Shares issued for settlement of debt | 94,130 | - | 1,412 | - | - | 1,412 | ||||||||||||||||||||||||||||||||
| Foreign currency translation adjustment | - | - | - | - | 121 | 121 | ||||||||||||||||||||||||||||||||
Net loss | - | - | - | (18,624) | - | (18,624) | ||||||||||||||||||||||||||||||||
| Balances as of September 30, 2024 | 3,150,062 | $ | 3 | $ | 178,397 | $ | (238,673) | $ | 10 | $ | (60,263) | |||||||||||||||||||||||||||
| Nine Months Ended September 30, 2023 | ||||||||||||||||||||||||||||||||||||||
| Common Stock | ||||||||||||||||||||||||||||||||||||||
| Number of Shares Issued and Outstanding | Par Value | Additional Paid- in Capital | Accumulated Deficit | Accumulated Other Comprehensive Loss | Total | |||||||||||||||||||||||||||||||||
| Balances as of December 31, 2022 | 1,463,300 | $ | 1 | $ | 153,298 | $ | (194,242) | $ | (67) | $ | (41,010) | |||||||||||||||||||||||||||
| Shares issued for services | 34,400 | 1 | 526 | - | - | 527 | ||||||||||||||||||||||||||||||||
| Shares issued for settlement of debt | 1,238,509 | 1 | 18,576 | - | - | $ | 18,577 | |||||||||||||||||||||||||||||||
| Foreign currency translation adjustment | - | - | - | - | (6) | (6) | ||||||||||||||||||||||||||||||||
| Net loss | - | - | - | (44,042) | - | (44,042) | ||||||||||||||||||||||||||||||||
| Balances as of September 30, 2023 | 2,736,209 | $ | 3 | $ | 172,400 | $ | (238,284) | $ | (73) | $ | (65,954) | |||||||||||||||||||||||||||
| (In thousands) | Nine Months Ended September 30, | ||||||||||
| 2024 | 2023 | ||||||||||
| Cash Flows - Operating Activities: | |||||||||||
| Net Loss | $ | (18,624) | $ | (44,042) | |||||||
| Adjustments to reconcile net loss to net cash used by operating activities | |||||||||||
| Depreciation and amortization | 736 | 780 | |||||||||
| Bad debt expense | 16 | 547 | |||||||||
| Shares issued for services | - | 224 | |||||||||
| Gain on extinguishment of debt | (5,205) | - | |||||||||
| Change in fair value of derivative liabilities | 17,633 | 29,943 | |||||||||
| Amortization of debt issuance costs and original issue discount | 4,792 | 5,656 | |||||||||
| Accrued interest | 2,749 | 5,529 | |||||||||
| Changes in operating assets and liabilities | |||||||||||
| Accounts receivable | 66 | 253 | |||||||||
| Inventory | (480) | (844) | |||||||||
| Prepaid expenses and other assets | 225 | (487) | |||||||||
| Accounts payable | (1,013) | 464 | |||||||||
| Accrued expenses | 763 | (1,326) | |||||||||
Contract liabilities | 56 | 50 | |||||||||
| Net Cash Provided by (Used in) Operating Activities | 1,714 | (3,253) | |||||||||
| Cash Flows - Investing Activities | |||||||||||
| Proceeds from sale of property and equipment | - | 13 | |||||||||
Purchase of property and equipment | (254) | (169) | |||||||||
| Net Cash Flows Used in Investing Activities | (254) | (156) | |||||||||
| Cash Flows - Financing Activities | |||||||||||
| Proceeds from convertible promissory notes | - | 1,202 | |||||||||
| Payment of note payable | (2,175) | - | |||||||||
| Proceeds from convertible notes payable | 1,300 | - | |||||||||
| Proceeds from promissory note payable, related party | 500 | - | |||||||||
| Proceeds from bridge notes advance | - | 2,994 | |||||||||
| Proceeds (Payments) from factoring, net | 449 | (710) | |||||||||
| Payments of principal on finance leases | (193) | (130) | |||||||||
| Net Cash Flow (Used in) Provided by Financing Activities | (119) | 3,356 | |||||||||
| Effect of Exchange Rates on Cash | 121 | (5) | |||||||||
| Net Change in Cash During Period | 1,462 | (58) | |||||||||
Cash at Beginning of Period | 1,797 | 1,153 | |||||||||
Cash at End of Period | $ | 3,259 | $ | 1,095 | |||||||
| Supplemental Information: | |||||||||||
| Cash paid for interest | $ | 3,189 | $ | 984 | |||||||
| Non-cash Investing and Financing Activities: | |||||||||||
| Shares issued for settlement of debt | 1,412 | - | |||||||||
| Write off deferred merger costs | 1,226 | - | |||||||||
| Warrants issued in conjunction with convertible promissory notes | 3,633 | 570 | |||||||||
| Conversion of convertible notes payable to common stock | - | 18,577 | |||||||||
| Capitalize default interest into senior secured debt | 3,850 | - | |||||||||
| Conversion of asset-based secured promissory notes to convertible promissory notes | 4,584 | - | |||||||||
| Embedded conversion feature on convertible promissory notes payable | - | (520) | |||||||||
| Common shares issued for advisory shares | - | 302 | |||||||||