Delaware | | | 3845 | | | 68-0533453 |
(State or Other Jurisdiction of Incorporation or Organization) | | | (Primary Standard Industrial Classification Code Number) | | | (I.R.S. Employer Identification Number) |
Phillip D. Torrence Honigman LLP 650 Trade Centre Way, Suite 200 Kalamazoo, Tel: (269) 337-7700 Fax: (269) 337-7703 | | | Neil P. Ayotte Senior Vice President, General Counsel, Secretary and Chief Compliance Officer Nuwellis, Inc. 12988 Valley View Road Eden Prairie, Minnesota 55344 Tel: (952) 345-4200 | | | New York, New York Tel: (212) |
Large accelerated filer | | | ☐ | | | Accelerated filer | | | ☐ |
Non-accelerated filer | | | ☒ | | | Smaller reporting company | | | ☒ |
| | | | Emerging growth company | | | ☐ |
| | Per Accompanying Common Warrant | | | Per Pre-Funded Warrant and Accompanying Common Warrant | | | Total | |
Public offering price | | | $ | | | $ | | | $ |
Placement agent fees(1) | | | $ | | | $ | | | $ |
Proceeds to us (before expenses) | | | $ | | | $ | | | $ |
(1) | We have agreed to pay the placement |
Delivery of the securities offered hereby is expected to be made on or about , 2024, subject to satisfaction of customary closing conditions. Roth Capital Partners |
| | As of September 30, 2023 (in thousands, except share and per share data) | | | As of December 31, 2023 (in thousands, except share and per share data) | |||||||||||||
| | Actual | | Pro Forma | | Pro Forma As Adjusted | | | Actual | | Pro Forma | | Pro Forma As Adjusted | |||||
Cash and cash equivalents | | $4,930 | | $6,412 | | 13,401 | | $3,800 | | 4,300 | | $8,585 | ||||||
Mezzanine Equity: | | | | |||||||||||||||
Series J convertible preferred stock, par value $0.0001 per share; authorized 600,000 shares, issued and outstanding 11,950, 82 and 82 shares, actual, pro forma, and pro forma as adjusted, respectively | | — | | — | | — | ||||||||||||
Stockholders’ equity: | | | | | | | ||||||||||||
Series A junior participating preferred stock, par value $0.0001 per share; authorized 30,000 shares, none outstanding actual, pro forma and pro forma as adjusted | | — | | — | | — | ||||||||||||
Series A junior participating preferred stock, par value $0.0001 per share; authorized 30,000 shares, none outstanding actual and pro forma, and pro forma as adjusted | | — | | — | | — | ||||||||||||
Series F convertible preferred stock, par value $0.0001 per share; authorized 18,000 shares, issued and outstanding 127 shares actual, pro forma and pro forma as adjusted | | — | | — | | — | | — | | — | | — | ||||||
Series J convertible preferred stock, par value $0.0001 per share; authorized 600,000 shares, issued and outstanding 0, 150,000 and 150,000 shares, actual, pro forma and pro forma as adjusted, respectively | | — | | — | | — | ||||||||||||
Common stock, par value $0.0001 per share; authorized 100,000,000 shares, issued and outstanding 1,864,265, 1,864,265 and 18,190,795 shares actual, pro forma and pro forma as adjusted, respectively | | — | | — | | 2 | ||||||||||||
Common stock, par value $0.0001 per share; authorized 100,000,000 shares, issued and outstanding 5,682,461, 6,801,443 and 20,381,019 shares actual, pro forma, and pro forma as adjusted, respectively | | 1 | | 1 | | 2 | ||||||||||||
Additional paid-in capital | | 289,980 | | 291,462 | | 298,449 | | 290,646 | | 291,146 | | 295,430 | ||||||
Accumulated other comprehensive income: | | | | | | | ||||||||||||
Foreign currency translation adjustment | | (24) | | (24) | | (24) | | (31) | | (31) | | (31) | ||||||
Unrealized gain on marketable securities | | — | | — | | | — | | — | | — | |||||||
Accumulated deficit | | (282,117) | | (282,117) | | (282,117) | | (287,626) | | (287,626) | | (287,626) | ||||||
Total stockholders’ equity | | 7,839 | | 9,321 | | 16,310 | | $2,990 | | 3,490 | | $7,775 |
(in thousands) | | | | | | | |||
Three months ended September 30, 2023 | | | Three months ended September 30, 2022 | | | Increase (Decrease) | | | % Change |
$2,412 | | | $2,065 | | | $347 | | | 16.8% |
(in thousands) | | | Three months ended September 30, 2023 | | | Three months ended September 30, 2022 | | | Increase (Decrease) | | | % Change |
Cost of goods sold | | | $1,031 | | | $806 | | | $225 | | | 27.9% |
Selling, general and administrative | | | $3,428 | | | $4,251 | | | $(823) | | | (19.4)% |
Research and development | | | $1,117 | | | $928 | | | $189 | | | 20.4% |
(in thousands) | | | | | | | |||
Nine months ended September 30, 2023 | | | Nine months ended September 30, 2022 | | | Increase (Decrease) | | | % Change |
$6,313 | | | $6,204 | | | $109 | | | 1.8% |
(in thousands) | | | Nine months ended September 30, 2023 | | | Nine months ended September 30, 2022 | | | Increase (Decrease) | | | % Change |
Cost of goods sold | | | $2,718 | | | $2,780 | | | $(62) | | | (2.2)% |
Selling, general and administrative | | | $13,582 | | | $12,920 | | | $662 | | | 5.1% |
Research and development | | | $4,050 | | | $3,141 | | | $909 | | | 28.9% |
Name | | | Fees Earned or Paid in Cash ($) | | | Option Awards ($)(1)(3) | | | Total ($) |
Steve Brandt(4) | | | 15,167 | | | 0 | | | 15,167 |
Maria Rosa Costanzo, M.D. | | | 53,792 | | | 0(2) | | | 53,792 |
John Erb | | | 60,000 | | | 5,859 | | | 65,859 |
Archelle Georgiou, M.D.(5) | | | 0 | | | 0 | | | 0 |
Michael McCormick(6) | | | 25,664 | | | 0 | | | 25,664 |
David McDonald(7) | | | 0 | | | 0 | | | 0 |
Jon W. Salveson(8) | | | 53,750 | | | 5,859 | | | 59,609 |
Gregory D. Waller | | | 63,000 | | | 5,859 | | | 68,859 |
Warren S. Watson(9) | | | 49,326 | | | 5,859 | | | 55,185 |
Total | | | 320,699 | | | 23,436 | | | 344,135 |
Name and Principal Position | | | Year | | | Salary ($) | | | Option Awards ($)(1)(2) | | | Non-equity Incentive Plan Compensation ($) | | | All Other Compensation ($)(3) | | | Total ($) |
Nestor Jaramillo, Jr. President & Chief Executive Officer | | | 2023 | | | 420,582 | | | 168,891 | | | 109,351 | | | 17,130 | | | 715,953 |
| | 2022 | | | 412,337 | | | 86,238 | | | 199,117 | | | 17,022 | | | 714,714 | |
Robert B. Scott Chief Financial Officer(4) | | | 2023 | | | 243,157 | | | 38,811 | | | 46,745 | | | 9,442 | | | 338,154 |
| | 2022 | | | — | | | — | | | — | | | — | | | — | |
Lynn L. Blake Former Chief Financial Officer(5) | | | 2023 | | | 248,681 | | | 99,982 | | | — | | | 11,040 | | | 359,702 |
| | 2022 | | | 65,417 | | | — | | | 26,744 | | | 642 | | | 92,803 | |
Neil P. Ayotte SVP, General Counsel & Chief Compliance Officer | | | 2023 | | | 326,457 | | | 63,945 | | | 80,798 | | | 16,083 | | | 487,283 |
| | 2022 | | | 289,848 | | | 22,434 | | | 92,165 | | | 9,104 | | | 413,551 |
| | 2022 | | | 2023 | |||||||||||||
| | Target | | | Earned | | | Target | | | Earned | |||||||
Name | | | % of Base Salary | | | $ | | | $ | | | % of Base Salary | | | $ | | | $ |
Nestor Jaramillo, Jr. | | | 55 | | | 226,785 | | | 199,117 | | | 65 | | | 273,378 | | | 109,351 |
Lynn Blake | | | 45 | | | 29,438 | | | 26,744 | | | 45 | | | 0 | | | 0 |
Robert B. Scott | | | 25 | | | 60,789 | | | 44,828 | | | 40 | | | 74,743 | | | 46,745 |
Neil Ayotte | | | 35 | | | 101,447 | | | 92,165 | | | 45 | | | 146,906 | | | 80,798 |
| | Option Awards(1) | ||||||||||
Name | | | Number of Securities Underlying Unexercised Options (#) Exercisable | | | Number of Securities Underlying Unexercised Options (#) Unexercisable | | | Option Exercise Price ($) | | | Option Expiration Date |
Nestor Jaramillo, Jr. | | | 28 | | | — | | | 10,260.00 | | | 5/22/2029 |
| | 92 | | | 35 | | | 930.00 | | | 1/22/2031 | |
| | 1,019 | | | 560 | | | 363.00 | | | 5/19/2031 | |
| | 442 | | | 569 | | | 94.00 | | | 3/3/2032 | |
| | — | | | 22,820 | | | 7.72 | | | 3/3/2033 | |
Lynn Blake | | | — | | | — | | | — | | | — |
Robert B. Scott | | | 9 | | | 3 | | | 930.00 | | | 1/22/2031 |
| | 38 | | | 21 | | | 359.00 | | | 5/18/2031 | |
| | 22 | | | 30 | | | 94.00 | | | 3/3/2032 | |
| | — | | | 1,133 | | | 7.72 | | | 3/3/2033 | |
| | — | | | 18,643 | | | 1.79 | | | 9/2/2033 | |
Neil P. Ayotte | | | 260 | | | 156 | | | 398.00 | | | 6/22/2031 |
| | 115 | | | 148 | | | 94.00 | | | 3/3/2032 | |
| | — | | | 8,640 | | | 7.72 | | | 3/3/2033 |
Name of Beneficial Owner | | | Number of Shares | | | Right to Acquire(1) | | | Total | | | Aggregate Percent of Class(2) |
John L. Erb | | | 4 | | | 5,861(3) | | | 5,865 | | | * |
Michael McCormick | | | — | | | — | | | — | | | * |
Maria Rosa Costanzo, M.D. | | | — | | | — | | | — | | | — |
Archelle Georgiou, M.D. | | | — | | | — | | | — | | | * |
Gregory D. Waller | | | — | | | 1,872 | | | 1,872 | | | * |
David McDonald | | | — | | | — | | | — | | | |
Robert B. Scott | | | — | | | 74 | | | 74 | | | * |
Nestor Jaramillo, Jr. | | | 4,098 | | | 1,694 | | | 5,792 | | | * |
Neil P. Ayotte | | | — | | | 403 | | | 403 | | | * |
Lynn Blake | | | 100 | | | — | | | 100 | | | * |
All current directors and executive officers as a group (9 persons) | | | 4,202 | | | 9,904 | | | 14,106 | | | *% |
• | requiring a 662∕3% super-majority stockholder approval in order for stockholders to alter, amend or repeal certain provisions of our certificate of incorporation; |
• | requiring a 662∕3% super-majority stockholder approval in order for stockholders to adopt, amend or repeal our bylaws; |
• | on or subsequent to that date, the business combination is approved by our board of directors and authorized at an annual or special meeting of stockholders, and not by written consent, by the affirmative vote of at least 66 2∕3% of the outstanding voting stock that is not owned by the interested stockholder. |
| | Per and Accompanying Common Warrant | | | Per Pre-Funded Warrant and Accompanying Common Warrant | | | Total | |
Public offering price | | | $ | | | $ | | | $ |
Placement | | | $ | | | $ | | | $ |
Proceeds to us (before expenses) | | | $ | | | $ | | | $ |
i. | to any legal entity which is a qualified investor as defined under the Prospectus Regulation; |
ii. | to fewer than 150 natural or legal persons (other than qualified investors as defined in the Prospectus Regulation), subject to obtaining the prior consent of the placement |
iii. | in any other circumstances falling within Article 1(4) of the Prospectus Regulation; |
• | our Annual Report on Form 10-K for the fiscal year ended December 31, 2023, filed with the SEC on March 11, 2024; |
• | our Current Report on Form 8-K filed with the SEC on February 6, 2024 and March 26, 2024; and |
• | the description of our common stock in our registration statement on Form 10 filed with the SEC on September 30, 2011, including Exhibit 4.14 to our Annual Report on Form 10-K for the fiscal year ended December 31, 2023. |
| | December 31, 2022 | | | December 31, 2021 | |
ASSETS | | | | | ||
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 |
| | | | |||
LIABILITIES AND STOCKHOLDERS’ EQUITY | | | | | ||
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 | | | — |
Operating lease liability | | | 760 | | | 956 |
Finance lease liability | | | — | | | 28 |
Other long-term liability | | | — | | | 179 |
Total liabilities | | | 12,316 | | | 4,470 |
Commitments and contingencies | | | | | ||
| | | | |||
Stockholders’ equity | | | | | ||
Series A junior participating preferred stock as of December 31, 2022 and December 31, 2021, par value $0.0001 per share; authorized 30,000 shares, none outstanding | | | — | | | — |
Series F convertible preferred stock as of December 31, 2022 and December 31, 2021, par value $0.0001 per share; authorized 127 shares, issued and outstanding 127 shares | | | — | | | — |
Series I convertible preferred stock as of December 31, 2022 and December 31, 2021, par value $0.0001 per share; authorized 1,049,280 and none, issued and outstanding 1,049,280 and none, respectively | | | — | | | — |
Preferred stock as of December 31, 2022 and December 31, 2021, par value $0.0001 per share; authorized 39,969,873 shares, none outstanding | | | — | | | — |
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 | | | — | | | — |
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 |
| | Year Ended December 31, | ||||
| | 2022 | | | 2021 | |
Net sales | | | $8,543 | | | $7,921 |
Cost of goods sold | | | 3,788 | | | 3,430 |
Gross profit | | | 4,755 | | | 4,491 |
Operating expenses: | | | | | ||
Selling, general and administrative | | | 17,584 | | | 19,039 |
Research and development | | | 4,342 | | | 4,978 |
Total operating expenses | | | 21,926 | | | 24,017 |
Loss from operations | | | (17,171) | | | (19,526) |
Other income (expense), net | | | | | ||
Other income (expense), net | | | 75 | | | (19) |
Financing expense | | | (9,247) | | | — |
Change in fair value of warrant liability | | | 11,827 | | | — |
Loss before income taxes | | | (14,516) | | | (19,545) |
Income tax expense | | | (9) | | | (9) |
Net loss | | | $(14,525) | | | $(19,554) |
Basic and diluted loss per share | | | $(83.55) | | | $(285.36) |
Weighted average shares outstanding – basic and diluted | | | 174 | | | 69 |
Other comprehensive loss: | | | | | ||
Unrealized gain (loss) on marketable securities | | | 80 | | | (24) |
Unrealized foreign currency translation adjustment | | | (7) | | | (4) |
Total comprehensive loss | | | $(14,452) | | | $(19,582) |
| | Outstanding Shares of Common Stock | | | Common Stock | | | Additional Paid in Capital | | | Accumulated Other Comprehensive Income | | | Accumulated Deficit | | | Stockholders’ Equity | |
Balance December 31, 2020 | | | 27,360 | | | $— | | | $249,663 | | | $(7) | | | $(233,338) | | | $16,318 |
Net loss | | | — | | | — | | | — | | | — | | | (19,554) | | | (19,554) |
Unrealized foreign currency translation adjustment | | | — | | | — | | | — | | | (4) | | | — | | | (4) |
Unrealized loss on marketable securities | | | — | | | — | | | — | | | (24) | | | — | | | (24) |
Stock-based compensation, net | | | — | | | — | | | 1,314 | | | — | | | — | | | 1,314 |
Issuance of common stock, net | | | 78,014 | | | — | | | 27,896 | | | — | | | — | | | 27,896 |
Exercise of warrants | | | 2 | | | — | | | 1 | | | — | | | — | | | 1 |
Balance December 31, 2021 | | | 105,376 | | | $— | | | $278,874 | | | $(35) | | | $(252,892) | | | $25,947 |
Net loss | | | — | | | — | | | — | | | — | | | (14,525) | | | (14,525) |
Unrealized foreign currency translation adjustment | | | — | | | — | | | — | | | (7) | | | — | | | (7) |
Unrealized gain on marketable securities | | | — | | | — | | | — | | | 80 | | | — | | | 80 |
Stock-based compensation, net | | | — | | | — | | | 862 | | | — | | | — | | | 862 |
Issuance of common stock, net | | | 209,940 | | | — | | | — | | | — | | | — | | | — |
Conversion of preferred stock into common stock | | | 221,078 | | | — | | | — | | | — | | | — | | | — |
Balance December 31, 2022 | | | 536,394 | | | $— | | | $279,736 | | | $38 | | | $(267,417) | | | $12,357 |
| | For the years ended December 31, | ||||
| | 2022 | | | 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) | | | — |
Financing expense | | | 9,247 | | | — |
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 operations | | | (15,149) | | | (17,843) |
| | | | |||
Investing activities: | | | | | ||
Purchases of marketable securities | | | — | | | (18,850) |
Proceeds from sales of marketable securities | | | 14,850 | | | 3,350 |
Purchase of property and equipment | | | (122) | | | (219) |
Net cash provided (used) in investing activities | | | 14,728 | | | (15,719) |
| | | | |||
Financing activities: | | | | | ||
Proceeds from public stock offerings, net | | | 9,449 | | | 27,896 |
Proceeds from warrant exercises | | | — | | | 1 |
Payments on finance lease liability | | | (26) | | | (26) |
Net cash provided by financing activities | | | 9,423 | | | 27,871 |
| | | | |||
Effect of exchange rate changes on cash | | | (7) | | | (4) |
Net increase in cash and cash equivalents | | | 8,995 | | | (5,695) |
Cash and cash equivalents—beginning of year | | | 8,742 | | | 14,437 |
Cash and cash equivalents—end of year | | | $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 | | | $— | | | $901 |
| | | | |||
Supplemental cash flow information | | | | | ||
Cash paid for income taxes | | | $9 | | | $11 |
(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 |
| | 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 |
(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) |
(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 |
(Dollars in thousands) | | | 2022 | | | 2021 |
Selling, general and administrative | | | $784 | | | $1,171 |
Research and development | | | 78 | | | 143 |
Total | | | $862 | | | $1,314 |
| | 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 |
| | 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 |
| | 2022 | | | 2021 | |||||||
(Dollars in thousands) | | | Fair Value | | | Level 1 | | | Fair Value | | | Level 1 |
Marketable securities | | | $569 | | | $569 | | | $15,463 | | | $15,463 |
| | 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 |
(in thousands) | | | 2022 | | | 2021 |
Domestic | | | $(14,551) | | | $(19,582) |
Foreign | | | 35 | | | 37 |
Loss before income taxes | | | $(14,516) | | | $(19,545) |
(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) |
(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) |
(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 | | | $— | | | $— |
(in thousands) | | | 2022 | | | 2021 |
Operating lease cost | | | $238 | | | $219 |
Variable lease cost | | | 127 | | | 123 |
Total | | | $365 | | | $342 |
(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 |
(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 |
(in thousands) | | | As reported | | | Adjustment | | | As revised |
Other income (expense) | | | (43) | | | 24 | | | (19) |
Unrealized gains (losses) on marketable securities | | | — | | | (24) | | | (24) |
| | (43) | | | — | | | (43) |
(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 |
| | September 30, 2023 | | | December 31, 2022 | |
ASSETS | | | (unaudited) | | | |
Current assets | | | | | ||
Cash and cash equivalents | | | $4,930 | | | $17,737 |
Marketable securities | | | — | | | 569 |
Accounts receivable | | | 1,425 | | | 1,406 |
Inventories, net | | | 2,336 | | | 2,661 |
Other current assets | | | 947 | | | 396 |
Total current assets | | | 9,638 | | | 22,769 |
Property, plant and equipment, net | | | 912 | | | 980 |
Operating lease right-of-use asset | | | 762 | | | 903 |
Other assets | | | 120 | | | 21 |
TOTAL ASSETS | | | $11,432 | | | $24,673 |
LIABILITIES AND STOCKHOLDERS’ EQUITY | | | | | ||
Current liabilities | | | | | ||
Accounts payable and accrued liabilities | | | $1,707 | | | $2,245 |
Accrued compensation | | | 1,021 | | | 2,161 |
Current portion of operating lease liability | | | 211 | | | 196 |
Current portion of finance lease liability | | | 8 | | | 28 |
Other current liabilities | | | 45 | | | 58 |
Total current liabilities | | | 2,992 | | | 4,688 |
Common stock warrant liability | | | — | | | 6,868 |
Operating lease liability | | | 601 | | | 760 |
Total liabilities | | | 3,593 | | | 12,316 |
| | | | |||
Commitments and contingencies | | | | | ||
| | | | |||
Stockholders’ equity | | | | | ||
Series A junior participating preferred stock as of September 30, 2023 and December 31, 2022, par value $0.0001 per share; authorized 30,000 shares, none outstanding | | | — | | | — |
Series F convertible preferred stock as of both September 30, 2023 and December 31, 2022, par value $0.0001 per share; authorized 127 shares, issued and outstanding 127 shares | | | — | | | — |
Series I convertible preferred stock as of September 30, 2023 and December 31, 2022, par value $0.0001; authorized 1,049,280, issued and outstanding none and 1,049,280, respectively | | | — | | | — |
Preferred stock as of both September 30, 2023 and December 31, 2022, par value $0.0001 per share; authorized 39,969,873 shares, none outstanding | | | — | | | — |
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 | | | — | | | — |
Additional paid-in capital | | | 289,980 | | | 279,736 |
Accumulated other comprehensive income: | | | | | ||
Foreign currency translation adjustment | | | (24) | | | (18) |
Unrealized gain on marketable securities | | | — | | | 56 |
Accumulated deficit | | | (282,117) | | | (267,417) |
Total stockholders’ equity | | | 7,839 | | | 12,357 |
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | | | $11,432 | | | $24,673 |
| | Three months ended September 30 | | | Nine months ended September 30 | |||||||
| | 2023 | | | 2022 | | | 2023 | | | 2022 | |
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 | | | — | | | — | | | (755) | | | — |
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 and diluted loss per share | | | $(1.81) | | | $(36.72) | | | $(10.21) | | | $(119.85) |
Weighted average shares outstanding – basic and diluted | | | 1,864 | | | 105 | | | 1,439 | | | 105 |
Other comprehensive loss: | | | | | | | | | ||||
Foreign currency translation adjustments | | | $— | | | $2 | | | $(6) | | | $1 |
Total comprehensive loss | | | $(3,370) | | $(3,868) | | | $(14,706) | | | $(12,628) |
| | Outstanding Shares of Common Stock | | | Common Stock | | | Additional Paid in Capital | | | Accumulated Other Comprehensive Income | | | Accumulated Deficit | | | Stockholders’ Equity | |
Balance December 31, 2021 | | | 105,376 | | | $— | | | $278,874 | | | $(35) | | | $(252,892) | | | $25,947 |
Net loss | | | — | | | — | | | — | | | — | | | (4,473) | | | (4,473) |
Unrealized foreign currency translation adjustment | | | — | | | — | | | — | | | (2) | | | — | | | (2) |
Stock-based compensation, net | | | — | | | — | | | 241 | | | — | | | — | | | 241 |
Balance March 31, 2022 | | | 105,376 | | | $— | | | $279,115 | | | $(37) | | | $(257,365) | | | $21,713 |
Net loss | | | — | | | — | | | — | | | — | | | (4,286) | | | (4,286) |
Foreign currency translation adjustment | | | — | | | — | | | — | | | 1 | | | — | | | 1 |
Stock-based compensation, net | | | — | | | — | | | 236 | | | — | | | — | | | 236 |
Balance June 30, 2022 | | | 105,376 | | | $— | | | $279,351 | | | $(36) | | | $(261,651) | | | $17,664 |
Net loss | | | — | | | — | | | — | | | — | | | (3,870) | | | (3,870) |
Foreign currency translation adjustment | | | — | | | — | | | — | | | 2 | | | — | | | 2 |
Stock-based compensation, net | | | — | | | — | | | 220 | | | — | | | — | | | 220 |
Balance September 30, 2022 | | | 105,376 | | | $— | | | $279,571 | | | $(34) | | | $(265,521) | | | $14,016 |
| | Outstanding Shares of Common Stock | | | Common Stock | | | Additional Paid in Capital | | | Accumulated Other Comprehensive Income | | | Accumulated Deficit | | | Stockholders’ Equity | |
Balance December 31, 2022 | | | 536,394 | | | $— | | | $279,736 | | | $38 | | | $(267,417) | | | $12,357 |
Net loss | | | — | | | — | | | — | | | — | | | (6,485) | | | (6,485) |
Unrealized foreign currency translation adjustment | | | — | | | — | | | — | | | (7) | | | — | | | (7) |
Unrealized gain on marketable securities | | | — | | | — | | | — | | | 6 | | | — | | | 6 |
Stock-based compensation, net | | | — | | | — | | | 181 | | | — | | | — | | | 181 |
Issuance costs related to 2022 common stock offering | | | — | | | — | | | (11) | | | — | | | — | | | (11) |
Conversion of preferred stock into common stock | | | 10,493 | | | — | | | — | | | — | | | — | | | — |
Reclassification of warrants to equity | | | — | | | — | | | 7,623 | | | — | | | — | | | 7,623 |
Conversion of warrants into common stock | | | 660,045 | | | — | | | — | | | — | | | — | | | — |
Balance March 31, 2023 | | | 1,206,932 | | | $— | | | $287,529 | | | $37 | | | $(273,902) | | | $13,664 |
Net loss | | | — | | | — | | | — | | | — | | | (4,845) | | | (4,845) |
Unrealized foreign currency translation adjustment | | | — | | | — | | | — | | | — | | | — | | | — |
Unrealized gain on marketable securities | | | — | | | — | | | — | | | (61) | | | — | | | (61) |
Stock-based compensation, net | | | — | | | — | | | 197 | | | — | | | — | | | 197 |
Issuance costs related to ATM offering | | | — | | | — | | | (98) | | | — | | | — | | | (98) |
Issuance of common stock from ATM offering | | | 657,333 | | | — | | | 2,217 | | | — | | | — | | | 2,217 |
Balance June 30, 2023 | | | 1,864,265 | | | $— | | | $289,845 | | | $(24) | | | $(278,747) | | | $11,074 |
Net loss | | | — | | | — | | | — | | | — | | | (3,370) | | | (3,370) |
Unrealized foreign currency translation adjustment | | | — | | | — | | | — | | | — | | | — | | | — |
Unrealized gain on marketable securities | | | — | | | — | | | — | | | — | | | — | | | — |
Stock-based compensation, net | | | — | | | — | | | 135 | | | — | | | — | | | 135 |
Issuance costs related to ATM offering | | | — | | | — | | | — | | | — | | | — | | | — |
Issuance of common stock from ATM offering | | | — | | | — | | | — | | | — | | | — | | | — |
Balance September 30, 2023 | | | 1,864,265 | | | $— | | | $289,980 | | | $(24) | | | $(282,117) | | | $7,839 |
| | Nine months ended September 30 | ||||
| | 2023 | | | 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 | | | — |
Net realized gain on marketable securities | | | (65) | | | — |
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 | | | — |
Additions to intangible assets | | | (99) | | | — |
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 | | | — |
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 decrease in cash and cash equivalents | | | (12,807) | | | (12,152) |
Cash and cash equivalents - beginning of period | | | 17,737 | | | 24,205 |
Cash and cash equivalents - end of period | | | $4,930 | | | $12,053 |
Supplemental cash flow information | | | | | ||
Inventory transferred to property, plant and equipment | | | $— | | | $37 |
Non-cash impact of conversion of warrants to common stock (see Note 3) | | | $6,868 | | | $— |
(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 |
| | 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 |
| | 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) |
| | 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 |
| | 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% |
| | September 30, 2023 | | | December 31, 2022 | |||||||
(in thousands) | | | Fair Value | | | Level 1 | | | Fair Value | | | Level 1 |
Marketable securities | | | $0 | | | $0 | | | $569 | | | $569 |
Item 13. | Other Expenses of Issuance and Distribution. |
SEC Registration Fee | | | $ |
FINRA Filing Fee | | | $ |
Legal Fees and Expenses | | | $250,000 |
Accounting Fees and Expenses | | | $ |
Miscellaneous Fees and Expenses | | | $ |
Transfer Agent and Registrar Fees | | | $12,200 |
Total | | | $ |
Item 14. | Indemnification of Directors and Officers. |
Item 15. | Recent Sales of Unregistered Securities. |
Item 16. | Exhibits and Financial Statement Schedules |
(a) | Exhibits |
| | | Incorporated By Reference | | | | | | | Incorporated By Reference | | | | |||||||||||||||||||||||
Exhibit Number | | Exhibit Description | | Form | | File Number | | Date of First Filing | | Exhibit Number | | Filed Herewith | | Exhibit Description | | Form | | File Number | | Date of First Filing | | Exhibit Number | | Filed Herewith | ||||||||||||
| Form of Placement Agency Agreement | | | | | | X | | Form of Placement Agency Agreement | | S-1/A | | 333- 276562 | | March 13, 2024 | | 1.1 | | ||||||||||||||||||
| | | | | | | | | | | | |||||||||||||||||||||||||
| Placement Agency Agreement dated as of October 12, 2023, by and between Nuwellis, Inc., Lake Street Capital Markets, LLC and Maxim Group LLC. | | 8-K | | 001-35312 | | October 17, 2023 | | 1.1 | | | Placement Agency Agreement dated as of October 12, 2023, by and between Nuwellis, Inc., Lake Street Capital Markets, LLC and Maxim Group LLC. | | 8-K | | 001-35312 | | October 17, 2023 | | 1.1 | | |||||||||||||||
| | | | | | | | | | | | |||||||||||||||||||||||||
| Fourth Amended and Restated Certificate of Incorporation | | 10 | | 001-35312 | | February 1, 2012 | | 3.1 | | | Fourth Amended and Restated Certificate of Incorporation | | 10 | | 001-35312 | | February 1, 2012 | | 3.1 | | |||||||||||||||
| | | | | | | | | | | | |||||||||||||||||||||||||
| Certificate of Amendment to the Fourth Amended and Restated Certificate of Incorporation | | 8-K | | 001-35312 | | January 13, 2017 | | 3.1 | | | Certificate of Amendment to the Fourth Amended and Restated Certificate of Incorporation | | 8-K | | 001-35312 | | January 13, 2017 | | 3.1 | | |||||||||||||||
| | | | | | | | | | | | |||||||||||||||||||||||||
| Certificate of Amendment to the Fourth Amended and Restated Certificate of Incorporation | | 8-K | | 001-35312 | | May 23, 2017 | | 3.1 | | | Certificate of Amendment to the Fourth Amended and Restated Certificate of Incorporation | | 8-K | | 001-35312 | | May 23, 2017 | | 3.1 | | |||||||||||||||
| | | | | | | | | | | | |||||||||||||||||||||||||
| Certificate of Amendment to the Fourth Amended and Restated Certificate of Incorporation | | 8-K | | 001-35312 | | October 12, 2017 | | 3.1 | | | Certificate of Amendment to the Fourth Amended and Restated Certificate of Incorporation | | 8-K | | 001-35312 | | October 12, 2017 | | 3.1 | | |||||||||||||||
| | | | | | | | | | | | |||||||||||||||||||||||||
| Certificate of Amendment to the Fourth Amended and Restated Certificate of Incorporation | | 8-K | | 001-35312 | | January 2, 2019 | | 3.1 | | | Certificate of Amendment to the Fourth Amended and Restated Certificate of Incorporation | | 8-K | | 001-35312 | | January 2, 2019 | | 3.1 | | |||||||||||||||
| | | | | | | | | | | | |||||||||||||||||||||||||
| Certificate of Amendment to the Fourth Amended and Restated Certificate of Incorporation | | 8-K/A | | 001-35312 | | October 16, 2020 | | 3.1 | | | Certificate of Amendment to the Fourth Amended and Restated Certificate of Incorporation | | 8-K/A | | 001-35312 | | October 16, 2020 | | 3.1 | | |||||||||||||||
| | | | | | | | | | | | |||||||||||||||||||||||||
| Certificate of Amendment to the Fourth Amended and Restated Certificate of Incorporation | | 8-K | | 001-35312 | | April 27, 2021 | | 3.1 | | | Certificate of Amendment to the Fourth Amended and Restated Certificate of Incorporation | | 8-K | | 001-35312 | | April 27, 2021 | | 3.1 | | |||||||||||||||
| | | | | | | | | | | | |||||||||||||||||||||||||
| Certificate of Amendment to the Fourth Amended and Restated Certificate of Incorporation | | 8-K | | 001-35312 | | December 9, 2022 | | 3.1 | | | Certificate of Amendment to the Fourth Amended and Restated Certificate of Incorporation | | 8-K | | 001-35312 | | December 9, 2022 | | 3.1 | | |||||||||||||||
| | | | | | | | | | | | |||||||||||||||||||||||||
| Third Amended and Restated Bylaws | | 8-K | | 001-35312 | | April 27, 2021 | | 3.2 | | | Third Amended and Restated Bylaws | | 8-K | | 001-35312 | | April 27, 2021 | | 3.2 | | |||||||||||||||
| | | | | | | | | | | | |||||||||||||||||||||||||
| Amendment to Third Amended and Restated Bylaws | | 8-K | | 001-35312 | | October 5, 2022 | | 3.1 | | | Amendment to Third Amended and Restated Bylaws | | 8-K | | 001-35312 | | October 5, 2022 | | 3.1 | | |||||||||||||||
| | | | | | | | | | | |
| | | Incorporated By Reference | | | | | | | Incorporated By Reference | | | | |||||||||||||||||||||||
Exhibit Number | | Exhibit Description | | Form | | File Number | | Date of First Filing | | Exhibit Number | | Filed Herewith | | Exhibit Description | | Form | | File Number | | Date of First Filing | | Exhibit Number | | Filed Herewith | ||||||||||||
| Form of Certificate of Designation of Series A Junior Participating Preferred Stock | | 8-K | | 001-35312 | | June 14, 2013 | | 3.1 | | | Form of Certificate of Designation of Series A Junior Participating Preferred Stock | | 8-K | | 001-35312 | | June 14, 2013 | | 3.1 | | |||||||||||||||
| | | | | | | | | | | | |||||||||||||||||||||||||
| Form of Certificate of Designation of Preferences, Rights and Limitations of Series F Convertible Preferred Stock | | S-1/A | | 333-221010 | | November 17, 2017 | | 3.7 | | | Form of Certificate of Designation of Preferences, Rights and Limitations of Series F Convertible Preferred Stock | | S-1/A | | 333-221010 | | November 17, 2017 | | 3.7 | | |||||||||||||||
| | | | | | | | | | | | |||||||||||||||||||||||||
| Certificate of Designation of Preferences, Rights and Limitations, filed with the Delaware Secretary of State on October 16, 2023, with respect to the Series J Convertible Preferred Stock | | 8-K | | 001-35312 | | October 17, 2023 | | 3.1 | | | Certificate of Designation of Preferences, Rights and Limitations, filed with the Delaware Secretary of State on October 16, 2023, with respect to the Series J Convertible Preferred Stock | | 8-K | | 001-35312 | | October 17, 2023 | | 3.1 | | |||||||||||||||
| | | | | | | | | | | | |||||||||||||||||||||||||
| Form of Warrant to Purchase Shares of Common Stock | | S-1/A | | 333-221010 | | November 17, 2017 | | 4.9 | | | Form of Warrant to Purchase Shares of Common Stock | | S-1/A | | 333-221010 | | November 17, 2017 | | 4.9 | | |||||||||||||||
| | | | | | | | | | | | |||||||||||||||||||||||||
| Form of Series 1 and Series 2 Warrant to Purchase Shares of Common Stock | | S-1/A | | 333-209102 | | February 25, 2019 | | 4.10 | | | Form of Series 1 and Series 2 Warrant to Purchase Shares of Common Stock | | S-1/A | | 333-209102 | | February 25, 2019 | | 4.10 | | |||||||||||||||
| | | | | | | | | | | | |||||||||||||||||||||||||
| Common Stock Purchase Warrant, dated May 30, 2019, between the Company and Redington, Inc. | | 10-Q | | 001-35312 | | August 8, 2019 | | 4.1 | | | Common Stock Purchase Warrant, dated May 30, 2019, between the Company and Redington, Inc. | | 10-Q | | 001-35312 | | August 8, 2019 | | 4.1 | | |||||||||||||||
| | | | | | | | | | | | |||||||||||||||||||||||||
| Form of Common Stock Purchase Warrant issued pursuant to the Securities Purchase Agreement, dated October 23, 2019, among the Company and the purchasers signatory thereto | | 8-K | | 001-35312 | | October 23, 2019 | | 4.1 | | | Form of Common Stock Purchase Warrant issued pursuant to the Securities Purchase Agreement, dated October 23, 2019, among the Company and the purchasers signatory thereto | | 8-K | | 001-35312 | | October 23, 2019 | | 4.1 | | |||||||||||||||
| | | | | | | | | | | | |||||||||||||||||||||||||
| Form of Common Stock Purchase Warrant issued pursuant to the Securities Purchase Agreement, dated November 4, 2019, among the Company and the purchasers signatory thereto | | 8-K | | 001-35312 | | November 4, 2019 | | 4.1 | | | Form of Common Stock Purchase Warrant issued pursuant to the Securities Purchase Agreement, dated November 4, 2019, among the Company and the purchasers signatory thereto | | 8-K | | 001-35312 | | November 4, 2019 | | 4.1 | | |||||||||||||||
| | | | | | | | | | | | |||||||||||||||||||||||||
| Form of Common Stock Pre-Funded Purchase Warrant issued pursuant to the Securities Purchase Agreement, dated November 4, 2019, among the Company and the purchasers signatory thereto | | 8-K | | 001-35312 | | November 4, 2019 | | 4.2 | |
| | | Incorporated By Reference | | | | | | | Incorporated By Reference | | | | |||||||||||||||||||||||
Exhibit Number | | Exhibit Description | | Form | | File Number | | Date of First Filing | | Exhibit Number | | Filed Herewith | | Exhibit Description | | Form | | File Number | | Date of First Filing | | Exhibit Number | | Filed Herewith | ||||||||||||
| Form of Common Stock Pre-Funded Purchase Warrant issued pursuant to the Securities Purchase Agreement, dated November 4, 2019, among the Company and the purchasers signatory thereto | | 8-K | | 001-35312 | | November 4, 2019 | | 4.2 | | ||||||||||||||||||||||||||
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| Form of Common Stock Purchase Warrant | | S-1/A | | 333-235385 | | January 23, 2020 | | 4.15 | | | Form of Common Stock Purchase Warrant | | S-1/A | | 333-235385 | | January 23, 2020 | | 4.15 | | |||||||||||||||
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| Form of Common Stock Purchase Warrant issued pursuant to the Securities Purchase Agreement, dated March 19, 2020, among the Company and the purchasers identified on the signature pages thereto | | 8-K | | 001-35312 | | March 20, 2020 | | 4.1 | | | Form of Common Stock Purchase Warrant issued pursuant to the Securities Purchase Agreement, dated March 19, 2020, among the Company and the purchasers identified on the signature pages thereto | | 8-K | | 001-35312 | | March 20, 2020 | | 4.1 | | |||||||||||||||
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| Form of Common Stock Purchase Warrant issued pursuant to the Securities Purchase Agreement, dated March 30, 2020, among the Company and the purchasers identified on the signature pages thereto | | 8-K | | 001-35312 | | March 30, 2020 | | 4.1 | | | Form of Common Stock Purchase Warrant issued pursuant to the Securities Purchase Agreement, dated March 30, 2020, among the Company and the purchasers identified on the signature pages thereto | | 8-K | | 001-35312 | | March 30, 2020 | | 4.1 | | |||||||||||||||
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| Form of Common Stock Purchase Warrant issued pursuant to the Securities Purchase Agreement, dated May 1, 2020, among the Company and the purchasers identified on the signature pages thereto | | 8-K | | 001-35312 | | May 4, 2020 | | 4.1 | | | Form of Common Stock Purchase Warrant issued pursuant to the Securities Purchase Agreement, dated May 1, 2020, among the Company and the purchasers identified on the signature pages thereto | | 8-K | | 001-35312 | | May 4, 2020 | | 4.1 | | |||||||||||||||
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| Form of Warrant to Purchase Shares of Common Stock | | S-1/A | | 333-24145 | | August 17, 2020 | | 4.19 | | | Form of Warrant to Purchase Shares of Common Stock | | S-1/A | | 333-24145 | | August 17, 2020 | | 4.19 | | |||||||||||||||
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| Warrant to Purchase Shares of Common Stock | | S-1/A | | 333-267368 | | October 13, 2022 | | 4.20 | | | Warrant to Purchase Shares of Common Stock | | S-1/A | | 333-267368 | | October 13, 2022 | | 4.20 | | |||||||||||||||
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| Form of Warrant to purchase shares of Series J Convertible Preferred Stock | | S-1/A | | 333-274610 | | September 29, 2023 | | 4.13 | | | Form of Warrant to purchase shares of Series J Convertible Preferred Stock | | S-1/A | | 333-274610 | | September 29, 2023 | | 4.13 | | |||||||||||||||
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| Specimen of Common Stock Certificate | | 10 | | 001-35312 | | September 30, 2011 | | 4.1 | | | Specimen of Common Stock Certificate | | 10 | | 001-35312 | | September 30, 2011 | | 4.1 | | |||||||||||||||
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| DaVita Inc. Common Stock Warrant Agreement+ | | 8-K | | 001-35312 | | June 21, 2023 | | 4.1 | | ||||||||||||||||||||||||||
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| Form of Common Stock Purchase Warrant | | | | | | X | |||||||||||||||||||||||||||||
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| Form of Pre-Funded Warrant | | S-1/A | | 333-276562 | | March 13, 2024 | | 4.17 | | ||||||||||||||||||||||||||
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| | | Incorporated By Reference | | | | | | | Incorporated By Reference | | | | |||||||||||||||||||||||
Exhibit Number | | Exhibit Description | | Form | | File Number | | Date of First Filing | | Exhibit Number | | Filed Herewith | | Exhibit Description | | Form | | File Number | | Date of First Filing | | Exhibit Number | | Filed Herewith | ||||||||||||
| DaVita Inc. Common Stock Warrant Agreement+ | | 8-K | | 001-35312 | | June 21, 2023 | | 4.1 | | ||||||||||||||||||||||||||
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| Form of Common Warrant | | | | | | X | |||||||||||||||||||||||||||||
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| Form of Pre-Funded Warrant | | | | | | X | |||||||||||||||||||||||||||||
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| Form of Warrant Agency Agreement | | | | | | X | | Form of Warrant Agency Agreement | | S-1/A | | 333-276562 | | March 13, 2024 | | 4.18 | | ||||||||||||||||||
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| Opinion of Honigman LLP | | | | | | X | | Opinion of Honigman LLP | | | | | | X | |||||||||||||||||||||
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| Patent License Agreement between Sunshine Heart, Inc. and Gambro UF Solutions, Inc. dated August 5, 2016 | | 8-K | | 001-35312 | | August 8, 2016 | | 10.1 | | | Patent License Agreement between Sunshine Heart, Inc. and Gambro UF Solutions, Inc. dated August 5, 2016 | | 8-K | | 001-35312 | | August 8, 2016 | | 10.1 | | |||||||||||||||
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| 2013 Non-Employee Directors’ Equity Incentive Plan† | | 14A | | 001-35312 | | April 5, 2013 | | App. A | | | 2013 Non-Employee Directors’ Equity Incentive Plan† | | 14A | | 001-35312 | | April 5, 2013 | | App. A | | |||||||||||||||
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| Form of Stock Option Grant Notice and Option Agreement for 2013 Non-Employee Directors’ Equity Incentive Plan† | | 8-K | | 001-35312 | | May 29, 2013 | | 10.2 | | | Form of Stock Option Grant Notice and Option Agreement for 2013 Non-Employee Directors’ Equity Incentive Plan† | | 8-K | | 001-35312 | | May 29, 2013 | | 10.2 | | |||||||||||||||
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| Form of Restricted Stock Unit Award Grant Notice and Agreement for 2013 Non-Employee Directors’ Equity Incentive Plan† | | 10-K | | 001-35312 | | March 20, 2015 | | 10.11 | | | Form of Restricted Stock Unit Award Grant Notice and Agreement for 2013 Non-Employee Directors’ Equity Incentive Plan† | | 10-K | | 001-35312 | | March 20, 2015 | | 10.11 | | |||||||||||||||
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| New-Hire Equity Incentive Plan† | | 10-Q | | 001-35312 | | August 8, 2013 | | 10.1 | | | New-Hire Equity Incentive Plan† | | 10-Q | | 001-35312 | | August 8, 2013 | | 10.1 | | |||||||||||||||
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| First Amendment to New-Hire Equity Incentive Plan† | | 10-Q | | 001-35312 | | November 12, 2013 | | 10.1 | | | First Amendment to New-Hire Equity Incentive Plan† | | 10-Q | | 001-35312 | | November 12, 2013 | | 10.1 | | |||||||||||||||
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| Second Amendment to New-Hire Equity Incentive Plan† | | S-8 | | 333-202904 | | March 20, 2015 | | 99.12 | | | Second Amendment to New-Hire Equity Incentive Plan† | | S-8 | | 333-202904 | | March 20, 2015 | | 99.12 | | |||||||||||||||
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| Third Amendment to New-Hire Equity Incentive Plan† | | S-8 | | 333-210215 | | March 15, 2016 | | 99.13 | | | Third Amendment to New-Hire Equity Incentive Plan† | | S-8 | | 333-210215 | | March 15, 2016 | | 99.13 | | |||||||||||||||
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| Fourth Amendment to New-Hire Equity Incentive Plan† | | 8-K | | 001-35312 | | May 30, 2017 | | 10.4 | | | Fourth Amendment to New-Hire Equity Incentive Plan† | | 8-K | | 001-35312 | | May 30, 2017 | | 10.4 | | |||||||||||||||
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| Fifth Amendment to New-Hire Equity Incentive Plan† | | 8-K | | 001-35312 | | January 18, 2018 | | 10.1 | | ||||||||||||||||||||||||||
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| Sixth Amendment to New-Hire Equity Incentive Plan† | | 10-Q | | 001-35312 | | August 8, 2019 | | 10.2 | | ||||||||||||||||||||||||||
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| Seventh Amendment to New-Hire Equity Incentive Plan† | | 8-K | | 001-35312 | | December 6, 2019 | | 10.1 | | ||||||||||||||||||||||||||
| | | | | |
| | | Incorporated By Reference | | | | | | | Incorporated By Reference | | | | |||||||||||||||||||||||
Exhibit Number | | Exhibit Description | | Form | | File Number | | Date of First Filing | | Exhibit Number | | Filed Herewith | | Exhibit Description | | Form | | File Number | | Date of First Filing | | Exhibit Number | | Filed Herewith | ||||||||||||
| Fifth Amendment to New-Hire Equity Incentive Plan† | | 8-K | | 001-35312 | | January 18, 2018 | | 10.1 | | ||||||||||||||||||||||||||
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| Sixth Amendment to New-Hire Equity Incentive Plan† | | 10-Q | | 001-35312 | | August 8, 2019 | | 10.2 | | ||||||||||||||||||||||||||
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| Seventh Amendment to New-Hire Equity Incentive Plan† | | 8-K | | 001-35312 | | December 6, 2019 | | 10.1 | | ||||||||||||||||||||||||||
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| Eighth Amendment to New-Hire Equity Incentive Plan† | | 8-K/A | | 001-35312 | | February 25, 2021 | | 10.1 | | | Eighth Amendment to New-Hire Equity Incentive Plan† | | 8-K/A | | 001-35312 | | February 25, 2021 | | 10.1 | | |||||||||||||||
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| Form of Stock Option Grant Notice and Option Agreement for New-Hire Equity Incentive Plan† | | 10-Q | | 001-35312 | | November 12, 2013 | | 10.2 | | | Form of Stock Option Grant Notice and Option Agreement for New-Hire Equity Incentive Plan† | | 10-Q | | 001-35312 | | November 12, 2013 | | 10.2 | | |||||||||||||||
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| 2017 Equity Incentive Plan† | | 8-K | | 001-35312 | | May 30, 2017 | | 10.1 | | | 2017 Equity Incentive Plan† | | 8-K | | 001-35312 | | May 30, 2017 | | 10.1 | | |||||||||||||||
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| First Amendment to the 2017 Equity Incentive Plan† | | 14A | | 001-35312 | | September 11, 2020 | | App. A | | | First Amendment to the 2017 Equity Incentive Plan† | | 14A | | 001-35312 | | September 11, 2020 | | App. A | | |||||||||||||||
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| Second Amendment to the 2017 Equity Incentive Plan† | | 10-K | | 001-35312 | | March 3, 2023 | | 10.17 | | | Second Amendment to the 2017 Equity Incentive Plan† | | 10-K | | 001-35312 | | March 3, 2023 | | 10.17 | | |||||||||||||||
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| Form of Stock Option Grant Notice and Option Agreement for 2017 Equity Incentive Plan† | | 8-K | | 001-35312 | | May 30, 2017 | | 10.2 | | | Form of Stock Option Grant Notice and Option Agreement for 2017 Equity Incentive Plan† | | 8-K | | 001-35312 | | May 30, 2017 | | 10.2 | | |||||||||||||||
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| Form of Restricted Stock Unit Grant Notice and Restricted Stock Unit Agreement for 2017 Equity Incentive Plan† | | 8-K | | 001-35312 | | May 30, 2017 | | 10.3 | | | Form of Restricted Stock Unit Grant Notice and Restricted Stock Unit Agreement for 2017 Equity Incentive Plan† | | 8-K | | 001-35312 | | May 30, 2017 | | 10.3 | | |||||||||||||||
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| Nuwellis, Inc. 2021 Inducement Plan† | | 8-K | | 001-35312 | | May 20, 2021 | | 10.1 | | | Nuwellis, Inc. 2021 Inducement Plan† | | 8-K | | 001-35312 | | May 20, 2021 | | 10.1 | | |||||||||||||||
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| First Amendment to the 2021 Inducement Plan† | | 8-K | | 001-35312 | | April 21, 2022 | | 10.1 | | | First Amendment to the 2021 Inducement Plan† | | 8-K | | 001-35312 | | April 21, 2022 | | 10.1 | | |||||||||||||||
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| Second Amendment to the 2021 Inducement Plan† | | 8-K | | 001-35312 | | March 1, 2023 | | 10.1 | | | Second Amendment to the 2021 Inducement Plan† | | 8-K | | 001-35312 | | March 1, 2023 | | 10.1 | | |||||||||||||||
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| Form of Stock Option Grant Notice, Option Agreement and Notice of Exercise under the Nuwellis, Inc. 2021 Inducement Plan† | | 8-K | | 001-35312 | | May 20, 2021 | | 10.2 | | | Form of Stock Option Grant Notice, Option Agreement and Notice of Exercise under the Nuwellis, Inc. 2021 Inducement Plan† | | 8-K | | 001-35312 | | May 20, 2021 | | 10.2 | | |||||||||||||||
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| Form of Indemnity Agreement for the Company’s executive officers and directors† | | 10 | | 001-35312 | | September 30, 2011 | | 10.1 | | ||||||||||||||||||||||||||
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| Form of Change in Control Agreement for the Company’s executive officers† | | 10-K | | 001-35312 | | March 20, 2015 | | 10.16 | | ||||||||||||||||||||||||||
| | | | | |
| | | Incorporated By Reference | | | | | | | Incorporated By Reference | | | | |||||||||||||||||||||||
Exhibit Number | | Exhibit Description | | Form | | File Number | | Date of First Filing | | Exhibit Number | | Filed Herewith | | Exhibit Description | | Form | | File Number | | Date of First Filing | | Exhibit Number | | Filed Herewith | ||||||||||||
| Form of Indemnity Agreement for the Company’s executive officers and directors† | | 10 | | 001-35312 | | September 30, 2011 | | 10.1 | | ||||||||||||||||||||||||||
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| Form of Change in Control Agreement for the Company’s executive officers† | | 10-K | | 001-35312 | | March 20, 2015 | | 10.16 | | ||||||||||||||||||||||||||
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| Non-Employee Director Compensation Policy (effective August 18, 2021)† | | 10-Q | | 001-35312 | | November 10, 2021 | | 10.2 | | | Non-Employee Director Compensation Policy (effective August 18, 2021)† | | 10-Q | | 001-35312 | | November 10, 2021 | | 10.2 | | |||||||||||||||
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| Non-Employee Director Compensation Policy (effective January 1, 2023) † | | 10-K | | 001-35312 | | March 3, 2023 | | 10.27 | | | Non-Employee Director Compensation Policy (effective January 1, 2023) † | | 10-K | | 001-35312 | | March 3, 2023 | | 10.27 | | |||||||||||||||
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| Lease Agreement dated October 21, 2011 by and between the Company and Silver Prairie Crossroads, LLC | | 10 | | 001-35312 | | December 16, 2011 | | 10.18 | | | Lease Agreement dated October 21, 2011 by and between the Company and Silver Prairie Crossroads, LLC | | 10 | | 001-35312 | | December 16, 2011 | | 10.18 | | |||||||||||||||
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| Second Amendment to Lease, dated as of April 20, 2015, by and between the Company and Capital Partners Industrial Fund I, LLLP dba Prairie Crossroads Business Center | | 8-K | | 001-35312 | | April 23, 2015 | | 10.1 | | | Second Amendment to Lease, dated as of April 20, 2015, by and between the Company and Capital Partners Industrial Fund I, LLLP dba Prairie Crossroads Business Center | | 8-K | | 001-35312 | | April 23, 2015 | | 10.1 | | |||||||||||||||
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| Third Amendment to Lease, dated as of August 3, 2018, by and between the Company and Capital Partners Industrial Fund I, LLLP | | 10-Q | | 001-35312 | | November 7, 2018 | | 10.2 | | | Third Amendment to Lease, dated as of August 3, 2018, by and between the Company and Capital Partners Industrial Fund I, LLLP | | 10-Q | | 001-35312 | | November 7, 2018 | | 10.2 | | |||||||||||||||
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| Fourth Amendment to Lease, dated as of November 18, 2021, by and between the Company and Capital Partners Industrial Fund I, LLLP | | 8-K | | 01-35312 | | November 23, 2021 | | 10.1 | | | Fourth Amendment to Lease, dated as of November 18, 2021, by and between the Company and Capital Partners Industrial Fund I, LLLP | | 8-K | | 01-35312 | | November 23, 2021 | | 10.1 | | |||||||||||||||
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| Warrant Agency Agreement between the Company and American Stock Transfer & Trust Company, LLC dated April 24, 2017 | | 8-K | | 001-35312 | | April 25, 2017 | | 10.1 | | | Warrant Agency Agreement between the Company and American Stock Transfer & Trust Company, LLC dated April 24, 2017 | | 8-K | | 001-35312 | | April 25, 2017 | | 10.1 | | |||||||||||||||
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| Form of Warrant Reprice Agreement | | 8-K | | 001-35312 | | June 29, 2018 | | 10.1 | | | Form of Warrant Reprice Agreement | | 8-K | | 001-35312 | | June 29, 2018 | | 10.1 | | |||||||||||||||
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| Warrant Agency Agreement, dated as of March 12, 2019, between the Company and American Stock Transfer & Trust Company, LLC | | 8-K | | 001-35312 | | March 13, 2019 | | 4.2 | | ||||||||||||||||||||||||||
| | | | | |
| | | Incorporated By Reference | | | | | | | Incorporated By Reference | | | | |||||||||||||||||||||||
Exhibit Number | | Exhibit Description | | Form | | File Number | | Date of First Filing | | Exhibit Number | | Filed Herewith | | Exhibit Description | | Form | | File Number | | Date of First Filing | | Exhibit Number | | Filed Herewith | ||||||||||||
| Warrant Agency Agreement, dated as of March 12, 2019, between the Company and American Stock Transfer & Trust Company, LLC | | 8-K | | 001-35312 | | March 13, 2019 | | 4.2 | | ||||||||||||||||||||||||||
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| Underwriting Agreement, dated as of March 8, 2019, by and between the Company and Ladenburg Thalmann & Co. Inc. | | 8-K | | 001-35312 | | March 13, 2019 | | 1.1 | | | Underwriting Agreement, dated as of March 8, 2019, by and between the Company and Ladenburg Thalmann & Co. Inc. | | 8-K | | 001-35312 | | March 13, 2019 | | 1.1 | | |||||||||||||||
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| Form of Employee Proprietary Information, Inventions Assignment and Non-Competition Agreement for the Company’s employees, including executive officers† | | 10-Q | | 001-35312 | | May, 9, 2019 | | 10.3 | | | Form of Employee Proprietary Information, Inventions Assignment and Non-Competition Agreement for the Company’s employees, including executive officers† | | 10-Q | | 001-35312 | | May, 9, 2019 | | 10.3 | | |||||||||||||||
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| Offer Letter, by and between the Company and Nestor Jaramillo, dated April 12, 2019† | | 10-Q | | 001-35312 | | May 9, 2019 | | 10.5 | | | Offer Letter, by and between the Company and Nestor Jaramillo, dated April 12, 2019† | | 10-Q | | 001-35312 | | May 9, 2019 | | 10.5 | | |||||||||||||||
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| Placement Agency Agreement, dated as of October 23, 2019, by and between the Company and Ladenburg Thalmann & Co. Inc. | | 8-K | | 001-35312 | | October 23, 2019 | | 1.1 | | | Placement Agency Agreement, dated as of October 23, 2019, by and between the Company and Ladenburg Thalmann & Co. Inc. | | 8-K | | 001-35312 | | October 23, 2019 | | 1.1 | | |||||||||||||||
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| Form of Securities Purchase Agreement, dated as of October 23, 2019, by and among the Company and the purchasers identified on the signature pages thereto | | 8-K | | 001-35312 | | October 23, 2019 | | 10.1 | | | Form of Securities Purchase Agreement, dated as of October 23, 2019, by and among the Company and the purchasers identified on the signature pages thereto | | 8-K | | 001-35312 | | October 23, 2019 | | 10.1 | | |||||||||||||||
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| Placement Agency Agreement, dated as of November 4, 2019, by and between the Company and Ladenburg Thalmann & Co. Inc. | | 8-K | | 001-35312 | | November 4, 2019 | | 1.1 | | | Placement Agency Agreement, dated as of November 4, 2019, by and between the Company and Ladenburg Thalmann & Co. Inc. | | 8-K | | 001-35312 | | November 4, 2019 | | 1.1 | | |||||||||||||||
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| Form of Securities Purchase Agreement, dated as of November 4, 2019, by and among the Company and the purchasers identified on the signature pages thereto | | 8-K | | 001-35312 | | November 4, 2019 | | 10.1 | | | Form of Securities Purchase Agreement, dated as of November 4, 2019, by and among the Company and the purchasers identified on the signature pages thereto | | 8-K | | 001-35312 | | November 4, 2019 | | 10.1 | | |||||||||||||||
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| Underwriting Agreement dated as of January 24, 2020, by and between the Company and Ladenburg Thalmann & Co. Inc. | | 8-K | | 001-35312 | | January 29, 2020 | | 1.1 | | ||||||||||||||||||||||||||
| | | | | |
| | | Incorporated By Reference | | | | | | | Incorporated By Reference | | | | |||||||||||||||||||||||
Exhibit Number | | Exhibit Description | | Form | | File Number | | Date of First Filing | | Exhibit Number | | Filed Herewith | | Exhibit Description | | Form | | File Number | | Date of First Filing | | Exhibit Number | | Filed Herewith | ||||||||||||
| Underwriting Agreement dated as of January 24, 2020, by and between the Company and Ladenburg Thalmann & Co. Inc. | | 8-K | | 001-35312 | | January 29, 2020 | | 1.1 | | ||||||||||||||||||||||||||
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| Warrant Agency Agreement, dated as of January 28, 2020, between the Company and American Stock Transfer & Trust Company, LLC | | 8-K | | 001-35312 | | January 29, 2020 | | 4.2 | | | Warrant Agency Agreement, dated as of January 28, 2020, between the Company and American Stock Transfer & Trust Company, LLC | | 8-K | | 001-35312 | | January 29, 2020 | | 4.2 | | |||||||||||||||
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| Placement Agency Agreement, dated as of March 19, 2020, by and between the Company and Ladenburg Thalmann & Co. Inc. | | 8-K | | 001-35312 | | March 20, 2020 | | 1.1 | | | Placement Agency Agreement, dated as of March 19, 2020, by and between the Company and Ladenburg Thalmann & Co. Inc. | | 8-K | | 001-35312 | | March 20, 2020 | | 1.1 | | |||||||||||||||
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| Form of Securities Purchase Agreement, dated as of March 19, 2020, by and among the Company and the purchasers identified on the signature pages thereto | | 8-K | | 001-35312 | | March 20, 2020 | | 10.1 | | | Form of Securities Purchase Agreement, dated as of March 19, 2020, by and among the Company and the purchasers identified on the signature pages thereto | | 8-K | | 001-35312 | | March 20, 2020 | | 10.1 | | |||||||||||||||
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| Placement Agency Agreement, dated as of March 30, 2020, by and between the Company and Ladenburg Thalmann & Co. Inc. | | 8-K | | 001-35312 | | March 30, 2020 | | 1.1 | | | Placement Agency Agreement, dated as of March 30, 2020, by and between the Company and Ladenburg Thalmann & Co. Inc. | | 8-K | | 001-35312 | | March 30, 2020 | | 1.1 | | |||||||||||||||
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| Form of Securities Purchase Agreement, dated as of March 30, 2020, by and among the Company and the purchasers identified on the signature pages thereto | | 8-K | | 001-35312 | | March 30, 2020 | | 10.1 | | | Form of Securities Purchase Agreement, dated as of March 30, 2020, by and among the Company and the purchasers identified on the signature pages thereto | | 8-K | | 001-35312 | | March 30, 2020 | | 10.1 | | |||||||||||||||
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| Form of Securities Purchase Agreement, dated as of May 1, 2020, by and among the Company and the purchasers identified on the signature pagers thereto | | 8-K | | 001-35312 | | May 4, 2020 | | 10.1 | | | Form of Securities Purchase Agreement, dated as of May 1, 2020, by and among the Company and the purchasers identified on the signature pagers thereto | | 8-K | | 001-35312 | | May 4, 2020 | | 10.1 | | |||||||||||||||
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| Underwriting Agreement, dated as of August 19, 2020, by and between the Company and Ladenburg Thalman & Co. Inc. | | 8-K | | 0001-35312 | | August 21, 2020 | | 1.1 | | | Underwriting Agreement, dated as of August 19, 2020, by and between the Company and Ladenburg Thalman & Co. Inc. | | 8-K | | 0001-35312 | | August 21, 2020 | | 1.1 | | |||||||||||||||
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| Warrant Agency Agreement, dated as of August 21, 2020, between the Company and American Stock Transfer & Trust Company, LLC | | 8-K | | 001-35312 | | August 21, 2020 | | 4.2 | | ||||||||||||||||||||||||||
| | | | | |
| | | Incorporated By Reference | | | | | | | Incorporated By Reference | | | | |||||||||||||||||||||||
Exhibit Number | | Exhibit Description | | Form | | File Number | | Date of First Filing | | Exhibit Number | | Filed Herewith | | Exhibit Description | | Form | | File Number | | Date of First Filing | | Exhibit Number | | Filed Herewith | ||||||||||||
| Warrant Agency Agreement, dated as of August 21, 2020, between the Company and American Stock Transfer & Trust Company, LLC | | 8-K | | 001-35312 | | August 21, 2020 | | 4.2 | | ||||||||||||||||||||||||||
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| Executive Employment Agreement, dated January 16, 2021, by and between the Company and Nestor Jaramillo, Jr.† | | 8-K | | 001-35312 | | January 19, 2021 | | 10.1 | | | Executive Employment Agreement, dated January 16, 2021, by and between the Company and Nestor Jaramillo, Jr.† | | 8-K | | 001-35312 | | January 19, 2021 | | 10.1 | | |||||||||||||||
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| Executive Employment Agreement, dated January 16, 2021, by and between the Company and John L. Erb† | | 8-K | | 001-35312 | | January 19, 2021 | | 10.2 | | | Executive Employment Agreement, dated January 16, 2021, by and between the Company and John L. Erb† | | 8-K | | 001-35312 | | January 19, 2021 | | 10.2 | | |||||||||||||||
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| Offer Letter by and between the Company and George Montague, effective as of June 28, 2021† | | 8-K | | 001-35312 | | June 22, 2021 | | 10.1 | | | Offer Letter by and between the Company and George Montague, effective as of June 28, 2021† | | 8-K | | 001-35312 | | June 22, 2021 | | 10.1 | | |||||||||||||||
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| Offer letter by and between the Company and Neil P. Ayotte, effective as of June 7, 2021† | | 10-Q | | 001-35312 | | August 12, 2021 | | 10.4 | | | Offer letter by and between the Company and Neil P. Ayotte, effective as of June 7, 2021† | | 10-Q | | 001-35312 | | August 12, 2021 | | 10.4 | | |||||||||||||||
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| Offer Letter by and between the Company and Lynn Blake, effective as of October 19, 2022† | | 8-K | | 001-35312 | | October 5, 2022 | | 10.1 | | | Offer Letter by and between the Company and Lynn Blake, effective as of October 19, 2022† | | 8-K | | 001-35312 | | October 5, 2022 | | 10.1 | | |||||||||||||||
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| First Amendment to Offer Letter between the Company and Lynn Blake† | | 8-K | | 001-35312 | | December 9, 2022 | | 10.1 | | | First Amendment to Offer Letter between the Company and Lynn Blake† | | 8-K | | 001-35312 | | December 9, 2022 | | 10.1 | | |||||||||||||||
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| Underwriting Agreement dated September 15, 2021, between the Company and Ladenburg Thalmann & Co. Inc., as the Representative of the several underwriters named in Schedule I thereto | | 8-K | | 001-35312 | | September 17, 2021 | | 1.1 | | | Underwriting Agreement dated September 15, 2021, between the Company and Ladenburg Thalmann & Co. Inc., as the Representative of the several underwriters named in Schedule I thereto | | 8-K | | 001-35312 | | September 17, 2021 | | 1.1 | | |||||||||||||||
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| Warrant Agency Agreement, dated as of October 18, 2022, between the Company and American Stock Transfer & Trust Company, LLC | | 8-K | | 001-35312 | | October 18, 2022 | | 4.2 | | | Warrant Agency Agreement, dated as of October 18, 2022, between the Company and American Stock Transfer & Trust Company, LLC | | 8-K | | 001-35312 | | October 18, 2022 | | 4.2 | | |||||||||||||||
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| Leak-Out Agreement | | S-1/A | | 333-267368 | | September 30, 2022 | | 10.70 | | | Leak-Out Agreement | | S-1/A | | 333-267368 | | September 30, 2022 | | 10.70 | | |||||||||||||||
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| Underwriting Agreement dated as of October 14, 2022, by and between Nuwellis, Inc. and Ladenburg Thalmann & Co. Inc. | | 8-K | | 001-35312 | | October 18, 2022 | | 1.1 | | ||||||||||||||||||||||||||
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| | | Incorporated By Reference | | | | | | | Incorporated By Reference | | | | |||||||||||||||||||||||
Exhibit Number | | Exhibit Description | | Form | | File Number | | Date of First Filing | | Exhibit Number | | Filed Herewith | | Exhibit Description | | Form | | File Number | | Date of First Filing | | Exhibit Number | | Filed Herewith | ||||||||||||
| Underwriting Agreement dated as of October 14, 2022, by and between Nuwellis, Inc. and Ladenburg Thalmann & Co. Inc. | | 8-K | | 001-35312 | | October 18, 2022 | | 1.1 | | ||||||||||||||||||||||||||
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| License and Distribution Agreement with SeaStar Medical Holding Corporation, dated as of December 27, 2022+ | | 10-K | | 001-35312 | | March 3, 2023 | | 10.63 | | | License and Distribution Agreement with SeaStar Medical Holding Corporation, dated as of December 27, 2022+ | | 10-K | | 001-35312 | | March 3, 2023 | | 10.63 | | |||||||||||||||
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| Supply and Collaboration Agreement dated as of June 19, 2023 by and between the Company and DaVita Inc. + | | 8-K | | 001-35312 | | June 21, 2023 | | 10.1 | | | Supply and Collaboration Agreement dated as of June 19, 2023 by and between the Company and DaVita Inc. + | | 8-K | | 001-35312 | | June 21, 2023 | | 10.1 | | |||||||||||||||
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| Registration Rights Agreement dated as of June 19, 2023 by and between the Company and DaVita Inc. | | 8-K | | 001-35312 | | June 21, 2023 | | 10.2 | | | Registration Rights Agreement dated as of June 19, 2023 by and between the Company and DaVita Inc. | | 8-K | | 001-35312 | | June 21, 2023 | | 10.2 | | |||||||||||||||
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| Transition Agreement, by and between Lynn Blake and the Company, dated as of August 4, 2023 | | 8-K | | 001-35312 | | August 8, 2023 | | 10.1 | | | Transition Agreement, by and between Lynn Blake and the Company, dated as of August 4, 2023 | | 8-K | | 001-35312 | | August 8, 2023 | | 10.1 | | |||||||||||||||
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| Consulting Agreement, by and between Lynn Blake and the Company, dated as of August 4, 2023 | | 8-K | | 001-35312 | | August 8, 2023 | | 10.2 | | | Consulting Agreement, by and between Lynn Blake and the Company, dated as of August 4, 2023 | | 8-K | | 001-35312 | | August 8, 2023 | | 10.2 | | |||||||||||||||
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| Offer Letter, by and between Robert B. Scott and the Company, effective as of September 2, 2023 | | 8-K | | 001-35312 | | August 18, 2023 | | 10.1 | | | Offer Letter, by and between Robert B. Scott and the Company, effective as of September 2, 2023 | | 8-K | | 001-35312 | | August 18, 2023 | | 10.1 | | |||||||||||||||
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| At The Market Offering Agreement, dated as of March 3, 2023, by and between the Company and Ladenburg Thalmann & Co. Inc. | | 10-K | | 001-35312 | | March 3, 2023 | | 1.1 | | | At The Market Offering Agreement, dated as of March 3, 2023, by and between the Company and Ladenburg Thalmann & Co. Inc. | | 10-K | | 001-35312 | | March 3, 2023 | | 1.1 | | |||||||||||||||
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| Form of Warrant Agency Agreement | | S-1/A | | 333-274610 | | September 29, 2023 | | 10.68 | | | Form of Warrant Agency Agreement | | S-1/A | | 333-274610 | | September 29, 2023 | | 10.68 | | |||||||||||||||
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| Form of Securities Purchase Agreement | | S-1/A | | 333-274610 | | September 29, 2023 | | 10.69 | | | Form of Securities Purchase Agreement | | S-1/A | | 333-274610 | | September 29, 2023 | | 10.69 | | |||||||||||||||
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| Form of Securities Purchase Agreement | | | | | | X | |||||||||||||||||||||||||||||
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| List of Subsidiaries | | 10-K | | 001-35312 | | March 3, 2023 | | 21 | | ||||||||||||||||||||||||||
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| Consent of Honigman LLP | | | | | | (included in Exhibit 5.1) | |||||||||||||||||||||||||||||
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| | | Incorporated By Reference | | | | | | | Incorporated By Reference | | | | |||||||||||||||||||||||
Exhibit Number | | Exhibit Description | | Form | | File Number | | Date of First Filing | | Exhibit Number | | Filed Herewith | | Exhibit Description | | Form | | File Number | | Date of First Filing | | Exhibit Number | | Filed Herewith | ||||||||||||
| Form of Securities Purchase Agreement | | | | | | X | |||||||||||||||||||||||||||||
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| List of Subsidiaries | | 10-K | | 001-35312 | | March 3, 2023 | | 21 | | ||||||||||||||||||||||||||
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| Consent of Honigman LLP | | | | | | (included in Exhibit 5.1) | |||||||||||||||||||||||||||||
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| Consent of Baker Tilly US | | | | | | X | | Consent of Baker Tilly US | | | | | | X | |||||||||||||||||||||
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| Power of Attorney | | S-1 | | 333-276562 | | January 18, 2024 | | 24.1 | | | Power of Attorney | | S-1 | | 333-276562 | | | 24.1 | | ||||||||||||||||
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| Filing Fee Table | | | | | | X | | Filing Fee Table | | | | | | X |
† | Indicates management compensatory plan, contract or arrangement. |
+ | Certain schedules and exhibits have been omitted pursuant to Item 601(a)(5) of Regulation S-K. A copy of any omitted schedule and/or exhibit will be furnished to the SEC upon request. Certain portions of the License and Distribution Agreement, Warrant, and the Supply and Collaboration Agreement have been redacted pursuant to Item 601(a)(6) and 601(b)(10)(iv) of Regulation S-K because the Company customarily and actually treats the redacted information as private or confidential and the omitted information is not material. Copies of the unredacted License and Distribution Agreement, Warrant, and Supply and Collaboration Agreement will be furnished to the SEC upon request. |
(b) | Financial Statement Schedules |
Item 17. | Undertakings |
(1) | To file, during any period in which offers or sales are being made, a post-effective amendment to this registration statement: |
(i) | To include any prospectus required by Section 10(a)(3) of the Securities Act of 1933; |
(ii) | To reflect in the prospectus any facts or events arising after the effective date of the registration statement (or the most recent post-effective amendment thereof) which, individually or in the aggregate, represent a fundamental change in the information set forth in the registration statement. Notwithstanding the foregoing, any increase or decrease in volume of securities offered (if the total dollar value of securities offered would not exceed that which was registered) and any deviation from the low or high end of the estimated maximum offering range may be reflected in the form of prospectus filed with the SEC pursuant to Rule 424(b) if, in the aggregate, the changes in volume and price represent no more than 20% change in the maximum aggregate offering price set forth in the “Calculation of Filing Fee Tables” or “Calculation of Registration Fee” table, as applicable, in the effective registration statement; |
(iii) | To include any material information with respect to the plan of distribution not previously disclosed in the registration statement or any material change to such information in the registration statement; |
(2) | That, for the purpose of determining any liability under the Securities Act of 1933, each such |
(3) | To remove from registration by means of a post-effective amendment any of the securities being registered which remain unsold at the termination of the offering. |
(4) | That, for the purpose of determining liability under the Securities Act of 1933 to any purchaser: each prospectus filed pursuant to Rule 424(b) as part of a registration statement relating to an offering, other than registration statements relying on Rule 430B or other than prospectuses filed in reliance on |
(5) | That, for the purpose of determining liability of the registrant under the Securities Act of 1933 to any purchaser in the initial distribution of the securities, the undersigned registrant undertakes that in a primary offering of securities of the undersigned registrant pursuant to this registration statement, regardless of the underwriting method used to sell the securities to the purchaser, if the securities are offered or sold to such purchaser by means of any of the following communications, the undersigned registrant will be a seller to the purchaser and will be considered to offer or sell such securities to such purchaser: |
(i) | any preliminary prospectus or prospectus of the undersigned registrant relating to the offering required to be filed pursuant to Rule 424; |
(ii) | any free writing prospectus relating to the offering prepared by or on behalf of the undersigned registrant or used or referred to by the undersigned registrant; |
(iii) | the portion of any other free writing prospectus relating to the offering containing material information about the undersigned registrant or its securities provided by or on behalf of the undersigned registrant; and |
(iv) | any other communication that is an offer in the offering made by the undersigned registrant to the purchaser. |
(6) | That, |
(i) | For purposes of determining any liability under the Securities Act, the information omitted from the form of prospectus filed as part of this registration statement in reliance on Rule 430A and contained in a form of prospectus filed by the undersigned registrant pursuant to Rule 424(b)(1) or (4) or 497(h) under the Securities Act shall be deemed to be part of this registration statement as of the time it was declared effective; and |
(ii) | For the purpose of determining any liability under the Securities Act, each post-effective amendment that contains a form of prospectus shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof. |
(7) | Insofar as indemnification for liabilities arising under the Securities Act of 1933 may be permitted to directors, officers and controlling persons of the registrant pursuant to the foregoing provisions, or otherwise, the registrant has been advised that in the opinion of the Securities and Exchange Commission such indemnification is against public policy as expressed in the Act and is, therefore, unenforceable. In the event that a claim for indemnification against such liabilities (other than the payment by the registrant of expenses incurred or paid by a director, officer or controlling person of the registrant in the successful defense of any action, suit or proceeding) is asserted by such director, officer or controlling person in connection with the securities being registered, the registrant will, unless in the opinion of its counsel the matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction the question whether such indemnification by it is against public policy as expressed in the Act and will be governed by the final adjudication of such issue. |
That, for purposes of determining any liability under the Securities Act of 1933, each filing of the registrant's annual report pursuant to Section 13(a) or 15(d) of the Securities Exchange Act of 1934 (and, where applicable, each filing of an employee benefit plan's annual report pursuant to Section 15(d) of the Securities Exchange Act of 1934) that is incorporated by reference in the registration statement shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof. |
| | NUWELLIS, INC. | ||||
| | | | |||
| | By: | | | /s/ Nestor Jaramillo, Jr. | |
| | | | Nestor Jaramillo, Jr. | ||
| | | | Chief Executive Officer |
Signature | | | Title | | | Date |
| | | | |||
* | | | Chairman of the Board | | | |
John L. Erb | | |||||
| | | | |||
| | President, Chief Executive Officer and Director (principal executive officer) | | | ||
Nestor Jaramillo, Jr. | | |||||
| | | | |||
* | | | Chief Financial Officer (principal financial officer and principal accounting officer) | | | |
Robert B. Scott | | |||||
| | | | |||
* | | | Director | | | |
Maria Rosa Costanzo, M.D. | | |||||
| | | | |||
* | | | Director | | | |
Michael McCormick | | |||||
| | | | |||
* | | | Director | | | |
Archelle Georgiou, M.D. | | |||||
| | | | |||
* | | | Director | | | |
Gregory Waller | | |||||
| | | | |||
* | | | Director | | | |
David McDonald | |
*By: | | | /s/ Nestor Jaramillo, Jr. | | | |
| | Nestor Jaramillo, Jr. | | | ||
| | Attorney-in-fact | | |