| Item 15. | Exhibits, and Financial Statement Schedules. |
|---|
The following documents are filed as a part of this Annual Report on Form 10-K:
| (a) | Financial Statements: The financial statements filed as part of this report are listed in Part II, Item 8. |
| (b) | Financial Statement Schedules: The schedules are either not applicable or the required information is presented in the consolidated financial statements or notes thereto. |
| (c) | Exhibits: The following exhibits are incorporated by reference or filed as part of this Annual Report on Form 10-K: |
EXHIBIT INDEX
| Incorporated By Reference |
|---|
| Exhibit Number · Exhibit Description · Form · File Number · Date of First Filing · Exhibit Number · Filed Herewith |
|---|
| 3.1 | Fourth Amended and Restated Certificate of Incorporation | 10 | 001-35312 | February 1, 2012 | 3.1 |
| 3.2 | Certificate of Amendment to the Fourth Amended and Restated Certificate of Incorporation | 8-K | 001-35312 | January 13, 2017 | 3.1 |
| 3.3 | Certificate of Amendment to Fourth Amended and Restated Certificate of Incorporation | 8-K | 001-35312 | May 23, 2017 | 3.1 |
| 3.4 | Certificate of Amendment to Fourth Amended and Restated Certificate of Incorporation | 8-K | 001-35312 | October 12, 2017 | 3.1 |
| 3.5 | Certificate of Amendment to Fourth Amended and Restated Certificate of Incorporation | 8-K | 001-35312 | January 2, 2019 | 3.1 |
| 3.6 | Certificate of Amendment to Fourth Amended and Restated Certificate of Incorporation | 8-K/A | 001-35312 | October 16, 2020 | 3.1 |
| 3.7 | Certificate of Amendment to Fourth Amended and Restated Certificate of Incorporation | 8-K | 001.-35312 | April 27, 2021 | 3.1 |
| 3.8 | Certificate of Amendment to Fourth Amended and Restated Certificate of Incorporation | 8-K | 001-35312 | December 9, 2022 | 3.1 |
| 3.9 | Third Amended and Restated Bylaws | 8-K | 001-35312 | April 27, 2021 | 3.2 |
| 3.10 | Amendment to Third Amended and Restated Bylaws | 8-K | 001-35312 | October 5, 2022 | 3.1 |
| 3.11 | Form of Certificate of Designation of Series A Junior Participating Preferred Stock | 8-K | 001-35312 | June 14, 2013 | 3.1 |
| 3.12 | Form of Certificate of Designation of Preferences, Rights and Limitations of Series F Convertible Preferred Stock | S-1/A | 001-35312 | November 17, 2017 | 3.7 |
| 3.13 | Certificate of Designation of Preferences, Rights and Limitations of Series I Convertible Preferred Stock | 8-K | 001-35312 | October 18, 2022 | 3.1 |
| 3.14 | Certificate of Designation of Preferences, Rights and Limitations of Series J Convertible Preferred Stock | 8-K | 001-35312 | October 17, 2023 | 3.1 |
| 4.1 | Form of Warrant to purchase shares of common stock | S-1/A | 333-221010 | November 17, 2017 | 4.9 |
| 4.2 | Form of Series 1 and Series 2 Warrant to Purchase Shares of Common Stock | S-1/A | 333-209102 | February 25, 2019 | 4.10 |
| 4.3 | Common Stock Purchase Warrant, dated May 30, 2019, between the Company and Redington, Inc. | 10-Q | 001-35312 | August 8, 2019 | 4.1 |
| 4.4 | 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 |
| 4.5 | 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 |
| 4.6 | 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 |
| 4.7 | Form of Common Stock Purchase Warrant | S-1/A | 333-235385 | January 23, 2020 | 4.15 |
| 4.8 | 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 |
| 4.9 | 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 |
| 4.10 | 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 |
| 4.11 | Form of Warrant to Purchase Shares of Common Stock | S-1/A | 333-24145 | August 17, 2020 | 4.19 | |
| 4.12 | Warrant to purchase shares of Common Stock | S-1/A | 333-267368 | October 13, 2022 | 4.20 | |
| 4.13 | Form of Warrant to purchase shares of common stock | S-1/A | 333-274610 | September 29, 2023 | 4.13 | |
| 4.14 | Description of Securities | | X |
| 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 | |
| 10.2 | 2013 Non-Employee Directors’ Equity Incentive Plan† | 14A | 001-35312 | April 5, 2013 | App. A | |
| 10.3 | Form of Stock Option Grant Notice and Option Agreement for 2013 Non-Employee Directors’ Equity Incentive Plan† | 10-K | 001-35312 | May 29, 2013 | 10.2 | |
| 10.4 | 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 | |
| 10.5 | New-Hire Equity Incentive Plan† | 10-Q | 001-35312 | August 8, 2013 | 10.1 | |
| 10.6 | First Amendment to New-Hire Equity Incentive Plan† | 10-Q | 001-35312 | November 12, 2013 | 10.1 | |
| 10.7 | Second Amendment to New-Hire Equity Incentive Plan† | S-8 | 333-202904 | March 20, 2015 | 99.12 | |
| 10.8 | Third Amendment to New-Hire Equity Incentive Plan† | S-8 | 333-210215 | March 15, 2016 | 99.13 | |
| 10.9 | Fourth Amendment to New-Hire Equity Incentive Plan† | 8-K | 001-35312 | May 30, 2017 | 10.4 |
| 10.10 | Fifth Amendment to New-Hire Equity Incentive Plan† | 8-K | 001-35312 | January 18, 2018 | 10.1 |
| 10.11 | Sixth Amendment to New-Hire Equity Incentive Plan† | 10-Q | 001-35312 | August 8, 2019 | 10.2 |
| 10.12 | Seventh Amendment to New-Hire Equity Incentive Plan† | 8-K | 001-35312 | December 6, 2019 | 10.1 |
| 10.13 | Eighth Amendment to New-Hire Equity Incentive Plan† | 8-K/A | 001-35312 | February 25, 2021 | 10.1 |
| 10.14 | Form of Stock Option Grant Notice and Option Agreement for New-Hire Equity Incentive Plan† | 10-Q | 001-35312 | November 12, 2013 | 10.2 |
| 10.15 | 2017 Equity Incentive Plan† | 8-K | 001-35312 | May 30, 2017 | 10.1 |
| 10.16 | First Amendment to the 2017 Equity Incentive Plan† | 14A | 001-35312 | September 11, 2020 | App. A |
| 10.17 | Second Amendment to the 2017 Equity Incentive Plan† | 10-K | 001-35312 | March 3, 2023 | 10.17 |
| 10.18 | Form of Stock Option Grant Notice and Option Agreement for 2017 Equity Incentive Plan† | 8-K | 001-35312 | May 30, 2017 | 10.2 |
| 10.19 | 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 |
| 10.20 | Nuwellis, Inc. 2021 Inducement Plan† | 8-K | 001-35312 | May 20, 2021 | 10.1 |
| 10.21 | First Amendment to the 2021 Inducement Plan† | 8-K | 001-35312 | April 21, 2022 | 10.1 |
| 10.22 | Second Amendment to the 2021 Inducement Plan † | 8-K | 001-35312 | March 1, 2023 | 10.1 |
| 10.23 | 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 |
| 10.24 | Form of Indemnity Agreement for the Company’s executive officers and directors† | 10 | 001-35312 | September 30, 2011 | 10.1 |
| 10.25 | Form of Change in Control Agreement for the Company’s executive officers† | 10-K | 001-35312 | March 20, 2015 | 10.16 |
| 10.26 | Non-Employee Director Compensation Policy (effective August 18, 2021)† | 10-Q | 001-35312 | November 10, 2021 | 10.2 |
| 10.27 | Non-Employee Director Compensation Policy (effective January 1, 2023) † | 10-K | 001-35312 | March 3, 2023 | 10.27 |
| 10.28 | Lease Agreement dated October 21, 2011 by and between the Company and Silver Prairie Crossroads, LLC | 10 | 001-35312 | December 16, 2011 | 10.18 |
| 10.29 | 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 |
| 10.30 | 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 |
| 10.31 | Fourth Amendment to Lease, dated as of November 18, 2021, by and between the Company and Capital Partners Industrial Fund I, LLLP | 8-K | 001-35312 | November 23, 2021 | 10.1 |
| 10.32 | Executive Employment Agreement between Sunshine Heart, Inc. and John L. Erb, dated March 1, 2016† | 8-K | 001-35312 | March 2, 2016 | 10.1 |
| 10.33 | Letter Agreement dated February 15, 2017 among the Company, Sabby Volatility Warrant Master Fund, Ltd. and Sabby Healthcare Master Fund, Ltd. | 8-K | 003-35312 | February 16, 2017 | 10.1 |
| 10.34 | 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 |
| 10.35 | Form of Warrant Reprice Agreement | 8-K | 001-35312 | June 29, 2018 | 10.1 |
| 10.36 | 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 |
| 10.37 | 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 |
| 10.38 | 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 |
| 10.39 | Offer Letter, by and between the Company and Nestor Jaramillo, dated April 12, 2019† | 10-Q | 001-35312 | May 9, 2019 | 10.5 |
| 10.40 | 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 |
| 10.41 | 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 |
| 10.42 | 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 |
| 10.43 | 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 |
| 10.44 | 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 |
| 10.45 | 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 |
| 10.46 | 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 |
| 10.47 | 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 |
| 10.48 | 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 |
| 10.49 | 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 |
| 10.50 | Form of Securities Purchase Agreement, dated as of May 1, 2020, by and among the Company and the purchasers identified on the signature pages thereto | 8-K | 001-35312 | May 4, 2020 | 10.1 |
| 10.51 | Underwriting Agreement, dated as of August 19, 2020, by and between the Company and Ladenburg Thalman & Co. Inc. | 8-K | 001-35312 | August 21, 2020 | 1.1 |
| 10.52 | 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 |
| 10.53 | 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 |
| 10.54 | 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 |
| 10.55 | 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 |
| 10.56 | 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 |
| 10.57 | 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 |
| 10.58 | 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 |
| 10.59 | Leak-Out Agreement | S-1/A | 333-267368 | September 30, 2022 | 10.70 |
| 10.60 | 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 |
| 10.61 | First Amendment to Offer Letter between the Company and Lynn Blake† | 8-K | 001-35312 | December 9, 2022 | 10.1 |
| 10.62 | 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 |
| 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 |
| 10.64 | At The Market Offering Agreement, dated as of March 2, 2023, by and between the Company and Ladenburg Thalmann & Co. Inc. | 10-K | 001-35312 | March 3, 2023 | 1.1 |
| 10.65+ | 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 | |
| 10.66 | 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 | |
| 10.67+ | DaVita Inc. Common Stock Warrant Agreement | 8-K | 001-35312 | June 21, 2023 | 4.1 | |
| 10.68† | Transition Agreement dated August 4, 2023 by and between Nuwellis, Inc. and Lynn Blake | 8-K | 001-35312 | August 8, 2023 | 10.1 | |
| 10.69† | Offer Letter by and between Nuwellis, Inc. and Robert B. Scott, effective as of September 2, 2023 | 8-K | 001-35312 | August 18, 2023 | 10.1 | |
| 10.70 | 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 | |
| 10.71 | Form of Securities Purchase Agreement | S-1/A | 333-274610 | September 29, 2023 | 10.69 | |
| 10.72 | Form of Warrant Agency Agreement | 8-K | 001-35312 | October 17, 2023 | 4.2 | |
| 10.73 | Consulting Agreement dated August 4, 2023 by and between Nuwellis, Inc. and Lunn Blake† | S-1/A | 333-274610 | September 29, 2023 | 10.68 | |
| 21 | List of Subsidiaries | | X |
| 23.1 | Consent of Baker Tilly US, LLP | | X |
| 24 | Power of Attorney (included on signature page) | | X |
| 31.1 | Section 302 Certification—CEO | X |
| 31.2 | Section 302 Certification—CFO | X |
| 32.1* | Section 906 Certification—CEO | X |
| 32.2* | Section 906 Certification — CFO | X |
| 97 | Policy for the Recovery of Erroneously Award Compensation | X |
| 101.INS | Inline XBRL Instance Document | X |
| 101.SCH | Inline XBRL Taxonomy Extension Schema Document | X |
| 101.CAL | Inline XBRL Taxonomy Extension Calculation Linkbase Document | X |
| 101.DEF | Inline XBRL Taxonomy Extension Definition Linkbase Document | X |
| 101.LAB | Inline XBRL Taxonomy Extension Label Linkbase Document | X |
| 101.PRE | Inline XBRL Taxonomy Extension Presentation Linkbase Document | X |
| 104 | Cover Page Interactive Data File (formatted as Inline XBRL contained in Exhibit 101) | 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 Supply Agreement have been redacted pursuant to Item 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 Agreement will be furnished to the SEC upon request. |
|---|
- Furnished herewith. This certification is being furnished solely to accompany this report pursuant to 18 U.S.C. 1350, and is not being filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and is not to be incorporated by reference into any filing of the registrant, whether made before or after the date hereof, regardless of any general incorporation language in such filing.
