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, MI 49002 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 | | | David E. Danovitch Aaron M. Schleicher Sullivan & Worcester LLP 1633 Broadway New York, New York 10019 (212) 660-3060 |
Large accelerated filer | | | ☐ | | | Accelerated filer | | | ☐ |
Non-accelerated filer | | | ☒ | | | Smaller reporting company | | | ☒ |
| | | | Emerging growth company | | |
| | Per Unit | | | Per Pre-Funded Unit | | | Total | |
Public offering price | | | $ | | | $ | | | $ |
Placement agent fees(1) | | | $ | | | ||||
| | $ | |||||||
Proceeds to us (before expenses) | | | $ | | | $ | | | $ |
(1) |
LAKE STREET | | | | | MAXIM GROUP LLC |
1 | Murugan R et al. Nature Rev Nephrol. 2020; 1-14. |
2 | Koratala A et al. Cardiorenal Med. 2022;12(4):141-154. |
3 | Vaara ST et al. Crit Care.2012; 16: 1-11. |
4 | Koratala A et al Cardiorenal Med. 2022;12(4):141-154 |
5 | Stein, A, et. al. Critical Care, 2012:16:R99. |
6 | Iribarne A, et al. Ann Thorac Surg. 2014; 98(4): 1274-80. |
7 | Ronco C, Costanzo MR, Bellomo R, et al. (2010) Fluid Overload Diagnosis and Management. Basel, Switzerland: Karger. |
8 | Sutherland SM, et al. Am J Kidney Disease. 2010; 5(2): 316-25. |
9 | Gillespie RS, et al. Ped Nephro. 2004; 19(12): 1394-99. |
10 | Kazory A & Costanzo MR. Adv Chronic Kidney Dis. 2018; 25(5): 434-442. |
11 | Fonarow GC. Rev Cardiovasc Med. 2003; 4: s21-30. |
12 | Kamath SA. Int J of Nephrol. 2011; 1-6. |
13 | Ellison DH. Cardio.2001;96:132-143 |
14 | Costanzo MR, et al. J Am Coll Cardiol. 2017 May 16;69(19):2428-2445. |
15 | From Premier Applied Sciences database. |
16 | Reimbursement estimates from MCRA. |
17 | Costanzo MR, et al. J Am Coll Cardiol. 2017;69(19):2428-2445. |
18 | McIlvennan CK, Eapen ZJ, Allen LA. Circulation. 2015 May 19;131(20):1796-803. |
20 | Ahmed A, et al. Eur Heart J. 2006 Jun;27(12):1431-9. |
21 | Kazory A & Costanzo MR. Adv Chronic Kidney Dis. 2018; 25(5): 434-442; 30. |
22 | Testani JM, Hanberg JS, Cheng S et al. Circ Heart Fail. 2016; 9(1): e002370. |
24 | Costanzo MR, et al. J Am Coll Cardiol. 2017;69(19):2428-2445. |
25 | Kamath SA. Int J of Nephrol. 2011: 1-6. |
26 | Felker MG & Mentz RJ. J Am Coll Cardiol. 2012;59(24):2145-53. |
27 | Testani JM. Circ Heart Fail. 2016 Jan;9(1):e002370. |
28 | Hoorn EJ & Ellison DH. Am J Kidney Dis. 2017;69(1):136-142. |
29 | Gheorghiade M, et al. Eur Heart J Suppl. 2005; 7:B13– 19. |
30 | Orso D, et al. Eur Rev Med Pharmacol Sci. 2021 Apr;25(7):2971-2980. |
31 | Costanzo MR, et al. J Am Coll Cardiol. 2017;69(19):2428- 2445. |
32 | Thandra A, et al. Clin Invest. 2023; 365(2): 145-51. |
33 | Felker GM, et al. N Engl J Med. 2011; 364:797–805. |
34 | Costanzo MR, et al. J Am Coll Cardiol. 2007; 49(6):675-683. |
• | Reduces hospitalization by 81% |
• | Rehospitalizations with Aquadex were 48% lower than the national average at 30 days; |
• | Reduces length of hospital stay when initiated early, resulting in average savings of $3,975 (14%); |
• | Stabilizes or improves cardiac hemodynamics; |
• |
35 | Agostoni PG, et al. J Am Coll Cardiol. 1993; 21(2):424-431. |
36 | Kazory A, et al. Cardiorenal Med. 2023;13(1)1-8. |
37 | Costanza MR, et. al. Value Health. 2018; 21 (Suppl 1):S167. |
38 | SAFE Trial: Jaski BE, et al. J Card Fail. 2003; 9(3): 227-231. |
39 | RAPID Trial: Bart BA, et al. J Am Coll Cardiol. 2005; 46(11): 2043-2046. |
40 | Watson R et al. Am Heart J Plus: Cardiol: Res & Pract. 2022; 242:1-6. |
41 | Watson R et al. Am Heart J Plus: Cardiol: Res & Pract. 2022; 242:1-6. |
42 | Costanza MR, et. al. Value Health. 2018; 21 (Suppl 1):S167. |
43 | Boga M, et al. Perf. 2000; 15:143-150. |
44 | Kiziltepe U, et al. Ann Thorac Surg 2001;71:684–93. |
45 | Kazory A, et al. Cardiorenal Med. 2023;13(1)1-8. |
46 | Agostoni PG et al. J Am Coll Cardiol. 1993;21(2):424-31. |
• | No significant changes to kidney function;47 |
• | The use of continuous hematocrit monitoring and SvO2 sensor provides guided-therapy ultrafiltration.48 |
• | Following ultrafiltration, neurohormonal activation is reset toward a more physiological condition and diuretic efficacy is restored; |
47 | Kazory A, et al. Cardiorenal Med. 2023;13(1)1-8. |
48 | Starr MC, et al. Pediatric Nephrology. 2024; 39(2):597-601. |
49 | Costanzo MR, et al. J Am Coll Cardiol. 2005; 46(11): 2047-51. |
50 | Shah, K, et al. J Am Coll Cardiol. 2017 Nov, 70 (20) 2476–2486. |
51 | Bozhurt B, et al. J Card Fail. J Card Fail. 2023; 29(10): 1412-42. |
52 | Benjamin EJ, et al. Circ. 2017;135:00-00. (e378). |
53 | Fonarow GC, et al. Rev Cardiovasc Med. 2003; 4: s21-30. |
54 | Testani JM, et al. Circ Heart Fail. 2016; 9(1): e002370. |
55 | Arrigo M et al. Nat Rev Dis Primers. 2020; 6(16):1-15. |
56 | Fonarow et al. Rev Cardiovasc Med. 2003;4: Suppl 7:S21-30. |
57 | Costanzo MR, et al. J Am Coll Cardiol. 2017 May 16;69(19):2428-2445. |
58 | Sax D, et al. J Card Fail. |
59 |
60 |
61 | McIlvennan C et al. |
62 | See Appendix to Company Investor Presentation filed with the SEC on Form 8-K/A, dated January 9, 2024. |
63 | https://idataresearch.com/new-study-shows-approximately-340000-cabg-procedures-per-year-in-the-united-states/. |
64 | https://idataresearch.com/over-182000-heart-valve-replacements-per-year-in-the-united-states/. |
65 | Grand View Research. Market Research Report. 2015; 978-1-68038-603-5. |
66 |
67 |
68 | Xu J, et al. |
69 | Xu J, et al. |
70 | Granado RC et al. BMC Nephro. 2016;17:109-18. |
71 | Crawford TC, et al. Ann Thorac Surg. 2017;103:32-40. |
72 | Iribane A, et al. Ann Thorac Surg. 2014;98:1274-80. |
73 | Iribarne A, et al. Ann Thorac Surg. 2014 Oct; 98(4): 1274-80. |
74 | Beckles DL et al. J Card Surg.2022; 37: 2951-57. |
75 | Engelman D, et al. Ann Thorac Surg. 2023;115:11-5A |
76 | See Appendix to Company Investor Presentation filed with the SEC on Form 8-K/A, dated January 9, 2024. |
77 | Jayaprasad, N. Heart Views. 2016; 17(3): 92–99. |
78 | https://www.cdc.gov/ncbddd/heartdefects/data.html. |
79 | Karamlou T, et al. J Thorac Cardiovasc Surg. 2013 Feb; 145(2):470-5. |
80 | https://www.organdonor.gov/about/donors/child-infant.html. |
81 | Sutherland SM, et al. Am J Kidney Dis. 2010; 55(2):315-25. |
82 | Gillespie RS, et al. Ped Nephro. 2004; 19(12):1394-99. |
83 | See Appendix to Company Investor Presentation filed with the SEC on Form 8-K/A, dated January 9, 2024. |
○ | CV mortality |
○ | HF event |
○ | Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) score |
84 | Watson R, et al. Am Heart J Plus: Cardiol Res & Pract 24. 2022; 1-6. |
85 | Watson R, et al. Am Heart J Plus: Cardiol Res & Pract 24. 2022; 1-6. |
86 | Kazory et al. Cardiorenal Med. 2023;13:1-8. |
87 | Kazory A, et al. Cardio Renal Med. 2023.12(1):1-8. |
88 | Costanzo MR, et al. Val in Health. 2018: 21(1): s167. |
89 | Costanzo MR, et al. JACC: Heart Failure. 2016;4(2):95-105. |
90 | Menon S, et al. Clin J Am Soc Nephrol. 2019;14(10):1432-1440. |
91 | Menon S, et al. Clin J Am Soc Nephrol. 2019;14(10):1432-1440. |
| | As of September 30, 2023 (in thousands, except share and per share data) | |||||||
| | Actual | | | Pro Forma | | | Pro Forma As Adjusted | |
Cash and cash equivalents | | | $4,930 | | | $6,412 | | | 13,401 |
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 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 |
Additional paid-in capital | | | 289,980 | | | 291,462 | | | 298,449 |
Accumulated other comprehensive income: | | | | | | | |||
Foreign currency translation adjustment | | | (24) | | | (24) | | | (24) |
Unrealized gain on marketable securities | | | — | | | — | | | |
Accumulated deficit | | | (282,117) | | | (282,117) | | | (282,117) |
Total stockholders’ equity | | | 7,839 | | | 9,321 | | | 16,310 |
(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% |
92 | Murugan R et al. Nature Rev Nephrol. 2020; 1-14. |
93 | Vaara ST et al. Crit Care. 2012; 16: 1-11. |
94 | Koratala A et al. Cardiorenal Med. 2022;12(4):141-154. |
95 | Stein, A, et. al. Critical Care; 2012:16:R99. |
96 | Iribarne A, et al. Ann Thorac Surg. 2014; 98(4): 1274-80. |
97 | Salahuddin N et al. BMC Nephro. 222017;18(1):1-8. |
98 | Ronco C, et al. (2010) Fluid Overload Diagnosis and Management. Basel, Switzerland: Karger. |
99 | Sutherland SM, et al. Am J Kidney Disease. 2010; 5(2): 316-25. |
100 | Gillespie RS, et al. Ped Nephro. 2004; 19(12): 1394-99. |
101 | Kazory A & Costanzo MR. Adv Chronic Kidney Dis. 2018; 25(5): 434-442. |
102 | Fonarow GC. Rev Cardiovasc Med. 2003; 4: s21-30. |
103 | Kamath, SA. Int J of Nephrol. 2011; 1-6. |
104 | Ellison DH. Cardiol. 2001;96:132-143 |
105 | Costanzo MR, et al. J Am Coll Cardiol. 2017;69(19):2428-2445. |
106 | From Premier Applied Sciences database. |
107 | Reimbursement estimates from MCRA. |
108 | Costanzo MR, et al. J Am Coll Cardiol. 2017;69(19):2428-2445. |
109 | McIlvennan CK, et al. Circ. 2015;131(20):1796-803. |
110 | From Premier Applied Sciences database. |
111 | Ahmed A, et al. Eur Heart J. 2006;27(12):1431-9. |
112 | Kazory A & Costanzo MR. Adv Chronic Kidney Dis. 2018; 25(5): 434-442; 30. |
113 | Testani JM, et al. Circ Heart Fail. 2016; 9(1): e002370. |
114 | Testani JM, et al. Circ Heart Fail. 2016; 9(1): e002370. |
115 | Costanzo MR, et al. J Am Coll Cardiol. 2017;69(19):2428-2445. |
116 | Kamath SA. Int J of Nephrol. 2011:1-6. |
117 | Felker MG & Mentz RJ. J Am Coll Cardiol. 2012;59(24):2145-53. |
118 | Testani JM, et al. Circ Heart Fail. 2016;9(1):e002370. |
119 | Hoorn EJ & Ellison DH. Am J Kidney Dis. 2017;69(1):136-142. |
120 | Gheorghiade M, et al. Eur Heart J Suppl. 2005; 7:B13–19. |
121 | Orso D, et al. Eur Rev Med Pharmacol Sci. 2021;25(7):2971-2980. |
122 | Costanzo MR, et al. J Am Coll Cardiol. 2017;69(19):2428-2445. |
123 | Thandra A, et al. Clin Invest. 2023; 356(2): 145-51. |
124 | Felker GM, et al. N Engl J Med. 2011; 364:797–805. |
125 | Costanzo MR, et al. J Am Coll Cardiol. 2007; 49(6):675-683. |
• | Reduces hospitalization by 81%131 compared to diuretics; |
• | Rehospitalizations with Aquadex were 48% lower than the national average at 30 days;132 |
• | Reduces length of hospital stay when initiated early, resulting in average savings of $3,975 (14%);133 |
• | Stabilizes or improves cardiac hemodynamics;134, 135 |
• | Predictably removes excess isotonic fluid (extracts water and sodium while sparing potassium and magnesium; decrease risk of electrolyte abnormalities);136, 137 |
• | No significant changes to kidney function;138 |
126 | Agostoni PG, et al. J Am Coll Cardiol. 1993; 21(2):424-431. |
127 | Kazory A,et al. Cardiorenal Med. 2023;13(1)1-8. |
128 | Costanza MR, et. al. Value Health. 2018; 21 (Suppl 1):S167. |
129 | SAFE Trial: Jaski BE, et al. J Card Fail. 2003; 9(3): 227-231; RAPID Trial. |
130 | Bart BA, et al. J Am Coll Cardiol. 2005; 46(11): 2043-2046. |
131 | Watson R et al. J Cardiac Fail. 2020; 26(10): s56. |
132 | Watson R et al. J Cardiac Fail. 2020; 26(10): s56. |
133 | Costanza MR, et. al. Value Health. 2018; 21 (Suppl 1):S167. |
134 | Boga M, et al. Perf. 2000; ;15:143-150. |
135 | Kiziltepe U, et al. Ann Thorac Surg 2001;71:684–93. |
136 | Kazory A, et al. Cardiorenal Med. 2023;13(1)1-8. |
137 | Agostoni PG et al. J Am Coll Cardiol. 1993;21(2):424-31. |
138 | Kazory A, et al. Cardiorenal Med. 2023;13(1)1-8. |
• | The use of continuous hematocrit monitoring and SvO2 sensor provides guided-therapy ultrafiltration.139 |
• | Following ultrafiltration, neurohormonal activation is reset toward a more physiological condition and diuretic efficacy is restored;140 |
139 | Starr MC, et al. Ped Nephro. 2024;39(2):597-601. |
140 | Costanzo MR, et al. J Am Coll Cardiol. 2005; 46(11): 2047-51. |
141 | Shah, K, et al. J Am Coll Cardiol. 2017 Nov, 70 (20) 2476–2486. |
142 | Bozhurt B, et al. J Card Fail. 2023; 29(10): 1412-42. |
143 | Benjamin EJ, et al. Circ. 2017;135:00-00. (e378). |
144 | Fonarow GC. Rev Cardiovasc Med. 2003; 4: s21-30. |
145 | Testani JM, et al. Circ Heart Fail. 2016; 9(1): e002370. |
146 | Arrigo M et al. Nat Rev Dis Primers.2020;6(16):1-15. |
147 | Fonarow et al. Rev Cardiovasc Med. 2003;4: Suppl 7:S21-30. |
148 | Costanzo MR, et al. J Am Coll Cardiol. 2017;69(19):2428-2445. |
149 | Sax D, et al. J Card Fail. 2022: 28(10): 1545-59. |
150 | Voigt J, et al. Clin Cardiol. 2014;37(5): 312–321. |
151 | Heidenreich PA, et al. Circ Heart Fail. 2013;6(3):606-619. |
152 | McIlvennan C et al. Circ. 2015;131(20):1796-1803. |
153 | See Appendix to Company Investor Presentation filed with the SEC on Form 8-K/A, dated January 9, 2024. |
154 | https://idataresearch.com/new-study-shows-approximately-340000-cabg-procedures-per-year-in-the-united-states/. |
155 | https://idataresearch.com/over-182000-heart-valve-replacements-per-year-in-the-united-states/. |
156 | Kruger A et al. J Cardiovasc Dev Dis. 2023;10(6);263-78. |
157 | Bowdish ME, et al. Ann Thorac Surg. 2021; 111(6): 1770-1780. |
158 | Grand View Research. Market Research Report. 2015; 978-1-68038-603-5. |
159 | Xu J et al. Med. 2015. 94(33):e1360 |
160 | Xu J, et al. Med. 2015;94(33):e1360. 2017;103:32-40. |
161 | Granado RC et al. BMC Nephro. 2016;17:109-18. |
162 | Crawford TC, et al. Ann Thorac Surg. 2017;103:32-40. |
163 | Iribane A, et al. Ann Thorac Surg. 2014;98:1274-80. |
164 | Iribarne A, et al. Ann Thorac Surg. 2014; 98(4): 1274-80. |
165 | Beckles DL et al. J Card Surg. 2022; 37: 2951-57. |
166 | Engelman D, et al. Ann Thorac Surg. 2023;115:11-5A |
167 | See Appendix to Company Investor Presentation filed with the SEC on Form 8-K/A, dated January 9, 2024. |
168 | Jayaprasad, N. Heart Views. 2016; 17(3): 92–99. |
169 | https://www.cdc.gov/ncbddd/heartdefects/data.html. |
170 | Karamlou T, et al. J Thorac Cardiovasc Surg. 2013 Feb;145(2):470-5. |
171 | https://www.organdonor.gov/about/donors/child-infant.html. |
172 | Sutherland SM, et al. Am J Kidney Dis. 2010;55(2). |
173 | Gillespie RS, et al. Ped Nephrol. 2004;19(12): 1394-99. |
174 | See Appendix to Company Investor Presentation filed with the SEC on Form 8-K/A, dated January 9, 2024. |
○ | CV mortality |
○ | HF event |
○ | Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) score |
175 | Watson R et al. Am Heart J Plus: Cardiol Res & Pract 24.2022;1-6. |
176 | Watson R, et al. Am Heart J Plus: Cardiol Res & Pract 24. 2022; 1-6. |
177 | Jain A, et al. Heart Fail Rev. 2016;21(5):611-9. |
178 | Kazory A, et al. Cardiorenal Med. 2023;13:1-8. |
179 | Costanzo MR, et al. Val in Health. 2018: 21(1): s167. |
180 | Costanzo MR, et al. Val in Health. 2018: 21(1): s167. |
181 | Menon S, et al. Clin J Am Soc Nephrol. 2019 ;14(10):1432-1440. |
182 | Menon S, et al. Clin J Am Soc Nephrol. 2019 ;14(10):1432-1440. |
183 | Elliott MJ. Ann Thorac Surg. 1993;56:1518-22. fluid overload |
184 | Selewski DT, et al. Crit Care Med. 2012; 40(9): 2694-2699. |
185 | Riley AA. BMC Nephrology. 2018; 19:268-80. |
186 | https://www.ncbi.nlm.nih.gov/pubmed/23833312 |
187 | Urban S, et al. Adv Clin Exp Med. 2021;30(7):737-746. |
188 | Grodin JL, et al. Eur J of Heart Fail. 2018;20(7):1148-1156. |
189 | Rao VS, et al. Circ Heart Fail. 2019;12 (6):e005552. |
190 | Urban S, et al. Adv Clin Exp Med. 2021;30(7):737-746. |
191 | Beckles D. et al. J of Card Surg. Fail. 2022; 37(10): 2951-2957. |
192 | Pinney S, et al. Poster from Heart Failure Society of America Meeting; October 2022; Washington, DC. |
193 | Hass DC, et al. Amer Heart J Plus.; Cardio Res & Pract 2022; 24:1-6 (100230) |
Name | | | Age | | | Position(s) | | | Director Class – Term Ending |
Nestor Jaramillo, Jr. | | | 66 | | | President & Chief Executive Officer; Director | | | Class I – 2026 |
Robert B. Scott | | | 44 | | | Chief Financial Officer | | | N/A |
Neil P. Ayotte | | | 60 | | | Senior Vice President, General Counsel and Chief Compliance Officer | | | N/A |
John L. Erb | | | 74 | | | Chairman of the Board; Director | | | Class III – 2025 |
Maria Rosa Costanzo | | | 69 | | | Director | | | Class II – 2024 |
Archelle Georgiou, M.D. | | | 61 | | | Director | | | Class II – 2024 |
Michael McCormick | | | 62 | | | Director | | | Class I – 2026 |
David McDonald | | | 63 | | | Director | | | Class I – 2026 |
Gregory D. Waller | | | 74 | | | Director | | | Class III – 2025 |
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 |
(1) | This amount reflects stock options granted under the 2013 Directors’ Plan on May 19, 2023. The amounts reported represent the grant date fair value of the stock options. Valuation assumptions used in determining the grant date fair value are included in Note 4 to the condensed consolidated financial statements for the quarter ended September 30, 2023, which are included in this prospectus. The grant date fair value per share of the stock options granted on May 19, 2023 to all directors was approximately $2.73 per share. |
(2) | Dr. Costanzo elected not to receive any equity compensation for her role as a director. |
(3) | As of December 31, 2023, each non-employee director had the following number of shares underlying outstanding options (both vested and unvested): Dr. Costanzo 0; Mr. Erb 2,391, Dr. Georgiou 0; Mr. McCormick 0, Mr. McDonald 0, and Mr. Waller 2,408. |
(4) | Mr. Brandt resigned from the Board effective January 16, 2023. |
(5) | Dr. Georgiou was appointed to the Board effective November 1, 2023. |
(6) | Mr. McCormick was appointed to the Board effective June 1, 2023. |
(7) | Mr. McDonald was appointed to the Board effective November 1, 2023. |
(8) | Mr. Salveson resigned from the Board effective October 31, 2023. |
(9) | Mr. Watson resigned from the Board effective June 2, 2023. |
Name and Principal Position | | | Year | | | Salary ($) | | | 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 |
(1) | Reflects a stock option granted under the Company’s New Hire Equity Incentive Plan or 2021 Inducement Plan, as applicable. |
(2) | The fair value of each stock option is estimated at the grant date using the Black-Scholes option pricing model. The fair value of stock options under the Black-Scholes option pricing model requires management to make assumptions regarding projected employee stock option exercise behaviors, risk-free interest rates, volatility of the Company’s stock price and expected dividends, if any. |
(3) | For each named executive officer, amounts include employer matching contributions made on the officer’s behalf to the Company’s 401(k) Plan, contributions to the officer’s health savings account and Company payments for life insurance premiums. |
(4) | Mr. Scott was promoted to Chief Financial Officer of the Company effective September 2, 2023. |
(5) | Ms. Blake resigned as Chief Financial Officer effective September 1, 2023. |
| | 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 |
(1) | The underlying shares vest as follows: 25% of the shares vest on the one-year anniversary of the grant date; the remaining shares vest in 36 equal consecutive monthly installments thereafter, so that all of the shares will be vested on the four-year anniversary of the grant date. |
○ | other than for cause or upon the participant’s death or disability, the participant may exercise his or her option (to the extent the option was vested as of the date of termination) within such period of time ending on the earlier of (i) the date three months following the termination or (ii) the expiration of the term of the option. If the option is not exercised within such period, it will terminate. |
○ | upon the participant’s disability, the participant may exercise his or her option (to the extent the option was vested as of the date of termination) within such period of time ending on the earlier of (i) the date 12 months following the termination or (ii) the expiration of the term of the option. If the option is not exercised within such period, it will terminate as a result of the participant’s death, or if the participant dies within the period during which the option may be exercised after the termination of the participant’s continuous service for a reason other than death, the option may be exercised (to the extent the option was vested as of the date of death) by the participant’s estate within the period ending on the earlier of (i) the date 18 months following the date of death or (ii) the expiration of the term of the option. If the option is not exercised within such period, it will terminate. |
○ | for cause, the option will terminate upon the date of termination, and the participant will be prohibited from exercising his or her option from and after such time. |
Name of Beneficial Owner | | | Number of Shares | | | Right to Acquire(1) | | | Total | | | Aggregate Percent of Class(2) |
John L. Erb | | | 4 | | | 5,146(3) | | | 5,150 | | | * |
Michael McCormick | | | — | | | 820 | | | 820 | | | * |
Maria Rosa Costanzo, M.D. | | | — | | | — | | | — | | | — |
Jon W. Salveson | | | — | | | 1,157 | | | 1,157 | | | * |
Gregory D. Waller | | | — | | | 1,157 | | | 1,157 | | | * |
Robert B. Scott | | | — | | | 65 | | | 65 | | | * |
Nestor Jaramillo, Jr. | | | 4,098 | | | 1,490 | | | 5,588 | | | * |
Neil P. Ayotte | | | — | | | 351 | | | 351 | | | * |
Lynn Blake | | | 100 | | | 0 | | | 100 | | | * |
All current directors and executive officers as a group (8 persons) | | | 4,102 | | | 10,186 | | | 14,288 | | | *% |
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 | | | *% |
* | Less than one percent. |
(1) | Except as otherwise described below, amounts reflect the number of shares that such holder could acquire through (i) the exercise of outstanding stock options, (ii) the vesting/settlement of outstanding RSUs, (iii) the exercise of outstanding warrants to purchase common stock, and (iv) the conversion of outstanding Series F Preferred Stock, in each case within 60 days after |
(2) | Based on |
(3) | Consists of (i) |
• | 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∕ |
| | Per Unit | | | Pre-Funded Units | | | Total | |
Public offering price | | | $ | | | $ | | | $ |
Placement agents’ fees (8.0%) | | | $ | | | $ | |||
| | $ | |||||||
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 agents; or |
iii. | in any other circumstances falling within Article 1(4) of the Prospectus Regulation; |
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| | 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 |
Production Equipment | | | 3-7 years |
Office Furniture and Fixtures | | | 3-5 years |
Computer Software and Equipment | | | 3-4 years |
Loaners and demo equipment | | | 1-5 years |
Leasehold improvements | | | 3-5 years |
| | 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 |
(in thousands) | | | |
October 18, 2022 warrant issuance | | | $18,695 |
Change in fair value | | | (11,827) |
Ending balance December 31, 2022 | | | $6,868 |
| | 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 |
(in thousands) | | | |
Balance at December 31, 2022 | | | $6,868 |
Change in fair value | | | 755 |
Balance at January 4, 2023 (revaluation date) | | | 7,623 |
Warrants reclassified to equity | | | (7,623) |
Balance at September 30, 2023 | | | $— |
Item 13. | Other Expenses of Issuance and Distribution. |
SEC | | | $ |
FINRA | | | |
Legal | | | |
| | ||
| | ||
| | ||
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 | | | | | ||||||||||
Exhibit Number | | | Exhibit Description | | | Form | | | File Number | | | Date of First Filing | | | Exhibit Number | | | Filed Herewith |
| | 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 | | | 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 | | | 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 | | | 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 | | | ||
| | | | | | | | | | | | |||||||
| | 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 | | | ||
| | | | | | | | | | | | |||||||
| | 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 | | | ||
| | | | | | | | | | | |
| | | | Incorporated By Reference | | | | | ||||||||||
Exhibit Number | | | Exhibit Description | | | Form | | | File Number | | | Date of First Filing | | | Exhibit Number | | | Filed Herewith |
| | Form of Placement Agency Agreement | | | | | | | | | | | X | |||||
| | | | | | | | | | | | |||||||
| | 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 | | | ||
| | | | | | | | | | | | |||||||
| | 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 | | | 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/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 | | | December 9, 2022 | | | 3.1 | | | ||
| | | | | | | | | | | | |||||||
| | 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 | | | ||
| | | | | | | | | | | |
| | | | Incorporated By Reference | | | | | ||||||||||
Exhibit Number | | | Exhibit Description | | | Form | | | File Number | | | Date of First Filing | | | Exhibit Number | | | Filed Herewith |
3.13 | | | Form of Certificate of Designation of Preferences, Rights and Limitations of Series J Convertible Redeemable Preferred Stock* | | | | | | | | | | | |||||
| | | | | | | | | | | | |||||||
| | 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 | | | ||
| | | | | | | | | | | | |||||||
| | 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 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 | | | ||
| | | | | | | | | | | | |||||||
| | Form of Common Stock Purchase Warrant | | | S-1/A | | | 333-235385 | | | January 23, 2020 | | | 4.15 | | | ||
| | | | | | | | | | | | |||||||
| | 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 | | | ||
| | | | | | | | | | | |
| | | | Incorporated By Reference | | | | | ||||||||||
Exhibit Number | | | 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 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 | | | ||
| | | | | | | | | | | | |||||||
| | 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 | | | ||
| | | | | | | | | | | | |||||||
| | 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 November 4, 2019, among the Company and the purchasers signatory thereto | | | 8-K | | | 001-35312 | | | November 4, 2019 | | | 4.1 | | | ||
| | | | | | | | | | | |
| | | | Incorporated By Reference | | | | | ||||||||||
Exhibit Number | | | Exhibit Description | | | Form | | | File Number | | | Date of First Filing | | | Exhibit Number | | | Filed Herewith |
| | 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 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 Warrant to Purchase Shares of Common Stock | | | S-1/A | | | 333-24145 | | | August 17, 2020 | | | 4.19 | | | ||
| | | | | | | | | | | | |||||||
| | 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 Series J Convertible Preferred Stock* | | | | | | | | | | | |||||
| | | | | | | | | | | | |||||||
| | Specimen of Common Stock Certificate | | | 10 | | | 001-35312 | | | September 30, 2011 | | | 4.1 | | | ||
| | | | | | | | | | | | |||||||
| | DaVita Inc. Common Stock Warrant Agreement+ | | | 8-K | | | 001-35312 | | | June 21, 2023 | | | 4.1 | | | ||
| | | | | | | | | | | | |||||||
5.1 | | | Opinion of Honigman LLP* | | | | | | | | | | | |||||
| | | | | | | | | | | | |||||||
| | 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 | | | ||
| | | | | | | | | | | | |||||||
| | 2013 Non-Employee Directors’ Equity Incentive Plan† | | | 14A | | | 001-35312 | | | April 5, 2013 | | | App. A | | | ||
| | | | | | | | | | | | |||||||
| | 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 | | | ||
| | | | | | | | | | | |
| | | | Incorporated By Reference | | | | | ||||||||||
Exhibit Number | | | 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 | | | ||
| | | | | | | | | | | | |||||||
| | Form of Common Stock Purchase Warrant | | | S-1/A | | | 333-235385 | | | January 23, 2020 | | | 4.15 | | | ||
| | | | | | | | | | | | |||||||
| | 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 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 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 Warrant to Purchase Shares of Common Stock | | | S-1/A | | | 333-24145 | | | August 17, 2020 | | | 4.19 | | | ||
| | | | | | | | | | | | |||||||
| | Warrant to Purchase Shares of Common Stock | | | S-1/A | | | 333-267368 | | | October 13, 2022 | | | 4.20 | | | ||
| | | | | | | | | | | | |||||||
| | Form of Warrant to purchase shares of Series J Convertible Preferred Stock | | | S-1/A | | | 333-274610 | | | September 29, 2023 | | | 4.13 | | | ||
| | | | | | | | | | | | |||||||
| | Specimen of Common Stock Certificate | | | 10 | | | 001-35312 | | | September 30, 2011 | | | 4.1 | | | ||
| | | | | | | | | | | |
| | | | Incorporated By Reference | | | | | ||||||||||
Exhibit Number | | | Exhibit Description | | | Form | | | File Number | | | Date of First Filing | | | Exhibit Number | | | Filed Herewith |
| | 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 | | | ||
| | | | | | | | | | | | |||||||
| | New-Hire Equity Incentive Plan† | | | 10-Q | | | 001-35312 | | | August 8, 2013 | | | 10.1 | | | ||
| | | | | | | | | | | | |||||||
| | First Amendment to New-Hire Equity Incentive Plan† | | | 10-Q | | | 001-35312 | | | November 12, 2013 | | | 10.1 | | | ||
| | | | | | | | | | | | |||||||
| | Second Amendment to New-Hire Equity Incentive Plan† | | | S-8 | | | 333-202904 | | | March 20, 2015 | | | 99.12 | | | ||
| | | | | | | | | | | | |||||||
| | Third Amendment to New-Hire Equity Incentive Plan† | | | S-8 | | | 333-210215 | | | March 15, 2016 | | | 99.13 | | | ||
| | | | | | | | | | | | |||||||
| | Fourth Amendment to New-Hire Equity Incentive Plan† | | | 8-K | | | 001-35312 | | | May 30, 2017 | | | 10.4 | | | ||
| | | | | | | | | | | | |||||||
| | Fifth Amendment to New-Hire Equity Incentive Plan† | | | 8-K | | | 001-35312 | | | January 18, 2018 | | | 10.1 | | | ||
| | | | | | | | | | | | |||||||
| | Sixth Amendment to New-Hire Equity Incentive Plan† | | | 10-Q | | | 001-35312 | | | August 8, 2019 | | | 10.2 | | | ||
| | | | | | | | | | | | |||||||
| | Seventh Amendment to New-Hire Equity Incentive Plan† | | | 8-K | | | 001-35312 | | | December 6, 2019 | | | 10.1 | | | ||
| | | | | | | | | | | | |||||||
| | Eighth Amendment to New-Hire Equity Incentive Plan† | | | 8-K/A | | | 001-35312 | | | February 25, 2021 | | | 10.1 | | | ||
| | | | | | | | | | | | |||||||
| | Form of Stock Option Grant Notice and Option Agreement for New-Hire Equity Incentive Plan† | | | 10-Q | | | 001-35312 | | | November 12, 2013 | | | 10.2 | | | ||
| | | | | | | | | | | | |||||||
| | 2017 Equity Incentive Plan† | | | 8-K | | | 001-35312 | | | May 30, 2017 | | | 10.1 | | | ||
| | | | | | | | | | | | |||||||
| | First Amendment to the 2017 Equity Incentive Plan† | | | 14A | | | 001-35312 | | | September 11, 2020 | | | App. A | | | ||
| | | | | | | | | | | | |||||||
| | Second Amendment to the 2017 Equity Incentive Plan† | | | 10-K | | | 001-35312 | | | March 3, 2023 | | | 10.17 | | | ||
| | | | | | | | | | | | |||||||
| | Form of Stock Option Grant Notice and Option Agreement for 2017 Equity Incentive Plan† | | | 8-K | | | 001-35312 | | | May 30, 2017 | | | 10.2 | | | ||
| | | | | | | | | | | |
| | | | Incorporated By Reference | | | | | ||||||||||
Exhibit Number | | | 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 | | | ||
| | | | | | | | | | | | |||||||
| | Form of Common Warrant | | | | | | | | | | | X | |||||
| | | | | | | | | | | | |||||||
| | Form of Pre-Funded Warrant | | | | | | | | | | | X | |||||
| | | | | | | | | | | | |||||||
| | Form of Warrant Agency Agreement | | | | | | | | | | | X | |||||
| | | | | | | | | | | | |||||||
| | Opinion of Honigman LLP | | | | | | | | | | | X | |||||
| | | | | | | | | | | | |||||||
| | 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 | | | ||
| | | | | | | | | | | | |||||||
| | 2013 Non-Employee Directors’ Equity Incentive Plan† | | | 14A | | | 001-35312 | | | April 5, 2013 | | | App. A | | | ||
| | | | | | | | | | | | |||||||
| | 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 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 | | | ||
| | | | | | | | | | | | |||||||
| | New-Hire Equity Incentive Plan† | | | 10-Q | | | 001-35312 | | | August 8, 2013 | | | 10.1 | | | ||
| | | | | | | | | | | | |||||||
| | First Amendment to New-Hire Equity Incentive Plan† | | | 10-Q | | | 001-35312 | | | November 12, 2013 | | | 10.1 | | | ||
| | | | | | | | | | | | |||||||
| | Second Amendment to New-Hire Equity Incentive Plan† | | | S-8 | | | 333-202904 | | | March 20, 2015 | | | 99.12 | | | ||
| | | | | | | | | | | | |||||||
| | Third Amendment to New-Hire Equity Incentive Plan† | | | S-8 | | | 333-210215 | | | March 15, 2016 | | | 99.13 | | | ||
| | | | | | | | | | | | |||||||
| | Fourth Amendment to New-Hire Equity Incentive Plan† | | | 8-K | | | 001-35312 | | | May 30, 2017 | | | 10.4 | | | ||
| | | | | | | | | | | |
| | | | Incorporated By Reference | | | | | ||||||||||
Exhibit Number | | | Exhibit Description | | | Form | | | File Number | | | Date of First Filing | | | Exhibit Number | | | Filed Herewith |
| | 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 | | | ||
| | | | | | | | | | | | |||||||
| | Nuwellis, Inc. 2021 Inducement Plan† | | | 8-K | | | 001-35312 | | | May 20, 2021 | | | 10.1 | | | ||
| | | | | | | | | | | | |||||||
| | First Amendment to the 2021 Inducement Plan† | | | 8-K | | | 001-35312 | | | April 21, 2022 | | | 10.1 | | | ||
| | | | | | | | | | | | |||||||
| | Second Amendment to the 2021 Inducement Plan† | | | 8-K | | | 001-35312 | | | March 1, 2023 | | | 10.1 | | | ||
| | | | | | | | | | | | |||||||
| | 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 Indemnity Agreement for the Company’s executive officers and directors† | | | 10 | | | 001-35312 | | | September 30, 2011 | | | 10.1 | | | ||
| | | | | | | | | | | | |||||||
| | Form of Change in Control Agreement for the Company’s executive officers† | | | 10-K | | | 001-35312 | | | March 20, 2015 | | | 10.16 | | | ||
| | | | | | | | | | | | |||||||
| | Non-Employee Director Compensation Policy (effective August 18, 2021)† | | | 10-Q | | | 001-35312 | | | November 10, 2021 | | | 10.2 | | | ||
| | | | | | | | | | | | |||||||
| | Non-Employee Director Compensation Policy (effective January 1, 2023) † | | | 10-K | | | 001-35312 | | | March 3, 2023 | | | 10.27 | | | ||
| | | | | | | | | | | | |||||||
| | Lease Agreement dated October 21, 2011 by and between the Company and Silver Prairie Crossroads, LLC | | | 10 | | | 001-35312 | | | December 16, 2011 | | | 10.18 | | | ||
| | | | | | | | | | | | |||||||
| | 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 | | | ||
| | | | | | | | | | | |
| | | | Incorporated By Reference | | | | | ||||||||||
Exhibit Number | | | 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 | | | ||
| | | | | | | | | | | | |||||||
| | Sixth Amendment to New-Hire Equity Incentive Plan† | | | 10-Q | | | 001-35312 | | | August 8, 2019 | | | 10.2 | | | ||
| | | | | | | | | | | | |||||||
| | Seventh Amendment to New-Hire Equity Incentive Plan† | | | 8-K | | | 001-35312 | | | December 6, 2019 | | | 10.1 | | | ||
| | | | | | | | | | | | |||||||
| | Eighth Amendment to New-Hire Equity Incentive Plan† | | | 8-K/A | | | 001-35312 | | | February 25, 2021 | | | 10.1 | | | ||
| | | | | | | | | | | | |||||||
| | Form of Stock Option Grant Notice and Option Agreement for New-Hire Equity Incentive Plan† | | | 10-Q | | | 001-35312 | | | November 12, 2013 | | | 10.2 | | | ||
| | | | | | | | | | | | |||||||
| | 2017 Equity Incentive Plan† | | | 8-K | | | 001-35312 | | | May 30, 2017 | | | 10.1 | | | ||
| | | | | | | | | | | | |||||||
| | First Amendment to the 2017 Equity Incentive Plan† | | | 14A | | | 001-35312 | | | September 11, 2020 | | | App. A | | | ||
| | | | | | | | | | | | |||||||
| | Second Amendment to the 2017 Equity Incentive Plan† | | | 10-K | | | 001-35312 | | | March 3, 2023 | | | 10.17 | | | ||
| | | | | | | | | | | | |||||||
| | 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 Restricted Stock Unit Grant Notice and Restricted Stock Unit Agreement for 2017 Equity Incentive Plan† | | | 8-K | | | 001-35312 | | | May 30, 2017 | | | 10.3 | | | ||
| | | | | | | | | | | | |||||||
| | Nuwellis, Inc. 2021 Inducement Plan† | | | 8-K | | | 001-35312 | | | May 20, 2021 | | | 10.1 | | | ||
| | | | | | | | | | | | |||||||
| | First Amendment to the 2021 Inducement Plan† | | | 8-K | | | 001-35312 | | | April 21, 2022 | | | 10.1 | | | ||
| | | | | | | | | | | | |||||||
| | Second Amendment to the 2021 Inducement Plan† | | | 8-K | | | 001-35312 | | | March 1, 2023 | | | 10.1 | | | ||
| | | | | | | | | | | | |||||||
| | 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 | | | ||
| | | | | | | | | | | |
| | | | Incorporated By Reference | | | | | ||||||||||
Exhibit Number | | | Exhibit Description | | | Form | | | File Number | | | Date of First Filing | | | Exhibit Number | | | Filed Herewith |
| | 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 | | | ||
| | | | | | | | | | | | |||||||
| | 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 | | | ||
| | | | | | | | | | | | |||||||
| | 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 | | | ||
| | | | | | | | | | | | |||||||
| | Form of Warrant Reprice Agreement | | | 8-K | | | 001-35312 | | | June 29, 2018 | | | 10.1 | | | ||
| | | | | | | | | | | | |||||||
| | 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 | | | ||
| | | | | | | | | | | | |||||||
| | 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 | | | ||
| | | | | | | | | | | | |||||||
| | 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 | | | ||
| | | | | | | | | | | | |||||||
| | Offer Letter, by and between the Company and Nestor Jaramillo, dated April 12, 2019† | | | 10-Q | | | 001-35312 | | | May 9, 2019 | | | 10.5 | | | ||
| | | | | | | | | | | | |||||||
| | 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 | | | ||
| | | | | | | | | | | |
| | | | Incorporated By Reference | | | | | ||||||||||
Exhibit Number | | | 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 | | | ||
| | | | | | | | | | | | |||||||
| | Form of Change in Control Agreement for the Company’s executive officers† | | | 10-K | | | 001-35312 | | | March 20, 2015 | | | 10.16 | | | ||
| | | | | | | | | | | | |||||||
| | Non-Employee Director Compensation Policy (effective August 18, 2021)† | | | 10-Q | | | 001-35312 | | | November 10, 2021 | | | 10.2 | | | ||
| | | | | | | | | | | | |||||||
| | Non-Employee Director Compensation Policy (effective January 1, 2023) † | | | 10-K | | | 001-35312 | | | March 3, 2023 | | | 10.27 | | | ||
| | | | | | | | | | | | |||||||
| | Lease Agreement dated October 21, 2011 by and between the Company and Silver Prairie Crossroads, LLC | | | 10 | | | 001-35312 | | | December 16, 2011 | | | 10.18 | | | ||
| | | | | | | | | | | | |||||||
| | 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 | | | ||
| | | | | | | | | | | | |||||||
| | 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 | | | ||
| | | | | | | | | | | | |||||||
| | 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 | | | ||
| | | | | | | | | | | | |||||||
| | 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 | | | ||
| | | | | | | | | | | | |||||||
| | Form of Warrant Reprice Agreement | | | 8-K | | | 001-35312 | | | June 29, 2018 | | | 10.1 | | | ||
| | | | | | | | | | | |
| | | | Incorporated By Reference | | | | | ||||||||||
Exhibit Number | | | Exhibit Description | | | Form | | | File Number | | | Date of First Filing | | | Exhibit Number | | | Filed Herewith |
| | 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 | | | ||
| | | | | | | | | | | | |||||||
| | 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 | | | ||
| | | | | | | | | | | | |||||||
| | 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 | | | ||
| | | | | | | | | | | | |||||||
| | 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 | | | ||
| | | | | | | | | | | | |||||||
| | 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 | | | ||
| | | | | | | | | | | | |||||||
| | 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 | | | ||
| | | | | | | | | | | | |||||||
| | 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 | | | ||
| | | | | | | | | | | | |||||||
| | 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 | | | ||
| | | | | | | | | | | | |||||||
| | 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 | | | ||
| | | | | | | | | | | |
| | | | Incorporated By Reference | | | | | ||||||||||
Exhibit Number | | | 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 | | | ||
| | | | | | | | | | | | |||||||
| | 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 | | | ||
| | | | | | | | | | | | |||||||
| | 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 | | | ||
| | | | | | | | | | | | |||||||
| | Offer Letter, by and between the Company and Nestor Jaramillo, dated April 12, 2019† | | | 10-Q | | | 001-35312 | | | May 9, 2019 | | | 10.5 | | | ||
| | | | | | | | | | | | |||||||
| | 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 | | | ||
| | | | | | | | | | | | |||||||
| | 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 | | | ||
| | | | | | | | | | | | |||||||
| | 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 | | | ||
| | | | | | | | | | | | |||||||
| | 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 | | | ||
| | | | | | | | | | | |
| | | | Incorporated By Reference | | | | | ||||||||||
Exhibit Number | | | Exhibit Description | | | Form | | | File Number | | | Date of First Filing | | | Exhibit Number | | | Filed Herewith |
| | 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 | | | ||
| | | | | | | | | | | | |||||||
| | 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 | | | ||
| | | | | | | | | | | | |||||||
| | 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 | | | ||
| | | | | | | | | | | | |||||||
| | 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 John L. Erb† | | | 8-K | | | 001-35312 | | | January 19, 2021 | | | 10.2 | | | ||
| | | | | | | | | | | | |||||||
| | 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 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 Lynn Blake, effective as of October 19, 2022† | | | 8-K | | | 001-35312 | | | October 5, 2022 | | | 10.1 | | | ||
| | | | | | | | | | | | |||||||
| | First Amendment to Offer Letter between the Company and Lynn Blake† | | | 8-K | | | 001-35312 | | | December 9, 2022 | | | 10.1 | | | ||
| | | | | | | | | | | | |||||||
| | 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 | | | ||
| | | | | | | | | | | |
| | | | Incorporated By Reference | | | | | ||||||||||
Exhibit Number | | | 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 | | | ||
| | | | | | | | | | | | |||||||
| | 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 | | | ||
| | | | | | | | | | | | |||||||
| | 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 | | | ||
| | | | | | | | | | | | |||||||
| | 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 | | | ||
| | | | | | | | | | | | |||||||
| | 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 | | | ||
| | | | | | | | | | | | |||||||
| | 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 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 | | | ||
| | | | | | | | | | | | |||||||
| | 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 | | | ||
| | | | | | | | | | | |
| | | | Incorporated By Reference | | | | | ||||||||||
Exhibit Number | | | Exhibit Description | | | Form | | | File Number | | | Date of First Filing | | | Exhibit Number | | | Filed Herewith |
| | 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 | | | ||
| | | | | | | | | | | | |||||||
| | Leak-Out Agreement | | | S-1/A | | | 333-267368 | | | September 30, 2022 | | | 10.70 | | | ||
| | | | | | | | | | | | |||||||
| | 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 | | | ||
| | | | | | | | | | | | |||||||
| | License and Distribution Agreement with SeaStar Medical Holding Corporation, dated as of December 27, 2022+ | | | 10-K | | | 001-35312 | | | March 3, 2023 | | | 10.63 | | | ||
| | | | | | | | | | | | |||||||
| | 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 | | | ||
| | | | | | | | | | | | |||||||
| | 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 | | | ||
| | | | | | | | | | | | |||||||
| | 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 | | | ||
| | | | | | | | | | | | |||||||
| | 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 | | | ||
| | | | | | | | | | | | |||||||
| | 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 | | | ||
| | | | | | | | | | | | |||||||
| | 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 | | | ||
| | | | | | | | | | | | |||||||
10.68 | | | Form of Warrant Agency Agreement* | | | | | | | | | | | |||||
| | | | | | | | | | | |
| | | | Incorporated By Reference | | | | | ||||||||||
Exhibit Number | | | 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 | | | ||
| | | | | | | | | | | | |||||||
| | 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 John L. Erb† | | | 8-K | | | 001-35312 | | | January 19, 2021 | | | 10.2 | | | ||
| | | | | | | | | | | | |||||||
| | 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 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 Lynn Blake, effective as of October 19, 2022† | | | 8-K | | | 001-35312 | | | October 5, 2022 | | | 10.1 | | | ||
| | | | | | | | | | | | |||||||
| | First Amendment to Offer Letter between the Company and Lynn Blake† | | | 8-K | | | 001-35312 | | | December 9, 2022 | | | 10.1 | | | ||
| | | | | | | | | | | | |||||||
| | 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 | | | ||
| | | | | | | | | | | | |||||||
| | 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 | | | ||
| | | | | | | | | | | | |||||||
| | Leak-Out Agreement | | | S-1/A | | | 333-267368 | | | September 30, 2022 | | | 10.70 | | | ||
| | | | | | | | | | | |
| | | | Incorporated By Reference | | | | | ||||||||||
Exhibit Number | | | 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 | | | ||
| | | | | | | | | | | | |||||||
| | License and Distribution Agreement with SeaStar Medical Holding Corporation, dated as of December 27, 2022+ | | | 10-K | | | 001-35312 | | | March 3, 2023 | | | 10.63 | | | ||
| | | | | | | | | | | | |||||||
| | 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 | | | ||
| | | | | | | | | | | | |||||||
| | 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 | | | ||
| | | | | | | | | | | | |||||||
| | 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 | | | ||
| | | | | | | | | | | | |||||||
| | 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 | | | ||
| | | | | | | | | | | | |||||||
| | 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 | | | ||
| | | | | | | | | | | | |||||||
| | 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 | | | ||
| | | | | | | | | | | | |||||||
| | Form of Warrant Agency Agreement | | | S-1/A | | | 333-274610 | | | September 29, 2023 | | | 10.68 | | | ||
| | | | | | | | | | | | |||||||
| | Form of Securities Purchase Agreement | | | S-1/A | | | 333-274610 | | | September 29, 2023 | | | 10.69 | | | ||
| | | | | | | | | | | |
| | | | Incorporated By Reference | | | | | ||||||||||
Exhibit Number | | | Exhibit Description | | | Form | | | File Number | | | Date of First Filing | | | Exhibit Number | | | Filed Herewith |
10.69 | | | Form of Securities Purchase Agreement to be entered into in this Offering* | | | | | | | | | | | |||||
| | | | | | | | | | | | |||||||
10.70 | | | Form of Placement Agency Agreement by and between the Company, Lake Street Capital Markets, LLC and Maxim Group, LLC* | | | | | | | | | | | |||||
| | | | | | | | | | | | |||||||
| | List of Subsidiaries | | | 10-K | | | 001-35312 | | | March 3, 2023 | | | 21 | | | ||
| | | | | | | | | | | | |||||||
| | Consent of Baker Tilly US, LLP | | | | | | | | | | | X | |||||
| | | | | | | | | | | | |||||||
23.2 | | | Consent of Honigman LLP* | | | | | | | | | | | (included in Exhibit 5.1) | ||||
| | | | | | | | | | | | |||||||
| | Power of Attorney | | | | | | | | | | | X (included on signature page) | |||||
| | | | | | | | | | | | |||||||
| | Filing Fee Table | | | | | | | | | | | X |
| | | | Incorporated By Reference | | | | | ||||||||||
Exhibit Number | | | Exhibit Description | | | Form | | | File Number | | | Date of First Filing | | | Exhibit Number | | | Filed Herewith |
| | Form of Securities Purchase Agreement | | | | | | | | | | | X | |||||
| | | | | | | | | | | | |||||||
| | List of Subsidiaries | | | 10-K | | | 001-35312 | | | March 3, 2023 | | | 21 | | | ||
| | | | | | | | | | | | |||||||
| | Consent of Honigman LLP | | | | | | | | | | | (included in Exhibit 5.1) | |||||
| | | | | | | | | | | | |||||||
| | Consent of Baker Tilly US | | | | | | | | | | | X | |||||
| | | | | | | | | | | | |||||||
| | Power of Attorney | | | S-1 | | | 333-276562 | | | January 18, 2024 | | | 24.1 | | | ||
| | | | | | | | | | | | |||||||
| | 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) |
Item 17. |
(1) | To file, during any period in which offers or sales are being made, a post-effective amendment to this registration statement: |
(i) |
(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 Rule 430A, shall be deemed to be part of and included in the registration statement as of the date it is first used after effectiveness. Provided, however, that no statement made in a registration statement or prospectus that is part of the registration statement or made in a document incorporated or deemed incorporated by reference into the registration statement or prospectus that is part of the registration statement will, as to a purchaser with a time of contract of sale prior to such first use, supersede or modify any statement that was made in the registration statement or prospectus that was part of the registration statement or made in any such document immediately prior to such date of first use. |
(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 |
(i) |
(ii) |
(iii) |
(iv) |
(6) | 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. |
(7) |
| | 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 | | | ||
| ||||||
| | | | |||
| | Director | | | ||
Gregory Waller | | |||||
| | | | |||
* | | | Director | | | January 30, 2024 |
David McDonald | |
By: | | | /s/ Nestor Jaramillo, Jr. | | | |
| | Nestor Jaramillo, Jr. | | | ||
| | Attorney-in-fact | | |