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 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 | | | Michael F. Nertney Ellenoff Grossman & Schole LLP 1345 Avenue of the Americas New York, NY 10105-0302 Tel: (212) 370-1300 Fax: (212) 401-4741 |
Large accelerated filer ☐ | | | Accelerated filer ☐ | | | Non-accelerated filer ☒ | | | Smaller reporting company ☒ |
| | | | | | Emerging growth company ☐ |
| | Per Class A Unit | | | Per Class B Unit(1) | | | Per Share | | | Total | |
Public offering price | | | | | | | | | ||||
Underwriting discounts(2) | | | | | | | | | ||||
Proceeds, before expenses, to Nuwellis, Inc. | | | | | | | | |
(1) | The public offering price and underwriting discount corresponds to (x) in respect of the Class A Units (i) a public offering price per share of common stock of $[ ] and (ii) a public offering price per warrant of $[ ] and (y) in respect of the Class B Units (i) a public offering price per share of Series I Preferred Stock of $[ ] and (ii) a public offering price per warrant to purchase one share of common stock of $[ ]. |
(2) | We have agreed to pay certain expenses of the underwriters in this offering. We refer you to “Underwriting” on page 33 for additional information regarding underwriting compensation. |
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1 | https://my.clevelandclinic.org/health/diseases/22962-hypervolemia |
2 | Schwinger RHG. Cardiovasc Diagn Ther.2021;11(1); 263-76. |
3 | Hoorn EJ & Ellison DH. Am J Kidney Dis.2016; 69(1): 136-42. |
4 | Wise R et al. World J Surg.2017; 41: 1170-83. |
5 | Stein, A et. al. Critical Care, 2012; 16: R99; 1-9 |
6 | Iribarne A, et al. Ann Thorac Surg. 2014 Oct; 98(4): 1274-80 |
7 | Kazory A & Ross EA. Heart. 2009; 95: 1047-51. |
8 | Kazory A & Ross EA. Heart. 2009; 95: 1047-51. |
9 | Felker MG et al. J Am Coll Cardiol. 2012 Jun 12;59(24):2145-53. |
10 | Felker MG et al. J Am Coll Cardiol. 2012 Jun 12;59(24):2145-53. |
11 | Felker MG et al. J Am Coll Cardiol. 2012 Jun 12;59(24):2145-53. |
12 | Heidenreich P et al. ACC, AHA, HFSA 2022 Heart Failure guidelines. J Am Coll Cardiol. 2021. 1-159. |
13 | Felker MG et al. J Am Coll Cardiol. 2012 Jun 12;59(24):2145-53. |
14 | Felker MG et al. J Am Coll Cardiol. 2020; 75(10); 1179-97. |
15 | Kamath SA.. Int J of Nephrol. 2011. Article ID 190230; 1-6. |
16 | Costanzo MR, et al. J Am Coll Cardiol. 2017;69(19):2428-45. |
17 | Kamath SA.. Int J of Nephrol. 2011. Article ID 190230; 1-6. |
18 | Felker MG et al. J Am Coll Cardiol. 2012 Jun 12;59(24):2145-53. |
19 | Heidenreich P et al. ACC, AHA, HFSA 2022 Heart Failure guidelines. J Am Coll Cardiol. 2021. 1-159. |
20 | Wise R et al. World J Surg. 2017; 41: 1170-83. |
21 | Felker MG et al. J Am Coll Cardiol. 2020; 75(10); 1179-97. |
22 | Felker GM et al. New Engl J Med. 2011; 364(9): 797-805. |
23 | Gheorghiade M, Filippatos G. Eur Heart J Suppl. 2005; 7: B13–19. |
24 | Costanzo MR, et al. J Am Coll Cardiol. 2017;69(19):2428-45. |
25 | Gheorghiade M, Filippatos G. Eur Heart J Suppl. 2005; 7: B13–19. |
26 | Felker GM et al. New Engl J Med. 2011; 364(9): 797-805. |
27 | Costanzo MR, et al. J Am Coll Cardiol. 2007; 49(6): 675-83. |
28 | Peterangelo M. Prog Cardiol Nurs. 2008; 23: 168-72. |
29 | Costanzo MR, et al. J Am Coll Cardiol. 2017; 69(19): 2428-45. |
30 | Jaski BA et al. J Card Fail. 2003; 9(3): 227-31. |
31 | Costanzo MR, et al. J Am Coll Cardiol. 2017; 69(19): 2428-45. |
• | Provides control over rate and total volume of fluid removed by allowing a medical practitioner to specify the amount of fluid to be removed from each individual patient;42 |
• | Can be performed via peripheral or central venous access43; |
• | Removes isotonic fluid (extracts sodium while sparing potassium and magnesium);44, 45 |
• | Following ultrafiltration, neurohormonal activation is reset toward a more physiological condition and diuretic efficacy is restored46, 47; |
• | Provides highly automated operation with only one setting required to begin therapy48; |
• | Uses a single-use, disposable auto-loading blood filter circuit that facilitates easy set-up49; |
• | Has a built-in console that guides the medical practitioner through the setup and operational process; and |
• | Has demonstrated decreased hospital readmissions and reduced length of stay duration resulting in cost savings at 90 days.50, 51, 52, 53 |
32 | Costanzo MR, et al. J Am Coll Cardiol. 2017; 69(19): 2428-45. |
33 | Kazory A. Clin J Am Soc Nephro. 2013; 8; 1816-28. |
34 | Luciani GB, et al. Circ. 2001 Sep 18; 104(12 Suppl 1): I253-I259. |
35 | Kiziltepe, U, et al. Ann Thorac Surg. 2001 Feb;71(2): 684-93. |
36 | Sahoo, TK, et al. Indian J Thorac Cardiovas Surg. 2007 Jun;23(2): 116-124. |
37 | Costanzo MR, et. al. Value Health. 2018; 21 (Suppl 1): S167. |
38 | Felker GM et al. New Engl J Med. 2011; 364(9): 797-805. |
39 | Costanzo MR, et al. J Am Coll Cardiol. 2017; 69(19): 2428-45. |
40 | Bart BE at al. J Am Coll Cardiol. 2005 Dec 6; 46(11): 2043-46. |
41 | Costanzo MR et al. J Am Coll Cardiol. 2005; 46(11): 2047-51. |
42 | Peterangelo M. Prog Cardiol Nurs. 2008; 23:168-72. |
43 | Peterangelo M. Prog Cardiol Nurs. 2008; 23:168-72. |
44 | Felker GM et al. New Engl J Med. 2011; 364(9): 797-805. |
45 | Kazory A. Clin J Am Soc Nephro. 2013; 8; 1816-28. |
46 | Costanzo MR, et al. J Am Coll Cardiol. 2017; 69(19): 2428-45. |
47 | Kazory A. Clin J Am Soc Nephro. 2013; 8; 1816-28. |
48 | Costanzo MR, et al. J Am Coll Cardiol. 2007; 49(6): 675-83. |
49 | Felker GM et al. New Engl J Med. 2011; 364(9): 797-805. |
50 | Costanzo MR, et al. J Am Coll Cardiol. 2017; 69(19): 2428-45. |
51 | Kazory A. Clin J Am Soc Nephro. 2013; 8; 1816-28. |
52 | Costanzo MR, et. al. Value Health. 2018; 21 (Suppl 1): S167. |
53 | Costanzo MR et al. J Am Coll Cardiol. 2005; 46(11): 2047-51. |
• | A console, a piece of capital equipment containing electromechanical pumps and an LCD screen; |
• | A one-time disposable blood circuit set, consisting of an integrated collection of tubing, filter, sensors, and connectors that contain and deliver the blood from and back to the patient; and |
• | A disposable catheter, consisting of a small, dual-lumen extended length catheter designed to access the peripheral venous system of the patient and to simultaneously withdraw blood and return filtered blood to the patient. |
• | 1,200,259 shares of common stock issuable upon the exercise of outstanding stock options, having a weighted average exercise price of $4.78 per share; |
• | 1,630,627 shares of our common stock issuable upon the exercise of outstanding warrants (other than the warrants offered hereby) with a weighted-average exercise price of $25.47 per share; |
• | 50,800 shares of common stock issuable upon the conversion of the 127 outstanding shares of our Series F Preferred Stock; |
• | 1,921,713 shares of our common stock reserved for future issuance under our equity incentive plans; |
• | 7,196,401 shares of common stock underlying the Series I Preferred Stock; and |
• | 17,991,003 shares of common stock underlying the warrants. |
• | We have limited history of operations and limited experience in sales and marketing, and we might be unsuccessful in increasing our sales and cannot assure you that we will ever generate substantial revenue or be profitable. |
• | We have incurred operating losses since our inception and anticipate that we will continue to incur operating losses in the near-term. To date, the Company has been funded by equity financings, and although the Company believes that it will be able to successfully fund its operations, there can be no assurance that it will be able to do so or that it will ever operate profitably. If this financing is not successful or if we raise less than we intend, we will need to raise additional capital to fund our operations beyond the second quarter of 2023. If additional capital is not available, we will have to delay, reduce or cease operations. These factors raise substantial doubt about the Company’s ability to continue as a going concern through the next twelve months. |
• | Our near-term prospects are highly dependent on revenues from a single product, the Aquadex System. We face significant challenges in expanding market acceptance of the Aquadex System, which could adversely affect our potential sales. |
• | We depend on a limited number of customers, the loss of which, or failure of which to order our products in a particular period, could cause our revenues to decline. |
• | We have limited commercial manufacturing experience and could experience difficulty in producing commercial volumes of the Aquadex System and related components or may need to depend on third parties for manufacturing. |
• | We depend upon third-party suppliers, including single source suppliers, making us vulnerable to supply problems and price fluctuations. |
• | The COVID-19 outbreak and other public health threats or outbreaks of communicable diseases could have a material adverse effect on our operations and overall financial performance. |
• | We have been negatively impacted by the prioritization of COVID-19 patients in hospitals. |
• | If we cannot develop adequate distribution, customer service and technical support networks, then we may not be able to market and distribute the Aquadex System effectively and our sales will suffer. |
• | We compete against many companies, some of which have longer operating histories, more established products and greater resources than we do, which may prevent us from achieving further market penetration or improving operating results. |
• | The competition for qualified personnel is particularly intense in our industry. If we are unable to retain or hire key personnel, we may not be able to sustain or grow our business. |
• | Significant additional governmental regulation could subject us to unanticipated delays which would adversely affect our sales. |
• | Product defects, resulting in lawsuits for product liability, could harm our business, results of operations and financial condition. |
• | We may face significant risks associated with international operations, which could have a material adverse effect on our business, financial condition and results of operations. |
• | If we are not able to maintain sufficient quality controls, then the approval or clearance of our products by the European Union, the FDA or other relevant authorities could be withdrawn, delayed or denied and our sales will suffer. |
• | If we violate any provisions of the Federal Food, Drug, and Cosmetic Act (“FDC Act”) or any other statutes or regulations, then we could be subject to enforcement actions by the FDA or other governmental agencies. |
• | We cannot assure you that our products will be safe or that there will not be serious injuries or product malfunctions. Further, we are required under applicable law to report any circumstances relating to our |
• | We face significant uncertainty in the industry due to government healthcare reform. |
• | We are subject, directly or indirectly, to United States federal and state healthcare fraud and abuse and false claims laws and regulations. Prosecutions under such laws have increased in recent years and we may become subject to such litigation. If we are unable to, or have not fully complied with such laws, we could face substantial penalties. |
• | Failure to comply with anti-bribery, anti-corruption, and anti-money laundering laws could subject us to penalties and other adverse consequences. |
• | If we acquire other businesses, products or technologies, we could incur additional impairment charges and will be subject to risks that could hurt our business. |
• | We may not be able to protect our intellectual property rights effectively, which could have an adverse effect on our business, financial condition or results of operations. |
• | Intellectual property litigation could be costly and disruptive to us. |
• | If we were unable to protect the confidentiality of our proprietary information and know-how, the value of our technology and system could be adversely affected. |
• | Our products could infringe patent rights of others, which may require costly litigation and, if we are not successful, could cause us to pay substantial damages or limit our ability to commercialize our products. |
• | We may be subject to claims that our employees have wrongfully used or disclosed alleged trade secrets of their former employers. |
• | Security breaches, loss of data and other disruptions could compromise sensitive information related to our business or prevent us from accessing critical information and expose us to liability, which could adversely affect our business and our reputation. |
• | our quarterly or annual operating results; |
• | changes in our earnings estimates; |
• | investment recommendations by securities analysts following our business or our industry; |
• | additions or departures of key personnel; |
• | changes in the business, earnings estimates or market perceptions of our competitors; |
• | our failure to achieve operating results consistent with securities analysts’ projections; |
• | future announcements concerning us, including our clinical and product development strategy, or our competitors; |
• | regulatory developments, disclosure regarding completed, ongoing or future clinical studies and enforcement actions bearing on advertising, marketing or sales; |
• | acquisition or loss of significant manufacturers, distributors or suppliers or an inability to obtain sufficient quantities of materials needed to manufacture our system; |
• | fluctuations of investor interest in the medical device sector; |
• | changes in industry, general market or economic conditions; and |
• | announcements of legislative or regulatory changes. |
• | the existence of other opportunities or the need to take advantage of changes in timing of our existing activities; |
• | the need or desire on our part to accelerate, increase or eliminate existing initiatives due to, among other things, changing market conditions and competitive developments; and/or |
• | if strategic opportunities present themselves (including acquisitions, joint ventures, licensing and other similar transactions). |
| | As of June 30, 2022 (in thousands, except share and per share data) | ||||
| | Actual | | | As Adjusted | |
Cash and cash equivalents | | | $15,345 | | | 24,598 |
Stockholders’ equity: | | | | | ||
Series A junior participating preferred stock, par value $0.0001 per share; authorized 30,000 shares, none outstanding | | | — | | | |
Series F convertible preferred stock, par value $0.0001 per share; authorized 127 shares, issued and outstanding 127 shares | | | — | | | |
Series I convertible preferred stock, par value $0.0001 per share; authorized none and 7,196,401 shares, respectively, issued and outstanding none and 7,196,401 shares, respectively | | | | | ||
Preferred stock, par value $0.0001 per share; authorized 39,969,873 shares, respectively, none outstanding | | | | | ||
Common stock, par value $0.0001 per share; authorized 100,000,000 shares, issued and outstanding 10,537,606 shares | | | 1 | | | 3 |
Additional paid-in capital | | | 279,350 | | | 288,602 |
Accumulated other comprehensive income: | | | | | ||
Foreign currency translation adjustment | | | (12) | | | (12) |
Accumulated deficit | | | (261,675) | | | (261,675) |
Total stockholders’ equity | | | 17,664 | | | 26,917 |
• | 1,200,259 shares of common stock issuable upon the exercise of outstanding stock options, having a weighted average exercise price of $4.78 per share; |
• | 1,630,627 shares of our common stock issuable upon the exercise of outstanding warrants (other than the warrants offered hereby) with a weighted-average exercise price of $25.47 per share; |
• | 50,800 shares of common stock issuable upon the conversion of the 127 outstanding shares of our Series F Preferred Stock; |
• | 1,921,713 shares of our common stock reserved for future issuance under our equity incentive plans; |
• | 7,196,401 shares of common stock underlying the Series I Preferred Stock; and |
• | 17,991,003 shares of common stock underlying the warrants. |
Name of Beneficial Owner | | | Number of Shares | | | Right to Acquire(1) | | | Total | | | Aggregate Percent of Class(2) |
John L. Erb | | | 385 | | | 56,038(3) | | | 56,423 | | | *% |
Steve Brandt | | | — | | | 17,176 | | | 17,176 | | | * |
Maria Rosa Costanzo, M.D. | | | — | | | — | | | — | | | — |
Jon W. Salveson | | | — | | | 17,208 | | | 17,208 | | | * |
Gregory D. Waller | | | — | | | 17,223 | | | 17,223 | | | * |
Warren S. Watson | | | — | | | 17,208 | | | 17,208 | | | * |
Nestor Jaramillo, Jr. | | | — | | | 63,911 | | | 63,911 | | | * |
George Montague | | | — | | | 20,845 | | | 20,845 | | | * |
Neil P. Ayotte | | | — | | | 13,896 | | | 13,896 | | | * |
All current directors and executive officers as a group (9 persons) | | | 385 | | | 223,505 | | | 223,890 | | | 2.1% |
* | 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 September 1, 2022. |
(2) | Based on 10,537,606 shares outstanding as of September 1, 2022. |
(3) | Consists of (i) 15,338 shares issuable upon the exercise of outstanding stock options, (ii) 700 shares issuable upon the exercise of outstanding warrants to purchase common stock and (iii) 40,000 shares issuable upon conversion of outstanding shares of Series F Convertible Preferred Stock (assuming all 100 shares of Series F Convertible Preferred Stock held by Mr. Erb are converted at once and rounded up to the nearest whole share). |
• | the number of directors on our board of directors, the classification of our board of directors and the terms of the members of our board of directors; |
• | the limitations on removal of any of our directors described below under “Description of Securities –Anti-Takeover Effects of Certain Provisions of Our Certificate of Incorporation and Bylaws and Delaware Law;” |
• | the ability of our directors to fill any vacancy on our board of directors by the affirmative vote of a majority of the directors then in office under certain circumstances; |
• | the ability of our board of directors to adopt, amend or repeal our bylaws and the super-majority vote of our stockholders required to adopt, amend or repeal our bylaws described above; |
• | the limitation on action of our stockholders by written action described below under “Description of Securities –-Anti-Takeover Effects of Certain Provisions of Our Certificate of Incorporation and Bylaws and Delaware Law;” |
• | the choice of forum provision described below under “Description of Securities –Choice of Forum;” |
• | the limitations on director liability and indemnification described below under the heading “Description of Securities –Limitation on Liability of Directors and Indemnification;” and |
• | the super-majority voting requirement to amend our certificate of incorporation described above. |
• | providing for our board of directors to be divided into three classes with staggered three-year terms, with only one class of directors being elected at each annual meeting of our stockholders and the other classes continuing for the remainder of their respective three-year terms; |
• | authorizing our board of directors to issue from time to time any series of preferred stock and fix the voting powers, designation, powers, preferences and rights of the shares of such series of preferred stock; |
• | prohibiting stockholders from acting by written consent in lieu of a meeting; |
• | requiring advance notice of stockholder intention to put forth director nominees or bring up other business at a stockholders’ meeting; |
• | prohibiting stockholders from calling a special meeting of stockholders; |
• | requiring a 66 2∕3% super-majority stockholder approval in order for stockholders to alter, amend or repeal certain provisions of our certificate of incorporation; |
• | requiring a 66 2∕3% super-majority stockholder approval in order for stockholders to adopt, amend or repeal our bylaws; |
• | providing that, subject to the rights of the holders of any series of preferred stock to elect additional directors under specified circumstances, neither the board of directors nor any individual director may be removed without cause; |
• | creating the possibility that our board of directors could prevent a coercive takeover of our Company due to the significant amount of authorized, but unissued shares of our common stock and preferred stock; |
• | providing that, subject to the rights of the holders of any series of preferred stock, the number of directors shall be fixed from time to time exclusively by our board of directors pursuant to a resolution adopted by a majority of the total number of authorized directors; and |
• | providing that any vacancies on our board of directors under certain circumstances will be filled only by a majority of our board of directors then in office, even if less than a quorum, and not by the stockholders. |
• | prior to that date, our board of directors approved either the business combination or the transaction that resulted in the stockholder becoming an interested stockholder; |
• | upon consummation of the transaction that resulted in the stockholder becoming an interested stockholder, the interested stockholder owned at least 85% of our voting stock outstanding at the time the transaction commenced, excluding for purposes of determining the number of shares outstanding (but not the outstanding voting stock owned by the interested stockholder) those shares owned by (i) persons who are directors and also officers and (ii) employee stock plans in which employee participants do not have the right to determine confidentially whether shares held subject to the plan will be tendered in a tender or exchange offer; or |
• | on or subsequent to that date, the business combination is approved by our board of directors and authorized at an annual or special meeting of stockholders, and not by written consent, by the affirmative vote of at least 66 2∕3% of the outstanding voting stock that is not owned by the interested stockholder. |
• | breach of their duty of loyalty to us or our stockholders; |
• | act or omission not in good faith or that involves intentional misconduct or a knowing violation of law; |
• | unlawful payment of dividends or redemption of shares as provided in Section 174 of the DGCL; or |
• | transaction from which the directors derived an improper personal benefit. |
Underwriters | | | Class A Units | | | Class B Units |
Ladenburg Thalmann & Co. Inc. | | | [ ] | | | [ ] |
Total | | | [ ] | | | [ ] |
| | Per Class A Unit(1) | | | Per Class B Unit(1) | | | Total without Exercise of Overallotment | | | Total with Full Exercise of Overallotment | |
Public offering price | | | | | | | | | ||||
Underwriting discount to be paid to the underwriters by us (8.0%)(2)(3) | | | | | | | | | ||||
Proceeds to us (before expenses) | | | | | | | | |
(1) | The public offering price and underwriting discount corresponds to (x) in respect of the Class A Units (i) a public offering price per share of common stock of $[ ] and (ii) a public offering price per warrant of $[ ] and (y) in respect of the Class B Units (i) a public offering price per share of Series I Preferred Stock of $[ ] and (ii) a public offering price per warrant of $[ ]. |
(2) | We have also agreed to reimburse the accountable expenses of the representative, including legal fees, in this offering, up to a maximum of $85,000. |
(3) | We have granted a 45 day option to the representative to purchase up to [ ] additional shares of common stock (up to 15% of the shares of common stock plus the number of shares of common stock issuable upon conversion of shares of Series I Preferred Stock) and/or additional warrants exercisable for up to an additional [ ] shares of common stock (up to 15% of the warrants sold in this offering) at the assumed public offering price per share of common stock and the assumed public offering price per warrant set forth above less the underwriting discounts and commissions solely to cover over-allotments, if any. |
• | our history and our prospects; |
• | the industry in which we operate; |
• | our past and present operating results; |
• | the previous experience of our executive officers; and |
• | the general condition of the securities markets at the time of this offering. |
• | Syndicate covering transactions involve purchases of securities in the open market after the distribution has been completed in order to cover syndicate short positions. Such a naked short position would be closed out by buying securities in the open market. A naked short position is more likely to be created if the underwriters are concerned that there could be downward pressure on the price of the securities in the open market after pricing that could adversely affect investors who purchase in the offering. |
• | Stabilizing transactions permit bids to purchase the underlying security so long as the stabilizing bids do not exceed a specific maximum and are engaged in for the purpose of preventing or retarding a decline in the market price of the shares of common stock while this offering is in progress. |
• | Penalty bids permit the underwriters to reclaim a selling concession from a syndicate member when the securities originally sold by the syndicate member are purchased in a stabilizing or syndicate covering transaction to cover syndicate short positions. |
• | our Annual Report on Form 10-K for the fiscal year ended December 31, 2021, filed with the SEC on March 3, 2022; |
• | our Quarterly Reports on Form 10-Q for the quarter ended March 31, 2022, filed with the SEC on May 12, 2022 and for the quarter ended June 30, 2022, filed with the SEC on August 11, 2022; |
• | our Current Reports on Form 8-K filed with the SEC on April 21, 2022, May 18, 2022, May 26, 2022, June 3, 2022, and September 23, 2022; |
• | the information specifically incorporated by reference into our Annual Report on Form 10-K for the year ended December 31, 2021 from our definitive proxy statement for the annual meeting of stockholders held on May 17, 2022, filed with the SEC on April 11, 2022, and supplemented on May 18, 2022 and by Form 8-K on May 26, 2022 for the adjournment of the annual meeting of stockholders held on May 25, 2022; |
• | our definitive proxy statement for the annual meeting of stockholders held on May 17, 2022, filed with the SEC on April 11, 2022, and supplemented on May 18, 2022 and by form 8-K on May 26, 2022 for the adjournment of the annual meeting of stockholders held on May 25, 2022; |
• | the description of our common stock in our registration statement on Form 10 filed with the SEC on September 30, 2011, including any amendment or report filed for the purpose of updating such description; and |
• | the description of our Series A Junior Participating Preferred Stock, par value $0.0001 per share, in our registration statement on Form 8-A filed with the SEC on June 14, 2013. |
Item 13. | Other Expenses of Issuance and Distribution. |
| | Amount to be Paid | |
SEC registration fee | | | $2,225 |
FINRA filing fee | | | 2,300 |
Legal fees and expenses | | | 235,000 |
Printing expenses | | | 15,000 |
Accountant’s fees and expenses | | | 65,000 |
Transfer agent and registrar fees | | | 12,000 |
Miscellaneous expenses | | | 15,000 |
Total | | | $346,525 |
Item 14. | Indemnification of Directors and Officers. |
• | from any breach of the director’s duty of loyalty to us or our stockholders; |
• | from acts or omissions not in good faith or which involve intentional misconduct or a knowing violation of law; |
• | under Section 174 of the DGCL; and |
• | from any transaction from which the director derived an improper personal benefit. |
Item 15. | Recent Sales of Unregistered Securities. |
• | On October 25, 2019, the registrant closed on a registered direct offering of its common stock and in a concurrent private placement, the registrant agreed to issue to the investors in the registered direct offering unregistered warrants to purchase up to 19,196 shares of the registrant’s common stock at an exercise price of $42.30 per share, which were exercisable six months from the date of issuance, and will expire five years from the initial exercise date. This issuance was made pursuant to the exemption from registration contained in Section 4(a)(2) of the Securities Act. Ladenburg Thalmann acted as lead placement agent and WestPark Capital, Inc. acted as co-placement agent in connection with the private placement. |
• | On November 6, 2019, the registrant closed on a registered direct offering of its common stock, or common equivalents, and in a concurrent private placement, the registrant agreed to issue to the investors in the registered direct offering unregistered warrants to purchase up to 40,638 shares of the registrant’s common stock at an exercise price of $29.83 per share, which were exercisable upon the |
• | On March 23, 2020, the registrant closed on a registered direct offering of its common stock, or common equivalents, and in a concurrent private placement, the registrant agreed to issue to the investors in the registered direct offering unregistered warrants to purchase up to 138,715 shares of the registrant’s common stock at an exercise price of $11.18 per share, which were exercisable upon the six-month anniversary of the date of issuance, and will expire five years from the date of issuance. This issuance was made pursuant to the exemption from registration contained in Section 4(a)(2) of the Securities Act. Ladenburg Thalmann acted as placement agent in connection with the private placement. |
• | On April 1, 2020, the registrant closed on a registered direct offering of its common stock, or common equivalents, and in a concurrent private placement, the registrant agreed to issue to the investors in the registered direct offering unregistered warrants to purchase up to 85,506 shares of the registrant’s common stock at an exercise price of $11.15 per share, which were exercisable upon the date of issuance, and will expire five and a half years from the initial exercise date. This issuance was made pursuant to the exemption from registration contained in Section 4(a)(2) of the Securities Act. Ladenburg Thalmann acted as placement agent in connection with the private placement. |
• | On May 5, 2020, the registrant closed on a registered direct offering of its common stock, or common equivalents, and in a concurrent private placement, the registrant agreed to issue to the investors in the registered direct offering unregistered warrants to purchase up to 59,966 shares of the registrant’s common stock at an exercise price of $12.30 per share, which were exercisable upon the date of issuance, and will expire five and a half years from the initial exercise date. This issuance was made pursuant to the exemption from registration contained in Section 4(a)(2) of the Securities Act. Ladenburg Thalmann acted as placement agent in connection with the private placement. |
Item 16. | Exhibits and Financial Statement Schedules. |
| | | | Incorporated By Reference | | | | | ||||||||||
Exhibit Number | | | Exhibit Description | | | Form | | | File Number | | | Date of First Filing | | | Exhibit Number | | | Filed Herewith |
| | Form of Underwriting Agreement | | | | | | | | | | | X | |||||
| | | | | | | | | | | | |||||||
| | Asset Purchase Agreement between Sunshine Heart, Inc. and Gambro UF Solutions, Inc. dated August 5, 2016 | | | 8-K | | | 001-35312 | | | August 8, 2016 | | | 2.1 | | | ||
| | | | | | | | | | | | |||||||
| | 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 | | | ||
| | | | | | | | | | | |
| | | | Incorporated By Reference | | | | | ||||||||||
Exhibit Number | | | Exhibit Description | | | Form | | | File Number | | | Date of First Filing | | | Exhibit Number | | | Filed Herewith |
| | 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 | | | ||
| | | | | | | | | | | | |||||||
| | Second Amended and Restated Bylaws | | | 8-K | | | 001-35312 | | | April 27, 2021 | | | 3.2 | | | ||
| | | | | | | | | | | | |||||||
| | Form of Certificate of Designation of Series A Junior Participating Preferred Stock | | | 8-K | | | 001-35312 | | | June 14, 2013 | | | 3.1 | | | ||
| | | | | | | | | | | | |||||||
| | Form of Certificate of Designation of Preferences, Rights and Limitations of Series F Convertible Preferred Stock | | | S-1/A | | | 333-221010 | | | November 17, 2017 | | | 3.7 | | | ||
| | | | | | | | | | | | |||||||
| | Form of Certificate of Designation of Preferences, Rights and Limitations of Series I Convertible Preferred Stock | | | | | | | | | | | X | |||||
| | | | | | | | | | | | |||||||
| | Warrant to Purchase Stock, dated February 18, 2015, issued to Silicon Valley Bank | | | 8-K | | | 001-35312 | | | February 19, 2015 | | | 4.1 | | | ||
| | | | | | | | | | | | |||||||
| | Warrant to Purchase Stock, dated February 18, 2015, issued to Life Science Loans, LLC | | | 8-K | | | 001-35312 | | | February 19, 2015 | | | 4.2 | | | ||
| | | | | | | | | | | | |||||||
| | Form of Common Stock Purchase Warrant issued pursuant to the Securities Purchase Agreement, dated July 20, 2016, among the Company and the purchasers signatory thereto | | | 8-K | | | 001-35312 | | | July 22, 2016 | | | 4.2 | | | ||
| | | | | | | | | | | | |||||||
| | Form of Common Stock Purchase Warrant issued to Northland Securities, Inc. | | | 8-K | | | 001-35312 | | | July 22, 2016 | | | 4.3 | | | ||
| | | | | | | | | | | | |||||||
| | Registration Rights Agreement between Sunshine Heart, Inc. and Gambro UF Solutions, Inc. dated August 5, 2016 | | | 8-K | | | 001-35312 | | | August 8, 2016 | | | 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 October 30, 2016, among the Company and the purchasers signatory thereto | | | 8-K | | | 001-35312 | | | October 31, 2016 | | | 4.1 | | | ||
| | | | | | | | | | | | |||||||
| | Form of Common Stock Purchase Warrant issued pursuant to the Letter Agreement between the Company and the purchasers signatory thereto, dated February 15, 2017 | | | 8-K | | | 001-35312 | | | February 16, 2017 | | | 4.1 | | | ||
| | | | | | | | | | | | |||||||
| | Form of Common Stock Purchase Warrant issued pursuant to the Underwriting Agreement between the Company and Ladenburg Thalmann & Co. Inc., dated April 19, 2017 | | | S-1/A | | | 333-216841 | | | April 5, 2017 | | | 4.8 | | | ||
| | | | | | | | | | | | |||||||
| | 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 | | | ||
| | | | | | | | | | | |
| | | | Incorporated By Reference | | | | | ||||||||||
Exhibit Number | | | Exhibit Description | | | Form | | | File Number | | | Date of First Filing | | | Exhibit Number | | | Filed Herewith |
| | 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 | | | | | | | | | | | X | |||||
| | | | | | | | | | | | |||||||
| | Specimen of Common Stock Certificate | | | 10 | | | 001-35312 | | | September 30, 2011 | | | 4.1 | | | ||
| | | | | | | | | | | | |||||||
| | 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 | | | ||
| | | | | | | | | | | | |||||||
| | Loan and Security Agreement between Sunshine Heart, Inc. and Silicon Valley Bank dated August 5, 2016 | | | 8-K | | | 001-35312 | | | August 8, 2016 | | | 10.2 | | | ||
| | | | | | | | | | | | |||||||
| | Amended and Restated 2002 Stock Plan† | | | 10 | | | 001-35312 | | | December 16, 2011 | | | 10.2 | | | ||
| | | | | | | | | | | |
| | | | Incorporated By Reference | | | | | ||||||||||
Exhibit Number | | | Exhibit Description | | | Form | | | File Number | | | Date of First Filing | | | Exhibit Number | | | Filed Herewith |
| | Form of Notice of Stock Option Grant and Option Agreement for Amended and Restated 2002 Stock Plan† | | | 10 | | | 001-35312 | | | September 30, 2011 | | | 10.3 | | | ||
| | | | | | | | | | | | |||||||
| | Second Amended and Restated 2011 Equity Incentive Plan, as amended† | | | 14A | | | 001-35312 | | | July 27, 2012 | | | App. A | | | ||
| | | | | | | | | | | | |||||||
| | Form of Stock Option Grant Notice and Option Agreement for 2011 Equity Incentive Plan† | | | 10 | | | 001-35312 | | | September 30, 2011 | | | 10.5 | | | ||
| | | | | | | | | | | | |||||||
| | Form of Stock Option Grant Notice and Option Agreement (Senior Management) for 2011 Equity Incentive Plan† | | | 10 | | | 001-35312 | | | September 30, 2011 | | | 10.6 | | | ||
| | | | | | | | | | | | |||||||
| | Form of Stock Option Grant Notice and Option Agreement (Director) for 2011 Equity Incentive Plan† | | | 8-K | | | 001-35312 | | | September 18, 2012 | | | 10.1 | | | ||
| | | | | | | | | | | | |||||||
| | Form of Stock Grant Notice and Award Agreement for 2011 Equity Incentive Plan† | | | 8-K | | | 001-35312 | | | September 10, 2013 | | | 10.1 | | | ||
| | | | | | | | | | | | |||||||
| | Form of Restricted Stock Unit Grant Notice and Agreement for 2011 Equity Incentive Plan† | | | 8-K | | | 001-35312 | | | September 10, 2013 | | | 10.2 | | | ||
| | | | | | | | | | | | |||||||
| | 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 | | | ||
| | | | | | | | | | | |
| | | | Incorporated By Reference | | | | | ||||||||||
Exhibit Number | | | Exhibit Description | | | Form | | | File Number | | | Date of First Filing | | | Exhibit Number | | | Filed Herewith |
| | 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 | | | ||
| | | | | | | | | | | | |||||||
| | 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 | | | ||
| | | | | | | | | | | | |||||||
| | 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 | | | ||
| | | | | | | | | | | |
| | | | Incorporated By Reference | | | | | ||||||||||
Exhibit Number | | | Exhibit Description | | | Form | | | File Number | | | Date of First Filing | | | Exhibit Number | | | Filed Herewith |
| | 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 | | | ||
| | | | | | | | | | | | |||||||
| | 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 | | | ||
| | | | | | | | | | | | |||||||
| | Executive Employment Agreement between Sunshine Heart, Inc. and John L. Erb, dated March 1, 2016† | | | 8-K | | | 001-35312 | | | March 2, 2016 | | | 10.1 | | | ||
| | | | | | | | | | | | |||||||
| | Letter Agreement dated February 15, 2017 among the Company, Sabby Volatility Warrant Master Fund, Ltd. and Sabby Healthcare Master Fund, Ltd. | | | 8-K | | | 001-35312 | | | February 16, 2017 | | | 10.1 | | | ||
| | | | | | | | | | | | |||||||
| | Warrant Agency Agreement between the Company and American Stock Transfer & Trust Company, LLC dated April 24, 2017 | | | 8-K | | | 001-35312 | | | April 25, 2017 | | | 10.1 | | | ||
| | | | | | | | | | | | |||||||
| | Warrant Agency Agreement, by and between CHF Solutions, Inc. and American Stock Transfer & Trust Company, LLC dated November 27, 2017 | | | 8-K | | | 001-35312 | | | November 28, 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 |
| | Consulting Agreement, dated as of January 28, 2019, between CHF Solutions, Inc. and Steve Brandt† | | | 10-K | | | 001-35312 | | | February 21, 2019 | | | 10.44 | | | ||
| | | | | | | | | | | | |||||||
| | 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 | | | ||
| | | | | | | | | | | | |||||||
| | Underwriting Agreement dated as of January 24, 2020, by and between the Company and Ladenburg Thalmann & Co. Inc. | | | 8-K | | | 001-35312 | | | January 29, 2020 | | | 1.1 | | | ||
| | | | | | | | | | | |
| | | | Incorporated By Reference | | | | | ||||||||||
Exhibit Number | | | Exhibit Description | | | Form | | | File Number | | | Date of First Filing | | | Exhibit Number | | | Filed Herewith |
| | 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 | | | ||
| | | | | | | | | | | | |||||||
| | Placement Agency Agreement, dated as of May 1, 2020, by and between the Company and Ladenburg Thalmann & Co. Inc. | | | 8-K | | | 001-35312 | | | May 4, 2020 | | | 1.1 | | | ||
| | | | | | | | | | | | |||||||
| | 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 | | | ||
| | | | | | | | | | | | |||||||
| | Lock-Up and Voting Agreement | | | S-1/A | | | 333-24145 | | | August 17, 2020 | | | 4.20 | | | ||
| | | | | | | | | | | | |||||||
| | 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 | | | ||
| | | | | | | | | | | |
| | | | Incorporated By Reference | | | | | ||||||||||
Exhibit Number | | | Exhibit Description | | | Form | | | File Number | | | Date of First Filing | | | Exhibit Number | | | Filed Herewith |
| | 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 | | | ||
| | | | | | | | | | | | |||||||
| | Underwriting Agreement, dated March 17, 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 | | | March 17, 2021 | | | 1.1 | | | ||
| | | | | | | | | | | | |||||||
| | Offer Letter by and between the Company and George Montague, effective as of June 28, 2021† | | | 8-K | | | 001-35312 | | | June 22, 2021 | | | 10.1 | | | ||
| | | | | | | | | | | | |||||||
| | 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 | | | ||
| | | | | | | | | | | | |||||||
| | 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 | | | ||
| | | | | | | | | | | | |||||||
| | Form of Warrant Agency Agreement | | | | | | | | | | | X | |||||
| | | | | | | | | | | | |||||||
| | Leak-Out Agreement | | | | | | | | | | | X | |||||
| | | | | | | | | | | | |||||||
| | List of Subsidiaries | | | 10-K | | | 001-35312 | | | March 3, 2022 | | | 21 | | | ||
| | | | | | | | | | | | |||||||
| | Consent of Baker Tilly US, LLP | | | | | | | | | | | X | |||||
| | | | | | | | | | | | |||||||
| | Consent of Honigman LLP | | | | | | | | | Included in Exhibit 5.1 | | | |||||
| | | | | | | | | | | | |||||||
| | Power of Attorney | | | S-1 | | | 333-267368 | | | September 9, 2022 | | | 24 | | | ||
| | | | | | | | | | | | |||||||
| | Filing Fee Table | | | | | | | | | | | X |
† | Indicates management compensatory plan, contract or arrangement. |
Item 17. | Undertakings. |
(1) | The undersigned registrant hereby undertakes: |
a. | That, for the purpose of determining any liability under the Securities Act of 1933, each such post-effective amendment shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof. |
b. | 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. |
c. | For purposes of determining any liability under the Securities Act of 1933, the information omitted from the form of prospectus filed as part of this registration statement in reliance upon Rule 430A and contained in a form of prospectus filed by the registrant pursuant to Rule 424(b) (1) or (4) or 497(h) under the Securities Act shall be deemed to be part of this registration statement as of the time it was declared effective. |
For the purpose of determining any liability under the Securities Act of 1933, each post-effective amendment that contains a form of prospectus shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof. |
d. | That, for the purpose of determining liability of the registrant under the Securities Act of 1933 to any purchaser in the initial distribution of the securities: |
The undersigned registrant undertakes that in a primary offering of securities of the undersigned registrant pursuant to this registration statement, regardless of the underwriting method used to sell the securities to the purchaser, if the securities are offered or sold to such purchaser by means of any of the following communications, the undersigned registrant will be a seller to the purchaser and will be considered to offer or sell such securities to such purchaser: |
(i) | Any preliminary prospectus or prospectus of the undersigned registrant relating to the offering required to be filed pursuant to Rule 424; |
(ii) | Any free writing prospectus relating to the offering prepared by or on behalf of the undersigned registrant or used or referred to by the undersigned registrant; |
(iii) | The portion of any other free writing prospectus relating to the offering containing material information about the undersigned registrant or its securities provided by or on behalf of the undersigned registrant; and |
(iv) | Any other communication that is an offer in the offering made by the undersigned registrant to the purchaser. |
(2) | 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. |
(3) | The undersigned registrant hereby undertakes that, for purposes of determining any liability under the Securities Act of 1933, each filing of the registrant’s annual report pursuant to section 13(a) or section 15(d) of the Securities Exchange Act of 1934 (and, where applicable, each filing of an employee benefit plan’s annual report pursuant to Section 15(d) of the Securities Exchange Act of 1934) that is incorporated by reference in the registration statement shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof. |
| | NUWELLIS, INC. | ||||
| | | | |||
| | By: | | | /s/ Nestor Jaramillo, Jr. | |
| | | | Nestor Jaramillo, Jr. | ||
| | | | Chief Executive Officer |
Signature | | | Title | | | Date |
| | | | |||
* | | | Chairman of the Board | | | September 29, 2022 |
John L. Erb | | |||||
| | | | |||
/s/ Nestor Jaramillo, Jr. | | | President, Chief Executive Officer and Director (principal executive officer) | | | September 29, 2022 |
Nestor Jaramillo, Jr. | | |||||
| | | | |||
* | | | Chief Financial Officer (principal financial officer and principal accounting officer) | | | September 29, 2022 |
George Montague | | |||||
| | | | |||
* | | | Director | | | September 29, 2022 |
Steve Brandt | | |||||
| | | | |||
* | | | Director | | | September 29, 2022 |
Maria Rosa Costanzo | | |||||
| | | | |||
* | | | Director | | | September 29, 2022 |
Jon W. Salveson | | |||||
| | | | |||
* | | | Director | | | September 29, 2022 |
Gregory Waller | | |||||
| | | | |||
* | | | Director | | | September 29, 2022 |
Warren Watson | |
*By: | | | /s/ Nestor Jaramillo, Jr. | | | |
| | Nestor Jaramillo, Jr. Attorney-in-fact | | |
Very truly yours,
|
||
NUWELLIS, INC.
|
||
By:
|
||
Name:
|
||
Title:
|
Address for Notice:
|
|
Nuwellis, Inc.
|
|
12988 Valley View Road
|
|
Eden Prairie, MN 55344
|
|
Attention:
|
Nestor Jaramillo Jr.
|
President and Chief Executive Officer
|
Telecopy: | |
Copy to: | |
Honigman LLP | |
650 Trade Centre Way, Suite 200 | |
Kalamazoo, Michigan 49002-0402 | |
E-mail: |
ptorrence@honigman.com
|
Attention: |
Phillip D. Torrence
|
Accepted on the date first above written.
|
|
LADENBURG THALMANN & CO. INC.
|
|
As the Representative of the several
|
|
Underwriters listed on Schedule I
|
|
By:
|
Ladenburg Thalmann & Co. Inc.
|
By:
|
Name:
|
Nicholas Stergis
|
|
Title:
|
Managing Director
|
Address for Notice:
|
|
640 Fifth Avenue, 4th Floor
|
|
New York, New York 10019
|
|
Attn:
|
General Counsel
|
Copy to:
|
|
Ellenoff Grossman & Schole LLP
|
|
1345 Avenue of the Americas
|
|
New York, New York 10105
|
|
E-mail:
|
capmkts@egsllp.com
|
Attention:
|
Michael Nertney
|
Underwriters
|
Closing Shares
|
Closing Preferred Shares
|
Closing Warrants
|
Closing Purchase Price
|
Ladenburg Thalmann & Co. Inc.
|
$
|
|||
Total
|
$
|
c) |
Mechanics of Conversion
|
Name: Nestor Jaramillo, Jr. | Name: Neil Ayotte |
|
Title: President and Chief Executive Officer | Title: Secretary |
Date to Effect Conversion: _____________________________________________________________________________________________________________
|
|
Number of shares of Preferred Stock owned prior to Conversion: ______________________________________________________________________________
|
|
Number of shares of Preferred Stock to be Converted: _______________________________________________________________________________________
|
|
Stated Value of shares of Preferred Stock to be Converted: ___________________________________________________________________________________
|
|
Number of shares of Common Stock to be Issued: __________________________________________________________________________________________
|
|
Applicable Conversion Price:___________________________________________________________________________________________________________
|
|
Number of shares of Preferred Stock subsequent to Conversion: _______________________________________________________________________________
|
|
Address for Delivery: ______________________
or
DWAC Instructions:
Broker no: _________
Account no: ___________
|
|
[HOLDER]
By:___________________________________
Name:
Title:
|
Warrant Shares:
|
Issue Date:
|
|
, 2022 |
(A) |
=
|
as applicable: (i) the VWAP on the Trading Day immediately preceding the date of the applicable Notice of Exercise if such Notice of Exercise is (1) both executed and delivered pursuant to Section 2(a) hereof
on a day that is not a Trading Day or (2) both executed and delivered pursuant to Section 2(a) hereof on a Trading Day prior to the opening of “regular trading hours” (as defined in Rule 600(b)(68) of Regulation NMS promulgated under the
federal securities laws) on such Trading Day, (ii) at the option of the Holder, either (y) the VWAP on the Trading Day immediately preceding the date of the applicable Notice of Exercise or (z) the Bid Price of the Common Stock on the
principal Trading Market as reported by Bloomberg L.P. as of the time of the Holder’s execution of the applicable Notice of Exercise if such Notice of Exercise is executed during “regular trading hours” on a Trading Day and is delivered
within two (2) hours thereafter (including until two (2) hours after the close of “regular trading hours” on a Trading Day) pursuant to Section 2(a) hereof or (iii) the VWAP on the date of the applicable Notice of Exercise if the date of such
Notice of Exercise is a Trading Day and such Notice of Exercise is both executed and delivered pursuant to Section 2(a) hereof after the close of “regular trading hours” on such Trading Day;
|
(B)
|
=
|
the Exercise Price of this Warrant, as adjusted hereunder; and
|
(X) |
=
|
the number of Warrant Shares that would be issuable upon exercise of this Warrant in accordance with the terms of this Warrant if such exercise were by means of a cash exercise rather than a cashless
exercise.
|
Nuwellis, Inc.
|
|||
12988 Valley View Road
|
|||
Eden Prairie, MN 55344
|
|||
Attention:
|
Nestor Jaramillo, Jr.
|
||
Chief Executive Officer
|
|||
Telecopy:
|
(952) 345-4200
|
Honigman LLP
|
|||
650 Trade Centre Way, Suite 200
|
|||
Kalamazoo, Michigan 49002-0402
|
|||
E-mail:
|
ptorrence@honigman.com
|
||
Attention:
|
Phillip D. Torrence
|
NUWELLIS, INC.
|
||
By:
|
|
|
Name:
|
||
Title:
|
TO:
|
NUWELLIS, INC.
|
|
||
[SIGNATURE OF HOLDER]
|
|
Name of Investing Entity:
|
Signature of Authorized Signatory of Investing Entity:
|
Name of Authorized Signatory:
|
Title of Authorized Signatory:
|
Date:
|
Name:
|
|||
(Please Print)
|
|||
Address:
|
|||
(Please Print)
|
|||
Phone Number:
|
|||
Email Address:
|
|||
Dated:
|
_______________ __,
|
||
Holder’s Signature:
|
|||
Holder’s Address:
|
(269) 337-7700
Fax: (269) 337-7701
|
Nuwellis, Inc.
12988 Valley View Road
Eden Prairie, Minnesota 55344
|
Re:
|
Registration Statement on Form S-1
|
Honigman LLP • 650 Trade Centre Way • Suite 200 • Kalamazoo, Michigan 49002-0402
|
|
1. |
When the Certificate of Designation has been properly filed with the Delaware Secretary of State and the shares of Preferred Stock covered by the Registration Statement have been offered, sold, issued and delivered by the Company as described in the Registration Statement and the related prospectus and in accordance with, and in the manner set forth in, the Underwriting Agreement (including, without limitation, the payment in full of all applicable consideration therefor), against payment therefor, such shares of Preferred Stock covered by the Registration Statement will be validly issued, fully paid and non-assessable. |
|
|
2.
|
The shares of Common Stock included in the Units and covered by the Registration Statement, when offered, sold, issued and delivered by the Company as described in the Registration Statement and the related
prospectus and in accordance with, and in the manner set forth in, the Underwriting Agreement (including, without limitation, the payment in full of all applicable consideration therefor), against payment therefor, will be validly issued,
fully paid and non-assessable.
|
3. |
The shares of Common Stock covered by the Registration Statement and issuable upon exercise of the warrants included in the Units, when they and such warrants are offered, sold, issued and delivered by the
Company and such warrants are validly exercised as described in the Registration Statement and the related prospectus and in accordance with, and in the manner set forth in, the Underwriting Agreement (including, without limitation, the
payment in full of all applicable consideration therefor, including the purchase price for such warrant and the exercise price of such warrant, and the issuance and delivery to the persons exercising such warrants of the underlying shares
of Common Stock), against payment therefor, will be validly issued, fully paid and non-assessable.
|
4. |
The shares of Common Stock covered by the Registration Statement and issuable upon conversion of the shares of Preferred Stock included in the Units, when they and such shares of Preferred Stock are
offered, sold, issued and delivered by the Company and such shares of Preferred Stock are validly converted as described in the Registration Statement and the related prospectus and in accordance with, and in the manner set forth in, the
Underwriting Agreement and the Company’s Certificate of Incorporation, including the Certificate of Designation, (including, without limitation, the payment in full of all applicable consideration therefor, including the purchase price
for such shares of Preferred Stock, and the issuance and delivery to the persons converting such shares of Preferred Stock of the underlying shares of Common Stock), will be validly issued, fully paid and non-assessable.
|
Honigman LLP • 650 Trade Centre Way • Suite 200 • Kalamazoo, Michigan 49002-0402
|
|
5. |
When the warrants covered by the Registration Statement and issued as part of the Units have been offered, sold, issued, duly executed and delivered by the Company as described in the Registration Statement and
the related prospectus, and in accordance with, and in the manner set forth in the Underwriting Agreement and such warrants (including, without limitation, the payment in full of all applicable consideration therefor), against payment
therefor, such warrants underlying the Units will constitute binding obligations of the Company. |
|
|
6. |
The Units covered by the Registration Statement, when offered, sold, issued and delivered by the Company as described in the Registration Statement and the related prospectus and in accordance with, and in the
manner set forth in, the Underwriting Agreement (including, without limitation, the payment in full of all applicable consideration therefor), against payment therefor, will be validly issued, fully paid and non-assessable. |
Honigman LLP • 650 Trade Centre Way • Suite 200 • Kalamazoo, Michigan 49002-0402
|
|
Honigman LLP • 650 Trade Centre Way • Suite 200 • Kalamazoo, Michigan 49002-0402
|
(a) |
If to the Company, to:
Nuwellis, Inc.
12988 Valley View Road
Eden Prairie, Minnesota 55344
E-mail:
Attention:
With a copy (which shall not constitute notice) to:
Honigman LLP
650 Trade Centre Way, Suite 200
Kalamazoo, MI 49002
E-mail:
Attention:
|
(b) |
If to the Warrant Agent, to:
American Stock Transfer & Trust Company, LLC
6201 15th Avenue
Brooklyn, New York 11219
E-mail:
Attention:
|
NUWELLIS, INC. |
|||
By:
|
|||
Name: | |||
Title: | |||
AMERICAN STOCK TRANSFER & TRUST COMPANY, LLC |
|||
By:
|
|||
Name: | |||
Title: | |||
1.
|
Name of Holder of [_______] [_______] Warrants in form of Global Warrants: ___________________________
|
2.
|
Name of Holder in Warrant Certificate (if different from name of Holder of Warrants in form of Global Warrants): ________________________________
|
3.
|
Number of Warrants in name of Holder in form of Global Warrants: ___________________
|
4.
|
Number of Warrants for which Warrant Certificate shall be issued: __________________
|
5.
|
Number of Warrants in name of Holder in form of Global Warrants after issuance of Warrant Certificate, if any: ___________
|
6.
|
[_______] [_______] Warrant Certificate shall be delivered to the following address:
|
Monthly Warrant Administration Fee (per Warrant Issue)
|
$____.00
|
||
EXCHANGE OF WARRANTS INTO COMMON SHARES
|
|||
Per Manual Exercise of Warrants (until established on DTC WARR System)
|
$____.00
|
1
|
Date that is ___ Trading Days following Effective Date
|
2
|
Pro rata portion of 30% among investors executing Leak-Out Agreements, based on the aggregate amount to be paid by each such investor for the Class A Units and/or Class B Units
|
Sincerely,
|
|||
NUWELLIS, INC.
|
|||
By:
|
|||
Name:
|
|||
Title:
|
Agreed to and Accepted:
|
|||
“HOLDER”
|
|||
By:
|
|
||
Name:
|
|||
Title:
|
|||
E-mail:
|
Security
Type
|
Security Class Title
|
Fee
Calculation
or Carry
Forward
Rule
|
Amount
Registered
|
Proposed
Maximum
Offering price
Maximum
Aggregate
Offering Price
Per Unit
|
Maximum
Aggregate Offering
Price (1)(3)
|
Fee Rate
|
Amount of
Registration
Fee
|
||||||||||||||||||||
Fees to Be Paid
|
|||||||||||||||||||||||||||
Equity
|
Class A Units, consisting of (i) shares
of Common Stock, par value $0.0001
per share and (ii) Warrants to
purchase Common Stock
|
Rule 457(o)
|
$7,200,000
|
$92.70 per
$1,000,000
|
$667.44
|
||||||||||||||||||||||
Equity
|
Common Stock, par value $0.0001
per share (2)
|
||||||||||||||||||||||||||
Equity
|
Warrants to purchase Common Stock
included in the Class A Units (2)(4)
|
||||||||||||||||||||||||||
Equity
|
Class B Units, consisting of (i) shares
of Series I Preferred Stock, par value
$0.0001 per shares, (ii) Common Stock
issuable on conversion of
Series I Preferred Stock, and
(iii) Warrants to purchase Common Stock
|
Rule 457(o)
|
$4,800,000
|
$92.70 per
$1,000,000
|
$444.96
|
||||||||||||||||||||||
Equity
|
Series I Convertible Preferred Stock,
par value $0.0001 per share (2)
|
||||||||||||||||||||||||||
Equity
|
Common Stock issuable upon
conversion of Series I
Convertible Preferred Stock (2)(5)
|
||||||||||||||||||||||||||
Equity
|
Warrants to purchase Common
Stock included in the Class B
Units (2)(4)
|
||||||||||||||||||||||||||
Equity
|
Shares of Common Stock
issuable upon exercise of
Warrants (2)
|
$12,000,000
|
$92.70 per $1,000,000
|
$1,112.40
|
|||||||||||||||||||||||
Total Offering Amounts
|
$24,000,000.00
|
$2,224.80
|
|||||||||||||||||||||||||
Total Fees Previously Paid
|
$1,112.40
|
||||||||||||||||||||||||||
Total Fee Offsets
|
$0.00
|
||||||||||||||||||||||||||
Net Fee Due
|
$1,112.40
|
(1)
|
Estimated solely for the purpose of calculating the amount of the registration fee in accordance with Rule 457(i) and Rule 457(o) under the
Securities Act of 1933 (the "Securities Act").
|
(2)
|
Pursuant to Rule 416 under the Securities Act, the securities registered hereby also include an indeterminate number of additional securities as
may from time to time become issuable by reason of stock splits, stock dividends, recapitalizations, or other similar transactions.
|
(3)
|
Includes the price of additional shares of Common Stock and/or Warrants that may be issued upon exercise of the option granted to the underwriter
to cover over-allotments, if any.
|
(4)
|
No registration fee required pursuant to Rule 457(g).
|
(5)
|
No registration fee required pursuant to Rule 457(i).
|