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 Shu Wei 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 | | | Total | |
Public offering price | | | $15.00 | | | $6,000,000 |
Placement agent fees(1) | | | $1.20 | | | $480,000 |
Proceeds, before expenses, to us(2) | | | $13.80 | | | $5,520,000 |
(1) | Represents a cash fee equal to 8% of the aggregate purchase price paid by investors in this offering. We have also agreed to reimburse the placement agents for certain of their offering-related expenses. See “Plan of Distribution” beginning on page 54 of this prospectus for a description of the compensation to be received by the Placement Agent. |
(2) | The amount of offering proceeds to us presented in this table does not give effect to any exercise of the Warrants. |
LAKE STREET | | | | | MAXIM GROUP LLC |
1 | Stein, A, et. al. Critical Care, 2012:16:R99. |
2 | Ronco C, Costanzo MR, Bellomo R, et al. (2010) Fluid Overload Diagnosis and Management. Basel, Switzerland: Karger. |
3 | Ellison DH. Diuretic therapy and resistance in congestive heart failure. Cardiology.2001;96:132-143. |
4 | Costanzo MR, et al. J Am Coll Cardiol. 2017 May 16;69(19):2428-2445. |
5 | From Premier Applied Sciences database. |
6 | Reimbursement estimates from MCRA. |
7 | Costanzo MR, et al. J Am Coll Cardiol. 2017 May 16;69(19):2428-2445. |
8 | Kamath SA. The role of ultrafiltration in patients with decompensated heart failure. Int J of Nephrol. 2011. |
9 | Felker MG. Diuretics and ultrafiltration in acute decompensated heart failure J Am Coll Cardiol 2012 Jun 12;59(24):2145-53. |
10 | Testani JM, Hanberg JS, Cheng S, et al. Rapid and highly accurate prediction of poor loop diuretic natriuretic response in patients with heart failure. Circ Heart Fail. 2016 Jan;9(1):e002370. |
11 | Hoorn EJ and Ellison DH. Diuretic Resistance. Am J Kidney Dis. 2017;69(1):136-142. |
12 | Costanzo MR, Ronco C, Abrahman WT, et al. Extracorporeal ultrafiltration for fluid overload in heart failure. J Am Coll Cardiol. 2017;69(19):2428-2445. |
13 | Gheorghiade M, Filippatos G. Reassessing treatment of acute heart failure syndromes: the ADHERE registry. Eur Heart J Suppl. 2005; 7:B13–19. |
14 | Felker GM, Lee KL, Bull DA, et al. Diuretic strategies in patients with acute decompensated heart failure. N Engl J Med. 2011; 364:797–805. |
15 | Costanzo MR, Guglin ME, Saltzberg MT, et al. Ultrafiltration versus intravenous diuretics for patients hospitalized for acute decompensated heart failure. J Am Coll Cardiol. 2007; 49(6):675-683. |
16 | Agostoni PG, Marenzi GC, Pepi M, et al. Isolated ultrafiltration in moderate congestive heart failure. J Am Coll Cardiol. 1993; 21(2):424-431. |
17 | Costanza MR, et. al. Ultrafiltration vs. Diuretics for the Treatment of Fluid Overload in Patients with Heart Failure: A Hospital Cost Analysis. Value Health. 2018; 21 (Suppl 1):S167. |
• | Reduces hospitalization by 81%19 compared to diuretics; |
• | Rehospitalizations with Aquadex were 48% lower than the national average at 30 days;19 |
• | Reduces length of hospital stay when initiated early, resulting in average savings of $3,975 (14%);20-21 |
• | No significant changes to kidney function;19 |
• | Stabilizes or improves cardiac hemodynamics;22-25 |
• | Predictably removes excess fluid; |
• | Safe, easy-to-use, and flexible in application; |
• | Provides complete 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; |
• | Can be performed via peripheral or central venous access; |
• | Removes isotonic fluid (extracts sodium while sparing potassium and magnesium);26 |
• | Following ultrafiltration, neurohormonal activation is reset toward a more physiological condition and diuretic efficacy is restored;27 |
• | Provides highly automated operation with only one setting required to begin therapy; |
• | Utilizes a single-use, disposable auto-loading blood filter circuit that facilitates easy set-up; and |
• | Has a built-in console that guides the medical practitioner through the setup and operational process. |
• | A console, a piece of capital equipment containing electromechanical pumps, an LCD screen and stand; |
• | A one-time disposable blood circuit set, 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, 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. |
18 | SAFE Trial: Jaski BE, et al. J Card Fail. 2003 Jun; 9(3): 227-231; RAPID Trial: Bart BA, et al. J Am Coll Cardiol. 2005 Dec 6; 46(11): 2043-2046. |
19 | Watson R et al. J Cardiac Fail. 2020; 26(10): s56. |
20 | Kiziltepe, U, et al. Ann Thorac Surg. 2001;71(2): 684-93. |
21 | Sahoo, TK, et al. Indian J Thorac Cardiovas Surg. 2007;23(2): 116-24. |
22 | Boga et al. Perfusion. 2000;15:143-50. |
23 | Onoe et al. Perfusion. 2001;16:37-42.65. |
23 | Costanzo MR et al. JACC. 2005; 46(11); 2457-51. |
25 | Costanzo, et. al., ISPOR 23rd Annual Int’l Mtg., May 19-23, 2018, Baltimore, MD, USA. |
26 | Ali SS, et al. Congest Heart Fail. 2009; 15(1):1-4. |
27 | Marenzi G, et al. J Am Coll Cardiol. 2001 Oct; 38(4): 963-968. |
(i) | alter or change adversely the powers, preferences or rights given to the Series J Convertible Preferred Stock or alter or amend adversely the Certificate of Designations; |
(ii) | increase the number of authorized shares of Series J Convertible Preferred Stock; or |
(iii) | enter into any agreement with respect to any of the foregoing. |
• | 111,275 shares of our common stock issuable upon the exercise of outstanding stock options, having a weighted average exercise price of $36.78 per share; |
• | 1,308,271 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 $35.51 per share; |
• | 5,080 shares of our common stock issuable upon the conversion of the 127 outstanding shares of our Series F Preferred Stock; and |
• | 49,456 shares of our common stock reserved for future issuance under our equity incentive plans. |
• | the conversion of the Series J Convertible Preferred Stock sold in this offering; and |
• | no exercise of the Warrants issued in connection with this offering. |
• | 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, we have been funded by equity financings, and although we believe that we will be able to successfully fund our operations, there can be no assurance that we will be able to do so or that we 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 fourth 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. |
• | The trading price of our common stock price has been, and could continue to be, volatile. |
• | The rights of holders of our capital stock will be subject to, and could be adversely affected by, the rights of holders of our outstanding preferred stock and stock that may be issued in the future. |
• | A more active, liquid trading market for our common stock may not develop, and the price of our common stock may fluctuate significantly. |
• | Our ability to use U.S. net operating loss carryforwards and other tax attributes might be limited. |
• | We do not intend to pay cash dividends on our common stock in the foreseeable future. |
• | Investors in Units may have to pay taxes (or have taxes withheld) in certain circumstances with respect to our Series J Convertible Preferred Stock or the Warrants, even though holders would not receive any cash. |
• | There may be future sales of our securities or other dilution of our equity, which may adversely affect the market price of our common stock. |
• | This is a best-efforts offering, no minimum amount of securities is required to be sold, and we may not raise the amount of capital we believe is required for our business plans. |
• | 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, 2023 (in thousands, except share and per share data) | ||||
| | Actual | | | As Adjusted(1) | |
Cash and cash equivalents | | | $8,896 | | | 14,051 |
Stockholders’ equity: | | | | | ||
Series A junior participating preferred stock, par value $0.0001 per share; authorized 30,000 shares, none outstanding actual and as adjusted | | | — | | | — |
Series F convertible preferred stock, par value $0.0001 per share; authorized 127 shares, issued and outstanding 127 shares actual and as adjusted | | | — | | | — |
Series J convertible preferred stock, par value $0.0001 per share; authorized none and 1,700,000 shares, actual and as adjusted respectively, issued and outstanding none and 1,567,821 shares, actual and as adjusted respectively | | | — | | | — |
Preferred stock, par value $0.0001 per share; authorized 39,969,873 shares, none outstanding actual and as adjusted | | | — | | | — |
Common stock, par value $0.0001 per share; authorized 100,000,000 shares, issued and outstanding 1,864,265 shares actual and as adjusted | | | — | | | — |
Additional paid-in capital | | | 289,845 | | | 295,000 |
Accumulated other comprehensive income: | | | | | ||
Foreign currency translation adjustment | | | (24) | | | (24) |
Unrealized gain on marketable securities | | | — | | | — |
Accumulated deficit | | | (278,747) | | | (278,747) |
Total stockholders’ equity | | | 11,074 | | | 16,229 |
(1) | As adjusted balance does not include Series J Convertible Redeemable Preferred Stock classified as liability or equity due to indeterminate conversion activity to take place upon issuance. |
• | 114,004 shares of our common stock issuable upon the exercise of outstanding stock options, having a weighted average exercise price of $41.67 per share; |
• | 1,308,271 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 $35.51 per share; |
• | 5,080 shares of our common stock issuable upon the conversion of the 127 outstanding shares of our Series F Preferred Stock; and |
• | 46,727 shares of our common stock reserved for future issuance under our equity incentive plans;. |
• | the conversion of the Series J Convertible Preferred Stock sold in this offering; and |
• | no exercise of the Warrants issued in connection with this offering. |
Name of Beneficial Owner | | | Number of Shares | | | Right to Acquire(1) | | | Total | | | Aggregate Percent of Class(2) |
John L. Erb | | | 4 | | | 5,325(3) | | | 5,329 | | | * |
Michael McCormick | | | — | | | 820 | | | 820 | | | * |
Maria Rosa Costanzo, M.D. | | | — | | | — | | | — | | | — |
Jon W. Salveson | | | — | | | 1,336 | | | 1,336 | | | * |
Gregory D. Waller | | | — | | | 1,336 | | | 1,336 | | | * |
Robert B. Scott | | | — | | | 66 | | | 66 | | | * |
Nestor Jaramillo, Jr. | | | 4,098 | | | 1,526 | | | 5,624 | | | * |
Neil P. Ayotte | | | — | | | 360 | | | 360 | | | * |
Lynn Blake | | | 100 | | | 0 | | | 100 | | | * |
All current directors and executive officers as a group (8 persons) | | | 4,102 | | | 10,769 | | | 14,871 | | | *% |
* | 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 27, 2023. |
(2) | Based on 1,864,265 shares outstanding as of September 27, 2023. |
(3) | Consists of (i) 1,319 shares issuable upon the exercise of outstanding stock options, (ii) 6 shares issuable upon the exercise of outstanding warrants to purchase common stock and (iii) 4,000 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 Capital Stock –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 Capital Stock –-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 Capital Stock –Choice of Forum;” |
• | the limitations on director liability and indemnification described below under the heading “Description of Capital Stock –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. |
• | any merger or consolidation involving the corporation or a direct or indirect majority-owned subsidiary of the corporation and the interested stockholder; |
• | any sale, lease, mortgage, pledge transfer, or other disposition of the assets of the corporation or direct or indirect majority-owned a subsidiary of the corporation to or with the interested stockholder, which assets have an aggregate value equal to 10% or more of the fair value of the assets on a consolidated basis or the aggregate market value of the outstanding stock of the corporation; |
• | subject to certain exceptions, any transaction that results in the issuance or transfer by the corporation or a direct or indirect majority-owned subsidiary of the corporation of any stock of the corporation or subsidiary to the interested stockholder; |
• | any transaction involving the corporation or direct or indirect majority-owned subsidiary of the corporation that has the effect of increasing the proportionate share of the stock or any class or series of the corporation or the subsidiary beneficially owned by the interested stockholder; or |
• | the receipt by the interested stockholder of the benefit of any loans, advances, guarantees, pledges or other financial benefits by or through the corporation or direct or indirect majority-owned subsidiary of the corporation. |
• | 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. |
• | An individual citizen or resident of the United States; |
• | a corporation, or other entity taxable as a corporation for U.S. federal income tax purposes, that was created or organized in or under the laws of the United States, any state thereof or the District of Columbia; |
• | an estate whose income is subject to U.S. federal income tax regardless of its source; or |
• | a trust (i) whose administration is subject to the primary supervision of a U.S. court and which has one or more U.S. persons who have the authority to control all substantial decisions of the trust or (ii) which has made a valid election to be treated as a U.S. person. |
• | the gain is effectively connected with the non-U.S. holder’s conduct of a U.S. trade or business and, if an applicable income tax treaty so provides, is attributable to a “permanent establishment” or a “fixed base” maintained by such non-U.S. holder in the United States, in which case the non-U.S. holder generally will be taxed on such gain at the graduated U.S. federal income tax rates applicable to U.S. holders (as described in “U.S. Holders-Sale, Exchange or Other Taxable Disposition of Series J Convertible Stock, Common Stock and Warrants-Sale, Exchange or Other Taxable Disposition – General” above and, if the non-U.S. holder is a foreign corporation, the branch profits tax described in “Distributions in General” above also may apply to such gain; |
• | the non-U.S. holder is a nonresident alien individual who is present in the United States for 183 days or more in the taxable year of the taxable disposition and certain other conditions are met, in which case the non-U.S. holder will be subject to a 30% tax (or such lower rate as may be specified by an applicable income tax treaty between the United States and such holder’s country of residence) on the net gain derived from the taxable disposition, which may be offset by certain U.S. source capital losses of the non-U.S. holder, if any; or |
• | we are, or have been, at any time during the five-year period preceding such taxable disposition (or the non-U.S. holder’s holding period, if shorter) a “U.S. real property holding corporation” (“USRPHC”). We believe that we are not, and we do not expect to be for the foreseeable future, a USRPHC (and this discussion assumes we are not and will not be a USRPHC). |
| | Per Unit | | | Total | |
Public offering price | | | $15.00 | | | $6,000,000 |
Placement agents’ fees (8.0%) | | | $1.20 | | | $480,000 |
Proceeds, before expenses, to us | | | $13.80 | | | $5,520,000 |
• | 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. |
(1) | offer, pledge, announce the intention to sell, sell, contract to sell, sell any option or contract to purchase, purchase any option or contract to sell, grant any option, right or warrant to purchase, make any short sale or otherwise transfer or dispose of, directly or indirectly, any shares of our common stock or any securities convertible into or exercisable or exchangeable for shares of our common stock (including without limitation, our common stock which may be deemed to be beneficially owned by the undersigned in accordance with the rules and regulations of the SEC and securities which may be issued upon exercise of a stock option or warrant), whether now owned or hereafter acquired (the “Undersigned’s Securities”); |
(2) | enter into any swap or other arrangement that transfers to another, in whole or in part, any of the economic consequences of ownership of the Undersigned’s Securities; |
(3) | make any demand for or exercise any right with respect to the registration of any shares of our common stock or any security convertible into or exercisable or exchangeable for our common stock; or |
(4) | publicly announce or disclose the intention to do any of the foregoing. |
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; |
• | does not constitute a disclosure document or a prospectus under Chapter 6D.2 of the Corporations Act 2001 (Cth), or the Corporations Act; |
• | has not been, and will not be, lodged with the Australian Securities and Investments Commission, or ASIC, as a disclosure document for the purposes of the Corporations Act and does not purport to include the information required of a disclosure document for the purposes of the Corporations Act; and |
• | may only be provided in Australia to select investors who are able to demonstrate that they fall within one or more of the categories of investors, available under section 708 of the Corporations Act, or the Exempt Investors. |
• | our Annual Report on Form 10-K for the fiscal year ended December 31, 2022, filed with the SEC on March 3, 2023; |
• | our Quarterly Reports on Form 10-Q for the quarter ended March 31, 2023, filed with the SEC on May 9, 2023; and for the quarter ended June 30, 2023, filed with the SEC on August 8, 2023; |
• | our Current Reports on Form 8-K filed with the SEC on January 5, 2023, January 18, 2023, March 1, 2023, May 22, 2023, June 5, 2023, June 21, 2023, August 8, 2023, and August 18, 2023; |
• | the information specifically incorporated by reference into our Annual Report on Form 10-K for the year ended December 31, 2022 from our definitive proxy statement for the annual meeting of stockholders held on May 19, 2023, filed with the SEC on April 7, 2023; |
• | our definitive proxy statement for the annual meeting of stockholders held on May 19, 2023, filed with the SEC on April 7, 2023; |
• | 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 | | | $992 |
FINRA filing fee | | | 2,300 |
Legal fees and expenses | | | 235,000 |
Printing expenses | | | 33,500 |
Accountant’s fees and expenses | | | 65,000 |
Warrant agent fees | | | 12,000 |
Transfer agent and registrar fees | | | 12,000 |
Miscellaneous fees and expenses | | | 15,000 |
Total | | | $375,792 |
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 June 19, 2023, the registrant granted a warrant to DaVita, Inc. (“DaVita”), pursuant to a Supply and Collaboration Agreement (“Supply Agreement”) dated as of June 19, 2023, pursuant to which DaVita will pilot the Aquadex ultrafiltration therapy system to treat adult patients with congestive heart failure and related conditions within select U.S. markets. The warrant represents the right to purchase up to an aggregate of 1,289,081 shares of common stock of the Company, par value $0.0001 per share, at an exercise price of $3.2996 per share, provided that at no time can it be exercised for an amount of shares that would represent greater than 19.9% ownership in the Company (the “DaVita Warrant”) subject to certain vesting milestones. The DaVita Warrant is expected to vest in four tranches as follows (i): 25% upon the Company’s receipt of notice to extend the Supply Agreement past the initial pilot-term (the “Ultrafiltration Services Approval”); (ii) 25% upon the attainment by the Company of a net revenue achievement from DaVita’s efforts pursuant to the Supply Agreement within twelve months of the Ultrafiltration Services Approval; (iii) 25% upon the attainment by the Company of a net revenue achievement from DaVita’s efforts pursuant to the Supply Agreement within twenty-four months of Ultrafiltration Services Approval; and (iv) 25% upon the attainment by the Company of a net revenue achievement from DaVita’s efforts pursuant to the Supply Agreement within thirty-six months of Ultrafiltration Services Approval. This issuance was made in reliance upon the exemption for transactions by an issuer not involving any public offering under Section 4(a)(2) of the Securities Act and Rule 506 of Regulation D promulgated thereunder. |
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 Placement Agency Agreement by and between the Company, Lake Street Capital Markets, LLC and Maxim Group, LLC | | | S-1 | | | 333-274610 | | | September 29, 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 | | | ||
| | | | | | | | | | | | |||||||
| | Form of Certificate of Designation of Series A Junior Participating Preferred Stock | | | 8-K | | | 001-35312 | | | June 14, 2013 | | | 3.1 | | | ||
| | | | | | | | | | | |
| | | | Incorporated By Reference | | | | | ||||||||||
Exhibit Number | | | Exhibit Description | | | Form | | | File Number | | | Date of First Filing | | | Exhibit Number | | | Filed Herewith |
| | Form of Certificate of Designation of 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 J Convertible Redeemable Preferred Stock | | | S-1 | | | 333-274610 | | | September 29, 2023 | | | 3.13 | | | ||
| | | | | | | | | | | | |||||||
| | 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 | | | ||
| | | | | | | | | | | |
| | | | 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 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 | | | 333-274610 | | | September 29, 2023 | | | 4.13 | | | ||
| | | | | | | | | | | | |||||||
| | 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 | | | ||
| | | | | | | | | | | | |||||||
| | Opinion of Honigman LLP | | | S-1 | | | 333-274610 | | | September 29, 2023 | | | 5.1 | | | ||
| | | | | | | | | | | | |||||||
| | Patent License Agreement between Sunshine Heart, Inc. and Gambro UF Solutions, Inc. dated August 5, 2016 | | | 8-K | | | 001-35312 | | | August 8, 2016 | | | 10.1 | | | ||
| | | | | | | | | | | | |||||||
| | 2013 Non-Employee Directors’ Equity Incentive Plan† | | | 14A | | | 001-35312 | | | April 5, 2013 | | | App. A | | | ||
| | | | | | | | | | | |
| | | | Incorporated By Reference | | | | | ||||||||||
Exhibit Number | | | Exhibit Description | | | Form | | | File Number | | | Date of First Filing | | | Exhibit Number | | | Filed Herewith |
| | 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 | | | ||
| | | | | | | | | | | | |||||||
| | 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 | | | ||
| | | | | | | | | | | |
| | | | Incorporated By Reference | | | | | ||||||||||
Exhibit Number | | | Exhibit Description | | | Form | | | File Number | | | Date of First Filing | | | Exhibit Number | | | Filed Herewith |
| | 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 | | | ||
| | | | | | | | | | | | |||||||
| | 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 |
| | 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 | | | ||
| | | | | | | | | | | | |||||||
| | 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 | | | ||
| | | | | | | | | | | |
| | | | Incorporated By Reference | | | | | ||||||||||
Exhibit Number | | | Exhibit Description | | | Form | | | File Number | | | Date of First Filing | | | Exhibit Number | | | Filed Herewith |
| | 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 | | | ||
| | | | | | | | | | | | |||||||
| | 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 | | | ||
| | | | | | | | | | | |
| | | | Incorporated By Reference | | | | | ||||||||||
Exhibit Number | | | Exhibit Description | | | Form | | | File Number | | | Date of First Filing | | | Exhibit Number | | | Filed Herewith |
| | 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 | | | ||
| | | | | | | | | | | | |||||||
| | 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 | | | 333-274610 | | | September 29, 2023 | | | 10.68 | | | ||
| | | | | | | | | | | | |||||||
| | Form of Securities Purchase Agreement to be entered into in this Offering | | | S-1 | | | 333-274610 | | | September 29, 2023 | | | 10.69 | | | ||
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| | List of Subsidiaries | | | 10-K | | | 001-35312 | | | March 3, 2023 | | | 21 | | | ||
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| | Consent of Baker Tilly US, LLP | | | S-1 | | | 333-274610 | | | September 29, 2023 | | | 23.1 | | | ||
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| | Consent of Honigman LLP | | | | | | | | | | | (included in Exhibit 5.1) | |||||
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| | | | Incorporated By Reference | | | | | ||||||||||
Exhibit Number | | | Exhibit Description | | | Form | | | File Number | | | Date of First Filing | | | Exhibit Number | | | Filed Herewith |
| | Power of Attorney | | | S-1 | | | 333-274610 | | | September 21, 2023 | | | 24.1 | | | ||
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| | Filing Fee Table | | | S-1 | | | 333-274610 | | | September 29, 2023 | | | 107 | | |
† | 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. |
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. |
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: |
(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. | ||||
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| | By: | | | /s/ Nestor Jaramillo, Jr. | |
| | | | Nestor Jaramillo, Jr. | ||
| | | | Chief Executive Officer |
Signature | | | Title | | | Date |
| | | | |||
* | | | Chairman of the Board | | | October 4, 2023 |
John L. Erb | | |||||
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* | | | President, Chief Executive Officer and Director (principal executive officer) | | | October 4, 2023 |
Nestor Jaramillo, Jr. | | |||||
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* | | | Chief Financial Officer (principal financial officer and principal accounting officer) | | | October 4, 2023 |
Robert B. Scott | | |||||
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* | | | Director | | | October 4, 2023 |
Maria Rosa Costanzo, M.D. | | |||||
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* | | | Director | | | October 4, 2023 |
Michael McCormick | | |||||
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* | | | Director | | | October 4, 2023 |
Jon W. Salveson | | |||||
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* | | | Director | | | October 4, 2023 |
Gregory Waller | |
*By: | | | /s/ Nestor Jaramillo, Jr. | | | |
| | Nestor Jaramillo, Jr. | | | ||
| | Attorney-in-fact | | |