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S-3 Filing
Nuwellis (NUWE) S-3Shelf registration
Filed: 1 Jul 24, 5:06pm
Delaware | | | 68-0533453 |
(State or other jurisdiction of incorporation or organization) | | | (I.R.S. Employer Identification Number) |
Large accelerated filer | | | ☐ | | | Accelerated filer | | | ☐ |
Non-accelerated filer | | | ☒ | | | Smaller reporting company | | | ☒ |
| | | | Emerging growth company | | | ☐ |
1 | Murugan R et al. Nature Rev Nephrol. 2020; 1-14. |
2 | Koratala A et al. Cardiorenal Med. 2022;12(4):141-154. |
3 | Vaara ST et al. Crit Care. 2012; 16: 1-11. |
4 | Koratala A et al. Cardiorenal Med. 2022;12(4):141-154. |
5 | Stein, A, et. al. Critical Care. 2012:16:R99. |
6 | Iribarne A, et al. Ann Thorac Surg. 2014; 98(4): 1274-80. |
7 | Ronco C, Costanzo MR, Bellomo R, et al. (2010) Fluid Overload Diagnosis and Management. Basel, Switzerland: Karger. |
8 | Sutherland SM, et al. Am J Kidney Disease. 2010; 5(2): 316-25. |
9 | Gillespie RS, et al. Ped Nephro. 2004; 19(12): 1394-99. |
10 | Kazory A & Costanzo MR. Adv Chronic Kidney Dis. 2018; 25(5): 434-442. |
11 | Fonarow GC. Rev Cardiovasc Med. 2003; 4: s21-30. |
12 | Kamath SA. Int J of Nephrol. 2011; 1-6. |
13 | Ellison DH. Cardio. 2001;96:132-143. |
14 | Costanzo MR, et al. J Am Coll Cardiol. 2017 May 16;69(19):2428-2445. |
15 | Gheorghiade M, et al. Eur Heart J Suppl. 2005; 7:B13- 19. |
16 | Ahmed A, et al. Eur Heart J. 2006 Jun;27(12):1431-9. |
17 | Testani JM, Hanberg JS, Cheng S et al. Circ Heart Fail. 2016; 9(1): e002370. |
18 | Costanzo MR, et al. J Am Coll Cardiol. 2017;69(19):2428-2445. |
19 | Kamath SA. Int J of Nephrol. 2011: 1-6. |
20 | Felker MG & Mentz RJ. J Am Coll Cardiol. 2012;59(24):2145-53. |
21 | 21 Testani JM. Circ Heart Fail. 2016 Jan;9(1):e002370. |
22 | Hoorn EJ & Ellison DH. Am J Kidney Dis. 2017;69(1):136-142. |
23 | Orso D, et al. Eur Rev Med Pharmacol Sci. 2021 Apr;25(7):2971-2980. |
24 | Costanzo MR, et al. J Am Coll Cardiol. 2017;69(19):2428- 2445. |
25 | Thandra A, et al. Clin Invest. 2023; 365(2): 145-51. |
26 | Felker GM, et al. N Engl J Med. 2011; 364:797-805. |
27 | Costanzo MR, et al. J Am Coll Cardiol. 2007; 49(6):675-683. |
• | In a single center, retrospective analysis of 335 consecutive patients, patients in whom there was follow-up for 12 months, there were 1.74 fewer rehospitalizations for HF in the year following UF when compared to the 12 months preceding UF; |
• | Rehospitalizations at 30 days with Aquadex were 12.4% compared with the national average at 30 days of 24%; |
• | Reduces length of hospital stay when initiated early, resulting in average savings of $3,975 (14%);33 |
• | Stabilizes or improves cardiac hemodynamics;34 35 |
• | 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; |
• | Predictably removes excess isotonic fluid (extracts water and sodium while sparing potassium and magnesium; decrease risk of electrolyte abnormalities);36 37 |
28 | Agostoni PG, et al. J Am Coll Cardiol. 1993; 21(2):424-431. |
29 | Kazory A, et al. Cardiorenal Med. 2023;13(1)1-8. |
30 | Costanza MR, et. al. Value Health. 2018; 21 (Suppl 1):S167. |
31 | SAFE Trial: Jaski BE, et al. J Card Fail. 2003; 9(3): 227-231. |
32 | RAPID Trial: Bart BA, et al. J Am Coll Cardiol. 2005; 46(11): 2043-2046. |
33 | Costanza MR, et. al. Value Health. 2018; 21 (Suppl 1):S167. |
34 | Boga M, et al. Perf. 2000; 15:143-150. |
35 | Kiziltepe U, et al. Ann Thorac Surg 2001;71:684-93. |
36 | Kazory A, et al. Cardiorenal Med. 2023;13(1)1-8. |
37 | Agostoni PG et al. J Am Coll Cardiol. 1993;21(2):424-31. |
• | No significant changes to kidney function;38 |
• | The use of continuous hematocrit monitoring and SvO2 sensor provides guided-therapy ultrafiltration.39 |
• | Following ultrafiltration, neurohormonal activation is reset toward a more physiological condition and diuretic efficacy is restored;40 |
• | 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. |
38 | Kazory A, et al. Cardiorenal Med. 2023;13(1)1-8. |
39 | Starr MC, et al. Pediatric Nephrology. 2024; 39(2):597-601. |
40 | Costanzo MR, et al. J Am Coll Cardiol. 2005; 46(11): 2047-51. |
• | designation or classification; |
• | aggregate principal amount or aggregate offering price; |
• | maturity, if applicable; |
• | original issue discount, if any; |
• | rates and times of payment of interest or dividends, if any; |
• | redemption, conversion, exchange or sinking fund terms, if any; |
• | ranking, if applicable; |
• | restrictive covenants, if any; |
• | voting or other rights, if any; |
• | conversion or exchange prices or rates, if any, and, if applicable, any provisions for changes to or adjustments in the conversion or exchange prices or rates and in the securities or other property receivable upon conversion or exchange; and |
• | important U.S. federal income tax considerations, if any. |
• | the names of those underwriters or agents; |
• | applicable fees, discounts and commissions to be paid to them; |
• | details regarding over-allotment options, if any; and |
• | the estimated net proceeds to us. |
• | 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 Common 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 Common 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 Common Stock – Choice of Forum;” |
• | the limitations on director liability and indemnification described below under the heading “Description of Common 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 662∕3% super-majority stockholder approval in order for stockholders to alter, amend or repeal certain provisions of our certificate of incorporation; |
• | requiring a 662∕3% super-majority stockholder approval in order for stockholders to adopt, amend or repeal our bylaws; |
• | 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. |
• | the purchase price, title and stated value of the preferred stock; |
• | the number of shares of the preferred stock offered, the liquidation preference per share and the offering price of the preferred stock; |
• | the dividend rate(s), period(s) or payment date(s) or method(s) of calculation applicable to the preferred stock; |
• | whether dividends are cumulative or non-cumulative and, if cumulative, the date from which dividends on the preferred stock will accumulate; |
• | our right, if any, to defer payment of dividends and the maximum length of any such deferral period; |
• | the procedures for auction and remarketing, if any, for the preferred stock; |
• | the provisions for a sinking fund, if any, for the preferred stock; |
• | the provision for redemption, if applicable, of the preferred stock; |
• | any listing of the preferred stock on any securities exchange; |
• | the terms and conditions, if applicable, upon which the preferred stock will be convertible into common stock, including the conversion price or manner of calculation and conversion period; |
• | voting rights, if any, of the preferred stock; |
• | whether interests in the preferred stock will be represented by depositary shares; |
• | a discussion of any material or special U.S. federal income tax considerations applicable to the preferred stock; |
• | the relative ranking and preferences of the preferred stock as to dividend rights and rights upon the liquidation, dissolution or winding up of our affairs; |
• | any limitations on issuance of any class or series of preferred stock ranking senior to or on a parity with the class or series of preferred stock as to dividend rights and rights upon the liquidation, dissolution or winding up of our affairs; and |
• | any other specific terms, preferences, rights, limitations or restrictions of the preferred stock. |
• | the title of the series of debt securities; |
• | any limit upon the aggregate principal amount that may be issued; |
• | the maturity date or dates on which the principal of the debt securities of the series is payable; |
• | the form of the debt securities of the series; |
• | the applicability of any guarantees; |
• | whether or not the debt securities will be secured or unsecured, and the terms of any secured debt; |
• | whether the debt securities rank as senior debt, senior subordinated debt, subordinated debt or any combination thereof, and the terms of any subordination; |
• | if the price (expressed as a percentage of the aggregate principal amount thereof) at which such debt securities will be issued is a price other than the principal amount thereof, the portion of the principal amount thereof payable upon declaration of acceleration of the maturity thereof, or if applicable, the portion of the principal amount of such debt securities that is convertible into another security or the method by which any such portion shall be determined; |
• | the interest rate or rates, which may be fixed or variable, or the method for determining the rate and the date interest will begin to accrue, the dates interest will be payable and the regular record dates for interest payment dates or the method for determining such dates; |
• | our right, if any, to defer payment of interest and the maximum length of any such deferral period; |
• | if applicable, the date or dates after which, or the period or periods during which, and the price or prices at which, we may, at our option, redeem the series of debt securities pursuant to any optional or provisional redemption provisions and the terms of those redemption provisions; |
• | the date or dates, if any, on which, and the price or prices at which we are obligated, pursuant to any mandatory sinking fund or analogous fund provisions or otherwise, to redeem, or at the holder’s option to purchase, the series of debt securities and the currency or currency unit in which the debt securities are payable; |
• | the denominations in which we will issue the series of debt securities, if other than denominations of $1,000 and any integral multiple thereof; |
• | any and all terms, if applicable, relating to any auction or remarketing of the debt securities of that series and any security for our obligations with respect to such debt securities and any other terms which may be advisable in connection with the marketing of debt securities of that series; |
• | whether the debt securities of the series shall be issued in whole or in part in the form of a global security or securities; the terms and conditions, if any, upon which such global security or securities may be exchanged in whole or in part for other individual securities; and the depositary for such global security or securities; |
• | if applicable, the provisions relating to conversion or exchange of any debt securities of the series and the terms and conditions upon which such debt securities will be so convertible or exchangeable, including the conversion or exchange price, as applicable, or how it will be calculated and may be adjusted, any mandatory or optional (at our option or the holders’ option) conversion or exchange features, the applicable conversion or exchange period and the manner of settlement for any conversion or exchange; |
• | if other than the full principal amount thereof, the portion of the principal amount of debt securities of the series which shall be payable upon declaration of acceleration of the maturity thereof; |
• | additions to or changes in the covenants applicable to the particular debt securities being issued, including, among others, the consolidation, merger or sale covenant; |
• | additions to or changes in the events of default with respect to the securities and any change in the right of the trustee or the holders to declare the principal, premium, if any, and interest, if any, with respect to such securities to be due and payable; |
• | additions to or changes in or deletions of the provisions relating to covenant defeasance and legal defeasance; |
• | additions to or changes in the provisions relating to satisfaction and discharge of the indenture; |
• | additions to or changes in the provisions relating to the modification of the indenture both with and without the consent of holders of debt securities issued under the indenture; |
• | the currency of payment of debt securities if other than U.S. dollars and the manner of determining the equivalent amount in U.S. dollars; |
• | whether interest will be payable in cash or additional debt securities at our or the holders’ option and the terms and conditions upon which the election may be made; |
• | the terms and conditions, if any, upon which we will pay amounts in addition to the stated interest, premium, if any and principal amounts of the debt securities of the series to any holder that is not a “United States person” for federal tax purposes; |
• | any restrictions on transfer, sale or assignment of the debt securities of the series; and |
• | any other specific terms, preferences, rights or limitations of, or restrictions on, the debt securities, any other additions or changes in the provisions of the indenture, and any terms that may be required by us or advisable under applicable laws or regulations. |
• | if we fail to pay any installment of interest on any series of debt securities, as and when the same shall become due and payable, and such default continues for a period of 90 days; provided, however, that a valid extension of an interest payment period by us in accordance with the terms of any indenture supplemental thereto shall not constitute a default in the payment of interest for this purpose; |
• | if we fail to pay the principal of, or premium, if any, on any series of debt securities as and when the same shall become due and payable whether at maturity, upon redemption, by declaration or otherwise, or in any payment required by any sinking or analogous fund established with respect to such series; provided, however, that a valid extension of the maturity of such debt securities in accordance with the terms of any indenture supplemental thereto shall not constitute a default in the payment of principal or premium, if any; |
• | if we fail to observe or perform any other covenant or agreement contained in the debt securities or the indenture, other than a covenant specifically relating to another series of debt securities, and our failure continues for 90 days after we receive written notice of such failure, requiring the same to be remedied and stating that such is a notice of default thereunder, from the trustee or holders of at least 25% in aggregate principal amount of the outstanding debt securities of the applicable series; and |
• | if specified events of bankruptcy, insolvency or reorganization occur. |
• | the direction so given by the holder is not in conflict with any law or the applicable indenture; and |
• | subject to its duties under the Trust Indenture Act, the trustee need not take any action that might involve it in personal liability or might be unduly prejudicial to the holders not involved in the proceeding. |
• | the holder has given written notice to the trustee of a continuing event of default with respect to that series; |
• | the holders of at least 25% in aggregate principal amount of the outstanding debt securities of that series have made written request, |
• | such holders have offered to the trustee indemnity satisfactory to it against the costs, expenses and liabilities to be incurred by the trustee in compliance with the request; and |
• | the trustee does not institute the proceeding, and does not receive from the holders of a majority in aggregate principal amount of the outstanding debt securities of that series other conflicting directions within 90 days after the notice, request and offer. |
• | to cure any ambiguity, defect or inconsistency in the indenture or in the debt securities of any series; |
• | to comply with the provisions described above under “Description of Debt Securities—Consolidation, Merger or Sale;” |
• | to provide for uncertificated debt securities in addition to or in place of certificated debt securities; |
• | to add to our covenants, restrictions, conditions or provisions such new covenants, restrictions, conditions or provisions for the benefit of the holders of all or any series of debt securities, to make the occurrence, or the occurrence and the continuance, of a default in any such additional covenants, restrictions, conditions or provisions an event of default or to surrender any right or power conferred upon us in the indenture; |
• | to add to, delete from or revise the conditions, limitations, and restrictions on the authorized amount, terms, or purposes of issue, authentication and delivery of debt securities, as set forth in the indenture; |
• | to make any change that does not adversely affect the interests of any holder of debt securities of any series in any material respect; |
• | to provide for the issuance of and establish the form and terms and conditions of the debt securities of any series as provided above under “Description of Debt Securities—General” to establish the form of any certifications required to be furnished pursuant to the terms of the indenture or any series of debt securities, or to add to the rights of the holders of any series of debt securities; |
• | to comply with the applicable procedures of the depository; |
• | to evidence and provide for the acceptance of appointment under any indenture by a successor trustee; or |
• | to comply with any requirements of the SEC in connection with the qualification of any indenture under the Trust Indenture Act. |
• | extending the fixed maturity of any debt securities of any series; |
• | reducing the principal amount, reducing the rate of or extending the time of payment of interest, or reducing any premium payable upon the redemption of any series of any debt securities; or |
• | reducing the percentage of debt securities, the holders of which are required to consent to any amendment, supplement, modification or waiver. |
• | provide for payment; |
• | register the transfer or exchange of debt securities of the series; |
• | replace stolen, lost or mutilated debt securities of the series; |
• | pay principal of and premium and interest on any debt securities of the series; |
• | maintain paying agencies; |
• | hold monies for payment in trust; |
• | recover excess money held by the trustee; |
• | compensate and indemnify the trustee; and |
• | appoint any successor trustee. |
• | issue, register the transfer of, or exchange any debt securities of that series during a period beginning at the opening of business 15 days before the day of mailing of a notice of redemption of any debt securities that may be selected for redemption and ending at the close of business on the day of the mailing; or |
• | register the transfer of or exchange any debt securities so selected for redemption, in whole or in part, except the unredeemed portion of any debt securities we are redeeming in part. |
• | the title of such securities; |
• | the offering price or prices and aggregate number of warrants offered; |
• | the currency or currencies for which the warrants may be purchased; |
• | the designation and terms of the securities with which the warrants are issued and the number of warrants issued with each such security or each principal amount of such security; |
• | the date on and after which the warrants and the related securities will be separately transferable; |
• | the minimum or maximum amount of such warrants which may be exercised at any one time; |
• | in the case of warrants to purchase debt securities, the principal amount of debt securities purchasable upon exercise of one warrant and the price at which, and currency in which, this principal amount of debt securities may be purchased upon such exercise; |
• | in the case of warrants to purchase common stock or preferred stock, the number of shares of common stock or preferred stock, as the case may be, purchasable upon the exercise of one warrant and the price at which, and the currency in which, these shares may be purchased upon such exercise; |
• | the effect of any merger, consolidation, sale or other disposition of our business on the warrant agreements and the warrants; |
• | the terms of any rights to redeem or call the warrants; |
• | the terms of any rights to force the exercise of the warrants; |
• | any provisions for changes to or adjustments in the exercise price or number of securities issuable upon exercise of the warrants; |
• | the dates on which the right to exercise the warrants will commence and expire; |
• | the manner in which the warrant agreements and warrants may be modified; |
• | a discussion of any material or special U.S. federal income tax considerations of holding or exercising the warrants; |
• | the terms of the securities issuable upon exercise of the warrants; and |
• | any other specific terms, preferences, rights or limitations of or restrictions on the warrants. |
• | in the case of warrants to purchase common stock or preferred stock, the right to receive dividends, if any, or payments upon our liquidation, dissolution or winding up or to exercise voting rights, if any; or |
• | in the case of warrants to purchase debt securities, the right to receive payments of principal of, or premium, if any, or interest on, the debt securities purchasable upon exercise or to enforce covenants in the applicable indenture. |
• | how it handles securities payments and notices; |
• | whether it imposes fees or charges; |
• | how it would handle a request for the holders’ consent, if ever required; |
• | whether and how you can instruct it to send you securities registered in your own name so you can be a holder, if that is permitted in the future; |
• | how it would exercise rights under the securities if there were a default or other event triggering the need for holders to act to protect their interests; and |
• | if the securities are in book-entry form, how the depositary’s rules and procedures will affect these matters. |
• | an investor cannot cause the securities to be registered in his or her name, and cannot obtain non-global certificates for his or her interest in the securities, except in the special situations we describe below; |
• | an investor will be an indirect holder and must look to his or her own bank or broker for payments on the securities and protection of his or her legal rights relating to the securities, as we describe above; |
• | an investor may not be able to sell interests in the securities to some insurance companies and to other institutions that are required by law to own their securities in non-book-entry form; |
• | an investor may not be able to pledge his or her interest in the global security in circumstances where certificates representing the securities must be delivered to the lender or other beneficiary of the pledge in order for the pledge to be effective; |
• | the depositary’s policies, which may change from time to time, will govern payments, transfers, exchanges and other matters relating to an investor’s interest in the global security; |
• | we and any applicable trustee have no responsibility for any aspect of the depositary’s actions or for its records of ownership interests in the global security, nor will we or any applicable trustee supervise the depositary in any way; |
• | the depositary may, and we understand that DTC will, require that those who purchase and sell interests in the global security within its book-entry system use immediately available funds, and your broker or bank may require you to do so as well; and |
• | financial institutions that participate in the depositary’s book-entry system, and through which an investor holds its interest in the global security, may also have their own policies affecting payments, notices and other matters relating to the securities. |
• | if the depositary notifies us that it is unwilling, unable or no longer qualified to continue as depositary for that global security and we do not appoint another institution to act as depositary within 90 days; |
• | if we notify any applicable trustee that we wish to terminate that global security; or |
• | if an event of default has occurred with regard to securities represented by that global security and has not been cured or waived. |
• | at a fixed price or prices, which may be changed; |
• | at market prices prevailing at the time of sale; |
• | at prices related to such prevailing market prices; or |
• | at negotiated prices. |
• | on or through the facilities of Nasdaq or any other securities exchange or quotation or trading service on which such securities may be listed, quoted or traded at the time of sale; and/or |
• | to or through a market maker other than on Nasdaq or such other securities exchanges or quotation or trading services. |
• | the name or names of any underwriters, dealers or agents, if any; |
• | the purchase price of the securities and the proceeds we will receive from the sale; |
• | any over-allotment options under which underwriters may purchase additional securities from us; |
• | any agency fees or underwriting discounts and other items constituting agents’ or underwriters’ compensation; |
• | any public offering price; |
• | any discounts or concessions allowed or reallowed or paid to dealers; and |
• | any securities exchange or market on which the securities may be listed. |
• | our Annual Report on Form 10-K for the fiscal year ended December 31, 2023, filed with the SEC on March 11, 2024; |
• | our Quarterly Report on Form 10-Q for the quarter ended March 31, 2024, filed with the SEC on May 8, 2024; |
• | our Current Reports on Form 8-K filed with the SEC on February 6, 2024 and March 26, 2024, May 1, 2024, May 29, 2024, June 6, 2024, June 10, 2024, and June 26, 2024; and |
• | the description of our common stock in our registration statement on Form 10 filed with the SEC on September 30, 2011, including Exhibit 4.14 to our Annual Report on Form 10-K for the fiscal year ended December 31, 2023. |
Item 14. | Other Expenses of Issuance and Distribution |
SEC registration fee | | | $3,960 |
FINRA filing fee | | | * |
Accounting fees and expenses | | | * |
Legal fees and expenses | | | * |
Transfer agent fees and expenses | | | * |
Trustee fees and expenses | | | * |
Printing and miscellaneous expenses | | | * |
Total | | | $* |
* | These fees are calculated based on the securities offered and the number of issuances and, accordingly, cannot be estimated at this time. |
Item 15. | Indemnification of Officers and Directors |
• | 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. |
| | | | Incorporated By Reference | ||||||||||||||
Exhibit Number | | | Exhibit Description | | | Form | | | File Number | | | Date of First Filing | | | Exhibit Number | | | Filed Herewith |
1.1 | | | Form of Underwriting Agreement* | | | | | | | | | | | |||||
| | Fourth Amended and Restated Certificate of Incorporation | | | 10 | | | 001-35312 | | | February 1, 2012 | | | 3.1 | | | ||
| | Certificate of Amendment to Fourth Amended and Restated Certificate of Incorporation | | | 8-K | | | 001-35312 | | | January 13, 2017 | | | 3.1 | | | ||
| | Certificate of Amendment to Fourth Amended and Restated Certificate of Incorporation | | | 8-K | | | 001-35312 | | | May 23, 2017 | | | 3.1 | | | ||
| | Certificate of Amendment to Fourth Amended and Restated Certificate of Incorporation | | | 8-K | | | 001-35312 | | | October 12, 2017 | | | 3.1 | | | ||
| | Certificate of Amendment to Fourth Amended and Restated Certificate of Incorporation | | | 8-K | | | 001-35312 | | | January 2, 2019 | | | 3.1 | | | ||
| | Certificate of Amendment to Fourth Amended and Restated Certificate of Incorporation | | | 8-K/A | | | 001-35312 | | | October 16, 2020 | | | 3.1 | | | ||
| | Certificate of Amendment to Fourth Amended and Restated Certificate of Incorporation | | | 8-K | | | 001-35312 | | | April 27, 2021 | | | 3.1 | | | ||
| | Certificate of Amendment to Fourth Amended and Restated Certificate of Incorporation | | | 8-K | | | 001-35312 | | | December 9, 2022 | | | 3.1 | | | ||
| | Certificate of Amendment to Fourth Amended and Restated Certificate of Incorporation | | | 8-K | | | 001-35312 | | | June 26, 2024 | | | 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 | | | ||
| | Specimen of Common Stock Certificate | | | 10 | | | 001-35312 | | | September 30, 2011 | | | 4.1 | | | ||
| | Form of Certificate of Designation of Series F Convertible Preferred Stock | | | S-1/A | | | 333-221010 | | | November 17, 2017 | | | 3.7 | | | ||
| | Certificate of Designation of Preferences, Rights and Limitations, filed with the Delaware Secretary of State on October 16, 2023, with respect to the Series J Convertible Preferred Stock | | | 8-K | | | 001-35312 | | | October 17, 2023 | | | 3.1 | | | ||
4.15 | | | Form of Specimen Preferred Stock Certificate and Form of Certificate of Designation of Preferred Stock* | | | | | | | | | | | |||||
| | Form of Indenture, between the Company and one or more trustees to be named | | | | | | | | | | | X | |||||
4.17 | | | Form of Debt Securities* | | | | | | | | | | | |||||
| | Form of Common Stock Warrant Agreement and Warrant Certificate | | | | | | | | | | | X |
| | | | Incorporated By Reference | ||||||||||||||
Exhibit Number | | | Exhibit Description | | | Form | | | File Number | | | Date of First Filing | | | Exhibit Number | | | Filed Herewith |
| | Form of Preferred Stock Warrant Agreement and Warrant Certificate | | | | | | | | | | | X | |||||
| | Form of Debt Securities Warrant Agreement and Warrant Certificate | | | | | | | | | | | X | |||||
| | Opinion of Honigman LLP | | | | | | | | | | | X | |||||
| | Consent of Baker Tilly US, LLP | | | | | | | | | | | X | |||||
| | Consent of Honigman LLP | | | | | | | | | | | Included in Exhibit 5.1 | |||||
| | Power of Attorney | | | | | | | | | | | Included on Signature Page | |||||
25.1 | | | Statement of Eligibility of Trustee under Indenture** | | | | | | | | | | | |||||
| | Filing Fee Table | | | | | | | | | | | X |
* | If required, to be filed by amendment or as an exhibit to a report filed under the Securities Exchange Act of 1934, as amended, and incorporated herein by reference. |
** | To be filed, if applicable, in accordance with the requirements of Section 305(b)(2) of the Trust Indenture Act of 1939 and Rule 5b-3 thereunder. |
Item 17. | Undertakings |
(1) | To file, during any period in which offers or sales are being made, a post-effective amendment to this registration statement: |
(i) | To include any prospectus required by Section 10(a)(3) of the Securities Act of 1933; |
(ii) | To reflect in the prospectus any facts or events arising after the effective date of the registration statement (or the most recent post-effective amendment thereof) which, individually or in the aggregate, represent a fundamental change in the information set forth in the registration statement. Notwithstanding the foregoing, any increase or decrease in volume of securities offered (if the total dollar value of securities offered would not exceed that which was registered) and any deviation from the low or high end of the estimated maximum offering range may be reflected in the form of prospectus filed with the Commission pursuant to Rule 424(b) if, in the aggregate, the changes in volume and price represent no more than 20% change in the maximum aggregate offering price set forth in the “Calculation of Filing Fee Tables” in the effective registration statement; and |
(iii) | To include any material information with respect to the plan of distribution not previously disclosed in the registration statement or any material change to such information in the registration statement; |
(2) | That, for the purpose of determining any liability under the Securities Act of 1933, each such 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. |
(3) | To remove from registration by means of a post-effective amendment any of the securities being registered which remain unsold at the termination of the offering. |
(4) | That, for the purpose of determining liability under the Securities Act of 1933 to any purchaser: |
(i) | Each prospectus filed by the registrant pursuant to Rule 424(b)(3) shall be deemed to be part of the registration statement as of the date the filed prospectus was deemed part of and included in the registration statement; and |
(ii) | Each prospectus required to be filed pursuant to Rule 424(b)(2), (b)(5), or (b)(7) as part of a registration statement in reliance on Rule 430B relating to an offering made pursuant to Rule 415(a)(1)(i), (vii), or (x) for the purpose of providing the information required by Section 10(a) of the Securities Act of 1933 shall be deemed to be part of and included in the registration statement as of the earlier of the date such form of prospectus is first used after effectiveness or the date of the first contract of sale of securities in the offering described in the prospectus. As provided in Rule 430B, for liability purposes of the issuer and any person that is at that date an underwriter, such date shall be deemed to be a new effective date of the registration statement relating to the securities in the registration statement to which that prospectus relates, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof. Provided, however, that no statement made in a registration statement or prospectus that is part of the registration statement or made in a document incorporated or deemed incorporated by reference into the registration statement or prospectus that is part of the registration statement will, as to a purchaser with a time of contract of sale prior to such effective date, supersede or modify any statement that was made in the registration statement or prospectus that was part of the registration statement or made in any such document immediately prior to such effective date. |
(5) | That, for the purpose of determining liability of the registrant under the Securities Act of 1933 to any purchaser in the initial distribution of the securities, the undersigned registrant undertakes that in a primary offering of securities of the undersigned registrant pursuant to this registration statement, regardless of the underwriting method used to sell the securities to the purchaser, if the securities are offered or sold to such purchaser by means of any of the following communications, the undersigned registrant will be a seller to the purchaser and will be considered to offer or sell such securities to such purchaser: |
(i) | Any preliminary prospectus or prospectus of the undersigned registrant relating to the offering required to be filed pursuant to Rule 424; |
(ii) | Any free writing prospectus relating to the offering prepared by or on behalf of the undersigned registrant or used or referred to by the undersigned registrant; |
(iii) | The portion of any other free writing prospectus relating to the offering containing material information about the undersigned registrant or its securities provided by or on behalf of the undersigned registrant; and |
(iv) | Any other communication that is an offer in the offering made by the undersigned registrant to the purchaser. |
(6) | That, 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. |
(7) | That for purposes of determining any liability under the Securities Act of 1933, (i) the information omitted from the form of prospectus filed as part of the registration statement in reliance upon Rule 430A and contained in the form of prospectus filed by the registrant pursuant to Rule 424(b)(l) or (4) or 497(h) under the Securities Act shall be deemed to be a part of the |
(8) | To file an application for the purpose of determining the eligibility of the trustee to act under subsection (a) of Section 310 of the Trust Indenture Act in accordance with the rules and regulations prescribed by the Commission under Section 305(b)(2) of the Trust Indenture Act. |
| | NUWELLIS, INC. | ||||
| | | | |||
| | By: | | | /s/ Nestor Jaramillo, Jr. | |
| | | | Nestor Jaramillo, Jr. | ||
| | | | President and Chief Executive Officer |
Signature | | | Title | | | Date |
| | | | |||
/s/ Nestor Jaramillo, Jr. | | | President, Chief Executive Officer and Director (principal executive officer) | | | July 1, 2024 |
Nestor Jaramillo, Jr. | | | ||||
| | | | |||
/s/ Robert B. Scott | | | Chief Financial Officer (principal financial officer and principal accounting officer) | | | July 1, 2024 |
Robert B. Scott | | | ||||
| | | | |||
/s/ Maria Rosa Costanzo | | | Director | | | July 1, 2024 |
Maria Rosa Costanzo | | | | | ||
| | | | |||
/s/ John L. Erb | | | Director | | | July 1, 2024 |
John L. Erb | | | | | ||
| | | | |||
/s/ Archelle Georgiou | | | Director | | | July 1, 2024 |
Archelle Georgiou | | | | | ||
| | | | |||
/s/ Michael McCormick | | | Director | | | July 1, 2024 |
Michael McCormick | | | | | ||
| | | | |||
/s/ David McDonald | | | Director | | | July 1, 2024 |
David McDonald | | | | | ||
| | | | |||
/s/ Gregory D. Waller | | | Director | | | July 1, 2024 |
Gregory D. Waller | | | | |