SEC Form 424B3 filed by Nuwellis Inc.
• | 3,906 shares of our Common Stock issuable upon the exercise of outstanding stock options, having a weighted average exercise price of $516.31 per share; |
• | 3,711,820 shares of our Common Stock issuable upon the exercise of outstanding warrants with a weighted-average exercise price of $18.38 per share; |
• | 68,961 shares of our Common Stock issuable upon the conversion of the 127 outstanding shares of our Series F Convertible Redeemable Preferred Stock, par value $0.0001 per share (the “Series F Convertible Preferred Stock”); |
• | 62 shares of our Common Stock issuable upon the conversion of the 88 outstanding shares of our Series J Convertible Redeemable Preferred Stock, par value $0.0001 per share (the “Series J Convertible Preferred Stock”); |
• | 23,762 shares of our Common Stock issuable upon the exercise of 1,920 warrants issued in October 2023 in a best efforts registered public offering; and |
• | 42,137 shares of our Common Stock reserved for future issuance under our equity incentive plans. |
• | 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. We will need to raise additional capital to fund |
• | 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. |
• | Nasdaq may delist our common stock from its exchange which could limit your ability to make transactions in our securities and subject us to additional trading restrictions. |
• | 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. |
• | 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 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 medically approved products that could result in deaths or serious injuries. These circumstances could trigger recalls, class action lawsuits and other events that could cause us to incur expenses and may also limit our ability to generate revenues from such products. |
• | 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. |
• | If we do not comply with certain tax regulations, including VAT, and similar regulations, we may be subject to additional taxes, customs duties, interest, and penalties in material amounts, which could materially harm our financial condition and operating results. |
• | 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. |
• | 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. |
Name of Selling Securityholder | | | Number of shares of common stock beneficially owned prior to the offering | | | Maximum number of shares of common stock to be sold pursuant to this prospectus | | | Number of shares of common stock beneficially owned after the offering | | | Percentage of shares of common stock beneficially owned after the offering (%) | |||
(1) | | | Armistice Capital, LLC | | | 878,988 | | | 377,000 | | | 501,988 | | | 24.4 |
(2) | | | Hudson Bay Master Fund Ltd. | | | 807,288 | | | 305,300 | | | 501,988 | | | 24.4 |
(3) | | | Bigger Capital Fund, LP. | | | 262,701 | | | 139,680 | | | 123,021 | | | 6 |
(4) | | | District 2 Capital Fund LP | | | 390,672 | | | 139,678 | | | 250,994 | | | 12.2 |
(5) | | | Alto Opportunity Master Fund, SPC – Segregated Master Fund Portfolio B | | | 339,769 | | | 103,774 | | | 235,995 | | | 11.5 |
(6) | | | L1 Capital Global Opportunities Master Fund | | | 372,518 | | | 171,524 | | | 200,994 | | | 9.8 |
(7) | | | Intracoastal Capital, LLC | | | 436,078 | | | 185,075 | | | 251,003 | | | 12.2 |
* | Indicates beneficial ownership of less than one percent. |
(1) | The shares of common stock registered hereby were acquired in the (i) July Private Placement (as defined below) and consist of 224,000 shares of common stock issuable upon the exercise of 112,000 of the July Warrants and (ii) August Private Placement (as defined below) and consist of 153,000 shares of common stock issuable upon the exercise of 153,000 of the August Warrants. The July Warrants and August Warrants are subject to a beneficial ownership limitation of 4.99%, which such limitation restricts the Selling Securityholder and its affiliates owning, after exercise, a number of shares of common stock in excess of the beneficial ownership limitation. The shares of common stock are directly held by Armistice Capital Master Fund Ltd., a Cayman Islands exempted company (“Master Fund”), and may be deemed to be beneficially owned by: (i) Armistice Capital, LLC (“Armistice Capital”), as the investment manager of Master Fund; and (ii) Steven Boyd, as the Managing Member of Armistice Capital. Armistice Capital has sole voting and dispositive control of the shares reported herein. The address of Master Fund is c/o Armistice Capital, LLC, 510 Madison Avenue, 7th Floor, New York, NY 10022. |
(2) | The shares of common stock registered hereby were acquired in the (i) July Private Placement and consist of 224,000 shares of common stock issuable upon the exercise of 112,000 of the July Warrants and (ii) August Private Placement (as defined below) and consist of 81,300 shares of common stock issuable upon the exercise of 81,300 of the August Warrants. The July Warrants are subject to a beneficial ownership limitation of 9.99%, which such limitation restricts the Selling Securityholder and its affiliates owning, after exercise, a number of shares of common stock in excess of the beneficial ownership limitation. The August Warrants are subject to a beneficial ownership limitation of 4.99%, which such limitation restricts the Selling Securityholder and its affiliates owning, after exercise, a number of shares of common stock in excess of the beneficial ownership limitation. The shares of common stock are directly held by Hudson Bay Master Fund Ltd, a Cayman Islands exempted company (“Hudson Bay”). Hudson Bay Capital Management LP, the investment manager of Hudson Bay, has sole voting and dispositive control of the shares reported herein. Sander Gerber is the managing member of Hudson Bay Capital GP LLC, which is the general partner of Hudson Bay Capital Management LP. Each of Hudson Bay and Sander Gerber disclaims beneficial ownership of the shares reported herein. The address of Hudson Bay is c/o Hudson Bay Capital Management LP, 28 Havemeyer Place, 2nd Floor, Greenwich, CT, 06830. |
(3) | The shares of common stock registered hereby were acquired in the (i) July Private Placement and consist of 89,680 shares of common stock issuable upon the exercise of 44,840 of the July Warrants and (ii) August Private Placement and consist of 50,000 shares of |
(4) | The shares of common stock registered hereby were acquired in the (i) July Private Placement and consist of 89,678 shares of common stock issuable upon the exercise of 44,839 of the July Warrants and (ii) August Private Placement and consist of 50,000 shares of common stock issuable upon the exercise of 50,000 of the August Warrants. The July Warrants and August Warrants are subject to a beneficial ownership limitation of 4.99%, which such limitation restricts the Selling Securityholder and its affiliates owning, after exercise, a number of shares of common stock in excess of the beneficial ownership limitation. The shares of common stock are directly held by District 2 Capital Fund, LP, a Delaware limited partnership (“District 2 Capital”), and may be deemed to be beneficially owned by: (i) District 2 GP LLC, as the general partner of District 2 Capital and (ii) Michael Bigger, as the Managing Member of District 2 GP LLC. District 2 GP LLC has sole voting and dispositive control of the shares reported herein. The address of District 2 Capital is 14 Wall Street, 2nd Floor, Huntington, New York, 11743. |
(5) | The shares of common stock registered hereby were acquired in the 2024 Private Placement and consist of 103,774 shares of common stock issuable upon the exercise of 51,887 of the July Warrants. The July Warrants are subject to a beneficial ownership limitation of 4.99%, which such limitation restricts the Selling Securityholder and its affiliates owning, after exercise, a number of shares of common stock in excess of the beneficial ownership limitation. The shares of common stock are directly held by Alto Opportunity Master Fund, SPC – Segregated Master Fund Portfolio B, a Cayman Islands exempted company (“Alto Opportunity”), and may be deemed to be beneficially owned by: (i) Ayrton Capital, LLC (“Ayrton Capital”), as the investment manager of the Alto Opportunity; and (ii) Waqas Khatri, as the Managing Member of Ayrton Capital. Ayrton Capital has sole voting and dispositive control of the shares reported herein. The address of Alto Opportunity is c/o Ayrton Capital, 55 Post Road West, 2nd Floor, Westport, Connecticut, 06880. |
(6) | The shares of common stock registered hereby were acquired in the (i) July Private Placement and consist of 103,774 shares of common stock issuable upon the exercise of 51,887 of the July Warrants and (ii) August Private Placement and consist of 67,750 shares of common stock issuable upon the exercise of 67,750 of the August Warrants. The July Warrants and August Warrants are subject to a beneficial ownership limitation of 4.99%, which such limitation restricts the Selling Securityholder and its affiliates owning, after exercise, a number of shares of common stock in excess of the beneficial ownership limitation. The shares of common stock are directly held by L1 Capital Global Opportunities Master Fund, a Cayman Islands exempted company (“L1 Capital”), and may be deemed to be beneficially owned by: (i) David Feldman and (ii) Joel Arber, each of whom are directors of L1, and have shared voting and shared dispositive control of the shares reported herein. The address of L1 Capital is 161A Shedden Road, 1 Artillery Court, PO Box 10085, Grand Cayman KY1-1001, Cayman Islands. |
(7) | The shares of common stock registered hereby were acquired in the (i) July Private Placement and consist of 103,774 shares of common stock issuable upon the exercise of 51, 887 of the July Warrants and (ii) August Private Placement and consist of 81,301 shares of common stock issuable upon the exercise of 81,301 of the August Warrants. The July Warrants and August 2024 are subject to a beneficial ownership limitation of 4.99%, which such limitation restricts the Selling Securityholder and its affiliates owning, after exercise, a number of shares of common stock in excess of the beneficial ownership limitation. The shares of common stock are directly held by Intracoastal Capital, LLC, a Delaware limited liability company (“Intracoastal”), and may be deemed to be beneficially owned by: (i) Mitchell P. Kopin (“Mr. Kopin”) and (ii) Daniel B. Asher (“Mr. Asher”), each of whom are managers of Intracoastal, and have shared voting and shared dispositive control of the shares reported herein. The address of Intracoastal Capital is 245 Palm Trail, Delray Beach, FL 33483. |
• | each person, or group of affiliated persons, who we know to beneficially own more than 5% of our Common Stock; |
• | each of our named executive officers and directors; and |
• | all of our executive officers and directors as a group. |
Name of Beneficial Owner | | | Number of Shares | | | Right to Acquire(1) | | | Total | | | Aggregate Percent of Class(2) |
Executive Officers and Directors | | | | | | | | | ||||
John L. Erb | | | — | | | 69,028(4) | | | 69,028 | | | 3.7% |
Michael McCormick | | | — | | | 595 | | | 595 | | | * |
Maria Rosa Costanzo, M.D. | | | — | | | — | | | — | | | — |
Archelle Georgiou, M.D. | | | — | | | 297 | | | 297 | | | * |
Gregory D. Waller | | | — | | | 67 | | | 67 | | | * |
David McDonald | | | — | | | 297 | | | 297 | | | * |
Robert B. Scott | | | — | | | 13 | | | 13 | | | * |
Nestor Jaramillo, Jr. | | | 117 | | | 314 | | | 431 | | | * |
Neil P. Ayotte | | | — | | | 111 | | | 111 | | | * |
Lynn Blake | | | 3 | | | — | | | 3 | | | * |
All current directors and executive officers as a group (9 persons) | | | 117 | | | 70,722 | | | 70,839 | | | 3.8% |
* | 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 August 26, 2024. |
(2) | Based on 1,866,890 shares outstanding as of August 26, 2024. |
(3) | Based upon statements in a Schedule 13G filed by Mitchell P. Kopin, Daniel B. Asher, and Intracoastal Capital LLC, pursuant to a Joint Filing Agreement, on August 2, 2024. According to the Schedule 13G, Mr. Kopin, Mr. Asher and Intracoastal Capital LLC have shared voting and shared dispositive control over 58,888 of the reported shares. The address of Mr. Kopin and Intracoastal Capital LLC is 245 Palm Trail, Delray Beach, Florida 33483. The address of Mr. Asher is 111 W. Jackson Boulevard, Suite 2000, Chicago, Illinois 60604. |
(4) | Consists of (i) 67 shares issuable upon the exercise of outstanding stock options and (ii) 68,961 shares issuable upon conversion of outstanding shares of Series F Convertible Preferred Stock (assuming all 127 shares of Series F Convertible Preferred Stock held by Mr. Erb are converted at once and rounded up to the nearest whole share). |
• | ordinary brokerage transactions and transactions in which the broker-dealer solicits purchasers; |
• | block trades in which the broker-dealer will attempt to sell the shares of common stock as agent but may position and resell a portion of the block as principal to facilitate the transaction; |
• | purchases by a broker-dealer as principal and resale by the broker-dealer for its account; |
• | an exchange distribution in accordance with the rules of the applicable exchange; |
• | privately negotiated transactions; |
• | settlement of short sales; |
• | in transactions through broker-dealers that agree with the Selling Securityholders to sell a specified number of such shares of common stock at a stipulated price per share of common stock; |
• | through the writing or settlement of options or other hedging transactions, whether through an options exchange or otherwise; |
• | a combination of any such methods of sale; or |
• | any other method permitted pursuant to applicable law. |
• | 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 our 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 our Capital Stock – Choice of Forum;” |
• | the limitations on director liability and indemnification described below under the heading “Description of our 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 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. |
• | our Annual Report on Form 10-K for the fiscal year ended December 31, 2023, filed with the SEC on March 11, 2024; |
• | our definitive proxy statement for our 2024 Annual Meeting of Stockholders filed with the SEC on May 17, 2024; |
• | our Quarterly Reports on Form 10-Q for the quarter ended March 31, 2024, filed with the SEC on May 8, 2024 and the quarter ended June 30, 2024, filed with the SEC on August 13, 2024; |
• | our Current Reports on Form 8-K filed with the SEC on February 6, 2024, March 26, 2024, May 1, 2024, May 29, 2024, June 6, 2024, June 10, 2024, June 26, 2024, July 3, 2024, July 17, 2024 (as amended on July 17, 2024), July 17, 2024, July 25, 2024, August 12, 2024, August 22, 2024, and August 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. |