Nuwellis, Inc.

S-11 ny20047229x3_s1.htm S-1

As filed with the Securities and Exchange Commission on May 30, 2025.

Registration No. 333-

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM S-1

REGISTRATION STATEMENT

UNDER

THE SECURITIES ACT OF 1933

(Exact name of registrant as specified in its charter)

(Address, Including Zip Code, and Telephone Number, Including Area Code, of Registrant’s Principal Executive Offices)

John L. Erb

Interim Chief Executive Officer

(Name, Address, Including Zip Code, and Telephone Number, Including Area Code, of Agent for Service)

Copies to:

Approximate date of commencement of proposed sale to the public: As soon as practicable after the effective date of this registration statement.

If any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933, check the following box. ☒

If this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐

If this Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐

If this Form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act:

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 7(a)(2)(B) of the Securities Act. ☐

The registrant hereby amends this registration statement on such date or dates as may be necessary to delay its effective date until the registrant shall file a further amendment which specifically states that this registration statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933 or until the registration statement shall become effective on such date as the Commission acting pursuant to said Section 8(a), may determine.

The information contained in this preliminary prospectus is not complete and may be changed. We may not sell these securities until the registration statement relating to these securities filed with the Securities and Exchange Commission is effective. This preliminary prospectus is not an offer to sell these securities and they are not soliciting an offer to buy these securities in any jurisdiction where any such offer or sale is not permitted.

SUBJECT TO COMPLETION, DATED MAY 30, 2025

PRELIMINARY PROSPECTUS

5,387,931 Shares of Common Stock

or

Pre-Funded Warrants to Purchase up to 5,387,931 Shares of Common Stock,

Series A Warrants to Purchase up to 10,775,862 Shares of Common Stock

Series B Warrants to Purchase up to 5,387,931 Shares of Common Stock

and

Representative Warrants to Purchase up to 161,637 Shares of Common Stock

Up to 21,713,361 Shares of Common Stock Issuable Upon Exercise of the Pre-Funded Warrants,

Series A Warrants, Series B Warrants and Representative Warrants

We are offering 5,387,931 shares of common stock (“common stock” or “Common Stock”), Series A Warrants to purchase up to 10,775,862 shares of our common stock which will expire five (5) years from the date of Warrant Stockholder Approval (the “Series A Warrants”) and Series B Warrants to purchase up to 5,387,931 shares of our common stock which will expire five (5) years from the date of Warrant Stockholder Approval (the “Series B Warrants” and, together with the Series A Warrants, the “common warrants”) at an assumed combined public offering price of $0.928 per share of common stock and accompanying common warrants, which was the closing price of our common stock on The Nasdaq Capital Market (“Nasdaq”) on May 23, 2025. The common warrants will be exercisable upon receipt of such stockholder approval as may be required by the applicable rules and regulations of Nasdaq (the “Warrant Stockholder Approval”). In the event that we are unable to obtain the Warrant Stockholder Approval, the common warrants will not be exercisable, and therefore the common warrants may not have any value.

Each common warrant is exercisable at an exercise price of $ per share. The common warrants will contain a one-time reset of the exercise price in the event that the Company implements a reverse stock split to the greater of: (i) 20% of the combined public offering price per share of common stock and accompanying common warrants in this offering and (ii) 90% of the five-day volume weighted average price for the five trading days immediately following the date of the implementation of a reverse stock split. The Series B Warrants will also include a zero cash exercise option allowing holders of a Series B Warrant the right to receive, without payment of any additional cash to the Company, an aggregate number of shares equal to the number of shares of common stock that would be issuable upon a cash exercise of such Series B Warrant. As a result, we will likely not receive any additional funds and do not expect to receive any additional funds upon the exercise of the Series B Warrants. See “Description of Securities We Are Offering” on page 46 of this prospectus for more information regarding the terms of the common warrants.

We are also offering to certain purchasers whose purchase of shares of common stock in this offering would otherwise result in the purchaser, together with its affiliates and certain related parties, beneficially owning more than 4.99% (or, at the election of the purchaser, 9.99%) of our outstanding common stock immediately following the consummation of this offering, the opportunity to purchase, if any such purchaser so chooses, pre-funded warrants to purchase shares of common stock (the “pre-funded warrants”), in lieu of shares of common stock. The purchase price of each pre-funded warrant (and accompanying common warrants) will be equal to the public offering price for the common stock (and accompanying common warrants) in this offering, minus $0.0001. Each pre-funded warrant is exercisable for one share of our common stock and has an exercise price of $0.0001 per share. For each pre-funded warrant that we sell, the number of shares of common stock we are offering will be reduced on a one-for-one basis. Each pre-funded warrant will be exercisable at any time after the date of issuance.

The price of our common stock on Nasdaq during recent periods will only be one of many factors in determining the final public offering price. Other factors to be considered in determining the final public offering price include our history, our prospects, the industry in which we operate, our past and present operating results, the previous experience of our executive officers and directors, the general condition of the securities markets at the time of this offering and discussions between the underwriters and prospective investors. The recent market price used throughout this prospectus may not be indicative of the final public offering price. All share numbers included in this prospectus are based upon an assumed public offering price of $0.928, the closing price of our common stock on Nasdaq on May 23, 2025.

The common stock (or pre-funded warrants) and the common warrants will be sold in combination, with each share of common stock (or pre-funded warrant to purchase one share of common stock) accompanied by a Series A Warrant to purchase two shares of common stock and a Series B Warrant to purchase one share of common stock. This prospectus also relates to the offering of common stock issuable upon exercise of the pre-funded warrants and common warrants. We collectively refer to the shares of common stock, pre-funded warrants and common warrants offered hereby, including the shares of common stock underlying the pre-funded warrants and common warrants, as the “securities.”

Our common stock is listed on Nasdaq under the symbol “NUWE.” On May 23, 2025, the last reported sale price of our common stock on Nasdaq was $0.928 per share. There is no established trading market for the pre-funded warrants or common warrants, and we do not expect a market to develop. We do not intend to apply for a listing of the pre-funded warrants or common warrants on any securities exchange or other nationally recognized trading system. Without an active trading market, the liquidity of the pre-funded warrants or common warrants will be limited.

We have granted a 45-day option to the underwriters to purchase up to 808,189 additional shares of common stock, and/or Series A Warrants to purchase up to 1,616,379 shares of common stock, and/or Series B Warrants to purchase up to 808,189 shares of common stock at their respective public offering prices, less estimated underwriting discounts and commissions. The option may be used to purchase such shares of common stock and/or common warrants, or any combination thereof, as determined by the underwriters.

We have agreed to issue to the representative warrants to purchase the number of shares of common stock equal to 3.0% of the aggregate number of shares of common stock and/or pre-funded warrants sold in this offering (the “Representative Warrants”). The Representative warrants will have an exercise price of (equal to 165% of the combined public offering price per share of common stock and accompanying common warrants) and be exercisable for five years from the commencement of sales of the offering.

The underwriters expect to deliver securities to purchasers in the offering on or about , 2025.

We are a “smaller reporting company” as defined under U.S. federal securities laws and, as such, have elected to comply with reduced public company reporting requirements. See “Prospectus Summary — Implications of Being a Smaller Reporting Company.” This prospectus complies with the requirements that apply to an issuer that is a smaller reporting company.

An investment in our securities involves a high degree of risk. Before making any investment decision, you should carefully read the discussion of the material risks of investing in our securities in “Risk Factors” beginning on page 9 of this prospectus and under similar headings in any amendment or supplement to this prospectus or in any filing with the Securities and Exchange Commission that is incorporated by reference herein.

Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or passed upon the accuracy or adequacy of this prospectus. Any representation to the contrary is a criminal offense.

Ladenburg Thalmann

The date of this prospectus is , 2025