Nuwellis, Inc.

Risk Factors

You should carefully consider the risks and uncertainties described in our Annual Report on Form 10-K for the year ended December 31, 2025, and in other reports filed thereafter with the SEC, before deciding to invest in or retain shares of our Common Stock. There have been no material changes to the Risk Factors previously disclosed in our Annual Report on Form 10-K for the year ended December 31, 2025, other than the following:

Risks Related to Our Business

On March 17, 2026, we completed the asset acquisition of Rendiatech Ltd. For a discussion of risks related to acquisitions and integration, including the Rendiatech transaction, see the risk factor titled “Our business could be adversely affected due to risks related to proposed acquisitions and the subsequent integration of such acquisitions” in Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2025.

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.

On June 8, 2026, the Company closed an offering of 54,381 shares of its common stock, pre-funded warrants to purchase 517,047 shares of common stock, in each case with accompanying Series C Warrants to purchase up to 1,714,286 shares of common stock and Series D Warrants to purchase up to 571,437 shares of common stock. The public offering price per share of common stock and accompanying warrants is $10.60 per share and accompanying warrants, and the public offering price per pre-funded warrant and accompanying warrants is $10.5965 per pre-funded warrant and accompanying warrants. The Series D Warrants had an exercise price of $10.60 and would be exercisable for a period of five years following the receipt of stockholder approval, as required by the applicable rules and regulations of Nasdaq. The Series C Warrants contain a one-time reset of the exercise price in the event that the Company implemented the 2026 Reverse Stock Split equal to the greater of: (i) 20% of the combined public offering price per share of common stock and accompanying warrants in the offering and (ii) the lowest daily volume weighted average price for the five trading days immediately following the date of the implementation of the 2026 Reverse Stock Split.

As a result of specific terms included in the Series C Warrants and the Series D Warrants, it was determined that outstanding Series C Warrants and the Series D Warrants should be classified as a liability on the Company’s balance sheet until (i) in the case of the Series C Warrants, the price reset is triggered in connection with the reverse split or (ii) the warrants are exercised for shares of common stock.

On June 25, 2026, the Company consummated a one-for-thirty-five reverse stock split of the Company’s issued and outstanding shares of common stock. As a result of this reverse stock split, the price reset provision of the Series C Warrants was triggered, resulting in the exercise price being reduced to $2.72 per share, and the transition of any outstanding Series C Warrants from being classified as a liability on the Company’s balance sheet into equity. On July 24, 2026 at a special meeting our stockholders approved, amongst other things, the exercise of the Series C Warrants and Series D Warrants in accordance with Nasdaq Listing Rule 5635(d). Following this special meeting, the holders of the Series D Warrants exercised a majority of the outstanding warrants, resulting in the removal of a majority of the liability associated with the outstanding Series D Warrants from the Company’s balance sheet.

As a result of the above, the Company’s stockholders’ equity as of June 30, 2026, as reported in the interim financial statements included in this Quarterly Report on Form 10-Q, was below the Stockholders’ Equity Requirement. However, as of the date of the filing of this Quarterly Report on Form 10-Q, the liability associated with the Series C Warrants has been reclassified as equity and a majority of the liability associated with the Series D Warrants has been removed, resulting in a pro forma stockholders’ equity of $4,392 (in thousands) as of June 30, 2026, and the Company believes it continues to be compliance with the minimum Stockholders’ Equity Requirement. However, there is no assurance that the Nasdaq Hearings Panel will agree with our conclusion or whether it will require a plan of compliance that details our ability to maintain compliance with the Stockholders’ Equity Requirement that we can provide.

On January 13, 2026, Nasdaq filed a rule proposal with the SEC to adopt a new continued listing requirement that would require all companies listed on Nasdaq to maintain a minimum market value of listed securities of $5 million. As proposed, if a company’s market value of listed securities falls below this threshold for 30 consecutive trading days, Nasdaq may immediately suspend trading and initiate delisting proceedings without affording the company a compliance cure period. This proposed rule would be in addition to Nasdaq’s existing continued listing requirements. On June 22, 2026, the SEC adopted the rule. If the market value of our common stock stays below the $5 million threshold or we otherwise fail to satisfy Nasdaq’s continued listing standards, we will face delisting proceedings on an accelerated basis. The delisting of our common stock from Nasdaq would materially reduce the liquidity of our common stock and result in a corresponding material reduction in the price of our common stock. In addition, delisting would likely harm our ability to raise capital through alternative financing sources on terms acceptable to us, or at all, and may result in the potential loss of confidence by investors, employees and fewer business development opportunities. The effective date of the rule was July 23, 2026, however, on July 29, 2026, the SEC temporarily stayed the effectiveness of such rule. It is not currently known when or if the rule may be reimplemented by the SEC and Nasdaq.

We continue to actively monitor our performance with respect to the listing standards and will consider available options to resolve any deficiency and maintain compliance with the Nasdaq rules. There can be no assurance that we will be able to maintain compliance or, if we fall out of compliance, regain compliance with any deficiency, or if we implement an option that regains our compliance, maintain compliance thereafter.

If our Common Stock is delisted from Nasdaq, our ability to raise capital through public offerings of our securities and to finance our operations could be adversely affected. We also believe that delisting would likely result in decreased liquidity and/or increased volatility in our Common Stock and could harm our business and future prospects. In addition, we believe that, if our Common Stock is delisted, our stockholders would likely find it more difficult to obtain accurate quotations as to the price of the Common Stock and it may be more difficult for stockholders to buy or sell our Common Stock at competitive market prices, or at all. If our common stock is delisted by Nasdaq, the price of our common stock may decline and our common stock may be eligible to be quoted on the OTC Bulletin Board, another over-the-counter quotation system, or on the pink sheets, which would negatively affect the liquidity of our common stock and an investor may find it more difficult to dispose of their common stock or obtain accurate quotations as to the market value of our common stock. Any such delisting action may materially adversely affect our ability to raise capital or pursue strategic transactions on acceptable terms, or at all.

Item 2.