# Nuwellis, Inc.: Form 10-Q for the period ended Jun 30, 2026

- Company: [Nuwellis, Inc.](/companies/nuwe.md) (CIK 1506492)
- Form: 10-Q
- Filed: 2026-08-13
- Accepted by EDGAR: Aug 13, 2026, 16:06 ET
- Period: 2026-06-30
- Accession: 0001140361-26-032810
- Inline XBRL: yes
- Main document: https://www.sec.gov/Archives/edgar/data/1506492/000114036126032810/ef20075189_10q.htm
- All documents and exhibits: https://www.sec.gov/Archives/edgar/data/1506492/000114036126032810/

## Figures reported in this filing

Standardized XBRL line items for the period ended 2026-06-30.

| Line item | Period | Value | XBRL concept |
| --- | --- | ---: | --- |
| Revenue | 3 months, 2026-04-01 to 2026-06-30 | $2.0m | us-gaap:RevenueFromContractWithCustomerExcludingAssessedTax |
| Revenue | 6 months, 2026-01-01 to 2026-06-30 | $4.4m | us-gaap:RevenueFromContractWithCustomerExcludingAssessedTax |
| Cost of revenue | 3 months, 2026-04-01 to 2026-06-30 | $471.0k | us-gaap:CostOfGoodsAndServicesSold |
| Cost of revenue | 6 months, 2026-01-01 to 2026-06-30 | $1.2m | us-gaap:CostOfGoodsAndServicesSold |
| Gross profit | 3 months, 2026-04-01 to 2026-06-30 | $1.5m | us-gaap:GrossProfit |
| Gross profit | 6 months, 2026-01-01 to 2026-06-30 | $3.2m | us-gaap:GrossProfit |
| Research and development | 3 months, 2026-04-01 to 2026-06-30 | $942.0k | us-gaap:ResearchAndDevelopmentExpense |
| Research and development | 6 months, 2026-01-01 to 2026-06-30 | $2.7m | us-gaap:ResearchAndDevelopmentExpense |
| Selling, general and administrative | 3 months, 2026-04-01 to 2026-06-30 | $3.7m | us-gaap:SellingGeneralAndAdministrativeExpense |
| Selling, general and administrative | 6 months, 2026-01-01 to 2026-06-30 | $8.2m | us-gaap:SellingGeneralAndAdministrativeExpense |
| Operating income | 3 months, 2026-04-01 to 2026-06-30 | −$3.2m | us-gaap:OperatingIncomeLoss |
| Operating income | 6 months, 2026-01-01 to 2026-06-30 | −$7.7m | us-gaap:OperatingIncomeLoss |
| Income tax | 3 months, 2026-04-01 to 2026-06-30 | $0 | us-gaap:IncomeTaxExpenseBenefit |
| Income tax | 6 months, 2026-01-01 to 2026-06-30 | $0 | us-gaap:IncomeTaxExpenseBenefit |
| Net income | 3 months, 2026-04-01 to 2026-06-30 | −$4.8m | us-gaap:NetIncomeLoss |
| Net income | 6 months, 2026-01-01 to 2026-06-30 | −$9.4m | us-gaap:NetIncomeLoss |
| Diluted EPS | 3 months, 2026-04-01 to 2026-06-30 | −$26.64 | us-gaap:EarningsPerShareDiluted |
| Diluted EPS | 6 months, 2026-01-01 to 2026-06-30 | −$77.88 | us-gaap:EarningsPerShareDiluted |
| Basic EPS | 3 months, 2026-04-01 to 2026-06-30 | −$26.64 | us-gaap:EarningsPerShareBasic |
| Basic EPS | 6 months, 2026-01-01 to 2026-06-30 | −$77.88 | us-gaap:EarningsPerShareBasic |
| Diluted shares (weighted) | 3 months, 2026-04-01 to 2026-06-30 | 181,243 shares | us-gaap:WeightedAverageNumberOfDilutedSharesOutstanding |
| Diluted shares (weighted) | 6 months, 2026-01-01 to 2026-06-30 | 120,263 shares | us-gaap:WeightedAverageNumberOfDilutedSharesOutstanding |
| Operating cash flow | 6 months, 2026-01-01 to 2026-06-30 | −$6.3m | us-gaap:NetCashProvidedByUsedInOperatingActivities |
| Capital expenditure | 6 months, 2026-01-01 to 2026-06-30 | $39.0k | us-gaap:PaymentsToAcquirePropertyPlantAndEquipment |
| Cash and equivalents | at 2026-06-30 | $3.9m | us-gaap:CashAndCashEquivalentsAtCarryingValue |
| Current assets | at 2026-06-30 | $7.9m | us-gaap:AssetsCurrent |
| Total assets | at 2026-06-30 | $9.1m | us-gaap:Assets |
| Current liabilities | at 2026-06-30 | $4.0m | us-gaap:LiabilitiesCurrent |
| Total liabilities | at 2026-06-30 | $11.2m | us-gaap:Liabilities |
| Shareholders' equity | at 2026-06-30 | −$2.1m | us-gaap:StockholdersEquity |

## Management's discussion and analysis

As filed, 12,425 characters.

### Management’s Discussion and Analysis of Financial Condition and Results of Operations

The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our interim condensed consolidated financial statements and related notes included in Part I, Item 1 of this Quarterly Report on Form 10-Q and the audited consolidated financial statements and related notes and Management’s Discussion and Analysis of Financial Condition and Results of Operations contained in our Annual Report on Form 10-K for the year ended December 31, 2025. This discussion contains forward-looking statements that involve risks and uncertainties. Our actual results could differ materially from those anticipated in the forward-looking statements as a result of a variety of factors, including those discussed in Part I, Item 1A “Risk Factors,” in our Annual Report on Form 10-K for the year ended December 31, 2025 and in our subsequent filings with the Securities and Exchange Commission (the “SEC”).

Unless otherwise specified or indicated by the context, “Nuwellis,” “Company,” “we,” “us,” and “our” refer to Nuwellis, Inc. and its subsidiary.

### FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that are based on our management's beliefs and assumptions and on information currently available to our management. Forward-looking statements include all statements that are not historical facts and include, without limitation, statements regarding our intent, belief or expectations with respect to our financial condition, results of operations, business strategy, plans and objectives of management, future operations and performance, and the markets in which we operate. Forward-looking statements generally are identified by the words “believe,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “strategy,” “plan,” “may,” “should,” “will,” “would,” “will be,” “will continue,” “will likely result,” and similar expressions. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those expressed in the forward-looking statements. Factors that may cause such differences include, but are not limited to, those discussed in Part I, Item 1A “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2025, and in our subsequent filings with the SEC. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.

### RECENT DEVELOPMENTS

Closed a registered public offering on June 8, 2026, raising approximately $6.0 million in gross proceeds.

Effectuated a one-for-thirty-five (1-for-35) reverse stock split of the Company’s common stock, effective June 25, 2026.

Appointed Mike McCormick as Chief Executive Officer effective June 30, 2026.

### CRITICAL ACCOUNTING POLICIES AND ESTIMATES

We have adopted various accounting policies to prepare our condensed consolidated financial statements in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”). Our most significant accounting policies are disclosed in Note 1 to the consolidated financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2025. There have been no material changes to our critical accounting policies and estimates from the information provided in Part II, Item 7, “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” of our Annual Report on Form 10-K for the year ended December 31, 2025.

### NEW ACCOUNTING PRONOUNCEMENTS

There were no new accounting pronouncements adopted during the three months ended June 30, 2026 that had a material effect on the Company’s condensed consolidated financial statements. For a discussion of accounting pronouncements recently adopted or issued, refer to Note 1 – Nature of Business and Significant Accounting Policies in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025.

### FINANCIAL OVERVIEW

Nuwellis is dedicated to advancing cardiorenal care by enabling earlier, safer, and more controlled fluid management for patients. Activities since inception have consisted principally of raising capital, performing research and product development, and conducting preclinical and clinical studies. During 2016, we acquired the Aquadex Business and announced that we were halting all clinical evaluations of our prior technology, the C-Pulse System. Since then, our activities have consisted mainly of expanding our sales and marketing efforts, as well as continued development of clinical evidence and new product development efforts. As of June 30, 2026, we had an accumulated deficit of $325.7 million, and we expect to incur losses for the foreseeable future. To date, we have been funded by public and private equity financings. Although we believe that we will be able to successfully fund our operations in the future, there can be no assurance that we will be able to do so or that we will ever operate profitably.

### Results of Operations

### Comparison of three months ended June 30, 2026 to three months ended June 30, 2025

### Net Sales

#### (in thousands)

| Three months ended June 30, 2026 | Three months ended June 30, 2025 | Increase (Decrease) | % Change |
| ---: | ---: | ---: | ---: |
| $1,969 | $1,725 | $244 | 14.1% |

Revenue is generated mainly from the sale of consoles and blood filters and catheters used in conjunction with the Aquadex System consoles. We sell primarily in the United States to hospitals and clinics through our direct salesforce. The increase in sales in the current year period is primarily due to a 209% increase in console sales, and a 9% increase in circuits reflecting continued increases in the number of patients treated with the Aquadex therapy.

### Costs and Expenses

Our costs and expenses were as follows:

*(in thousands)*

|  | Three months ended June 30, 2026 | Three months ended June 30, 2025 | Increase (Decrease) | % Change |
| --- | ---: | ---: | ---: | ---: |
| Cost of goods sold | $471 | $767 | $(296) | (38.6)% |
| Selling, general and administrative | $3,725 | $3,189 | $536 | 16.8% |
| Research and development | $942 | $675 | $267 | 39.6% |

### Cost of Goods Sold

The decrease in cost of goods sold for the three months ended June 30, 2026, compared to the three months ended June 30, 2025, was primarily due to the increase in margin from switching to contract manufacturing, KDI Precision Manufacturing.

### Selling, General and Administrative

The increase in selling, general and administrative expenses was primarily driven by increased headcount and sales related compensation from a 14.1% increase in sales vs prior year, and higher professional services fees.

### Research and Development (R&D)

The increase in R&D expenses was primarily driven by increased headcount and compensation-related expenses and higher consulting fees associated with increased sustained engineering expenses and improvements to our quality system.

### Comparison of six months ended June 30, 2026 to six months ended June 30, 2025

### Net Sales

#### (in thousands)

| Six months ended June 30, 2026 | Six months ended June 30, 2025 | Increase (Decrease) | % Change |
| ---: | ---: | ---: | ---: |
| $4,372 | $3,629 | $743 | 20.5% |

Revenue is generated mainly from the sale of disposable blood filters and catheters used in conjunction with the Aquadex system consoles. We sell primarily in the United States to hospitals and clinics through our direct salesforce. We sell outside of the United States to independent specialty distributors who in turn sell to hospitals and clinics in their geographic regions. The increase in sales in the current year period is primarily due to a 361% increase in console sales, and a 12% increase in circuits reflecting continued increases in the number of patients treated with the Aquadex therapy.

### Costs and Expenses

Our costs and expenses were as follows:

*(in thousands)*

|  | Six months ended June 30, 2026 | Six months ended June 30, 2025 | Increase (Decrease) | % Change |
| --- | ---: | ---: | ---: | ---: |
| Cost of goods sold | $1,190 | $1,604 | $(414) | (25.8)% |
| Selling, general and administrative | $8,249 | $6,766 | $1,483 | 21.9% |
| Research and development | $2,670 | $1,225 | $1,445 | 118.0% |

### Cost of Goods Sold

The decrease in cost of goods sold for the six months ended June 30, 2026, compared to the six months ended June 30, 2025, was primarily due to the increase in margin from switching to contract manufacturing, KDI Precision Manufacturing.

### Selling, General and Administrative

The increase in selling, general and administrative expenses was primarily driven by increased headcount and sales related compensation from a 20.5% increase in sales vs prior year, and higher professional services fees.

### Research and Development

The increase in R&D expenses was primarily driven by increased headcount and compensation-related expenses and higher consulting fees associated with increased sustained engineering expenses and improvements to our quality system.

### Liquidity and Capital Resources

### Sources of Liquidity

We have funded our operations primarily through cash on hand, equity issuances, and at-the-market offerings. As of June 30, 2026, and December 31, 2025, cash, cash equivalents, and restricted cash were $4.0 million and $1.2 million, respectively.

Our business strategy and ability to fund operations depend on growing the Aquadex Business through expanded sales, product adoption, and cost control, as well as the successful integration of the Rendiatech technology. We expect to seek additional financing in the future, primarily through equity offerings or the existing At-The-Market program assuming adequate shelf availability as calculated under SEC rules.

### Cash Flows

Net cash used in operating activities was $6.3 million for the six months ended June 30, 2026, compared to $4.6 million for the comparable prior-year period. This primarily reflects our net loss, partially offset by non-cash items (e.g., stock-based compensation, depreciation, warrant fair value changes) and changes in working capital.

Net cash used in investing activities was $293,000 and $4,000 for the six months ended June 30, 2026 and 2025 respectively, primarily for property and equipment purchases and cash paid for the Rendiatech Acquisition (net of cash acquired).

Net cash provided by financing activities was $9.4 million for the six months ended June 30, 2026, primarily from proceeds under the January 2026 PIPE warrants, January 2026 Warrant Inducement, and June 2026 Financing.

### Capital Resource Requirements

As of June 30, 2026, we had no material commitments for capital expenditures beyond ordinary course purchases.

We believe our existing capital resources will support operations through the end of the second quarter of 2027, but we will require additional capital to fund operations through the end of fiscal year 2027. See Note 1 – Going Concern for additional discussion.

### Forward-Looking Statements and Risk Factors

Certain statements in this Quarterly Report on Form 10-Q are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements are based on management's beliefs, assumptions, and expectations and information currently available. Forward-looking statements include statements regarding future operating performance, business strategy, product development, market acceptance, financing needs, and other matters. Such statements are identified by words such as "believe," "expect," "anticipate," "may," "will," "should," "could," "estimate," "plan," "potential," or similar expressions. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially, including those described in our Annual Report on Form 10-K for the year ended December 31, 2025, and subsequent SEC filings. We undertake no obligation to update forward-looking statements except as required by law.

## Controls and procedures

As filed, 3,100 characters.

### Controls and Procedures

### Evaluation of Disclosure Controls and Procedures

We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in our Exchange Act reports is recorded, processed, summarized and reported within the time periods specified in the SEC rules and forms and that such information is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer (together, the “Certifying Officers”), as appropriate, to allow for timely decisions regarding required disclosure.

In designing and evaluating disclosure controls and procedures, management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable, not absolute, assurance of achieving the desired objectives. Also, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that misstatements due to error or fraud will not occur or that all control issues and instances of fraud, if any, have been detected. These inherent limitations include the realities that judgments in decision-making can be faulty and that breakdowns can occur because of simple error or mistake. The design of any system of controls is based, in part, upon certain assumptions about the likelihood of future events and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions.

As of June 30, 2026, the end of the period covered by this report, we conducted an evaluation, under the supervision and with the participation of management, including the Certifying Officers, of the effectiveness of the design and operation of our disclosure controls and procedures as defined in Rules 13a-15(e) and 15d-15(e) of the Exchange Act. Our disclosure controls and procedures are designed to provide reasonable assurance of achieving their stated objectives. Based on their evaluation, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures were not effective at a reasonable assurance level as of June 30, 2026. The Certifying Officers based their conclusion on the fact that the Company has identified two material weaknesses in controls over financial reporting, as detailed in the 2025 Annual Report on Form 10-K. In light of this fact, management expects to perform additional analyses, reconciliations, and remediations.

### Changes in Internal Controls over Financial Reporting

There was no change in our internal control over financial reporting during our most recently completed fiscal quarter that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting. However, as a result of the identified material weaknesses, changes in our internal control over financial reporting will occur.

## Risk factors

As filed, 7,778 characters.

### 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.

Filed Aug 13, 2026.
Source: SEC EDGAR, the filing index for accession 0001140361-26-032810. Last ingested by Listed: Oct 24, 2026, 15:12 ET. No prices; not investment advice.