NUWE 8-K
Nuwellis, Inc. (NUWE)
8-K
2025-08-14
For: 2025-08-14
View Original
Added on
April 10, 2026
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
Current Report Pursuant to Section 13 or 15(d) of
the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): August 14, 2025
(Exact Name of Registrant as Specified in its Charter)
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(State or Other Jurisdiction of Incorporation or Organization)
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(Commission File Number)
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(I.R.S. Employer Identification No.)
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(Address of Principal Executive Offices) (Zip Code)
(952 ) 345-4200
(Registrant’s Telephone Number, Including Area Code)
Securities registered pursuant to Section 12(b) of the Act:
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Title of each class
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Trading Symbol(s)
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Name of each exchange on which registered
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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the
following provisions:
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter)
or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
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 13(a) of the Exchange Act. ☐
| Item 2.02 |
Results of Operations and Financial Condition.
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On August 14, 2025, Nuwellis, Inc. (the “Company”) issued a press release reporting its financial results for the three and six months ended June 30,
2025. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
In accordance with General Instruction B.2 of Form 8-K, the information included in this Current Report on Form 8-K (including Exhibit 99.1) is furnished
pursuant to Item 2.02 and shall not be deemed to be “filed” for the purpose of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section.
| Item 9.01 |
Financial Statements and Exhibits.
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| (d) |
Exhibits
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Exhibit No. Description
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Press Release, dated August 14, 2025, reporting the financial results of Nuwellis, Inc. for the three and six months ended June 30, 2025.
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
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Date: August 14, 2025
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NUWELLIS, INC.
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By:
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/s/ John L. Erb
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Name:
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John L. Erb
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Title:
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President and Chief
Executive Officer
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Exhibit 99.1
Nuwellis, Inc. Reports Second Quarter 2025
Financial Results and Business Highlights
Minneapolis, MN, August 14, 2025 (GLOBE NEWSWIRE) — Nuwellis, Inc. (Nasdaq: NUWE), a commercial-stage medical technology company dedicated to transforming care for fluid overload patients, today announced financial results for the
second quarter ended June 30, 2025, and provided a business update.
Second Quarter 2025 and Recent Business Highlights
Nuwellis continued to advance its strategic realignment during the second quarter, sharpening focus on high-impact growth areas in pediatric and cardiac surgery care while
laying the foundation for expansion in outpatient heart failure. Despite temporary revenue disruption related to an industry-wide sterilization vendor issue, the company took swift action to prioritize patient care, protect its most vulnerable
populations, and ensure strong momentum entering the third quarter.
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Revenue of $1.7 million, compared to $2.2 million in Q2 2024
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Pediatric category remains a key driver of sustained demand
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Executed a transition plan to outsource manufacturing to KDI Precision Manufacturing
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Completed a $5 million gross capital raise during the quarter
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Successfully grew to 47 pediatric centers that adopted Aquadex therapy as part of their fluid management apporach with the addition of two new centers across the Southeastern United States
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Expanded IP portfolio with granting of new U.S. patent covering the fluid bag design that passively drains once full
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“While we faced a temporary headwind this quarter due to a vendor issue, our response demonstrated the strength of our operational discipline and our commitment to
patients,” said John Erb, Chairman of the Board and CEO of Nuwellis. “We’re entering the second half of the year with clear priorities, a sharpened focus on our core markets, and the confidence that we’re executing on the right strategy to drive
long-term growth.”
Second Quarter 2025 Financial Results
Revenue for the second quarter of 2025 was $1.7 million, compared to $2.2 million in the second quarter of 2024. The year-over-year decline was primarily due to a product
backorder caused by an industry-wide sterilization delay.
Gross margin was 55.5% in Q2 2025, compared to 67.2% in Q2 2024. The margin contraction was primarily driven by under-absorption of fixed overhead because of lower
production volumes.
Selling, general and administrative (SG&A) expenses were $3.2 million, which is flat to Q2 2024. Research and development (R&D) expenses totaled $675K, compared to
$558K in the same period last year.
Total operating expenses for the quarter were $3.9 million, a 2% increase over prior year.
Operating loss for the quarter was $2.9 million, compared to $2.3 million in Q2 2024.
Net loss attributable to common shareholders was $12.6 million, or a loss of $60.99 per basic and diluted share, compared to $7.7 million, or a loss of $791.82 per share in
Q2 2024.
As of June 30, 2025, the company had $4.5 million in cash and cash equivalents and remained debt-free. Nuwellis completed a $5.0 million gross capital raise during the
quarter.
Conference Call and Webcast Information
Nuwellis will host a conference call and webcast today at 9:00 AM ET to discuss its first quarter results and recent business developments.
To access the live webcast, please visit the Investors page of the Nuwellis website at https://ir.nuwellis.com. Alternatively, participants may dial 1-800-245-3047 (U.S.)
or 1-203-518-9765 (International) and use conference ID: NUWEQ2. A replay will be available following the event.
About Nuwellis
Nuwellis, Inc. (Nasdaq: NUWE) is a commercial-stage medical device company dedicated to transforming the lives of patients suffering from fluid overload through science,
collaboration, and innovation. The company’s focus is on commercializing the Aquadex SmartFlow® system for ultrafiltration therapy. Nuwellis is headquartered in Minneapolis, Minnesota, with a wholly owned subsidiary in Ireland. For more
information, visit ir.nuwellis.com or follow us on LinkedIn or X.
About the Aquadex SmartFlow® System
The Aquadex SmartFlow system delivers clinically proven therapy using a simple, flexible, and smart method of removing excess fluid from patients suffering from
hypervolemia (fluid overload). The Aquadex SmartFlow system is indicated for temporary (up to 8 hours) or extended (longer than 8 hours in patients who require hospitalization) use in adult and pediatric patients weighing 20 kg or more whose fluid
overload is unresponsive to medical management, including diuretics. All treatments must be administered by a healthcare provider within an outpatient or inpatient clinical setting, under physician prescription, both having received training in
extracorporeal therapies.
Forward-Looking Statements
Certain statements in this release may be considered forward-looking statements within the meaning of the Private Securities
Litigation Reform Act of 1995, including without limitation, statements regarding future growth and market opportunities. Forward-looking statements are based on current assumptions and expectations and involve risks and uncertainties that could
cause actual results to differ materially. These risks are detailed in the Company's filings with the Securities and Exchange Commission. Nuwellis undertakes no obligation to update any forward-looking statements, whether as a result of new
information, future events, or otherwise.
Contacts:
Investors:
Robert Scott
Nuwellis
Chief Financial Officer
Media Contact:
Leah McMullen
Nuwellis
Director of Communications
NUWELLIS, INC. AND SUBSIDIARY
Condensed Consolidated Balance Sheets
(in thousands, except share and per share amounts)
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June 30,
2025
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December 31, 2024
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(Unaudited)
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ASSETS
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Current assets
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||||||||
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Cash and cash equivalents
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$
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4,450
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$
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5,095
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Accounts receivable
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1,193
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1,727
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Inventories, net
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2,028
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1,718
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Other current assets
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745
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315
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Total current assets
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8,416
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8,855
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Property, plant and equipment, net
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359
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478
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Operating lease right-of-use asset
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404
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510
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Other assets
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21
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21
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TOTAL ASSETS
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$
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9,200
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$
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9,864
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LIABILITIES, CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY
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Current liabilities
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Accounts payable and accrued liabilities
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$
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3,008
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$
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1,640
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Accrued compensation
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561
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640
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Current portion of operating lease liability
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249
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238
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Other current liabilities
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74
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41
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Total current liabilities
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3,892
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2,559
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Warrant liabilities
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14,074
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468
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Operating lease liability
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189
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307
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Total liabilities
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18,155
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3,334
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Commitments and contingencies
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Mezzanine Equity
Series J Convertible Preferred Stock as of June 30, 2025 and December 31, 2024, par value $0.0001 per share; authorized
600,000 shares, issued and outstanding 119 and 102, respectively
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5
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2
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Stockholders’ equity
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Series A junior participating preferred stock as of June 30, 2025 and December 31, 2024, par value $0.0001 per share; authorized 30,000
shares, none outstanding
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—
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—
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Series F convertible preferred stock as of June 30, 2025 and December 31, 2024, par value $0.0001 per share; authorized 18,000 shares,
issued and outstanding 27 and 127 shares, respectively
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—
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—
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Series F-1 convertible preferred stock as of June 30, 2025 and December 31, 2024, par value $0.0001 per share; authorized 18,000 shares,
issued and outstanding 34 and 0 shares, respectively
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—
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—
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Preferred stock as of June 30, 2025 and December 31, 2024, par value $0.0001 per share; authorized 39,352,000 shares, none
outstanding
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—
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—
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Common stock as of June 30, 2025 and December 31, 2024, par value $0.0001 per share; authorized 100,000,000 shares, issued
and outstanding 527,158 and 104,142, respectively
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—
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—
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Additional paid‑in capital
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305,452
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305,366
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Accumulated other comprehensive income:
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||||||||
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Foreign currency translation adjustment
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(54
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)
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(47
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)
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Accumulated deficit
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(314,358
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)
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(298,791
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)
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Total stockholders’ equity
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(8.960
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6,528
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TOTAL LIABILITIES, CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY
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$
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9,200
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$
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9,864
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NUWELLIS, INC. AND SUBSIDIARY
Condensed Consolidated Statements of Operations and Comprehensive Loss
(Unaudited)
(in thousands, except per share amounts and weighted average shares outstanding)
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Three months ended
June 30
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Six months ended
June 30
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2025
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2024
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2025
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2024
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Net sales
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$
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1,725
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$
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2,194
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$
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3,629
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$
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4,051
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Cost of goods sold
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767
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720
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1,604
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1,386
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Gross profit
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958
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1,474
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2,025
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2,665
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Operating expenses:
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Selling, general and administrative
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3,189
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3,236
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6,766
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7,842
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Research and development
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675
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558
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1,225
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1,892
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Total operating expenses
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3,864
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3,794
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7,991
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9,734
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Loss from operations
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(2,906
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)
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(2,320
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)
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(5,966
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)
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(7,069
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)
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Other income (expense), net
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10
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6
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17
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(95
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)
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Financing expense
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(10,553
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)
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(5,607
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)
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(10,553
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)
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(5,607
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)
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Change in fair value of warrant liabilities
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900
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198
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940
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720
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Loss before income taxes
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(12,549
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)
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(7,723
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)
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(15,562
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)
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(12,051
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) | ||||||||
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Income tax expense
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(4
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)
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(2
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)
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(5
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)
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(4
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)
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||||||||
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Net loss
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$
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(12,553
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)
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$
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(7,725
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)
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$
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(15,567
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)
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$
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(12,055
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) |
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Deemed dividend attributable to Series J Convertible Preferred Stock
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1
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—
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2
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541
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||||||||||||
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Net loss attributable to common shareholders
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$
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(12,552
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)
|
$
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(7,725
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)
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$
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(15,565
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)
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$
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(11,514
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)
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||||
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Basic and diluted loss per share
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$
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(60.99
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)
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$
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(791.82
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)
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$
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(100.44
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)
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$
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(139.74
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)
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||||
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Weighted average shares outstanding – basic and diluted
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205,839
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9,755
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154,991
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86,261
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||||||||||||
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Other comprehensive loss:
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||||||||||||||||
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Net Loss
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$
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(12,553
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)
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$
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(7,725
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)
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$
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(15,567
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)
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$
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(12,055
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)
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||||
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Foreign currency translation adjustments
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$
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(5
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)
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$
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(2
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)
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$
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(7
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)
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$
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(11
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)
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Total comprehensive loss
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$
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(12,558
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)
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$
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(7,727
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)
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$
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(15.574
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)
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$
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(12,066
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)
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NUWELLIS, INC. AND SUBSIDIARY
Condensed Consolidated Statements of Cash Flows
(Unaudited)
(in thousands)
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Six months ended
June 30
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||||||||
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2025
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2024
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|||||||
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Operating Activities:
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||||||||
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Net loss
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$
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(15,567
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)
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$
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(12,055
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)
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Adjustments to reconcile net loss to cash flows used in operating activities:
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||||||||
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Depreciation and amortization
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123
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151
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Stock-based compensation expense
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84
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273
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||||||
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Change in fair value of warrant liabilities
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(940
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)
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(720
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)
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Financing expense
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10,553
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5,607
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||||||
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Changes in operating assets and liabilities:
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||||||||
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Accounts receivable
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534
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659
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||||||
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Inventory, net
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(310
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)
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30
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|||||
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Other current assets
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(430
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)
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(395
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)
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Other assets and liabilities
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32
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5
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||||||
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Accounts payable and accrued expenses
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1,288
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829
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||||||
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Net cash used in operating activities
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(4,633
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)
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(5,616
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)
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Investing Activities:
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||||||||
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Purchases of property and equipment
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(4
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)
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(53
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)
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Net cash used in investing activities
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(4
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)
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(53
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)
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Financing Activities:
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||||||||
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Issuance of common stock and warrants from offering, net
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3,999
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2,403
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Proceeds from the exercise of Series J Convertible Preferred Warrants
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—
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500
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||||||
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Net cash provided by financing activities
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3,999
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2,903
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||||||
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Effect of exchange rate changes on cash
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(7
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)
|
(11
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)
|
||||
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Net decrease in cash and cash equivalents
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(645
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)
|
(2,777
|
)
|
||||
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Cash and cash equivalents - beginning of period
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5,095
|
3,800
|
||||||
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Cash and cash equivalents - end of period
|
$
|
4,450
|
$
|
1,023
|
||||
| Supplemental cash flow information | ||||||||
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Issuance of Series J Preferred Stock for exercise of Warrants
|
$
|
—
|
$
|
1,857
|
||||
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Issuance of Common Stock for conversion of Series J Preferred Stock
|
$
|
—
|
$
|
1,535
|
||||
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Issuance of Common Stock for conversion of Series F-1 Preferred Stock
|
$
|
1,100
|
$
|
—
|
||||
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Deemed dividend on Series J Preferred Stock
|
$
|
2
|
$
|
(541
|
)
|
|||
|
Common stock offering costs included in prepaids
|
$
|
—
|
$
|
306
|