Nuo Therapeutics, Inc.
For the period ended Jun 30, 2025. Filed Jul 31, 2025.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Jun 30, 2025 · Filed Jul 31, 2025
AURXStored price and day change unavailable
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-03-31; filed 2025-04-30.
0001437749-25-013653
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-06-30; filed 2025-07-31.
0001437749-25-024043
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 75 previous paragraphs and 86 current paragraphs.
60 unchanged; 14 reworded; 9 added; 1 removed; 0 previous and 3 current paragraphs rearranged.
Tables are not compared: 3 previous and 4 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (9)
Current report
The $1,500,000 upfront distribution fee will be recognized ratably as revenue on a straight-line basis over the initial five-year term of the Distribution Agreement.
Current report
On May 14, 2025, we entered into Amendment No. 1 (the “Amendment”) to the Distribution Agreement. The Amendment supplements the Distribution Agreement by additionally providing for an interim sales agency arrangement whereby Smith+Nephew is entitled to act as sales agent on an interim basis for the sale of products under the Aurix brand to certain Smith+Nephew customers. As compensation, Smith+Nephew is entitled to a commission on net sales of the Nuo branded products sold to the Smith+Nephew customers. The Amendment’s interim sales agency arrangement terminates upon the earlier of December 31, 2025 or the date notified in writing by Smith+Nephew upon not less than thirty days’ notice of such termination.
Current report
Comparison of Six Months Ended June 30, 2025 and 2024
Current report
Revenue and Gross Profit
Current report
Operating Expenses
Current report
Other Income (Expense)
Current report
On May 12, 2025, the SEC declared the Company's shelf registration statement on Form S-3 effective. The shelf registration statement enables us to offer and sell, from time to time in one or more offerings, shares of our common stock with an aggregate offering amount not exceeding $15 million. The shelf registration statement could provide us with access to liquidity from the public markets should we decide to utilize it for that purpose.
Current report
We had limited investing activities for the six months ended June 30, 2024.
Current report
Cash from financing activities for the six months ended June 30, 2024 reflects proceeds of (i) $650,875 from the sale of 867,833 shares of common stock in a private placement closed in May 2024 and (ii) $151,200 from the exercise of 270,000 warrants in June 2024.
Removed paragraphs (1)
Previous report
We had no investing activities for the three months ended March 31, 2024.
Reworded paragraphs (14)
Previous wording
On March 31, 2025, we entered into a Distribution Agreement (the “Distribution Agreement”) with a U.S. affiliate of Smith & Nephew PLC (“Smith+Nephew”), a global medical technology company. Under the Distribution Agreement, we will supply to Smith+Nephew its own private label of our Aurix product. Although Smith+Nephew will be the sole and exclusive distributor in the United States of a private label Aurix product (the “Private Label product”), we have the ability and will continue to market, distribute, and sell our own Aurix branded product.
Current wording
On March 31, 2025, we entered into a Distribution Agreement (the “Distribution Agreement”) with a U.S. affiliate of Smith & Nephew PLC (“Smith+Nephew”), a global medical technology company. Under the Distribution Agreement, we will supply Smith+Nephew its own private label of our Aurix product. Although Smith+Nephew will be the sole and exclusive distributor in the United States of a private label Aurix product (the “Private Label product”), we have the ability and will continue to market, distribute, and sell our own Aurix branded product.
Previous wording
We believe that Smith+Nephew will need time to establish and begin commercial sales of its Private Label product. As a result, we anticipate limited sales under the Distribution Agreement during the next 12 months. While the Distribution Agreement will provide us with revenues, we also will incur expenses at the outset of the Distribution Agreement to enable us to comply with its provisions as well as packaging, shipping, and related costs associated with delivering the Private Label product for Smith+Nephew. The amount of these expenses and costs will vary depending on the amount of purchase orders that we receive from Smith+Nephew.
Current wording
We believe that Smith+Nephew will need time to establish and begin commercial sales of its Private Label product. As a result, we anticipate modest sales under the Distribution Agreement during the next 12 months. While the Distribution Agreement will provide us with revenues, we also will incur expenses at the outset of the Distribution Agreement to enable us to comply with its provisions as well as packaging, shipping, and related costs associated with delivering the Private Label product for Smith+Nephew. The amount of these expenses and costs will vary depending on the amount of purchase orders that we receive from Smith+Nephew.
Previous wording
The description above of the Distribution Agreement is qualified by reference to the full text of such agreement, a copy of which is filed as Exhibit 10.1 to this Quarterly Report and incorporated herein.
Current wording
The description above of the Distribution Agreement is qualified by reference to the full text of such agreement, a copy of which was filed as Exhibit 10.1 to our Annual Report. The description above of the Amendment is qualified by reference to the full text of such agreement, a copy of which is filed as Exhibit 10.1 to this Quarterly Report and incorporated herein.
Previous wording
The amounts presented in this comparison section are rounded to the nearest thousand.
Current wording
The amounts presented in these comparison sections are rounded to the nearest thousand.
Previous wording
Product revenues for the three months ended March 31, 2025 totaled approximately $484,000 in comparison to product revenues of approximately $235,000 in the three months ended March 31, 2024 representing an increase of approximately $249,000. Associated gross profit was approximately $363,000 in the three months ended March 31, 2025 in comparison to approximately $184,000 of gross profit in the three months ended March 31, 2024. The increase in revenues and gross profit was due to an expanding customer base over the past year as hospital wound care facilities and providers become incrementally aware of the Aurix product and the 2021 Medicare NCD.
Current wording
Total revenues for the three months ended June 30, 2025 totaled approximately $700,000 including $75,000 of license fee revenue related to the Smith+Nephew distribution agreement. Product revenues for the three months ended June 30, 2025 totaled approximately $625,000 in comparison to product and total revenues of approximately $365,000 in the three months ended June 30, 2024 representing an increase of approximately $335,000. Associated gross profit was approximately $541,000 in the three months ended June 30, 2025 in comparison to approximately $299,000 of gross profit in the three months ended June 30, 2024. The increase in revenues and gross profit was due primarily to an expanding customer base over the past year as hospital wound care facilities and providers become incrementally aware of the Aurix product and the 2021 Medicare NCD as well as the initial license fee revenue under the Smith+Nephew distribution agreement.
Previous wording
Total operating expenses increased approximately $215,000 to approximately $1,109,000 comparing the three months ended March 31, 2025 to the three months ended March 31, 2024. The increase from the prior year was due primarily to increases in (i) professional fees of approximately $123,000 due largely to increased legal fees associated with the negotiation and finalization of the distribution agreement with Smith+Nephew and (ii) third party commission expense of approximately $67,000 for independent sales representatives and distributors resulting from increased Aurix product revenues.
Current wording
Total operating expenses increased approximately $352,000 to approximately $1,193,000 comparing the three months ended June 30, 2025 to the three months ended June 30, 2024. The increase from the prior year was due primarily to increases in (i) professional fees of approximately $129,000 due largely to increased legal and accounting fees associated with the finalization of the distribution agreement with Smith+Nephew and SEC registration statements filed in the quarter, (ii) third party commission expense of approximately $68,000 for independent sales representatives and distributors resulting from increased Aurix product revenues , and (iii) third party consulting expenses of approximately $63,000 primarily for our quality management system and reimbursement support services.
Previous wording
Interest income (expense), net for the three months ended March 31, 2025 represents interest expense associated with the financing of insurance premiums in excess of nominal interest income on reduced cash balances while other income for the period March 31, 2025 was nominal.
Current wording
Other income (expense), net for the three months ended June 30, 2025 and 2024 primarily represents interest income on cash balances in excess of interest expense associated with the financing of insurance premiums while other income for the three-month periods was nominal.
Previous wording
As of March 31, 2025, we had cash balances of approximately $0.1 million, total current assets of approximately $0.6 million and total current liabilities of approximately $1.3 million. As an operational business, we have a history of losses and are not currently profitable. For the years ended December 31, 2024, and 2023, we incurred net losses of approximately $2.3 million and $3.2 million, respectively. As of March 31, 2025, our accumulated deficit was approximately $33.0 million and our stockholders’ deficit was approximately $0.2 million.
Current wording
As of June 30, 2025, we had cash balances of approximately $0.3 million, total current assets of approximately $0.9 million and total current liabilities of approximately $1.0 million. As an operational business, we have a history of losses and are not currently profitable. For the years ended December 31, 2024, and 2023, we incurred net losses of approximately $2.3 million and $3.2 million, respectively. As of June 30, 2025, our accumulated deficit was approximately $33.6 million and our stockholders’ deficit was approximately $0.8 million.
Previous wording
Subsequent to March 31, 2025, we received $1.3 million from Smith+Nephew representing the balance of the upfront distribution fee under the Distribution Agreement.
Current wording
During the six-month period ended June 30, 2025, we received $1.5 million from Smith+Nephew representing the upfront distribution fee under the Distribution Agreement.
Previous wording
Effective January 1, 2024, pursuant to the provisions of the August 2022 Common Stock and Warrant Purchase Agreement with Pacific Medical, Inc. ("Pacific Med"), we issued to Pacific Med a warrant to purchase up to 500,000 shares of common stock at a price equal to $0.56, the 20-day volume weighted average closing price per share of our common stock ending December 31, 2023. A portion of the warrant was exercised on June 27, 2024 and we received proceeds of $151,200.
Current wording
Effective January 1, 2024, pursuant to the provisions of the August 2022 Common Stock and Warrant Purchase Agreement with Pacific Medical, Inc. ("Pacific Med"), we issued Pacific Med a warrant to purchase up to 500,000 shares of common stock at a price equal to $0.56, the 20-day volume weighted average closing price per share of our common stock ending December 31, 2023. A portion of the warrant was exercised during the six-month period ended June 30, 2024 and we received proceeds of $151,200.
Previous wording
Cash provided by operating activities for the three months ended March 31, 2025 of approximately $2,000 primarily reflects our net loss of approximately $746,000 adjusted by (i) approximately $474,000 net change in operating assets and liabilities (excluding deferred revenue), (ii) approximately $52,000 in total for amortization of right of use assets, depreciation of property and equipment, and stock-based compensation, and (iii) $200,000 in deferred revenue. The deferred revenue is due to the receipt in February 2025 of a $200,000 exclusivity payment from Smith+Nephew in conjunction with the private label distribution agreement which was executed as of March 31, 2025.
Current wording
Cash provided by operating activities for the six months ended June 30, 2025 of approximately $264,000 primarily reflects our net loss of approximately $1,396,000 adjusted by (i) the $1,425,000 increase in deferred revenues (ii) approximately $83,000 net change in operating assets and liabilities (excluding deferred revenue), and (iii) approximately $116,000 in total for amortization of right of use assets, depreciation of property and equipment, and stock-based compensation. The deferred revenue is due to the receipt of the $1.5 million upfront distribution fee from Smith+Nephew in conjunction with the private label distribution agreement which was effective as of March 31, 2025.
Previous wording
Cash used in operating activities for the three months ended March 31, 2024 of approximately $562,000 primarily reflects our net loss of approximately $708,000 adjusted by (i) approximately $98,000 net change in operating assets and liabilities, (ii) approximately $31,000 in total for amortization of right of use assets, depreciation of property and equipment, and stock-based compensation, and (iii) a provision for credit losses of $17,500.
Current wording
Cash used in operating activities for the six months ended June 30, 2024 of approximately $1,254,000 primarily reflects our net loss of approximately $1,249,000 adjusted by (i) approximately $76,000 net change in operating assets and liabilities, (ii) approximately $53,600 total depreciation and amortization expense and stock-based compensation expense and (iii) a provision for credit losses of $17,500.
Previous wording
Cash used in investing activities for the three months ended March 31, 2025 primarily represents $220,000 in expenditures for the purchase of centrifuge devices.
Current wording
Cash used in investing activities for the six months ended June 30, 2025 primarily represents $220,000 in expenditures for the purchase of centrifuge devices.
Previous wording
We did not have any financing activities for the three months ended March 31, 2025 and 2024.
Current wording
We did not have any financing activities for the six months ended June 30, 2025.
Rearranged current paragraphs (3)
Current report — wording carried from elsewhere
Total revenues for the six months ended June 30, 2025 totaled approximately $1,184,000 including $75,000 of license fee revenue related to the Smith+Nephew distribution agreement. Product revenues for the six months ended June 30, 2025 totaled approximately $1,109,000 in comparison to product revenues of approximately $599,000 in the six months ended June 30, 2024 representing an increase of approximately $511,000. Associated gross profit was approximately $904,000 in the six months ended June 30, 2025 in comparison to approximately $483,000 of gross profit in the six months ended June 30, 2024. The increase in revenues and gross profit was due to an expanding customer base over the past year as hospital wound care facilities and providers become incrementally aware of the Aurix product and the 2021 Medicare NCD as well as the initial license fee revenue under the Smith+Nephew distribution agreement.
Current report — wording carried from elsewhere
Total operating expenses increased approximately $567,000 to approximately $2,301,000 comparing the six months ended June 30, 2025 to the six months ended June 30, 2024. The increase from the prior year was due primarily to increases in (i) professional fees of approximately $199,000 due largely to increased legal and accounting fees associated with the negotiation and finalization of the Smith+Nephew distribution agreement and SEC registration statements filed in the period, (ii) third party commission expense of approximately $135,000 for independent sales representatives and distributors resulting from increased Aurix product revenues, and (iii) third party consulting expenses of approximately $83,000 primarily for our quality management system and reimbursement support services.
Current report — wording carried from elsewhere
Other income (expense), net for the six months ended June 30, 2025 primarily represents interest expense associated with the financing of insurance premiums in excess of interest income on cash balances while other income for the six-month periods was nominal.