Nuo Therapeutics, Inc.
For the period ended Mar 31, 2025. Filed Apr 30, 2025.
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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.
Mar 31, 2025 · Filed Apr 30, 2025
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Table of Contents
NUO THERAPEUTICS, INC.
TABLE OF CONTENTS
| Page | |
|---|---|
| PART I. FINANCIAL INFORMATION | |
| Item 1. Unaudited Consolidated Financial Statements | 1 |
| Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations | 13 |
| Item 3. Quantitative and Qualitative Disclosures About Market Risk | 18 |
| Item 4. Controls and Procedures | 19 |
| PART II. OTHER INFORMATION | |
| Item 1. Legal Proceedings | 20 |
| Item 1A. Risk Factors | 20 |
| Item 2. Unregistered Sales of Equity Securities and Use of Proceeds | 20 |
| Item 3. Defaults Upon Senior Securities | 20 |
| Item 4. Mine Safety Disclosures | 20 |
| Item 5. Other Information | 20 |
| Item 6. Exhibits | 21 |
| Signatures | 22 |
PART I
FINANCIAL INFORMATION
Item 1. Consolidated Financial Statements
CONSOLIDATED BALANCE SHEETS
| March 31, 2025 | December 31, 2024 | |
|---|---|---|
| ASSETS | ||
| Current assets | ||
| Cash | $55,655 | $283,714 |
| Accounts receivable, net | 276,532 | 248,205 |
| Inventory, net | 99,173 | 150,442 |
| Prepaid expenses and other current assets | 170,146 | 159,185 |
| Total current assets | 601,506 | 841,546 |
| Property and equipment, net | 391,559 | 177,022 |
| Operating lease right of use assets | 153,689 | 170,940 |
| Total assets | $1,146,754 | $1,189,508 |
| LIABILITIES AND STOCKHOLDERS' EQUITY/(DEFICIT) | ||
| Current liabilities | ||
| Accounts payable | $662,093 | $219,190 |
| Accrued expenses | 349,625 | 292,400 |
| Deferred revenue | 200,000 | - |
| Current portion of operating lease liabilities | 69,160 | 66,861 |
| Total current liabilities | 1,280,878 | 578,451 |
| Non-current portion of operating lease liabilities | 78,949 | 97,345 |
| Total liabilities | 1,359,827 | 675,796 |
| Commitments and contingencies (Note 8) | ||
| Stockholders' equity/(deficit) | ||
| Common stock; $0.0001 par value, 100,000,000 shares authorized, 46,816,114 shares issued and outstanding at March 31, 2025 and December 31, 2024 | 4,682 | 4,682 |
| Additional paid-in capital | 32,788,319 | 32,768,976 |
| Accumulated deficit | (33,006,074) | (32,259,946) |
| Total stockholders' equity/(deficit) | (213,073) | 513,712 |
| Total liabilities and stockholders' equity/(deficit) | $1,146,754 | $1,189,508 |
CONSOLIDATED STATEMENTS OF OPERATIONS
| Three Months ended March 31, 2025 | Three Months ended March 31, 2024 | |
|---|---|---|
| Revenue | ||
| Product sales | $484,381 | $234,577 |
| Total revenue | 484,381 | 234,577 |
| Costs of sales | 121,021 | 50,591 |
| Gross profit | 363,360 | 183,986 |
| Operating expenses | ||
| Selling, general and administrative | 1,108,507 | 893,232 |
| Total operating expenses | 1,108,507 | 893,232 |
| Loss from operations | (745,147) | (709,246) |
| Other income (expense) | ||
| Interest income (expense), net | (1,595) | 465 |
| Other income | 614 | - |
| Total other income (expenses) | (981) | 465 |
| Net loss | $(746,128) | $(708,781) |
| Loss per common share | ||
| Basic and diluted | $(0.02) | $(0.02) |
| Weighted average common shares outstanding | ||
| Basic and diluted | 46,816,114 | 44,241,516 |
CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’** EQUITY/(DEFICIT)**
For the Three Months Ended March 31, 2025 and 2024
| Common Stock | |||||
|---|---|---|---|---|---|
| Shares | Amount (par $0.0001) | Additional Paid-In Capital | Accumulated Deficit | Stockholders' Equity/(Deficit) | |
| Balance, January 1, 2025 | 46,816,114 | $4,682 | $32,768,976 | $(32,259,946) | $513,712 |
| Stock compensation expense | 19,343 | 19,343 | |||
| Net loss | - | - | - | (746,128) | (746,128) |
| Balance, March 31, 2025 | 46,816,114 | $4,682 | $32,788,319 | $(33,006,074) | $(213,073) |
| Common Stock | |||||
|---|---|---|---|---|---|
| Shares | Amount (par $0.0001) | Additional Paid-In Capital | Accumulated Deficit | Stockholders’ Equity | |
| Balance, January 1, 2024 | 44,241,516 | $4,424 | $30,970,965 | $(29,936,241) | $1,039,148 |
| Stock compensation expense | 3,081 | 3,081 | |||
| Net loss | - | - | - | (708,781) | (708,781) |
| Balance, March 31, 2024 | 44,241,516 | $4,424 | $30,974,046 | $(30,645,022) | $333,448 |
CONSOLIDATED STATEMENTS OF CASH FLOWS
| For the Three Months Ended March 31, | ||
|---|---|---|
| 2025 | 2024 | |
| CASH FLOWS FROM OPERATING ACTIVITIES: | ||
| Net loss | $(746,128) | $(708,781) |
| Adjustments to reconcile net loss to net cash used in operating activities: | ||
| Depreciation expense | 15,347 | 3,767 |
| Stock-based compensation | 19,343 | 3,081 |
| Provision for credit losses | 12,525 | 17,500 |
| Provision for inventory obsolescence | 9,119 | - |
| Amortization of operating lease right of use assets | 17,251 | 23,757 |
| Changes in operating assets and liabilities: | ||
| Accounts receivable, net | (40,852) | 3,434 |
| Inventory, net | 42,150 | (1,784) |
| Prepaid expenses and other current assets | (10,961) | 756 |
| Accounts payable | 442,903 | 91,808 |
| Accrued expenses | 57,225 | 26,029 |
| Deferred revenue | 200,000 | - |
| Operating lease liabilities | (16,097) | (22,016) |
| Net cash provided by (used in) operating activities | 1,825 | (562,449) |
| CASH FLOWS FROM INVESTING ACTIVITIES: | ||
| Purchases of property and equipment | (229,884) | - |
| Net cash used in investing activities | (229,884) | - |
| CASH FLOWS FROM FINANCING ACTIVITIES: | ||
| Net cash provided by financing activities | - | - |
| NET DECREASE IN CASH | (228,059) | (562,449) |
| Cash, beginning of period | 283,714 | 928,681 |
| Cash, end of period | $55,655 | $366,232 |
| SUPPLEMENTAL INFORMATION | ||
| Cash paid during the period for: | ||
| Interest expense | $1,716 | $1,213 |
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Note 1–** Description of Business**
Description of Business
Nuo Therapeutics, Inc. is a Delaware corporation organized in 1998 under the name Informatix Holdings, Inc. In 1999, Autologous Wound Therapy, Inc., an Arkansas Corporation, merged with and into Informatix Holdings, Inc. and the name of the surviving corporation was changed to Autologous Wound Therapy, Inc. In 2000, Autologous Wound Therapy, Inc. changed its name to Cytomedix, Inc. (“Cytomedix”). In 2001, Cytomedix, filed for bankruptcy, from which it emerged in 2002 under a Plan of Reorganization. In September 2007, Cytomedix received Section 510(k) clearance from the U. S. Food and Drug Administration (“FDA”) for the AutoloGel™ System, now known as the Aurix System (“Aurix”), for processing peripheral blood into an autologous platelet rich plasma ("PRP") for wound management. In 2010, Cytomedix acquired the Angel Whole Blood Separation System from Sorin Group USA, Inc. In 2012, Cytomedix, acquired Aldagen, Inc. (“Aldagen”), a privately held developmental cell-therapy company. Aldagen remains a non-operational, wholly owned subsidiary of the Company.
In 2014, Cytomedix changed its name to Nuo Therapeutics, Inc. In 2016, Nuo filed for and emerged from bankruptcy under a Chapter 11 Plan of Reorganization. Effective May 1, 2019, Nuo furloughed its remaining employees and ceased standard operational activities as it awaited developments concerning its reconsideration request with the Centers for Medicare & Medicaid Services (“CMS”) regarding Medicare coverage for Aurix. In April 2021, CMS issued a favorable National Coverage Determination (“NCD”) for autologous PRP products and Nuo restarted business activities in October 2021. Nuo's principal offices are located in Houston, Texas.
Note 2–** Liquidity and Summary of Significant Accounting Principles**
Liquidity
Since our inception, we have financed our operations by raising debt, issuing equity and equity-linked instruments, and executing licensing arrangements, and to a lesser extent by generating royalties and product revenues. In mid-2019, we ceased ongoing operational activities as we worked to reach a favorable outcome to Medicare reimbursement coverage for the Aurix System. In April 2021, CMS issued an NCD mandating national reimbursement coverage for Aurix when used in chronic non-healing wounds where a clinical diagnosis of diabetes exists for the patient. During the year ended December 31, 2024, we sold 2,000,000 shares of common stock to certain accredited investors pursuant to Securities Purchase Agreements in two private placements which closed in May and September 2024 for total proceeds of $1,500,000.
We have incurred, and continue to incur, recurring losses. As of March 31, 2025, we have an accumulated deficit of approximately $33.0 million and cash of approximately $0.1 million. Subsequent to March 31, 2025, we received $1.3 million from Smith+Nephew representing the balance of the upfront distribution fee under the private label distribution agreement. SeeNote 4–* Distribution Agreement with Smith+Nephew*for additional information.
The accompanying unaudited consolidated financial statements have been prepared assuming that we will continue as a going concern, which contemplates continuity of operations, realization of assets, and satisfaction of liabilities in the ordinary course of business. The propriety of using the going-concern basis is dependent upon, among other things, the achievement of future profitable operations, the ability to generate sufficient cash from operations, and potential other funding sources, including cash on hand, to meet our obligations as they become due.
We believe based on the operating cash requirements and capital expenditures expected for the next twelve months that our current resources and projected revenue from sales of Aurix products are insufficient to support our operations for the next 12 months from the date these financial statements are issued. As such, we believe that substantial doubt about our ability to continue as a going concern exists. The unaudited consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.
Even assuming we succeed in raising sufficient additional funds in the near future, we require additional capital and will seek to continue financing our operations with external capital for the foreseeable future. Any equity financing may cause further substantial dilution to our stockholders and could involve the issuance of securities with rights senior to the common stock. Any debt financing may require us to comply with additional onerous financial covenants and restrict our business operations. Our ability to complete additional financings is dependent on, among other things, market reception of the Company and perceived likelihood of success of our business model, the state of the capital markets at the time of any proposed equity or debt offering, state of the credit markets at the time of any proposed loan financing, and on the relevant transaction terms, among other things. We may not be able to obtain additional capital as required to finance our efforts, through equity or debt financing, other transactions, or any combination thereof, on satisfactory terms or at all. Additionally, any such financing, if at all obtained, may not be adequate to meet our capital needs and to support our operations.
Basis of Presentation and Principles of Consolidation
The accompanying unaudited consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”). Accordingly, they do not include all the information and footnotes required by accounting principles generally accepted in the United States of America (“U.S. GAAP”). In our opinion, the accompanying unaudited consolidated financial statements include all adjustments, consisting of normal recurring adjustments, which are necessary to present fairly our financial position, results of operations and cash flows. The consolidated balance sheet at December 31, 2024, has been derived from our audited financial statements as of that date. The interim unaudited consolidated results of operations are not necessarily indicative of the results that may occur for the full fiscal year. Certain information and footnote disclosure normally included in financial statements prepared in accordance with U.S. GAAP have been omitted pursuant to instructions, rules and regulations prescribed by the SEC. We believe that the disclosures provided herein are adequate to make the information presented not misleading when these unaudited condensed consolidated financial statements are read in conjunction with the audited financial statements and notes previously included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024.
The unaudited consolidated financial statements include the accounts of the Company and its wholly owned, controlled, and inactive subsidiary Aldagen, Inc. (“Aldagen”). All significant inter-company accounts and transactions are eliminated in consolidation. The Company operates its business inone operating segment consisting ofone reporting unit.
Use of Estimates
The preparation of financial statements in conformity with U.S. GAAP requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amount of revenues and expenses during the reporting period. In the accompanying unaudited condensed consolidated financial statements, estimates are used for, but not limited to stock-based compensation, recoverability and depreciable lives of long-lived assets, deferred taxes, and associated valuation allowance and allowances for inventory obsolescence and credit losses. Actual results could differ from those estimates.
Credit Concentration
We generate accounts receivable from the sale of our products. Specific customer receivable balances in excess of 10% of total receivables at March 31, 2025 and December 31, 2024 is listed below.
| March 31, 2025 | December 31, 2024 | |
|---|---|---|
| Customer A | 16% | * |
| Customer B | 15% | * |
| Customer C | 10% | 14% |
| Customer D | * | 16% |
| Customer E | * | 11% |
- less than 10%
Revenue from significant customers exceeding 10% of total revenues for the three months ended March 31, 2025 and March 31, 2024 is listed below. All our revenue for both periods was generated within the U.S.
| Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | |
|---|---|---|
| Customer A | 18% | * |
| Customer B | 18% | - |
| Customer E | 15% | - |
| Customer C | * | 14% |
| Customer F | * | 14% |
Historically, we have used single suppliers for several components of the Aurix product line. We outsource the manufacturing of various product components to contract manufacturers. While we believe these manufacturers demonstrate competency, reliability and stability, there is no assurance that one or more of them will not experience an interruption or inability to provide us with the products needed to satisfy customer demand. Additionally, while most of the components of Aurix are generally readily available on the open market, a reagent, bovine thrombin, is available exclusively through Pfizer, with whom we have an established vendor relationship.
Cash
When applicable, we consider all highly liquid instruments purchased with an original maturity of three months or less to be cash equivalents. We maintain our cash in the form of money market deposit accounts with financial institutions that we believe are credit worthy.
Accounts Receivable, net
We generate accounts receivable from the sale of the Aurix products and accounts receivable as of March 31, 2025 and December 31, 2024 reflect customer receivables from commercial sales activities.
We provide for an allowance against receivables for estimated losses that may result from a customer’s inability or unwillingness to pay. We estimate credit losses expected over the life of our trade receivables and contract assets based on historical information combined with current conditions that may affect a customer’s ability to pay and reasonable and supportable forecasts. While the Company uses various credit quality metrics, it primarily monitors collectability by reviewing the duration of collection pursuits on its delinquent trade receivables and historical write-off trends. Based on the Company’s experience, the customer's delinquency status, which is analyzed periodically, is the strongest indicator of the credit quality of the underlying trade receivables. Accounts are written off against the allowance for credit losses when we determine that amounts are not collectable. Recoveries of previously written-off accounts are recorded when collected. For the three month periods ending March 31, 2025 and 2024, we recorded provisions for credit losses of $12,525 and $17,500, respectively. As of March 31, 2025 and December 31, 2024, the allowance for credit losses was approximately $40,000 and $25,000, respectively.
Inventory, net
Our inventory is produced by third-party manufacturers and consists of raw materials and finished goods. Inventory cost is determined on a first-in, first-out basis and is stated at the lower of cost or net realizable value. We maintain an inventory of kits, reagents, and other disposables having shelf-lives that generally range from 12 months to two years.
As of March 31, 2025, our inventory consisted of approximately $70,000 of finished goods inventory and approximately $29,000 of raw materials acquired to facilitate the manufacturing of finished goods at our contract manufacturer and our warehouse/distribution facility. As of December 31, 2024, our inventory consisted of approximately $89,000 of finished goods inventory and approximately $61,000 of raw materials.
We provide for an allowance against inventory for estimated losses that may result in excess and obsolete inventory (i.e., from the expiration of products). Our allowance for expired inventory is estimated based upon the inventory’s remaining shelf-life and our anticipated ability to sell such inventory, which is estimated using past experience and future forecasts, within its remaining shelf life. Expired products are segregated and used for demonstration purposes only; we record the associated expense for this reserve to cost of sales in the consolidated statements of operations. For the three months ended we recorded a provision for inventory obsolescence of $9,119 and maintained a reserve for inventory obsolescence as of March 31, 2025 of $12,500. As of December 31, 2024, the reserve for inventory obsolescence was $18,675.
Property and Equipment, net
Property and equipment is stated at cost less accumulated depreciation. Assets are depreciated, using the straight-line method, over their estimated useful life ranging fromone tosix years. Maintenance and repairs are charged to operations as incurred.
Leases
At the inception of a contract, we determine if the arrangement is, or contains, a lease. Right-of-use (“ROU”) assets represent our right to use an underlying asset for the lease term and lease liabilities represent the obligation to make lease payments arising from the lease. Operating lease ROU assets and liabilities are recognized at commencement date based on the present value of lease payments over the lease term. Rent expense is recognized on a straight-line basis over the lease term.
We have made certain accounting policy elections whereby we (i) do not recognize ROU assets or lease liabilities for short-term leases (those with original terms of 12-months or less) and (ii) combine lease and non-lease elements of any operating leases.
Revenue Recognition
We analyze our revenue arrangements to determine the appropriate revenue recognition using the following steps: (i) identification of contracts with customers; (ii) identification of distinct performance obligations in the contract; (iii) determination of contract transaction price; (iv) allocation of contract transaction price to the performance obligations; and (v) determination of revenue recognition based on timing of satisfaction of the performance obligation. We recognize revenues upon the satisfaction of the performance obligations (upon transfer of control of promised goods or services to customers) in an amount that reflects the consideration to which we expect to be entitled in exchange for those goods or services. In certain instances where the revenue is variable and we cannot estimate the amount of consideration to which we expect to be entitled, we are constrained from initially recognizing revenue. In these cases, once the estimate is no longer constrained, we recognize revenue in the amount of consideration to which we expect to be entitled. The Smith+Nephew upfront distribution fee will be recognized ratably as revenue on a straight-line basis over the initial 5-year term of the Distribution Agreement.
We provide for the sale of our products, including disposable processing sets and supplies to customers. Revenue from the sale of products is recognized upon shipment of products to the customers. We do not maintain a reserve for returned products, as in the past those returns have not been material and are not expected to be material in the future. Direct costs associated with product sales are recorded at the time that revenue is recognized.
Stock-Based Compensation
The fair value of employee stock options is measured at the date of grant. Expected volatilities for options are based on the equally weighted average historical volatility from comparable public companies with an expected term consistent with ours. Expected years until exercise represents the period of time that options are expected to be outstanding. The risk-free rate for periods within the expected life of the option is based on the U.S. Treasury yield curve in effect at the time of grant. We assume that the dividend rate on our common stock will be zero. For the options granted during the three months ended March 31, 2025, we used a risk-free rate of 4.06%, an expected term of 5.5 years, and an expected stock volatility of 75%. There wereno options granted during the three months ended March 31, 2024. We have elected to recognize forfeitures of stock-based awards as they occur.
Income Taxes
We account for income taxes using the asset and liability method. Under the asset and liability method, current income tax expense or benefit is the amount of income taxes expected to be payable or refundable for the current year. Tax rate changes are reflected in income during the period such changes are enacted. We measure our deferred tax assets and liabilities using the enacted tax rates that we believe will apply in the years in which the temporary differences are expected to be recovered or paid. We expect that recent tax law changes contained in the Inflation Reduction Act and CHIPS Act will not have a material impact on the provision for income taxes.
A deferred income tax asset or liability is recognized for future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases and tax credits and loss carryforwards. Deferred tax assets are reduced by a valuation allowance when, in the opinion of management, it is more likely than not that some portion or all of the deferred tax assets will not be realized. All of our tax years remain subject to examination by the tax authorities.
Our policy for recording interest and penalties associated with audits is to record such items as a component of income before taxes. There were no such items in the three months ended March 31, 2025 and 2024.
Fair Value Measurements
Our consolidated balance sheets may include certain financial instruments that are carried at fair value. Fair value is the price that would be received from the sale of an asset or paid to transfer a liability assuming an orderly transaction in the most advantageous market at the measurement date. U.S. GAAP establishes a hierarchical disclosure framework which prioritizes and ranks the level of observability of inputs used in measuring fair value. These tiers include:
| ● | Level 1, defined as observable inputs such as quoted prices in active markets for identical assets; |
|---|---|
| ● | Level 2, defined as observable inputs other than Level 1 prices such as quoted prices for similar assets; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities; and |
| ● | Level 3, defined as unobservable inputs in which little or no market data exists, therefore requiring an entity to develop its own assumptions. |
An asset or liability’s level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement. At each reporting period, if applicable, we perform a detailed analysis of our assets and liabilities that are measured at fair value. All assets and liabilities for which the fair value measurement is based on significant unobservable inputs or instruments which trade infrequently and therefore have little or no price transparency are classified as Level 3.
Basic and Diluted Loss per Share
In periods of net loss, basic loss per share is computed by dividing net loss available to common stockholders by the weighted average number of shares of common stock outstanding during the period. In periods of net loss, diluted loss per share is calculated similarly to basic loss per share because the impact of all potential dilutive common shares is anti-dilutive.
For periods of net income, diluted earnings per share is computed using the more dilutive of the “treasury method” or “two class method.” Dilutive earnings per share under the “treasury method” is calculated by dividing net income available to common stockholders by the weighted- average number of shares outstanding plus the dilutive impact of all potential dilutive common shares, consisting primarily of common shares underlying common stock options and stock purchase warrants using the treasury stock method, and convertible notes using the if-converted method. Because none of the Company’s currently outstanding equity-linked financial instruments contain non-forfeitable rights to dividends, the “two class” method results in the same diluted earnings per share as the “treasury method.”
All of our potential dilutive securities are considered anti-dilutive for the three months ended March 31, 2025 and 2024. The following table sets forth the potential dilutive securities excluded from the calculation of diluted loss per share for the periods presented.
| Three months ended March 31, 2025 | Three months ended March 31, 2024 | |
|---|---|---|
| Shares underlying: | ||
| Common stock options | 3,334,958 | 3,189,167 |
| Stock purchase warrants | - | 450,000 |
| Financing participation right and contingent warrant | - | 500,000 |
| Performance shares | 300,000 | 300,000 |
| 3,634,958 | 4,439,167 | |
Segment Information
Operating segments are defined as components of an enterprise (business activity from which it earns revenue and incurs expenses) for which discrete financial information is available and regularly reviewed by the chief operating decision maker ("CODM") in deciding how to allocate resources and in assessing performance. The Company’s CODM is its Chief Executive and Financial Officer. The Company views its operations and manages its business as a single operating and reporting segment. All the Company’s long-lived assets are in the United States.
Recent Accounting Developments
In December 2023, the FASB issued final guidance in ASU No. 2023-09, Income Taxes (ASC 740): Improvements to Income Tax Disclosures requiring entities to provide additional information in the rate reconciliation and disclosures about income taxes paid. For public business entities, the guidance is effective for annual periods beginning after December 15, 2024. We are currently evaluating the effect of the adoption of this guidance.
We have evaluated all other issued and unadopted Accounting Standards Updates and believe the adoption of these standards will not have a material impact on our consolidated results of operations, financial position, or cash flows.
Note 3 –** Property and Equipment**
Property and equipment, net consisted of the following:
| March 31, 2025 | December 31, 2024 | |
|---|---|---|
| Medical equipment | $758,527 | $538,527 |
| Office/warehouse equipment | 48,019 | 48,019 |
| Warehouse/production equipment | 33,200 | 23,317 |
| 839,746 | 609,863 | |
| Less accumulated depreciation | (448,187) | (432,841) |
| Property and equipment, net | $391,559 | $177,022 |
Depreciation expense was $15,347 (of which $11,210 was charged to cost of goods sold) and $3,767 for the three months ended March 31, 2025 and 2024, respectively. None of our long-lived assets were deemed to be impaired during the three months ended March 31, 2025 and 2024.
Note 4–** Distribution Agreement with Smith+Nephew**
On March 31, 2025, we entered into a Distribution Agreement (the “Distribution Agreement”) with Smith & Nephew, Inc (“Smith+Nephew”), a U.S. subsidiary of Smith & Nephew PLC, 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 brand Aurix product.
Under the Distribution Agreement, Smith+Nephew will purchase Private Label product from us, from time to time at agreed upon transfer pricing and we will manufacture, package, and ship the Private Label product to Smith+Nephew’s customers in accordance with purchase orders and the Distribution Agreement. During the Initial Term of the Distribution Agreement commencing on the First Date of Sale by Smith+Nephew, minimum annual purchase commitments will apply to Smith+Nephew of an average of approximately $500,000 per year for Smith+Nephew to maintain exclusive distribution rights.
As consideration for entering into the Distribution Agreement, we have received an upfront fee of $1.5 million from Smith+Nephew and we are eligible for an additional $750,000 in milestone fees based on our establishment and maintenance of reimbursement in certain categories for the Aurix and the Private Label products. Such fees will be refundable to Smith+Nephew on a pro rata basis for the unexpired initial term of the Distribution Agreement if we do not comply with certain terms and conditions. In February 2025, we received $200,000 of the upfront distribution fee as an exclusivity payment which is reflected as deferred revenue as of March 31, 2025.
The Distribution Agreement is for an initial term offive years and is renewable for additionaltwo-year terms subject to earlier termination in accordance with the terms and conditions of the agreement. Although the Distribution Agreement is exclusive to Smith+Nephew in the United States, we are entitled to maintain our existing distributors and sales agents for the Aurix product. The Distribution Agreement also contains other standard and negotiated terms and conditions including non-solicitation of each parties’ customers based on identified customer lists, and liability and indemnity clauses.
In connection with entering into the Distribution Agreement, Smith+Nephew obtained certain additional information rights related to Nuo’s business and corporate matters. In particular, we provided Smith+Nephew a right of notification and a right of first negotiation over a defined period, in the event we receive from another party a proposal for (a) the license, assignment, transfer, or disposal of our Aurix product or related products, or (b) a business combination that we submit or recommend to our stockholders. These rights continue for a limited period of the initial term of the Distribution Agreement.
Note 5–** Stock Purchase Warrants**
The following schedule reflects outstanding stock purchase warrants as of March 31, 2025 and December 31, 2024:
| Description | March 31, 2025 | March 31, 2024 |
|---|---|---|
| 2022 Sales incentive warrants | 450,000 | 450,000 |
| 2024 Financing Participation warrant | - | 500,000 |
| Total | 450,000 | 950,000 |
During the year ended December 31, 2022, we issued two warrants to purchase (i)250,000 shares of common stock at an exercise price of $1.00 per share and expiring December 31, 2027 and (ii)200,000 shares of common stock at an exercise price of $1.50 per share and expiring December 31, 2028 to a distribution partner under an agreement whereby the warrants were exercisable subject to the distributor attaining certain performance goals based upon exceeding sales quota revenues for calendar years 2023 through potentially 2025. According to the warrants' vesting provisions, they will not be exercisable throughout the remainder of their term. The warrants are equity classified. Additionally, we agreed to issue certain additional warrants to acquire up to 500,000 shares of common stock to the same distribution partner where the issuance of the warrant was contingent upon future financing events. This warrant was issued as of January 1, 2024 and exercised in its entirety by the holder during the year ended December 31, 2024. SeeNote 6–Equity and Stock Based Compensationfor further information.
Note 6–** Equity and Stock-Based Compensation**
Under the Second Amended and Restated Certificate of Incorporation, we have the authority to issue a total of 101,000,000 shares of capital stock, consisting of 100,000,000 shares of common stock and 1,000,000 shares of preferred stock, par value $0.0001 per share, which will have such rights, powers and preferences as the Board of Directors shall determine.
Pacific Medical Common Stock and Warrant Purchase Agreement
On August 24, 2022, we entered into a Common Stock and Warrant Purchase Agreement (the “Agreement”) with Pacific Medical, Inc. (“Pacific Med”) for the sale and issuance of shares of common stock and warrants to purchase shares of common stock. Pacific Med is the exclusive distributor for the Aurix products within a territory that covers the states of Washington, Oregon, Idaho, Montana, Wyoming, most of California, the northern half of Nevada, plus Alaska.
Pursuant to the Agreement, Pacific Med purchased 500,000 shares of common stock for $500,000. As part of the purchase of common stock, we agreed to grant to Pacific Med the right to participate in any future financing by Nuo through December 31, 2023 (the “Participation Rights”) in connection with a listing of our common stock on a national securities exchange. The Participation Rights entitled Pacific Med to purchase up to 500,000 shares of common stock upon substantially the same terms, conditions, and price provided for in such financing. If such a financing did not occur by December 31, 2023, we agreed to issue Pacific Med a warrant with a January 1, 2024 issuance date and exercisable until June 30, 2024, to purchase up to 500,000 shares of common stock at a price equal to the lower of $2.00 per share or the 20-day volume weighted average closing price per share ending December 31, 2023 (the “2024 Financing Participation warrant”). We issued the 2024 Financing Participation warrant to Pacific Med on January 1, 2024 with an exercise price of $0.56 per share. Pacific Med exercised (i)270,000 of the warrants for cash proceeds of $151,200 and (ii) the remaining 230,000 warrants cashlessly in exchange for the issuance of 86,889 shares of common stock during the year ended December 31, 2024. The common stock and Participation Rights are equity classified.
As part of the Agreement and as additional incentive compensation with respect to Pacific Med’s performance under the sales and distribution arrangement, we also provided to Pacific Med two compensatory performance-based stock purchase warrants and certain contingently issuable performance shares. The first warrant entitled Pacific Med to purchase up to 250,000 shares of common stock at a price of $1.00 per share upon Pacific Med attaining certain performance goals based upon exceeding sales quota revenue for calendar years 2023 and/or 2024. The second warrant entitles Pacific Med to purchase up to 200,000 shares of Common Stock at a price of $1.50 per share upon Pacific Med attaining certain performance goals based upon exceeding sales quota revenue for calendar years 2024 and/or 2025. The warrants will expire December 31, 2027 and December 31, 2028, respectively. However, the performance goals providing for exercisability of the warrants were not achieved and the warrants will not be exercisable throughout the remainder of their term. We also agreed to issue up to 300,000 shares of common stock to Pacific Med subject to and upon the achievement of certain milestones set forth in the Agreement based upon sales of our products over defined 12-month periods of between $4.5 million by June 30, 2024 through at least $12.5 million in calendar year 2025 (the Performance Shares”). The fair value of the Performance Shares at the date of issuance was approximately $615,000 based on the closing stock price on the closing of the Agreement. As the issuance of the shares is not considered probable as of March 31, 2025, there wasno expense recognition for the three months ended March 31, 2025. When issuance is determined to be probable, the issuance date fair value of the shares through such date will be recognized with the balance of the fair value recognized ratably over the remaining period of performance.
Stock-Based Compensation
In July 2016, the Board of Directors approved the 2016 Omnibus Incentive Plan (the “Plan”), and in November 2016, holders of a majority of our capital stock approved the Plan, as amended and restated, which provides for the grant of equity and cash incentive awards to officers, directors and employees of, and consultants to, Nuo Therapeutics and its subsidiaries. Further, in March 2022, the Board approved an amendment to the Plan to increase the shares available to 4,250,000 and remove an annual evergreen provision, which was approved by the holders of a majority of our outstanding common stock and which became effective in June 2022.
A summary of stock option activity under the Plan during the three months ended March 31, 2025 is presented below:
| Stock Options – 2016 Omnibus Plan | Shares | Weighted Average Exercise Price | Weighted Average Remaining Contractual Term |
|---|---|---|---|
| Outstanding at January 1, 2025 | 3,258,958 | $0.61 | 5.30 |
| Granted | 76,000 | 1.19 | 10.0 |
| Exercised | - | - | - |
| Forfeited or expired | - | - | - |
| Outstanding at March 31, 2025 | 3,334,958 | $0.62 | 5.17 |
| Exercisable at March 31, 2025 | 2,805,375 | $0.65 | 4.38 |
There were 76,000 stock options granted to an employee and a third-party consultant during the three months ended March 31, 2025. The fair value of the options to vest over three years was approximately $59,800. The aggregate intrinsic value for outstanding and exercisable options as of March 31, 2025 was approximately $1,927,000 and $1,552,000 respectively. There wereno options granted during the three months ended March 31, 2024.
For the three months ended March 31, 2025 and 2024, we recorded stock-based compensation expense of $19,343 and $3,081, respectively. As of March 31, 2025, there was approximately $143,700 of unrecognized compensation cost related to the non-vested stock options which is expected to be recognized prior to year-end 2028.
Note 7–** Segment Information**
We manage our business activities on a consolidated basis and operate as asingle operating segment dedicated to developing and marketing products for chronic wound care that harness the regenerative capacity of the human body to trigger natural healing. We derive our revenue from product sales of the Aurix product line. The accounting policies of the segment are the same as those described inNote 2–* Liquidity and Summary of Significant Accounting Policies.*
Our CODM is Nuo's Chief Executive and Financial Officer, David E. Jorden. The CODM uses net loss, as reported in our consolidated statements of operations, in evaluating the performance of the segment and determining how to allocate our resources of as a whole. The CODM does not review assets in evaluating the results of the segment, and therefore, such information is not presented.
The following table presents the operating results of the segment:
| Three Months Ended March 31, | Three Months Ended March 31, | |
|---|---|---|
| 2025 | 2024 | |
| Total revenues | $484,381 | $234,577 |
| Less significant segment expenses: | ||
| Cost of sales (excluding provision for inventory obsolescence and applicable depreciation expense) | 100,692 | 50,591 |
| Total compensation and benefit costs (including third party commission expense) | 562,907 | 483,992 |
| Provisions for credit losses and inventory obsolescence | 21,644 | 17,500 |
| All other operating expenses (excluding depreciation and credit loss provision) (a) | 492,344 | 361,135 |
| Other segment items: | ||
| Depreciation, amortization of right of use assets, and stock-based compensation | 51,941 | 30,605 |
| Interest expense (income), net | 1,595 | (465) |
| Other expense (income), net | (614) | - |
| Consolidated net loss | $(746,128) | $(708,781) |
(a)All other operating expenses included in consolidated net loss includes professional fees, lease expenses, insurance costs, travel and entertainment expenses, and all other selling, general and administrative expenses.
Note 8–** Commitments and Contingencies**
Lease Agreements
In January 2022, we entered into a commercial operating lease agreement for office space in Florida, expiring on December 31, 2024. The lease required us to pay for insurance, taxes, and our share of common operating expenses. The lease resulted in an increase in right of use assets and lease liabilities of $89,312, using a discount rate of 10%. Effective March 24, 2024, Nuo and the landlord agreed to terminate the lease effective immediately. We incurredno costs related to the lease termination and the remaining right of use asset and operating lease liability were written off with the resulting immaterial difference recorded as a gain in other income.
In February 2022, we entered into an additional commercial operating lease for our primary office and warehouse/distribution space in Texas. The lease requires us to pay for insurance, taxes, and our share of common operating expenses. This lease expires in March 2027. This lease is classified as an operating lease and we established a right of use asset and lease liability using a 10% discount rate.
Total operating lease costs were approximately $29,000 and $36,500 for the three months ended March 31, 2025 and 2024, respectively, consisting solely of base rental and common area maintenance costs. We have no financing leases.
Future undiscounted cash flows under this lease are:
| 2025 | 60,205 |
| 2026 | 82,705 |
| 2027 | 21,284 |
| Total operating lease payments | 164,194 |
| Discount factor | (16,085) |
| Present value of operating lease liabilities | 148,109 |
| Current portion of operating lease liabilities | (69,160) |
| Non-current portion of operating lease liabilities | $78,949 |
Note 9–** Subsequent Events**
The Company has evaluated subsequent events through the date the consolidated financial statements were available to be issued. No material events requiring disclosure were identified.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.