AURX 10-K & 10-Q changes, risk factors and insider trading

Our Revenue Base Is Limited to a Single Product Seeking Market Adoption; We Need Substantial Additional Financing and our Ability to Successfully Affect Such Financing Could Be Limited.Adoption.

Our current revenue base is limited to our Aurix product, andincluding ourthe Private Label product. Our revenue from Aurix revenueand the Private Label product has been limited to date. We have a history of losses and are not currently profitable. For the year ended December 31, 2024,2025, we incurred a net loss of approximately $2.3$2.5 million. Even if we succeed in raisingincreasing substantialour additional funds,revenue, we expect tomay incur losses and negative operating cash flows in the immediate future. We may never generate sufficient revenues to achieve and maintain profitability.

Historically, we have financed our operations through a combination of the sale of debt, equity and equity-linked securities, licensing, royalty, and product revenues. Until we can generate a sufficient amount of revenues to finance our cash requirements, which we may never do, we need to finance future cash needs. It is substantially uncertain whether we will be able to obtain such financing on satisfactory terms or at all.

We only recently began re-implementing our commercialization strategy for Aurix in the second half of 2022. Thus, we still have a limited operating history. Continued operating losses, together with the risks associated with our ability to gain new customers for Aurix, may have a material adverse effect on our liquidity. We may also be forced to respond to unforeseen difficulties, such as decreased demand for our products and services, downward pricing trends, regulatory requirements, and unanticipated market pressures.

The Company reestablished commercial operations in 2022 and generated limited revenues of approximately $112,000 for the year ended December 31, 2022. For the year ended December 31, 2023, product revenues increased to approximately $609,000 while subsequently increasing to $1,365,000 for the year ended December 31, 2024. For the years ended December 31, 20242025 and 2023,2024, the Company had a net loss of approximately $2.3$2.5 million and $3.2$2.3 million, respectively. There can be no assurances that we will be able to achieve a level of revenues adequate to generate sufficient cash flow from operations or obtain funding from additional financing through private placements, public offerings and/or bank financing necessary to support our working capital requirements. It is uncertain whether we will be able to obtain such financing on satisfactory terms or at all. Our continuing losses and limited cash resources raise substantial doubt about our ability to continue as a going concern, and we need to raise substantial additional funds in order to continue to conduct our business. If we are unable to increase our revenues to secure sufficient capital to fund our operating activities, we may be forced to delay the completion of, or significantly reduce the scope of, our current business plan, delay the pursuit of commercial payor insurance reimbursement for our wound treatment technologies,product, and/or postpone the hiring of new personnel.

Should we seek to expand ourpursue commercialization internationally, we would be subject to international regulations, where the pricing of prescription pharmaceutical products and services and the level of government reimbursement may be subject to governmental control. In some countries, pricing negotiations with governmental authorities can take six to twelve months or longer after the receipt of marketing approval for a product. To obtain reimbursement or pricing approval in some countries, we may be required to conduct one or more clinical trials that compare the cost effectiveness of our product or product candidates to other available therapies. Conducting one or more of these clinical trials would be expensive and result in delays in the commercialization of our current and future products.

Even if positive clinical data is eventually achieved in any future clinical trials, we may not be able to enter into strategic partnerships, licensing, or other similar arrangements that we may consider necessary or appropriate to commercialize product candidates successfully,successfully or even have the resources necessary to seek such arrangements. Furthermore, even if such a strategic relationship regarding any of our current and future products or product candidates is reached, development milestones, clinical data, or other such benchmarks may not be achieved. Therefore, our products and product candidates may never proceed toward commercialization or drive cash infusions for us, and we may ultimately not be able to monetize the patents, existing clinical data, and other intellectual property.

Our future success depends on our ability to attract, retain, and motivate highly skilled management, scientific and sales personnel. As of December 31, 2024,2025, we had only nineten full-time employees. Our ability to maintain and provide services to our customers and our ability to provide the necessary support as part of any collaborations depends upon our ability to hire and retain business development and scientific and technical personnel with the skills necessary to keep pace with continuing changes in regenerative biological therapy technologies. Our current liquidity situation makes it unlikely that we will be able to hire additional personnel in the immediate future. Even assuming that we can resolve our immediate liquidity concerns, competition for such personnel is intense; we compete with pharmaceutical, biotechnology and healthcare companies with greater access to resources. Our inability to hire qualified personnel may lead to higher recruitment, relocation, and compensation costs for such personnel. These increased costs may make hiring new key personnel impractical.

Our success substantially depends on the continued service of key management, in particular David E. Jorden, our Chief Executive and Financial Officer, and Peter Clausen, our Chief Scientific and Operating Officer. We currently do not maintain key person insurance on,on Mr. Jorden or Dr. Clausen. The loss of Mr. Jorden or Dr. Clausen, or other key employees or executive officers, could adversely impact our ability to continue operations unless and until a replacement is identified.

We Rely on a Single Supplier for thea Reagent Used for Aurix and an Interruption in our Supply Chain for any Reagent of Component Could Have a Material Adverse Effect on our Business.

A reagent used for our Aurix product, bovine thrombin (Thrombin JMI), is available exclusively through Pfizer. Pfizer may unilaterally raise the prices for the reagent. If a temporary or permanent interruption in the supply of the bovine thrombin or any other reagent were to occur, or the manufacturing costs charged by Pfizer or any other current supplier exceed what we can reasonably afford, we would have to seek alternative sources of supply. There is no assurance we would be able to identify a suitable second source of supply or do so without significant delay. Despite our efforts to maintain an adequate supply of inventory, the loss of Pfizer,a supplier or its inability to provide us with an adequate supply of a reagent, could cause delay in the manufacture of our product, thereby impairing our ability to meet the demand of our customers and causing significant harm to our business. Any disruption of this nature or increased expenses could harm our commercialization efforts and adversely affect our operating results.

Risks Related to Distribution of Our Aurix Product

On March 31, 2025, we entered into a Distribution Agreement (the “Distribution Agreement”) with 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 (the “Private Label product”).of Aurix System. There is no assurance that Smith + Nephew will find a market for its Private Label product. The amount of oursales saleswe receive under the Distribution Agreement will depend in part on the amount of purchase orders that we receive from Smith+Nephew. If Smith+Nephew does not establish a sufficient market for its Private Label product, then our business and operating results and financial condition may be adversely affected.

While we currently manufacture, package, and ship our Aurix product, we have no history operating as a supplier for a private label product. Establishing and maintaining logistics to supply Private Label product will necessitate that we meet certain deadlines, performance measures and other standards, and compliance and other requirements. This will place demands on our management and financial resources, which may be burdensome particularly for a smaller company like ours. The costs and expenses associated with fulfilling purchase orders resulting from and generally complying with the Distribution Agreement will reduce the correspondingresulting income we earn. There can be no assurance that the demands on our management and financial resources related to the Distribution Agreement will not adversely affect our business and operating results and financial condition.

If Smith+Nephew determines that marketing and sales of its Private Label product do not meet its expectations or priorities, then Smith+Nephew may terminate the Distribution Agreement. The Distribution Agreement is for an initial term of five years, but Smith+Nephew has the ability to terminate upon 12 months’ notice. If Smith+Nephew determines that sales of its Private Label product do not meet expectation or priorities, or Smith+Nephew otherwise determines not to continue marketing the Private Label product, then Smith+Nephew may terminate the Distribution Agreement. In such an event, we would no longer generate revenues under the Distribution Agreement and our business and operating results and financial condition may be adversely affected.

In the market for biotechnology products, we face competition from pharmaceutical companies, biopharmaceutical companies, medical device companies, and other competitors. Despite theIn addition ofto the Private Label product and our Distribution Agreement with Smith+Nephew, we will continue to face other competitive forces. The chronic wound market has many therapies that compete with Aurix that have established habitual use patterns and provider contracts to encourage standardized use. Furthermore, other companies have developed or are developing products that could be in direct future competition with our current product line. Biotechnology development projects are characterized by intense competition. Thus, we may not be the first to market with any newly developed products and we may not successfully be able to market these products. If we are not able to participate and compete in the regenerative biological therapy market, our financial condition will be materially and adversely affected. We may not be able to compete effectively against such companies in the future. Many of these companies have substantially greater capital resources, larger marketing staff and more experience in commercializing products than we do. Recently developed technologies, or technologies that may be developed in the future, may be the basis for developments that will compete with our current and future products.

In addition and subject to the Distribution Agreement with Smith+Nephew, we may in the future selectively pursue strategic collaborations or engagements for, among other purposes, development, data collection, analysis, and/or commercialization of our product candidates, domestically or otherwise. There can be no assurance as to our ability to utilize the data from such engagements to their potential. Nor can there be any assurance, in general, that we will be able to identify suitable future collaborators or negotiate collaboration agreements on terms that are acceptable to us or at all. In any current or future third-party collaborations, we are and would be dependent upon the success of the collaborators in performing their responsibilities and their continued cooperation and engagement. For a variety of reasons outside of our control, our collaborators or third-party providers may not cooperate with us or perform their obligations under our agreements with them. We cannot control the amount and timing of our collaborators’ resources that will be devoted to performing their responsibilities under our agreements with them. Our collaborators may choose to pursue alternative technologies in preference to those being developed in collaboration with us. The development and commercialization of our product candidates will be delayed if collaborators fail to conduct their responsibilities in a timely manner or in accordance with applicable regulatory requirements or if they breach or terminate their collaboration agreements with us. Disputes with our collaborators could also result in product development delays, decreased revenues and litigation expenses. Furthermore, under the Distribution Agreement, we must offer Smith+Nephew certain licensing and distribution rights in connection with improvements to our Aurix product and new products, as well as additional notification and negotiationnegotiations rights.rights described above. These rights may prevent or limit our ability to use third-party collaborators and service providers.

Our success is also impacted by factors outside of our control. Our current technology and products are subject to extensive regulation by numerous governmental authorities in the U.S., both federal and state, and in foreign countries by various regulatory agencies. Specifically, our product is subject to regulation by the U.S. Food and Drug Administration, or FDA, and state regulatory agencies. The FDA regulates drugs, medical devices, and biologics that move in interstate commerce and requires that such products receive clearance or pre-marketing approval based on evidence of safety and efficacy. The regulations of government health ministries in foreign countries are analogous to those of the FDA in both application and scope. In addition, any change in current regulatory interpretations by, or the positions of, state regulatory officials where our product is used could materially and adversely affect our ability to sell our product in those states. The FDA will require us to obtain clearance or approval of new or modified devices when used for treating specific wounds or marketed with specific wound-healing claims, or for other products under development.

Any applicable manufacturer that fails to timely, accurately, or completely report the information required in accordance with the rules of the Sunshine Act is subject to a civil monetary penalty of, as of January 28, 2026, not less than $1,000,$1,443, but not more than $10,000,$14,432, for each payment or other transfer of value or ownership or investment interest not reported timely, accurately, or completely (up to $150,000$216,490). For “knowing” failures to report, the penalties increase to not less than $10,000,$14,432, but not more than $100,000,$144,329, for each such failure (up to $1,000,000$1,443,275). The amount of civil monetary penalties imposed on each applicable manufacturer or applicable group purchasing organization is aggregated separately. Subject to separate aggregate totals, the maximum combined annual total is $1,150,000.$1,659,765.

Several of the U.S. states have parallel reporting laws, sometimes accompanied with “gift bans” prohibiting manufacturers from making gifts or other remunerations to prescribers. MassachusettsThere and Vermont are two such states. Therealso are various penalties associated with noncompliance with the state laws, as well.laws.

We have initially and may in the future further seek to market some of our product candidates outside the U.S. In order to market our product candidates in the European Union and many other jurisdictions, we must submit clinical data concerning our product candidates and obtain separate regulatory approvals and comply with numerous and varying regulatory requirements. The approval procedure varies among countries and can involve additional testing. The time required to obtain approval from foreign regulators may be longer than the time required to obtain FDA approval. The regulatory approval process outside the U.S. may include all of the risks associated with obtaining FDA approval. In addition, in many countries outside the U.S., it is required that the product candidate be approved for reimbursement before it can be approved for sale in that country. In some cases, this may include approval of the price we intend to charge for our product, if approved. We may not obtain approvals from regulatory authorities outside the U.S. on a timely basis, or at all. Approval by the FDA does not ensure approval by regulatory authorities in other countries or jurisdictions, and approval by one regulatory authority outside the U.S. does not ensure approval by regulatory authorities in other countries or jurisdictions or by the FDA, but a failure or delay in obtaining regulatory approval in one country may negatively affect the regulatory process in other countries. We may not be able to file for regulatory approvals and may not receive the necessary approvals to commercialize any products in any market and therefore may not be able to generate sufficient revenues to support our business.

Shares of our common stock currently resumed trading on the OTCQB on August 22, 2022. Prior to then, due to a prior lack of current and publicly available information about the Company, trading in shares of our common stock was eligible only for unsolicited quotes on the “Expert Market” of the OTC Markets Group. Because quotations in Expert Market securities are restricted from public viewing, the designation severely limits the number of buyers of and effectively prevents the development of an active trading market in, designated securities. Even though shares of our common stock now trade on the OTCQB, there can be no assurance as to whether OTC Markets Group will continue to enable shares of our common stock to be quoted on a retail market or whether shares of our common stock can successfully be traded on other trading platforms. As a result, any limited trading of shares of our common stock subject to having a higher risk of wider spreads, increased volatility, and price dislocations.

Among the terms of the Distribution Agreement, we provided to Smith+Nephew for a period of 18 months a right of notification, and a right of first negotiation for 45 days, in the event we receive a proposal from another party 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. Under the Distribution Agreement, we also provided to Smith+Nephew a right of notification and participation in any proposed sale of our equity securities. There can be no assurance whether we will receive a proposal or offer, or consummate a relevant transaction, during the 18-month period through September 2026. There also can be no assurance whether we seek to sell equity securities during the term of the Distribution Agreement. The existence of these rights may adversely impact whether we receive licensing or similar proposals, whether we receive a business combination offer, or whether we seek to sell equity securities. Even if we receive such a proposal or offer, or sell securities, the existence of these rights held by Smith+Nephew may adversely affect to the price and terms of such a proposal, offer, or transaction, and the willingness of and timing for us or other parties to complete such a proposal, offer, or transaction.

Nuo is a regenerativecommercial-stage therapiesmedical device company focused on developing and marketing productsregenerative therapies for chronic wound care primarily within the U.S. We commercialize innovative cell-based technologies that harness the regenerative capacity of the human body to trigger natural healing. The use of autologous (i.e., from self or the patient’s own) biological therapies for tissue repair and regeneration is part of a transformative clinical strategy designed to improve long-term recovery in complex chronic conditions with significant unmet medical needs.

On March 31, 2025, we entered into athe Distribution Agreement (the “Distribution Agreement”) with a U.S. affiliate of Smith & Nephew PLC ("Smith+Nephew"),Nephew, a global medical technology company. Under the Distribution Agreement, we will supply Smith+Nephew with 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”),product, we have the ability and will continue to market, distribute, and sell our own Aurix branded product. The Distribution Agreement is for an initial term of five years and is renewable for additional two-year terms, subject to provisions for earlier termination.

Under the Distribution Agreement, Smith+Nephew will purchase Private Label product from us from time to time at agreed upon transfer pricing and we shall 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 onin theOctober date of first sale by Smith+Nephew,2025, 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, Smith+Nephew will paypaid us upan toupfront $2,250,000distribution fee of $1,500,000 for distribution rights and we are also eligible to be paid by Smith+Nephew an additional $750,000 in exchangefees forbased on our establishment and maintenance of reimbursement in certain categories for the Aurix and the Private Label products. SuchThese 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. A portion of the $2,250,000 was previously paid to us during the fiscal period ended March 31, 2025 in connection with entering into an exclusivity period to negotiate the Distribution Agreement.

We believe that Smith+Nephew will need time to establish and beginfull commercial sales of its Private Label product.product via its direct and indirect sales efforts. As a result, weour anticipate limited salesrevenues under the Distribution Agreement may increase modestly during the next 12 months. While the Distribution Agreement will provide us with revenues, we also will incur expenses at the outset ofunder 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.

Other income for the year ended December 31, 2025 was nominal in amount. Other income for the year ended December 31, 2024 primarily represents the gain of approximately $133,600 realized from the negotiated settlement of legacy accounts payable with third-party vendors including the full release of any ongoing payment liability.

As of December 31, 2024,2025, we had cash and cash equivalents of approximately $0.3$0.5 million, total current assets of approximately $0.8$1.4 million and total current liabilities of approximately $0.6$1.3 million. We have a history of losses and are not currently profitable. For the years ended December 31, 20242025 and 2023,2024, we incurred net losses of approximately $2.3$2.5 million and $3.2$2.3 million, respectively. As of December 31, 2024,2025, our accumulated deficit was approximately $32.3$34.8 million and our stockholders’ equitydeficit was approximately $0.5$1.0 million.

During the year ended December 31, 2023,2025, we sold 2,442,500527,612 shares of common stock to certain accredited investors pursuant to a Securities Purchase AgreementsAgreement in twoa private placementsplacement which closed in AugustJuly and December 20232025 for total proceeds of $1,997,500.$791,418. We issued 283,853 shares of common stock upon option exercises for gross proceeds of $113,541. As of December 31, 2025, $500,000 in secured notes were prefunded by two lenders which included $200,000 advanced from a related party.

Cash used in operating activities for the year ended December 31, 20242025 of approximately $2.2$0.9 million primarily reflects our net loss of approximately $2.3$2.5 million adjusted by (i) the net$1,275,000 effectincrease ofin deferred revenues, (iii) approximately $0.2 million in total for amortization of right of use assets, depreciation of property and equipment,equipment depreciation, and stock-based compensation,compensation and (iii) approximately $0.1 million in combined provisions for credit losses and inventory obsolescenceobsolescence. partiallyThe offsetdeferred byrevenue is due to the approximatelyreceipt $0.1of the $1.5 million gainupfront ondistribution settlementfee from Smith+Nephew in conjunction with the private label distribution agreement which was effective as of legacyMarch accounts31, payable balances.2025.

Cash used in operating activities for the year ended December 31, 20232024 of approximately $3.2$2.2 million primarily reflects our net loss of approximately $3.2$2.3 million adjusted by an offsetting approximately $0.3 millionthe net changeeffect in operating assets and liabilities andof (i) approximately $0.1$0.2 million in total for amortization of right of use assets, depreciation of property and equipment depreciation,equipment, and stock-based compensationcompensation, and (ii) approximately $0.2$0.1 million in combined provisions for credit losses and inventory obsolescence.obsolescence partially offset by the approximately $0.1 million gain on settlement of legacy accounts payable balances.

Cash used in investing activities for the year ended December 31, 20242025 of approximately $155,000$275,000 primarily represents ourapproximately $220,000 in expenditures for the purchase of Aurix centrifuge devices in the amount of approximately $151,000. We had limited investing activities of approximately $7,000 for the year ended December 31, 2023.devices.

See the discussion of Recent Accounting Developments in Note 2 - Liquidity and Summary of Significant Accounting Principles.Policies.

ThereExcept as described below in this Item 1A, there have been no material changes from the risk factors as previously disclosed in our Annual Report on Form 10-K for the fiscal year ended December 31, 2025.

Although the FDA cleared the Aurix System for marketing for wound care management in 2007 under Section 510(k) of the FDCA, economically viable reimbursement in the commercial market for the product only became viable with CMS's issuance of the NCD in 2021. For 2026, the CMS national average reimbursement rate for the Aurix System is $2,108 per treatment in place of service ("POS") 22 (hospital outpatient departments), which we believe provides appropriate payment to facilities for product usage. WeFor submitted public comments to CMS as part of its annual rule-making procedures under2027, the Physician Fee Schedule ("PFS") for payments to clinicians in primarily POS 11 (physician offices) in both 2023 and 2024. In November 2024, CMS issued its final PFS for calendar 2025 and established a national averageproposed payment of $890. In response to this final rule which removed the payment amount discretion from the MACs within POS 11, the Aurix System became economically viable within the physician office care setting effective January 1, 2025. For 2026, the CMS national average reimbursement rate for the Aurix System is $1,064 per treatment in POS 1122 is $2,360 pursuant to the proposed Outpatient Prospective Payment System (private“OPPS”) offices).covering Medicare payments in hospitals and ambulatory surgery centers.

As of MarchJune 31,30, 2026, we had established contractual relationships with more than 200 third-party entityentities and individual representatives. The number of sales agent representatives may continue to expand modestly in the months ahead, but the current focus is broadening commercial customer relationships with wound care providers operating in private office settings while continuing to engage with hospitals and hospital systems regarding expanded POS 22 usage while ensuring that the reimbursement mechanisms are appropriately administered by the local Medicare Administrative Contractors in support of the April 2021 NCD.

The amounts presented in thisthese comparison sectionsections are rounded to the nearest thousand.

Total revenues for the three months ended MarchJune 31,30, 2026 totaled approximately $1,302,000$1,769,000 including approximately $78,000 of distribution fee revenue related to the Smith+Nephew distribution agreement as amended. Product revenues for the three months ended MarchJune 31,30, 2026 totaled approximately $1,224,000$1,691,000 in comparison to Aurix only product and total revenues of approximately $484,000$625,000 for the three months ended MarchJune 31,30, 2025 representing an increase of approximately $740,000$1,066,000 or approximately 153%.170%. Product revenues associated with the Smith+Nephew private label distribution arrangement recognized during the three months ended MarchJune 31,30, 2026 consisted of (i) centrifuge devices sold to Smith+Nephew and (ii) fulfillment of purchase orders for stocking of Private Label kits. Associated gross profit was approximately $850,000$1,170,000 for the three months ended MarchJune 31,30, 2026 in comparison to approximately $363,000$541,000 of gross profit in the three months ended MarchJune 31,30, 2025.

The increase in revenues was due primarily to (i) increased Aurix product revenues resulting from an expanding customer base over the past year, (ii) Smith+Nephew related product revenues for centrifuge devices and kits solely and (iii) distribution fee revenue recognized under the distribution agreement as amended. Aggregate gross margin was approximately 65%66% for the three months ended MarchJune 31,30, 2026 as compared to approximately 75%77% for the three months ended MarchJune 31,30, 2025. The gross margin decline was primarily due to (i) the centrifuge devices sold to Smith+Nephew at a near zero gross margin on the negotiated transfer price of the devices and (ii) lower product gross margins on sales of Private Label kits to Smith+Nephew resulting from transfer pricing which was partially offset by approximately 4% of gross margin attributable directly to distribution fee revenue having no associated cost.

Total operating expenses increased approximately $188,000$144,000 to approximately $1,296,000$1,337,000 comparing the three months ended MarchJune 31,30, 2026 to the three months ended MarchJune 31,30, 2025. The increase from the prior year was due primarily to increases in (i) compensation and benefit costs of approximately $110,000$67,000 and (ii) third party commission expense of approximately $158,000$110,000 for independent sales representatives and distributors resulting from increased Aurix product revenues which was partially offset by a decrease in professional fees of approximately $74,000$78,000 primarily as the costs associated with theprior finalizationyear ofSEC theregistration Smith+Nephew distribution agreementexpenses were absent in the current year period.

Interest income (expense), net for the three months ended MarchJune 31,30, 2026 primarily represents (i) $25,000$50,250 of non-cash interest expense on the secured notes payable and (ii) $149,365$63,660 of debt discount amortization considered interest expense due to our election of the fair value option while other income (expense) for the three months ended MarchJune 31,30, 2025 was nominal.

As of MarchJune 31,30, 2026, we had cash balances of approximately $0.3$0.4 million, total current assets of approximately $1.5$2.0 million and total current liabilities of approximately $1.4$1.6 million. As an operational business, we have a history of losses and are not currently profitable. For the years ended December 31, 2025, and 2024, we incurred net losses of approximately $2.5 million and $2.3 million, respectively. As of MarchJune 31,30, 2026, our accumulated deficit was approximately $35.4$35.7 million and our stockholders’ deficit was approximately $1.4$1.5 million.

In January 2026, we received funding proceeds from the issuance of secured notes payable of $500,000 in addition to $500,000 of proceeds which were pre-funded on December 31, 2025. The total amount of notes payable at the initial closing was $1,000,000. In May 2026, we received additional proceeds of $675,000 from the issuance of secured notes payable in an interim funding.

Cash used in operating activities for the threesix months ended MarchJune 31,30, 2026 of approximately $784,000$1,021,000 primarily reflects our net loss of approximately $618,000$896,000 adjusted by (i) approximately $423,000$604,000 net change in operating assets and liabilities,liabilities and partially offset by (ii) non-cash interest expense and amortization of debt discount on notes payable issued of approximately $175,000,$289,000, and (iii) approximately $83,000$191,000 in total for amortization of right of use assets, depreciation of property and equipment, stock-based compensation, and vendor expense settled in shares of common stock.

Cash provided by operating activities for the threesix months ended MarchJune 31,30, 2025 of approximately $2,000$264,000 primarily reflects our net loss of approximately $746,000$1,396,000 adjusted by (i) the $1,425,000 increase in deferred revenues (ii) approximately $474,000$83,000 net change in operating assets and liabilities (excluding deferred revenue), and (iiiii) approximately $52,000$116,000 in total for amortization of right of use assets, depreciation of property and equipment, and stock-based compensation, and (iii) $200,000 increase in deferred revenue.compensation. The deferred revenue is due to the receipt in February 2025 of athe $200,000$1.5 exclusivitymillion paymentupfront distribution fee from Smith+Nephew in conjunction with the private label distribution agreement which was executedeffective as of March 31, 2025.

Cash used in investing activities for the threesix months ended MarchJune 31,30, 2026 was nominal while cash used in investing activities for the three months ended March 31,and 2025 primarily represents $220,000approximately $250,000 and $220,000, respectively in capital expenditures for the purchase of centrifuge devices.

For the threesix months ended MarchJune 31,30, 2026, we received an additional $500,000 in loan proceeds under the secured notes payable after $500,000 of proceeds were pre-funded on December 31, 2025.2025 and a further $675,000 in loan proceeds from an interim funding in May 2026. We did not have any financing activities for the threesix months ended MarchJune 31,30, 2025.