# Nuo Therapeutics, Inc.: Form 10-Q for the period ended Jun 30, 2023 - Company: [Nuo Therapeutics, Inc.](/companies/aurx.md) (CIK 1091596) - Form: 10-Q - Filed: 2023-08-14 - Accepted by EDGAR: Aug 14, 2023, 20:30 ET - Period: 2023-06-30 - Accession: 0001437749-23-023710 - Inline XBRL: yes - Main document: https://www.sec.gov/Archives/edgar/data/1091596/000143774923023710/aurx20230630_10q.htm - All documents and exhibits: https://www.sec.gov/Archives/edgar/data/1091596/000143774923023710/ ## Figures reported in this filing Standardized XBRL line items for the period ended 2023-06-30. | Line item | Period | Value | XBRL concept | | --- | --- | ---: | --- | | Revenue | 3 months, 2023-04-01 to 2023-06-30 | $118.2k | us-gaap:RevenueFromContractWithCustomerIncludingAssessedTax | | Revenue | 6 months, 2023-01-01 to 2023-06-30 | $179.3k | us-gaap:RevenueFromContractWithCustomerIncludingAssessedTax | | Cost of revenue | 3 months, 2023-04-01 to 2023-06-30 | $20.5k | us-gaap:CostOfGoodsAndServicesSold | | Cost of revenue | 6 months, 2023-01-01 to 2023-06-30 | $30.9k | us-gaap:CostOfGoodsAndServicesSold | | Gross profit | 3 months, 2023-04-01 to 2023-06-30 | $97.7k | us-gaap:GrossProfit | | Gross profit | 6 months, 2023-01-01 to 2023-06-30 | $148.4k | us-gaap:GrossProfit | | Selling, general and administrative | 3 months, 2023-04-01 to 2023-06-30 | $969.1k | us-gaap:SellingGeneralAndAdministrativeExpense | | Selling, general and administrative | 6 months, 2023-01-01 to 2023-06-30 | $1.9m | us-gaap:SellingGeneralAndAdministrativeExpense | | Operating income | 3 months, 2023-04-01 to 2023-06-30 | −$871.4k | us-gaap:OperatingIncomeLoss | | Operating income | 6 months, 2023-01-01 to 2023-06-30 | −$1.7m | us-gaap:OperatingIncomeLoss | | Net income | 3 months, 2023-04-01 to 2023-06-30 | −$871.9k | us-gaap:NetIncomeLoss | | Net income | 6 months, 2023-01-01 to 2023-06-30 | −$1.7m | us-gaap:NetIncomeLoss | | Basic EPS | 3 months, 2023-04-01 to 2023-06-30 | −$0.02 | us-gaap:EarningsPerShareBasic | | Basic EPS | 6 months, 2023-01-01 to 2023-06-30 | −$0.04 | us-gaap:EarningsPerShareBasic | | Operating cash flow | 6 months, 2023-01-01 to 2023-06-30 | −$1.7m | us-gaap:NetCashProvidedByUsedInOperatingActivities | | Capital expenditure | 6 months, 2023-01-01 to 2023-06-30 | $5.3k | us-gaap:PaymentsToAcquirePropertyPlantAndEquipment | | Cash and equivalents | at 2023-06-30 | $344.4k | us-gaap:CashAndCashEquivalentsAtCarryingValue | | Current assets | at 2023-06-30 | $1.0m | us-gaap:AssetsCurrent | | Total assets | at 2023-06-30 | $1.4m | us-gaap:Assets | | Current liabilities | at 2023-06-30 | $703.4k | us-gaap:LiabilitiesCurrent | | Total liabilities | at 2023-06-30 | $914.4k | us-gaap:Liabilities | | Shareholders' equity | at 2023-06-30 | $470.8k | us-gaap:StockholdersEquity | ## Management's discussion and analysis As filed, 26,259 characters. *The following discussion and analysis of the financial condition and results of operations of Nuo Therapeutics, Inc. ("Nuo Therapeutics," the "Company," "we," "us," or "our") should be read in conjunction with the financial statements and related notes appearing elsewhere in this Quarterly Report and our Annual Report on Form 10-K for the year ended December 31, 2022 (the “Annual Report”), filed with the U.S. Securities and Exchange Commission (the "SEC") on April 17, 2023.* ### Special Note Regarding Forward Looking Statements Certain statements, other than purely historical information in this Quarterly Report (including this section) constitute “forward-looking statements”. Forward-looking statements are inherently subject to risks and uncertainties and actual results and outcomes may differ materially from the results and outcomes discussed in or anticipated by the forward-looking statements. Forward-looking statements include, without limitation, any statement that may predict, forecast, indicate, or imply future results, performance, or achievements, and may contain the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “will,” “will be,” “will continue,” “will likely result,” “could,” “may” and words of similar import. These statements reflect the Company’s current view of future events and are subject to certain risks and uncertainties as noted in this Quarterly Report and in other reports filed by us with the SEC, including Forms 8-K, 10-Q, and 10-K. These risks and uncertainties include, among others, the following: - our limited revenue base and sources of working capital; - our limited operating experience; - our ability to continue as a going concern - the dilutive impact of raising additional equity or debt; - our ability to timely and accurately report our financial results and prevent fraud if we are unable to maintain effective disclosure and internal controls; - acceptance of our product by the medical community and patients; - our ability to obtain adequate reimbursement from third-party payors; - our ability to contract with healthcare providers; - our reliance on several single source suppliers and our ability to source raw materials at affordable costs; - our ability to protect our intellectual property; - our compliance with governmental regulations; - our ability to successfully sell and market the Aurix System; - our ability to attract and retain key personnel, including both our executive officers; and - our ability to successfully pursue strategic collaborations to help develop, support, or commercialize our current and future products. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results could differ materially from those anticipated in these forward-looking statements. In addition to the risks identified under the heading “Risk Factors” in our Annual Report and the other filings referenced above, other sections of this report may include additional factors which could adversely affect our business and financial performance. Moreover, we operate in a very competitive and rapidly changing environment. New risk factors emerge from time to time, and it is not possible for management to predict all such risk factors, nor can it assess the impact of all such risk factors on our business, or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. Given these risks and uncertainties, investors should not place undue reliance on forward-looking statements as a prediction of actual results. The Company undertakes no obligation and does not intend to update, revise or otherwise publicly release any revisions to its forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of any unanticipated events. ### Business Overview We are a regenerative therapies company focused on developing and marketing products 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, the patient’s own) biological therapies for tissue repair and regeneration is part of a clinical strategy designed to improve long-term recovery in inherently complex chronic conditions with significant unmet medical needs. Our current commercial offering consists of a point of care technology for the safe and effective separation of autologous blood to produce a platelet-based therapy for the chronic wound care market. This offering is known as “Aurix” or the “Aurix System”. The FDA cleared the Aurix System for marketing in 2007 as a device under Section 510(k) of the Federal Food, Drug, and Cosmetic Act (“FDCA”). Aurix is one of two platelet derived products cleared by the FDA for chronic wound care use and is indicated for most exuding wounds. The advanced wound care market, within which Aurix competes, is composed of advanced wound care dressings, wound care devices, and wound care biologics, and is estimated to be an approximate $10.8 billion global market in 2021 with the North American market estimated at approximately $4.15 billion in 2020. Estimates remain that 1-2% of population in the developed countries will suffer from a chronic wound at least once in their lifetime. According to the National Institute of Health, treatment of diabetic foot ulcers cost an estimated $9-$13 billion annually in the U.S. alone. An aging population and the still increasing prevalence of diabetes suggests a continued increase in the patient population at risk of developing chronic, non-healing wounds. The Aurix System produces a platelet rich plasma (“PRP”) gel at the point of care using the patient’s own platelets and plasma sourced from a small draw of peripheral blood. Aurix comprises a natural, endogenous complement of protein and non-protein signal molecules that contribute to effective healing. During treatment, the patient’s platelets are activated and release hundreds of growth factor proteins and other signaling molecules that form a biologically active hematogel. Aurix delivers concentrations of the natural complement of cytokines, growth factors and chemokines that are known to regulate angiogenesis (i.e., the development of new blood vessels), cell growth, and the formation of new tissue. Once applied to the prepared wound bed, the biologically active Aurix hematogel can restore the balance in the wound environment to transform a non-healing wound to a wound that heals naturally. In 2012, a Medicare National Coverage Determination (“NCD”) from CMS reversed a twenty-year old non-coverage decision for autologous blood derived products used in wound care. This NCD allowed for Medicare coverage under the Coverage with Evidence Development (“CED”) program. CED programs have been employed for a selected number variety of other therapies, including transcatheter aortic valve repair and cochlear implantation. Under the CED program, CMS provides reimbursement for items or services on the condition that they be furnished in approved clinical protocols or in the collection of additional clinical data. Under the CED program, a facility treating a patient with Aurix was reimbursed by Medicare when health outcomes data were collected to inform future coverage decisions. The intent of the CED program is to evaluate the outcomes of Aurix therapy for the broader Medicare population when it is used in a “real world” continuum of care. In May 2019, we transmitted a letter memorandum to CMS’ Coverage and Analysis Group (“CAG”) in support of our complete formal request for reconsideration of the then existing national coverage determination based on clinical data collected and published under the CED program. The complete formal public request for reconsideration was made on May 8, 2019 in accordance with the applicable requirements. On April 13, 2021, CMS issued a final coverage decision memo indicating that Medicare would nationally cover autologous PRP for the treatment of chronic non-healing diabetic wounds for a duration of 20 weeks under Section 1862(a)(1)(A) of the Social Security Act. This coverage applies when using devices whose FDA-cleared indications include the management of exuding cutaneous wounds, such as diabetic ulcers. Coverage of autologous PRP beyond 20 weeks for diabetic foot ulcers and for the treatment of all other chronic, non-diabetic, non-healing wounds will be determined by local Medicare Administrative Contractors. Although FDA cleared the Aurix System for marketing in 2007 under Section 510(k) of the FDCA, CMS only established economically viable reimbursement for the product beginning in 2016. For 2023, the Medicare national average reimbursement rate for the Aurix System is $1,725 per treatment, which we believe provides appropriate payment to facilities for product usage. We will market the Aurix System at an approximate cost of $800 per treatment to wound care providers. ### Our Strategy Our current commercial focus is establishing engagement with providers treating chronic non-healing wounds to demonstrate the clinical benefits we believe result from the use of Aurix in the treatment of complex wounds. Increasing physician awareness of the differentiating attributes of Aurix will be key to establishing a base of product revenues upon which to grow. We anticipate developing these relationships with clinical providers and treatment facilities primarily by establishing a variety of distributor arrangements throughout the United States. Our commercial team consists of five senior employees who are leveraging their current and historical relationships to establish distributor arrangements. As of June 30, 2023, we had established contractual relationships with more than 150 individual distributor representatives including. a multi-state agreement with Pacific Medical, Inc. covering multiple large markets in the western United States. The number of distributor representatives may continue to expand modestly in the months ahead but the current focus is establishing commercial customer relationships with wound care providers in primarily hospital outpatient wound care clinics and ensuring that the reimbursement mechanisms are appropriately administered by the local Medicare Administrative Contractors in support of the April 2021 national coverage determination. Commercially available Aurix product was first available in late May 2022 for demonstration and evaluation purposes. Through a growing distributor network, Aurix is presently being evaluated by various hospital/facility Value Analysis Committees (VACs) as part of the process of approving its clinical use. Limited commercial revenues were recorded beginning in the second half of 2022 and during the six months ended June 30, 2023 and we reasonably expect revenues to exhibit growth in subsequent periods. ### The Science Underlying Aurix/Platelet Rich Plasma ### Normal Wound Healing The science underlying wound healing is well-established. An immediate early event critical for wound healing is the influx of platelets to the wound site. Platelets bind to elements within damaged tissue such as collagen fragments and endogenous thrombin molecules and are activated to release a diversity of growth factors and other biomolecules from their alpha and dense granules (Reed 2000, Nieswandt, 2003). These biomolecules provide signals essential for biological responses regulating hemostasis and effective tissue regeneration. ### Chronic Wounds Dysregulation of numerous cellular and biological responses contribute to the chronic wound phenotype. Chronic wounds have reduced levels of growth factors and concomitant decreases in cellular proliferation (Mast 1996). There is increased cellular senescence (Telgenhoff 2005), and there generally is a lack of perfusion that can inhibit the delivery of nutrients and cells required for regeneration (Guo 2010). As the body attempts to stave off infection, elevated concentrations of free radicals accumulate in the chronic wound and further damage surrounding tissue (Moseley 2004, James 2003). ### Aurix Therapy Aurix has been cleared by FDA as safe and effective with an indication for chronic wounds such as leg ulcers, pressure ulcers, and diabetic ulcers and other exuding wounds such as mechanically or surgically debrided wounds. The Aurix therapeutic is formed by mixing a sample of a patient’s platelets and plasma with pharmaceutical grade thrombin and ascorbic acid. The thrombin activates platelets while ascorbic acid drives the synthesis of high tensile strength collagen, clears damaging free radicals and controls gel consistency. The topical dermal application of Aurix gel bypasses the lack of local perfusion to provide immediate signals for new tissue formation and ultimately healing. ### The Efficacy of Aurix Relates to Biological Activity Released by Platelets ### Regenerative Capacity More than 300 proteins are released by human platelets in response to thrombin activation (Coppinger 2004). Important examples include vascular endothelial cell growth factor (“VEGF”), platelet derived growth factor (“PDGF”), epidermal growth factor (“EGF”), fibroblast growth factor (“FGF”) and transforming growth factor-beta (“TGF-B”) (Eppley 2004, Everts 2006). These proteins are critical for organized wound healing, regulating responses such as vascularization, cell proliferation, cell differentiation, and deposition of new extracellular matrix (Goldman 2004). Platelets also release chemokines such as Interleukin-8 (“IL-8”), stromal cell derived factor-1 (“SDF-1”), and platelet factor-4 (“PF-4”) (Chatterjee 2011, Gear 2003) that control the mobilization and migration of stem cells and fibroblasts (Werner 2003 and Gillitzer 2001), which contribute to tissue regeneration. ### Anti-infective Activity Populations of bioburden in chronic wounds vary over time and wounds invariably retain or become re-infected with some level of bacteria that is detrimental to healing (Howell-Jones 2005). In addition to regenerative capacity, platelets release anti-microbial peptides effective against a broad range of pathogens including Methicillin Resistant Staphylococcus Aureus (“MRSA”) (Moojen 2007, Jia 2010, Tang 2002, Bielecki 2007). ### Clinical Efficacy Multiple efficacy and effectiveness studies have been published in peer reviewed journals documenting the impact of using Aurix to treat chronic wounds. Key data include: - In the published study of the clinical data collected during the CED program for diabetic foot ulcers, Aurix demonstrated a significant time to heal advantage compared to wounds treated with usual and customary care (including any available advanced therapy). A higher percentage of healing was observed across all wound severities (Wagner Grade 1-4) and in a patient population with significant comorbidities. (Gude W, Hagan D, Abood F, Clausen P: Aurix Gel is an Effective Intervention for Chronic Diabetic Foot Ulcers: A Pragmatic Randomized Controlled Trial. *Advances in Skin and Wound Care, 2019; 32(9): 416-426.)* - In a double blinded randomized controlled trial, 81% of the most common-sized diabetic foot ulcers healed with Aurix compared with 42% of control wounds. Mean time to healing was six weeks. (Driver V, Hanft J, Fylling, C et al.: A Prospective, Randomized, Controlled Trial of Autologous Platelet-Rich Plasma Gel for the Treatment of Diabetic Foot Ulcers. *Ostomy Wound Management*, 2006; 52(6): 68-87.) - In 285 chronic wounds in 200 patients, 96.5% of the wounds had a positive response within an average of 2.2 weeks with an average of 2.8 Aurix treatments (de Leon J, Driver VR, Fylling CP, Carter MJ, Anderson C, Wilson J, et al.: The Clinical Relevance of Treating Chronic Wounds with an Enhanced Near-physiological Concentration of Platelet-Rich Plasma (PRP) Gel. *Advances in Skin and Wound Care*, 2011; 24(8), 357-368.) - In a retrospective, longitudinal study of 40 Wagner grade II through IV diabetic foot ulcers, most with critical limb ischemia, wounds increased in size in the approximate 100 days prior to the initiation of comprehensive wound care treatment. Upon treatment with debridement, revascularization, antibiotics and off-loading, the wounds continued to increase in size over a subsequent 75-day period. Once they were then treated with Aurix, the wounds immediately changed healing trajectory and 83% of the wounds healed with an average of 6.1 Aurix treatments per wound (Sakata, J., Sasaki, S., Handa, K., et al. A Retrospective, Longitudinal Study to Evaluate Healing Lower Extremity Wounds in Patients with Diabetes Mellitus and Ischemia Using Standard Protocols of Care and Platelet-Rich Plasma Gel in a Japanese Wound Care Program. *Ostomy Wound Management*, 2012; 58(4):36-49.) ### Results of Operations ### Comparison of Three Months Ended June 30, 2023 and 2022 The amounts presented in this comparison section are rounded to the nearest thousand. #### Revenue and Gross Profit There were limited revenues of approximately $118,000 in the three months ended June 30, 2023 with approximately $98,000 of associated gross profit and a resulting gross margin of approximately 83%. There were no revenues in the three months ended June 30, 2022 as commercial revenue activities were not re-initiated until the third quarter of 2022. #### Operating Expenses Total operating expenses increased approximately $45,000 to approximately $969,000 comparing the three months ended June 30, 2023 to the three months ended June 30, 2022. The limited increase from the prior year was due primarily to increased compensation and benefits expense of approximately $90,000 as our employee headcount and related compensation increased beginning in the second quarter 2022 and was partially offset by decreases in consulting and professional fees ($35,000 decrease) and travel related expenses ($21,000 decrease). #### Other Income (Expense) Other income (expense) for the three months ended June 30, 2023 represents a nominal amount of net interest expense for the three months ended June 30, 2023. ### Comparison of Six Months Ended June 30, 2023 and 2022 The amounts presented in this comparison section are rounded to the nearest thousand. #### Revenue and Gross Profit There were limited revenues of approximately $179,000 in the six months ended June 30, 2023 with approximately $148,000 of associated gross profit and a resulting gross margin of approximately 83%. There were no revenues in the six months ended June 30, 2022 as commercial revenue activities were not re-initiated until the third quarter of 2022. #### Operating Expenses Total operating expenses increased approximately $429,000 to approximately $1,875,000 comparing the six months ended June 30, 2023 to the six months ended June 30, 2022. The increase from the prior year was due primarily to increased compensation and benefits expense of approximately $471,000 as our employee headcount and related compensation increased beginning in the second quarter 2022. A combined increase of approximately $128,000 in insurance expense ($59,000 increase), rent expense ($29,000 increase), sales infrastructure costs ($20,000 increase) and various other business expenses ($19,000 increase) was fully offset by a decrease of approximately $172,000 in consulting and professional fees including legal and accounting expenses as the six months ended June 30, 2022 period reflected higher professional fees associated with our efforts to return to current reporting status as a public company. #### Other Income (Expense) Other income for the six months ended June 30, 2022 primarily represents gains from the negotiated settlement of legacy accounts payable including the full release of any ongoing payment liability. ### Liquidity and Capital Resources ### Overview As of June 30, 2023, we had cash, cash equivalents, and restricted cash of approximately $0.4 million, total current assets of approximately $1.0 million and total current liabilities of approximately $0.7 million. As an operational business, we have a history of losses and are not currently profitable. For the years ended December 31, 2022, and 2021, we incurred net losses of approximately $3.2 million and $0.1 million, respectively. As of June 30, 2023, our accumulated deficit was approximately $28.5 million and our stockholders’ equity was approximately $0.5 million. We sold 3,957,757 shares of common stock to certain accredited investors pursuant to Security Purchase Agreements in two private placements which closed on April 29 and May 18, 2022 for gross proceeds of $3,957,757. On August 24, 2022, we entered into a Common Stock and Warrant Purchase 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. Pursuant to the Common Stock and Warrant Purchase Agreement, Pacific Med purchased 500,000 shares of the Company’s common stock for $500,000 in September 2022. As part of the Common Stock and Warrant Purchase Agreement, we agreed to grant to Pacific Med the right to participate in any future financing through December 31, 2023 (the “Participation Rights”) in connection with a listing of our common stock on a national securities exchange. The Participation Rights entitle 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 does not occur by December 31, 2023, the Common Stock and Warrant Purchase Agreement provides that we will 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. We sold 517,500 shares of common stock to certain accredited investors pursuant to a Security Purchase Agreement in a private placements which closed on August 1, 2023 for gross proceeds of $1,035,000. 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 secure sufficient capital to fund our operating activities, we may be forced to delay further the completion of, or significantly reduce the scope of, our current business plan. It is uncertain whether we will be able to obtain such financing on satisfactory terms or at all. We may not be able to obtain additional capital as required to finance our efforts, through equity or debt financing 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. We maintain our cash deposits primarily in financial institutions, which may at times exceed amounts covered by insurance provided by the U.S. Federal Deposit Insurance Corporation (“FDIC”). We have not experienced any losses related to amounts in excess of FDIC limits. ### Cash Flows Net cash provided by (used in) operating, investing, and financing activities for the periods presented were as follows: | | Six months ended June 30, 2023 | Six months ended June 30, 2022 | | --- | ---: | ---: | | Cash flows used in operating activities | $(1,727,641) | $(1,875,963) | | Cash flows used in investing activities | $(5,343) | $(51,535) | | Cash flow provided by financing activities | $- | $3,957,757 | #### Operating Activities Cash used in operating activities for the six months ended June 30, 2023 of approximately $1.7 million primarily reflects our net loss of approximately $1,728,000 adjusted by (i) approximately $33,000 net change in operating assets and liabilities and (ii) approximately $59,000 total depreciation and amortization expense and stock-based compensation expense. Cash used in operating activities for the six months ended June 30, 2022 of approximately $1,876,000 primarily reflects our net loss of approximately $1.3 million adjusted by i) a non-cash gain of approximately $146,000 from the negotiated settlement of legacy accounts payable obligations and ii) approximately $464,000 net change in operating assets and liabilities. #### Investing Activities We had limited investing activities for the six months ended June 30, 2023 and 2022 consisting of the purchase of property and equipment. #### Financing Activities We did not have any financing activities for the six months ended June 30, 2023. Cash flows from financing activities for the six months ended June 30, 2022 reflects proceeds raised from the sale of 3,957,757 shares of common stock in two private placements closed in April and May 2022. ### Inflation The Company believes that the rates of inflation in recent years have not had a significant impact on its operations. ### Off-Balance Sheet Arrangements The Company does not have any off-balance sheet arrangements. ### Critical Accounting Policies Our unaudited condensed consolidated financial statements included in Part I, Item 1 of this Quarterly Report are prepared in conformity with U.S. GAAP, which require us to make estimates and assumptions regarding future events that affect the amounts reported in our financial statements and accompanying notes. We base these estimates on our experience and assumptions regarding future events we believe to be reasonable under the circumstances. Actual results could differ from those estimates and such differences may be material to the unaudited condensed consolidated financial statements. We have described our most critical accounting policies in the “Management’s Discussion and Analysis of Financial Condition and Results of Operations” section of our Annual Report on Form 10-K for the year ended December 31, 2022. There have been no material changes to our critical accounting policies or estimates since December 31, 2022. ## Controls and procedures As filed, 2,017 characters. ### Evaluation of Disclosure Controls and Procedures Disclosure controls and procedures are controls and other procedures that are designed to ensure that information required to be disclosed in our reports filed or submitted under the Securities Exchange Act of 1934, as amended (the "Exchange Act"), is recorded, processed, summarized, and reported within the time periods specified in the SEC's rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed in our reports filed under the Exchange Act is accumulated and communicated to management, including our principal executive officer and principal financial officer, as appropriate, to allow timely decisions regarding required disclosure. Our management has carried out an evaluation, under the supervision and with the participation of our principal executive officer and principal financial officer, of the effectiveness of the design and operation of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act), as of June 30, 2023. Based upon that evaluation, our principal executive officer and principal financial officer concluded that, as of the end of the period covered by this report, our disclosure controls and procedures were not effective due to the un-remediated material weakness disclosed in our Annual Report on Form 10-K. In designing and evaluating our disclosure controls and procedures, we recognize that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives. ### Changes in Internal Control over Financial Reporting There were no changes in our internal control over financial reporting during the quarter ended June 30, 2023 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting. ### PART II ### OTHER INFORMATION ## Risk factors As filed, 160 characters. 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, 2022. Filed Aug 14, 2023. Source: SEC EDGAR, the filing index for accession 0001437749-23-023710. Last ingested by Listed: Oct 24, 2026, 15:02 ET. No prices; not investment advice.