Financial Performance - The company has incurred significant net losses since its inception and anticipates continuing to incur net losses for the foreseeable future [134]. - The company incurred net losses of $48,259,189 and $27,519,886 for the years ended December 31, 2025 and 2024, respectively, with an accumulated deficit of $142,679,800 as of December 31, 2025 [153]. - The company anticipates that net losses will increase in the foreseeable future due to rising business costs associated with advancing its clinical development program and seeking regulatory approval for IKT-001 [154]. - Cash, cash equivalents, and marketable securities totaled $178,764,028 as of December 31, 2025, but the company may exhaust its available capital resources sooner than expected [156]. Revenue Generation - As of the date of the report, the company has not generated any revenue from product sales and does not expect to do so in the near future [135]. - The successful development and commercialization of product candidates will require substantial additional funding beyond current financial resources [159]. Funding and Capital - In October 2024, the company completed a private placement of approximately $110 million [138]. - The company completed an underwritten public offering of approximately $115 million in November 2025 [138]. - The company has no committed source of additional capital, which may hinder its ability to continue operations or capitalize on business opportunities [159]. - Market volatility and potential future epidemics could adversely impact the company's ability to access capital when needed [159]. Product Development and Regulatory Approval - The company is highly dependent on the success of its initial product candidate, IKT-001, targeting pulmonary arterial hypertension (PAH) [134]. - The regulatory approval processes for the company's product candidates are lengthy, costly, and inherently unpredictable [134]. - The company plans to seek regulatory approval for its product candidates in the United States, EU, and other countries, but has never submitted an application for approval [174]. - The company has not completed any registrational clinical trials and faces significant challenges in successfully developing and commercializing IKT-001 [167]. - The company may face significant delays in its current and planned clinical trials, which could inhibit regulatory approval or market acceptance [134]. Clinical Trials - Clinical trials are expensive and time-consuming, with potential delays that could impair the ability to generate revenue [178]. - The success of clinical trials is uncertain, and failure can occur at any stage, impacting the ability to receive regulatory approval [189]. - The company may face challenges in patient enrollment for clinical trials, which could adversely affect trial completion and timelines [182]. - The company may encounter significant adverse events or side effects in clinical trials that could inhibit regulatory approval or market acceptance of its product candidates [168]. Competition - The company operates in a highly competitive environment, with significant competition from major pharmaceutical companies and research organizations [195]. - Competitors in the cardiopulmonary disease area include GlaxoSmithKline, Johnson and Johnson, and Merck and Co., among others [196]. - The company faces significant competition from larger firms with greater financial resources and expertise in research, development, and marketing, which could limit its commercial opportunities [197]. Manufacturing and Supply Chain - The company has limited manufacturing experience and relies on third-party suppliers for key raw materials [139]. - Manufacturing of product candidates is complex and reliant on external expertise, with potential delays in production affecting clinical trials and commercialization [199]. - The company completely outsources its manufacturing and does not have any manufacturing facilities, relying on third-party manufacturers for materials [289]. - The company relies on a small number of third-party suppliers for key raw materials, which poses risks related to pricing, availability, and quality [296]. Intellectual Property - The company has filed patent applications for its product candidates, but there is no assurance that these will be granted [301]. - The patent prosecution process is complex and costly, which may hinder the ability to protect intellectual property effectively [304]. - Loss of patent protection could adversely affect the company's competitive position and ability to commercialize products [305]. - The company may face challenges in protecting its intellectual property rights globally, as enforcement in foreign jurisdictions can be prohibitively expensive and less effective than in the United States [312]. Regulatory Risks - Regulatory approval processes for manufacturing are stringent, and failure to meet these standards could delay product commercialization [203]. - Changes in regulatory requirements or clinical trial design could materially affect the ability to conduct trials as planned [192]. - Non-compliance with regulatory requirements could lead to significant penalties, adversely affecting the company's value and operating results [249]. Compliance and Legal Risks - Compliance with healthcare laws is critical, as violations could lead to substantial penalties and negatively impact business operations [264][269]. - The company is subject to various privacy laws, including the California Consumer Privacy Act (CCPA), which may increase compliance costs and potential liabilities [272]. - The EU General Data Protection Regulation (GDPR) imposes extensive obligations on the company, with penalties for breaches reaching up to €20 million or 4% of global annual turnover, whichever is higher [275].

Revenue and Financial Performance - Total revenues for Sanuwave in 2025 reached $44.1 million, a 35% increase from $32.6 million in 2024[23]. - Revenue for the year ended December 31, 2025 was $44.1 million, a 35% increase from $32.6 million in 2024, driven by a 24% increase in UltraMIST® consumables sold and a 67% increase in UltraMIST® systems sold[206]. - Gross margins improved to 77% in 2025, up from 75% in 2024[198]. - Operating income rose by 29% to $4.9 million for the year ended December 31, 2025, compared to $3.8 million in 2024[198]. - Net income for 2025 was $11.8 million, or $1.38 per basic share, a significant increase from a net loss of $33.1 million in 2024[199]. - The increase in net income of $44.9 million was largely driven by a non-cash change in the fair value of derivatives and improved operational performance[199]. - Cash flows from operating activities for 2025 totaled $3.9 million, primarily from net income of $11.8 million adjusted for non-cash items[219]. - The company had an accumulated deficit of $242.7 million as of December 31, 2025, but successfully refinanced its debt, improving its financial position[213][215]. - Management believes the company has sufficient resources to meet its obligations for at least the next 12 months following successful refinancing and operational improvements[216]. Product and Market Overview - UltraMIST systems and consumables accounted for approximately 99% of total revenues in 2025, up from 98% in 2024[23]. - UltraMIST consumables generated about 58% of total revenues in 2025, expected to remain the largest revenue stream[35]. - As of December 31, 2025, there were 1,292 active UltraMIST systems in the field[35]. - The U.S. wound care market is estimated to exceed $67 billion annually, with growth driven by an aging population and rising incidences of chronic conditions[37][39]. - The UltraMIST system is FDA cleared and has category one reimbursement under CMS code 97610, facilitating its adoption by healthcare providers[27]. - The company holds over 60 patents related to its technology, providing a competitive advantage in the wound care market[55]. Strategic Initiatives - The Company aims to build a direct sales force and distribution network to enhance UltraMIST adoption in the U.S. and explore international expansion[40]. - Sanuwave's strategy focuses on transitioning wound care to a consultative model, improving patient outcomes while reducing treatment costs[46]. - The company may seek to expand operations and product lines through acquisitions, potentially increasing capital requirements[111]. Compliance and Regulatory Environment - The company must comply with FDA's current Good Manufacturing Practices (cGMP), which include quality control and assurance, and failure to comply may result in legal or regulatory actions[77]. - The company is registered as a Small Business Manufacturer with the FDA, which currently allows for reduced fees; however, if revenues exceed a certain threshold, full fees will apply[70]. - The company anticipates increased operational costs due to compliance with HIPAA and state-specific privacy laws as it expands its business[153]. - Noncompliance with HIPAA and related regulations could have a material adverse effect on the company's business and financial condition[154]. - The medical device industry is heavily regulated by the FDA, and failure to comply with regulations could lead to enforcement sanctions and product recalls[158]. Operational Challenges - The company faces competition from established medical device and pharmaceutical companies, which have greater financial resources and expertise[112]. - The company may face challenges in maintaining sufficient liquidity and positive operating results in the future[108]. - The company has identified material weaknesses in internal control over financial reporting, which had not been remediated as of December 31, 2025[100]. - Rapid growth may strain the company's resources, including personnel and IT systems, potentially affecting development and commercialization goals[127]. - Manufacturing output must increase to meet customer demand, with potential difficulties in manufacturing yields and component supply impacting revenue generation[128]. Cybersecurity and Data Protection - The company relies heavily on sophisticated information technology systems, facing risks from cybersecurity breaches and data leakage, which could negatively impact operations[124]. - Previous cybersecurity breaches from email spoofing have occurred, and despite investments in data protection, there is no assurance that future breaches can be prevented[125]. - The company has not experienced a material information security breach incident, but future incidents could have a material impact on its business strategy and financial condition[188]. Financial Reporting and Tax Liabilities - The company identified a historical state and local sales tax liability of approximately $44.2 million related to prior periods, necessitating a restatement of prior financial statements[101]. - The company has never paid cash dividends and does not anticipate doing so in the foreseeable future[180]. - General and administrative expenses rose to $19.4 million in 2025, a 50% increase from $12.9 million in 2024, primarily due to increased headcount and stock-based compensation[209]. - Selling and marketing expenses increased by 17% to $7.4 million in 2025, driven by higher headcount expenses and stock-based compensation[210]. - Research and development expenses doubled to $1.4 million in 2025 from $0.7 million in 2024, reflecting increased project and consulting costs[211]. Intellectual Property and Competitive Position - The protection of intellectual property is critical, and failure to secure patents could adversely affect the company's competitive position[160]. - The degree of intellectual property protection is uncertain, and challenges to patents could limit the company's ability to stop competitors[162]. - The company relies on trade secrets and proprietary know-how, and breaches of confidentiality agreements could harm its competitive position[163]. - Patent applications may not result in issued patents, and competitors may commercialize similar discoveries[165]. - Enforcing patents against third parties may require significant expenditures, impacting the company's competitiveness[169].

Cash Flows - Net cash flows from operating activities in 2025 amounted to US$ 4,959 million, a decrease of US$ 910 million from US$ 5,869 million in 2024[674]. - Net cash flows used in investing activities in 2025 were US$ 5,527 million, an increase of US$ 16 million compared to US$ 5,511 million in 2024, primarily due to acquisitions from business combinations[677]. - Net cash flows from financing activities in 2025 were US$ 517 million, primarily due to proceeds from loans net of debt repayments of US$ 1,610 million[678]. Debt and Liabilities - Total debt as of December 31, 2025, was US$ 14,082 million, with US$ 2,870 million maturing in less than one year[684]. - As of December 31, 2025, total other liabilities amounted to US$ 6,404 million, including provisions for lawsuits and environmental liabilities[684]. - The company committed to purchase goods and services for approximately US$ 6,735 million as of December 31, 2025, with US$ 1,778 million maturing in less than one year[679]. Capital Expenditures and Commitments - Capital expenditures in 2025 totaled US$ 4,993 million, with 75.7% allocated to upstream activities[683]. - Exploration and development commitments until the expiration of main permits amounted to US$ 699 million as of December 31, 2025[681]. Asset Management and Impairment - The recoverable amount of property, plant and equipment, intangible assets, and right-of-use assets is analyzed at year-end or when impairment indications arise[703]. - A hypothetical reduction of crude oil prices by US$ 5/bbl and natural gas prices by US$ 0.5/MBtu could decrease future cash flows for impairment by approximately US$ 3.1 billion, although no impairment loss would need to be recorded[703]. - Significant estimates and key sources of estimation uncertainty are detailed in the financial statements, impacting the assessment of asset impairment[702]. Operational Impact - The Argentine government's actions significantly impact the oil and gas industry, affecting company operations and financial performance[701]. Strategic Initiatives - The optimization plan of the conventional upstream portfolio includes the disposal of non-core assets, with significant progress made in 2025[686]. - The company executed an assignment agreement for the transfer of 100% of rights and obligations in certain exploitation concessions in January 2026[688].

Financial Performance - Research and development expenses decreased by approximately $0.3 million in 2025 to $6.283 million compared to $6.630 million in 2024, primarily due to increased government grants and a decrease in professional services [247]. - Sales, general and administrative expenses increased by approximately $3.5 million in 2025 to $8.460 million compared to $4.995 million in 2024, driven by higher payroll and related expenses for sales and marketing, as well as increased professional services [248]. - Financing income increased significantly by approximately $1.1 million in 2025 to $1.285 million compared to $182,000 in 2024, attributed to higher market gains on marketable securities [249]. - As of December 31, 2025, Microbot had a net working capital of approximately $76.4 million, a significant increase from $3.4 million as of December 31, 2024 [250]. - Since inception through December 31, 2025, Microbot has raised approximately $168.3 million in cash proceeds, with a total cumulative loss of approximately $104.1 million [251]. - As of December 31, 2025, Microbot has not recognized any revenues and anticipates continued net losses as it ramps up manufacturing and commercialization efforts [250]. Grants and Funding - Microbot received grants totaling approximately $2.5 million from the Israeli Innovation Authority for research and development activities, including a recent grant of approximately $673,000 approved in July 2025 [252]. - The company plans to continue raising capital through public and private issuances to fund commercialization activities for the LIBERTY Endovascular Robotic Surgical System, expected to launch in April 2026 [255]. - Microbot is obligated to pay royalties of 3%-5% on future sales related to grants received, with no repayment required if the project fails [253]. Cash Flow and Investments - Net cash flows used in operating activities increased to $(13,046) thousand in 2025 from $(8,827) thousand in 2024 [258]. - Net cash flows used in investing activities decreased to $(72,384) thousand in 2025, primarily due to increased purchases of marketable securities compared to 2024 [259]. - Net cash flows provided by financing activities rose to $86,240 thousand in 2025, attributed to increased issuances of common stock and warrants [259]. - The net increase in cash, cash equivalents, and restricted cash was $810 thousand in 2025, up from $646 thousand in 2024 [258]. Market and Operational Risks - Microbot's primary exposure to market risk is interest income sensitivity, which is affected by changes in U.S. interest rates [260]. - A significant portion of Microbot's business and operating expenses are conducted in currencies other than the U.S. dollar, exposing the company to foreign exchange risks [261]. - Exchange rate fluctuations may adversely impact future profitability and expenses, with potential credit loss from non-performance by counterparties of foreign currency contracts [262]. - Inflation has generally increased research and development expenses, but Microbot does not believe it significantly impacted results of operations for the periods presented [263]. Product Development - The LIBERTY Endovascular Robotic Surgical System is designed to eliminate the need for extensive capital equipment and dedicated staff, targeting the peripheral vasculature market [233].

Market Opportunities and Growth Strategies - The RFID and IoT solutions have been integrated into over 1.5 billion applications globally, showcasing significant market penetration[16]. - The company aims to grow its market share and profitability by focusing on higher margin opportunities and optimizing its manufacturing facility in Thailand[24]. - The healthcare growth initiative targets medication adherence, consumable authentication, and condition monitoring, addressing significant unmet needs in the market[26]. - A multi-year exclusive supply agreement was signed with IFCO to develop next-generation smart BLE labels for reusable plastic containers, indicating strategic market expansion[27]. - The company’s growth strategy includes three pillars: Perform, Accelerate, and Transform, aimed at optimizing core business, accelerating growth initiatives, and pursuing inorganic growth opportunities[23]. - The RFID market opportunity is projected to reach hundreds of billions of units over time, driven by digitization and IoT expansion[22]. Financial Performance and Results - Net revenue for 2025 was $21.5 million, a decrease of 19% from $26.6 million in 2024, primarily due to lower unit sales of RFID transponder products and reduced sales to the largest customer[141]. - Gross profit increased to $1.3 million in 2025 from $0.3 million in 2024, resulting in a gross profit margin of 6.1%, up from 1.3% in the previous year[142][143]. - The net loss from continuing operations for 2025 was $18.003 million, compared to a loss of $25.911 million in 2024, showing an improvement in operational performance[206]. - Total operating expenses for 2025 were $23.453 million, down from $28.301 million in 2024, reflecting a reduction in costs[206]. - The company reported interest income of $5.023 million in 2025, significantly higher than $1.352 million in 2024, contributing positively to the financial results[206]. Operational Challenges and Risks - The company experienced delays and reductions in customer orders during fiscal years 2025 and 2024 due to adverse macroeconomic conditions[59]. - The global semiconductor shortage that began in 2021 negatively impacted the company's ability to meet product demand[63]. - The company faces risks from increased competition in the RFID industry, which may lead to downward pressure on pricing and reduced margins[44]. - The company is vulnerable to supply disruptions due to reliance on suppliers and contract manufacturers[63]. - Adverse global economic conditions, including inflation and geopolitical tensions, may materially affect the company's financial condition[58]. Research and Development - The company employs 155 employees, with 24 in R&D, indicating a strong focus on innovation and product development[39]. - The company has a robust R&D team in Germany and Southeast Asia, focusing on advanced RFID and BLE technologies[33]. - Research and development expenses decreased by 16% to $3.3 million in 2025, representing 15% of net revenue, due to realignment of personnel and transition of activities to Thailand[146][147]. Supply Chain and Manufacturing - The manufacturing facility in Thailand is certified to ISO 9001:2015 and ISO 14001:2015 standards, ensuring high-quality production[35]. - The company transitioned all RFID inlay, tag, and label production to a new manufacturing facility in Thailand, significantly reducing manufacturing overhead costs and increasing production efficiency[131]. - Approximately 15% of the company's business is exposed to U.S. tariffs due to manufacturing in Thailand, which may increase costs unless offset by other strategies[135]. Shareholder and Stock Information - As of March 2, 2026, 1,092,015 shares are reserved for future grants under equity incentive plans, and 8,756,341 shares are reserved for other potential issuances[96]. - The company has not repurchased any shares under the Stock Repurchase Program in 2025, following the repurchase of 463,779 shares for approximately $1.9 million in 2024[161]. - Stockholders' equity decreased from $154.069 million in 2024 to $140.701 million in 2025, reflecting the impact of net losses on equity[204]. Currency and Tax Considerations - The company’s financial results may be affected by changes in foreign currency exchange rates and compliance with foreign laws[78]. - A significant portion of the company's business is conducted in foreign currencies, primarily the Euro and Thai Baht, which may lead to currency exchange gains and losses[85]. - The company has federal and state income tax net operating loss carryforwards of $96.5 million and $46.5 million, respectively, which will expire at various dates[182]. Legal and Compliance Risks - The company faces risks from third-party claims and litigation, which could adversely affect its results of operations and incur substantial costs[89]. - The likelihood of intellectual property infringement claims may increase as the number of products and competitors in the RFID market grows[90]. - The complexity of European patent laws has increased, with a new unitary patent system effective from June 1, 2023, impacting European patents[87].

Financial Performance - As of December 31, 2025, total revenue for DBM Global Inc. (DBMG) was $1,210.3 million, with SSC contributing $687.5 million (56.8%), Banker Steel $246.3 million (20.3%), and GrayWolf $237.4 million (19.6%) [33] - DBMG's sales pipeline includes approximately $10.6 billion in potential revenue generation, indicating strong future growth prospects [34] - DBMG operates with a total backlog of $1,723.9 million as of December 31, 2025, with 39.5% of this backlog having minimal bonding requirements [37] - The company experiences seasonal fluctuations, with the highest revenues typically in the fiscal fourth quarter and lowest in the first fiscal quarter [62] Customer Base and Market Strategy - DBMG's two largest customers represented approximately 22.1% of its revenues in 2025, down from 25.5% in 2024, suggesting a diversification in customer base [33] - The company aims to expand and diversify its revenue base by targeting projects with higher margins and less risk of large margin fluctuations [36] - DBMG's strategic focus includes pursuing large, value-added projects, leveraging its full range of steel construction services to achieve higher margins [31] Workforce and Operations - The company has 3,587 full-time employees and 151 part-time employees, indicating a stable workforce to support its operations [24] - DBMG's workforce consisted of 3,525 full-time and 141 part-time employees as of December 31, 2025 [3] - Approximately 23.9% of DBMG's employees are covered under various collective bargaining agreements [3] Cost Management and Supply Chain - DBMG has secured fixed price agreements from steel mills to limit raw material cost exposure, enhancing its cost management strategy [37] - DBMG purchased approximately 67.2% of the total value of steel and steel components from two domestic steel vendors in 2025 [2] Innovation and Technology - The company emphasizes innovative services, particularly in building information modeling (BIM) and digital engineering, to maintain a competitive edge in complex projects [36] - R2 Technologies has developed CryoAesthetics™ technologies for skin lightening and brightening, addressing a fast-growing segment in aesthetic dermatology [4] - R2 Technologies has a patent portfolio comprising 129 issued patents and 7 pending applications as of December 31, 2025 [75] - The Glacial Rx product is FDA cleared and is used for various dermatologic procedures, enhancing patient experience and generating additional revenue [68] - The Glacial fx product was launched in Q3 2023, expanding R2's North America market into non-medical and retail chains [67] Competition and Market Challenges - R2 Technologies faces significant competition in both U.S. and international markets, with many aesthetic products available internationally due to less stringent regulations [63][64] - The company is adapting to changes in federal legislation and FCC rules that may affect its operations and financial results [108] - Broadcasting's strategy focuses on attracting high-quality content providers for nationwide distribution, leveraging its national footprint and cloud infrastructure [107] - The company faces increasing competition from streaming services, digital platforms, and Full Power stations, which impacts its market share [103] Partnerships and Investments - MediBeacon, a partner company, received FDA approval for its TGFR system in January 2025, which assesses kidney function without requiring blood draws [80] - MediBeacon's partnership with Huadong includes a $30 million investment for exclusive commercialization rights in Greater China, with approximately $31.4 million received by December 31, 2025 [84] - Following FDA approval in January 2025, Pansend's convertible notes totaling $12.9 million were converted into Series 3 Preferred Stock [86] - Huadong's investment in MediBeacon's preferred stock was received at a pre-money valuation of approximately $420 million [86] Broadcasting Operations - HC2 Broadcasting operated 257 stations as of December 31, 2025, including three Full Power stations and 201 Low Power Television (LPTV) stations [92] - Broadcasting's stations can broadcast approximately 2,000 subchannels and reach 112 markets in the U.S. and Puerto Rico, including 39 of the top 40 markets [92] - Broadcasting operates 252 stations connected to a cloud-based IP backbone, allowing for remote operation and significant cost savings [107] - The company generates revenue primarily from the sale of television airtime, with contracts typically being short-term in nature [102] Regulatory and Compliance - DBMG's operations are affected by various federal, state, and local environmental protection laws, which have become increasingly stringent [6] - Broadcasting's FCC licenses must be renewed every eight years, with the next renewal cycle expected in 2025 [105] - Environmental regulations have not materially impacted the company's capital expenditures or competitive position [112] Company Information - INNOVATE was incorporated in 1994 and is based in Delaware [113] - The company provides free access to its Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K on its website [113] - Details regarding executive officers, directors, and code of conduct are included in Item 10 of the Form 10-K [114] - Information about the Audit Committee and Financial Expert will be available in the 2026 Proxy Statement [114] - There are no applicable quantitative and qualitative disclosures about market risk [468]

Financial Performance - Zentalis Pharmaceuticals reported a net loss of $137.1 million for the year ended December 31, 2025, compared to a net loss of $165.9 million in 2024, representing a 17.3% decrease in losses [19]. - The net loss per common share for 2025 was $1.91, an improvement from $2.33 in 2024 [19]. - The total operating expenses for 2025 were $152.8 million, down from $258.6 million in 2024, marking a 41% reduction [19]. - The company reported no revenues from licensing and sales of intellectual property in 2025, compared to $67.4 million in 2024 [19]. Research and Development - Research and development expenses decreased to $107.3 million in 2025 from $167.8 million in 2024, a reduction of 64.5 million or 36.1% [12]. - The completion of enrollment for the DENALI Part 2a trial is expected to support dose confirmation in the first half of 2026, with topline results anticipated by year-end 2026 [4]. - The company plans to initiate the Phase 3 ASPENOVA trial in the first half of 2026, comparing azenosertib to standard-of-care chemotherapy for Cyclin E1-positive PROC patients [5]. - Zentalis is also exploring the combination of azenosertib with bevacizumab in the ongoing MUIR study for earlier treatment settings in ovarian cancer [5]. Cash Position - As of December 31, 2025, the company had cash, cash equivalents, and marketable securities totaling $245.9 million, providing a cash runway into late 2027 [5]. Administrative Expenses - General and administrative expenses significantly decreased to $37.7 million in 2025 from $87.1 million in 2024, a decline of 56.7% [12].

Financial Performance - The company reported net losses of $19.5 million for the year ended December 31, 2025, a decrease of 11% from a net loss of $21.8 million in 2024[177]. - The company incurred losses from operations of $20.9 million and used $15.6 million in cash for operating activities in 2025, a decrease from $16.8 million in 2024[182]. Expenses - Research and development expenses decreased by $2.2 million or 19%, to $10.0 million in 2025 from $12.2 million in 2024, primarily due to lower costs related to the VenoValve study[179]. - Selling, general and administrative expenses decreased by $0.7 million or 6%, to $10.9 million in 2025 from $11.6 million in 2024, driven by non-recurring legal costs incurred in 2024[180]. Cash Position - The cash balance as of December 31, 2025, was $3.1 million, with total cash and investments amounting to $28.2 million[182]. - The company anticipates an increase in cash burn rate to between $4 million and $5 million per quarter in 2026, while having sufficient cash to fund operations through mid-2027[185]. Product Development - The enVVe System, a next-generation non-surgical venous valve product, has completed pre-clinical testing and discussions with the FDA regarding the pivotal trial are expected to begin in 2026[173]. - The company is focused on obtaining FDA approval for the enVVe System, with no current devices approved for surgical or non-surgical replacement venous valves[172]. - The company will continue to incur costs related to clinical trials for the VenoValve and enVVe System as it seeks regulatory approval for its product candidates[183]. Corporate Actions - A reverse stock split of one-for-thirty-five (1:35) was approved and became effective on January 20, 2026[175].

Financial Position - As of December 31, 2025, the company had approximately $10.1 million in cash and cash equivalents, including restricted cash[115]. - As of December 31, 2025, the company's cash and cash equivalents were approximately $10.1 million, including restricted cash[172]. - In January 2026, the company generated proceeds of $29.3 million from the issuance of shares of common stock[115]. - As of March 18, 2026, the company has $18.2 million in convertible notes outstanding, convertible at a weighted average rate of $1.28 per share, and $13.8 million in preferred stock convertible at a weighted average rate of $1.25 per share[198]. - If all outstanding convertible notes and preferred shares are converted, the company would need to issue approximately 25.7 million shares of common stock, leading to potential dilution for existing shareholders[199]. Risks and Challenges - The company may face risks associated with debt financing, including insufficient cash flow to meet principal and interest payments[117]. - The company relies on a limited number of third-party manufacturers, which could adversely affect growth and profitability if relationships dissolve[122]. - The company is exposed to risks associated with shipping products from China, including customs duties and trade restrictions[125]. - The company may face challenges in accurately estimating inventory and production requirements for its smart products[124]. - The company may not be able to successfully implement cost reduction measures, which could adversely affect financial condition and results of operations[124]. - The company may issue dilutive securities and incur debt obligations in connection with acquisitions, which could negatively impact profitability[131]. - The company's product business may become significantly dependent on contracts awarded through competitive bidding processes, which involve substantial time and resources with no guarantee of contract awards[132]. - Failure to consistently win new contract awards could materially and adversely affect the company's growth strategy, financial condition, and results of operations[133]. - The company faces risks related to the protection of its intellectual property, which could adversely affect its business and financial condition if not adequately protected[135]. - The expiration or loss of patent protection may impact future revenues and operating income, as the company relies heavily on intellectual property protections[140]. - The company faces risks from unstable market conditions, including high inflation, interest rates, and geopolitical factors, which may adversely affect financial performance and stock price[170]. - The company may face challenges in securing necessary financing due to deteriorating credit and financial markets, which could hinder growth strategies[170]. - The company is vulnerable to economic and political conditions in Israel, which may impact operations and revenues[173]. - Cybersecurity incidents at third-party providers could lead to operational disruptions and financial harm, as the company relies on these vendors for critical services[178]. - The company is subject to governmental regulations regarding data privacy and cybersecurity, which could increase operational costs and affect business performance[188]. - The company faces risks related to compliance with evolving data protection laws, which could result in fines and damage to reputation if not adhered to[190]. Operational Considerations - The company acquired Belami, an e-commerce platform, in 2023, which may require significant resources and investments[130]. - The company may need to hire and train a sizable number of employees for full-scale commercial manufacturing operations[123]. - Compliance with quality and safety standards is essential, and failure to meet these standards could lead to product recalls and negatively affect financial performance[141]. - The company relies on third parties for product distribution, which may limit control over sales efforts and expose the company to financial risks if distributors face difficulties[145]. - The company strives to obtain certifications for its products, and failure to achieve or maintain these certifications could adversely impact net sales[149]. - Defects in the mobile application and its underlying technology may lead to adverse publicity and financial repercussions, affecting market acceptance and customer claims[150]. - The company is implementing a new enterprise resource planning (ERP) system, which is critical for operational efficiency and may require significant financial and human resources[192]. - The company is incorporating artificial intelligence capabilities into its product offerings, which may present operational and reputational risks if not managed properly[182]. - The evolving regulatory landscape surrounding AI technologies may impose significant operational costs and limit the company's ability to utilize AI effectively[182]. Compliance and Governance - The Company incurs increased costs as a public entity, including legal and compliance expenses, which could divert management's attention from business operations[160]. - Compliance with the Sarbanes-Oxley Act and other regulations imposes significant requirements on the Company, potentially increasing legal and financial compliance costs[161]. - The Company must maintain effective internal controls over financial reporting, and any deficiencies could adversely affect investor confidence and stock value[166]. - A material weakness in internal controls could prevent timely and accurate financial statements, leading to a decline in stock price and potential regulatory sanctions[168]. - The Company faces inherent limitations in its internal control systems, which may not prevent all errors or fraud, potentially resulting in material misstatements[169]. - The concentration of voting power among executive officers and preferred stockholders may limit the influence of common stockholders on corporate matters[203]. - The company's articles of incorporation and bylaws include provisions that may inhibit non-negotiated mergers or other business combinations[211]. - The board of directors has the authority to designate and issue shares of preferred stock without requiring stockholder vote or approval[211]. - A majority stockholder vote is required to remove directors from office, or a majority of the board of directors if for cause[211]. - There are limitations on who may call special meetings of stockholders, which could further impact governance[211]. Market Conditions - The stock price has experienced volatility due to fluctuations in the equity markets, which may not correlate with the company's actual operating performance[171]. - The company’s stock price has been volatile and may continue to fluctuate significantly due to various uncontrollable factors[196]. - Market conditions, including inflation and geopolitical issues, may negatively impact the company's financial condition and share price[209]. - The company may incur additional costs to comply with cybersecurity regulations, which are becoming increasingly complex and unpredictable[189]. - The company has anti-takeover provisions in its charter documents and under Florida law that could discourage or delay a change in control, potentially affecting the trading price of its common stock[211].

Financial Performance - The net loss for the year ended December 31, 2025, was $48.3 million, or $0.49 per share, compared to a net loss of $27.5 million, or $1.16 per share in 2024, indicating a year-over-year increase in net loss of 75.5%[5] - Net loss for the year ended December 31, 2025, was $48,259,189, compared to a net loss of $27,519,886 in 2024, representing an increase of 75%[19] - Cash flows from operating activities resulted in a net cash used of $27,786,464 in 2025, up from $19,148,067 in 2024, indicating a 45% increase in cash outflow[19] - The accumulated deficit increased to $142.7 million as of December 31, 2025, from $94.4 million in 2024, reflecting a rise of 51%[15] Cash and Securities - As of December 31, 2025, cash, cash equivalents, and marketable securities totaled $178.8 million, up from $97.5 million as of December 31, 2024, representing an increase of approximately 83%[5] - Cash and cash equivalents at the end of 2025 were $139,220,208, significantly up from $56,490,579 at the end of 2024, marking a 147% increase[19] - Proceeds from the issuance of common stock, pre-funded warrants, and warrants amounted to $107,617,495 in 2025, compared to $103,477,668 in 2024, showing a 4% increase[19] - Net cash provided by financing activities was $108,462,963 in 2025, compared to $103,477,668 in 2024, reflecting a 5% increase[19] - Purchases of investments in marketable securities were $39,094,847 in 2025, down from $60,455,103 in 2024, indicating a 35% decrease[19] - Maturities of investments in marketable securities increased to $41,600,000 in 2025 from $23,450,902 in 2024, representing a 77% increase[19] Expenses - Research and development expenses rose to $29.8 million in 2025 from $17.2 million in 2024, reflecting a 73.5% increase, which includes a $7.4 million non-cash write-off related to the acquisition of CorHepta[6] - Selling, general and administrative expenses increased to $23.6 million in 2025 from $11.4 million in 2024, marking a 106.1% rise, which includes $1.0 million in severance expenses[7] - Stock-based compensation expense rose to $15,309,924 in 2025, compared to $8,140,617 in 2024, which is an increase of 88%[19] - The write-off of in-process research and development was $7,357,294 in 2025, with no such expense recorded in 2024[19] Clinical Development - The Company is advancing IKT-001 into a global pivotal Phase 3 study in Pulmonary Arterial Hypertension (PAH), named IMPROVE-PAH, with approximately 140 patients in Part A and 346 patients in Part B[4] - The IMPROVE-PAH study is expected to be conducted at up to approximately 180 sites worldwide, with regulatory submissions filed in over 20 countries[9] - The Company has received confirmation of acceptance under the FAST-EU initiative, which aims to accelerate the approval of multinational clinical trials, potentially reducing authorization timelines to a maximum of 10 weeks[9] Assets - The total assets as of December 31, 2025, were $181.2 million, compared to $98.6 million as of December 31, 2024, indicating a growth of approximately 83.7%[15]