Operational Performance - As of December 31, 2025, the company has a total of 550 productive wells, with 365 net wells[83]. - In 2025, the company turned 33 gross development wells to sales, compared to 8 gross wells in 2024, indicating a significant increase in operational activity[86]. - The company has 10 gross development wells in progress as of December 31, 2025, with 7 net wells expected to come online in Q1 2026[87]. - The total developed acreage in the DJ Basin is 53,350 gross acres and 41,302 net acres, while undeveloped acreage totals 44,778 gross acres and 26,711 net acres[89]. - Approximately 21% of net undeveloped acreage (14,311 acres) may expire in 2026 if production is not established, with plans to extend certain leases[91]. - The company has no exploratory drilling activities or dry holes reported for the years ended December 31, 2025, and 2024[87]. - The company has 59 full-time employees as of December 31, 2025, and has not experienced any work stoppages, indicating stable employee relations[154]. Financial Performance - For the years ended December 31, 2025 and 2024, the company incurred a net loss attributable to Prairie Operating Co. common stockholders of $60.9 million and $40.9 million, respectively, with an accumulated deficit of $87.7 million and $119.8 million as of December 31, 2025 and 2024[223]. - The company has historically relied on cash from financing activities to fund substantially all of its cash requirements, indicating a dependency on external capital[223]. - The company may require significant additional capital to fund its growing operations, including planned drilling of oil and natural gas wells, and may not be able to obtain sufficient capital[224]. - The company’s ability to obtain external financing may be subject to uncertainties, including its future financial condition and results of operations[226]. - The company has outstanding Series D Preferred Stock convertible into 1,196,337 shares of Common Stock, and Series F Preferred Stock convertible into 21,468,687 shares of Common Stock[257]. - The Series F Preferred Stock was issued for approximately $148.3 million and is convertible into shares of Common Stock at a price of $5.00 per share[256]. - The company has outstanding warrants that provide the right to purchase an aggregate of 5,019,163 shares of Common Stock at $7.49 per share[258]. - For the year ended December 31, 2025, the company incurred a basic and diluted loss per common share of $1.35[263]. Regulatory Environment - Regulatory compliance is a significant factor affecting operations, with potential changes in laws and regulations that could impact costs and operational capabilities[99]. - The FTC can impose fines of approximately $1,510,803 per violation per day for market manipulation as of 2025, adjusted annually for inflation[106]. - FERC has the authority to assess civil penalties of up to $1,000,000 per day for violations of the NGA, with the maximum penalty increasing to $1,584,648 per violation per day in January 2025[111]. - The CFTC can seek civil penalties of up to approximately $1,487,712 as of 2025 for violations of anti-market manipulation sections of the CEA, adjusted annually for inflation[112]. - The federal Energy Policy Act of 2005 introduced anti-market manipulation provisions, enhancing FERC's enforcement authority[111]. - Changes in FERC or state policies may adversely affect the availability and reliability of transportation services on interstate and intrastate pipelines[107]. - The regulation of natural gas transportation and sales is primarily governed by the Natural Gas Act of 1938 and enforced by FERC[109]. - The Clean Water Act imposes strict controls on the discharge of pollutants into state waters, requiring permits for such discharges[123]. - The Oil Pollution Act of 1990 imposes joint and several liability on responsible parties for oil spill damages, affecting operational costs[125]. - State regulation of natural gas gathering facilities may increase, impacting operational compliance and costs[115]. - The classification of natural gas gathering facilities is subject to ongoing litigation, which may affect operational costs and regulatory compliance[114]. - The company is subject to increased regulatory scrutiny regarding air emissions, with new standards requiring routine leak monitoring and emissions controls for existing sources[128]. - The EPA's proposed rule to expand the Greenhouse Gas Reporting Program could raise compliance costs for the company, with new reporting obligations effective from January 1, 2025[131]. - The Inflation Reduction Act of 2022 introduced a methane emissions charge starting at $900 per metric ton in 2024, which could significantly impact operational costs[134]. - Colorado's Senate Bill 19-181 mandates a 16% royalty on oil production and a 13% royalty on gas production for force-pooled interests, affecting the company's financial obligations[144]. - The CECMC has implemented new regulations that could increase well costs and extend the time required to obtain drilling permits, creating uncertainty for future development plans[146]. - The company faces potential operational delays and increased costs due to stricter local government regulations on oil and natural gas facility siting[145]. - The EPA's recent actions regarding GHG emissions could lead to significant costs for compliance and operational adjustments[135]. - The company may incur additional costs if federal regulations on hydraulic fracturing are adopted, impacting exploration and production activities[139]. - The identification of new endangered species could impose restrictions on the company's operations, potentially affecting reserve development[141]. - The company is subject to ongoing legal challenges regarding climate-related disclosure rules, which could impact reporting requirements and associated costs[132]. - The company is subject to various environmental regulations that may increase operational costs and affect project timelines[160]. - The company’s operations are concentrated in the DJ Basin, which exposes it to geographic-specific risks[160]. - The regulatory burden on the oil and natural gas industry is increasing, which may lead to higher costs and reduced profitability[200]. - The company faces potential increased operating costs due to new climate-related disclosure regulations, which may also restrict access to capital[205]. - The United Nations' Paris Agreement aims for a 30% reduction in global methane emissions from 2020 levels by 2030, impacting fossil fuel funding[206]. - Litigation risks are rising as various entities allege that energy companies contribute to climate change, which could adversely affect the company's financial condition[207]. - Financial risks are increasing as institutional investors shift towards non-fossil fuel sectors, with over $130 trillion committed to net zero goals by GFANZ[208]. - The company’s operations may be affected by physical risks from climate change, including severe weather events that could damage assets and disrupt supply chains[209]. - Regulatory scrutiny on hydraulic fracturing is increasing, potentially leading to higher costs and operational delays due to new permitting and disclosure requirements[214]. - Access to water for operations may be restricted due to drought or new regulations, impacting planned exploration and production activities[215]. - The company may face increased costs and operational challenges related to the disposal of produced water due to regulatory changes and seismic activity concerns[216][217]. - Future legislation could eliminate certain federal income tax deductions for oil and natural gas exploration, adversely affecting financial performance[219]. - Changes in U.S. trade policy and tariffs may create volatility in commodity markets, impacting the company's operations and results[220]. Strategic Considerations - The company plans to develop and operate existing and future E&P assets, which will require substantial additional capital that may not be raised on acceptable terms[167]. - The company faces risks related to obtaining necessary permits for drilling, which can delay operations and affect financial performance[163]. - The company has entered into hedging arrangements to mitigate risks associated with fluctuations in oil and natural gas prices, but these may also lead to financial losses[162]. - The success of drilling operations is uncertain, with risks including the possibility of not encountering commercially productive reserves and unexpected drilling conditions[170]. - The company intends to pursue horizontal drilling in the DJ Basin, which is generally more complex and costly than vertical drilling, increasing operational risks[174]. - Future capital requirements will depend on various factors, including the ability to raise additional capital through equity or debt financing, which could dilute existing stockholders' ownership[168]. - The company relies on midstream infrastructure for marketing oil and natural gas production, and any inability to access such infrastructure could materially affect its business[185]. - Estimated reserves of oil, natural gas, and NGLs are based on assumptions that may prove inaccurate, affecting the present value of reserves[183]. - The company may incur material impairments of oil and natural gas properties if drilling results are less than anticipated or if capital constraints limit operations[175]. - The availability of transportation options for oil and natural gas production is subject to federal and state regulations, which can impact the company's operations[186]. - The company faces strong competition from major integrated oil and natural gas companies and numerous independent firms, which may have larger capital resources and operational capabilities[190]. - All exploration and production (E&P) assets are located in the DJ Basin, making the company vulnerable to regional risks such as natural disasters and regulatory changes[193]. - Recent leadership changes, including the resignation of the CEO and retirement of the President, may impact the company's strategic direction and operational effectiveness[230]. - The company may explore strategic acquisitions and joint ventures, which could disrupt ongoing business and may not result in profitable operations[238]. - The terms of the company's indebtedness may restrict its future business operations, including limitations on paying dividends and incurring additional debt[236]. - Future litigation or governmental proceedings could result in material adverse consequences, including substantial payments that may affect the company's liquidity[242]. - The company has experienced stock price volatility, with a low of $1.57 and a high of $9.50 per share during the 12 months ended December 31, 2025[263]. - The trading market for Common Stock may be influenced by analysts' coverage; a downgrade or lack of coverage could lead to a decline in stock price[271]. - The company has broad discretion to issue additional securities, which may result in substantial dilution to stockholders[270].

Product Development and Clinical Trials - Cyclerion is focusing on developing CYC-126 as a novel anesthetic-based therapy for treatment-resistant depression (TRD), which represents a significant clinical and commercial opportunity [26]. - CYC-126 combines propofol and dexmedetomidine, administered through a personalized delivery system, aiming to improve patient outcomes in a hospital setting [29]. - The company plans to initiate a Phase 2 proof-of-concept study for CYC-126 in Australia in the second half of 2026, with U.S. enrollment expected to start in the first half of 2027 [27]. - More than one-third of patients with medication-treated major depressive disorder (MDD) are estimated to meet criteria for TRD, representing approximately 2.8 to 3 million adults in the U.S. [30]. - The company has in-licensed a product candidate for treatment-resistant depression (TRD), but the development may never lead to marketable products [123]. - The completion or commencement of clinical studies may face delays due to regulatory holds or negative results from ongoing studies [149]. - Challenges in recruiting participants and obtaining necessary approvals can further delay clinical studies [150]. - The regulatory approval processes for product candidates are lengthy and unpredictable, with no approvals obtained for any product candidates to date [148]. - The company may face difficulties in enrolling participants in future clinical studies, potentially delaying product candidate progress [123]. - The NDA submission process includes extensive nonclinical and clinical trials, with a focus on safety and efficacy, and must comply with federal regulations [78]. - Clinical trials are conducted in three phases, with Phase 3 trials involving a larger participant group to demonstrate effectiveness and safety [83]. Financial Position and Funding - The company has incurred significant losses and has never generated revenue from product sales, anticipating continued losses for the foreseeable future [123]. - There is substantial doubt regarding the company's ability to continue as a going concern, necessitating additional funding in the near-term [123]. - The company plans to seek additional capital through equity or financing transactions to support the Phase 2 trials and general working capital [35]. - As of December 31, 2025, the company had approximately $3.2 million in unrestricted cash and cash equivalents, which management believes will not be sufficient to fund operations through mid-2026 [137]. - The company may need to raise additional funding in the near term, which may not be available on acceptable terms, potentially forcing it to curtail operations [137]. - The company has never generated revenue from product sales and may never achieve profitability [135]. - The company has a limited operating history with no products approved for commercial sale, which poses risks to its financial position [123]. Intellectual Property and Licensing - Cyclerion has entered into a license agreement with MIT, which could yield up to $4.4 million in milestone payments and tiered royalties based on future net sales of licensed products [27]. - A collaboration agreement with Medsteer SAS includes potential milestone payments of up to $3.7 million and annual royalties based on future net sales [27]. - The company has 22 issued U.S. patents and 12 pending U.S. patent applications related to its sGC programs, indicating a strong intellectual property position [56]. - The olinciguat patent portfolio includes 16 issued U.S. patents and five pending applications, with coverage extending to 2034 and beyond [65]. - The company entered into an Option to License Agreement for olinciguat, receiving an option fee of $150,000, but the agreement was terminated in October 2025 [53]. - The company is exploring potential licensing opportunities for olinciguat following the termination of the Option Agreement [53]. - The company has licensed a patent application from MIT for its TRD strategy and intends to apply for additional patents related to this product strategy [57]. - The company is subject to a non-compete agreement with Tisento until July 2028, restricting the development of competing products [48]. - The company’s patent term may be extended under the Drug Price Competition and Hatch-Waxman Act, allowing for additional protection for FDA-approved drugs [71]. - The pharmaceutical industry is characterized by extensive litigation regarding patents, which can be costly and time-consuming [188]. - If patents are invalidated or found unenforceable, the company's business and financial condition could be materially harmed [186]. - The company may face challenges regarding the inventorship or ownership of its patents, which could impact its intellectual property rights [191]. Regulatory Compliance and Risks - The FDA approval process for drugs requires substantial time and financial resources, with the potential for administrative or judicial sanctions for non-compliance [74]. - The company must comply with extensive FDA regulations post-approval, including recordkeeping and periodic reporting [96]. - The company is subject to U.S. federal and foreign anti-corruption laws, including the FCPA, which may impact its operations [102]. - Compliance with FDA regulations is critical, as failure to meet these standards could delay regulatory approval and commercialization of product candidates [170]. - The company faces risks related to the potential misappropriation of confidential information shared with third parties, which could adversely affect its competitive position [171]. - Compliance with healthcare regulations is critical, as violations could lead to substantial penalties, including civil and criminal penalties, which may harm financial results [214]. - The company may face claims regarding the wrongful use of trade secrets, which could result in litigation and distract management [203]. Market Competition and Challenges - The company faces competition from major pharmaceutical firms and specialized biotechs in the TRD market, which may impact its market position [108]. - The company faces significant competition from major pharmaceutical and biotechnology companies, which may have greater financial resources and expertise in research and development [220]. - Regulatory approval for product candidates is crucial; failure to obtain approvals before competitors could hinder market entry and financial performance [219]. - The competitive landscape includes potential litigation regarding intellectual property rights, which could limit demand for the company's product candidates [221]. - The potential market for the company's product candidates may be smaller than estimated, impacting revenue and profitability [205]. - The company lacks an established infrastructure for sales and marketing, which could hinder the commercialization of approved product candidates [206]. - Regulatory approval does not guarantee market acceptance, which is crucial for generating sufficient revenue [208]. - The reimbursement process for product candidates is time-consuming and costly, with uncertainty regarding coverage and adequate reimbursement levels [211]. - The company may not be able to provide sufficient data to gain acceptance for coverage and reimbursement, affecting commercialization efforts [212]. - Pricing negotiations for prescription drugs in the European Union can take considerable time and may be influenced by governmental controls, potentially harming business if reimbursement is limited [213]. - The Inflation Reduction Act of 2022 and other healthcare reforms may adversely affect revenue prospects and the ability to set fair prices for products [222]. - Future growth may depend on the ability to commercialize products outside the United States, which involves additional regulatory burdens and risks [223]. - Foreign sales could be impacted by governmental controls, political instability, trade restrictions, and changes in tariffs [224].

Revenue Performance - Total revenue for the three months ended February 28, 2026, was $247,799,000, representing a 4% increase compared to $238,015,000 for the same period in 2025[61]. - Software licenses revenue increased by 16% to $67,581,000 in Q1 2026, up from $58,445,000 in Q1 2025, accounting for 27% of total revenue[62]. - Maintenance revenue slightly increased by 1% to $100,339,000, while SaaS revenue grew by 2% to $70,461,000; professional services revenue decreased by 11% to $9,418,000[63]. - The company's Annualized Recurring Revenue (ARR) was $863.0 million as of February 28, 2026, representing a 2% increase year-over-year from $849.0 million as of February 28, 2025[84]. - The net retention rate has generally ranged between 99% and 100% for all periods presented, indicating strong customer retention and expansion[86]. Expenses - Cost of software licenses rose by 3% to $3,013,000, representing 4% of software licenses revenue, attributed to increased royalty costs[64]. - Product development expenses increased by 9% to $50,474,000, accounting for 20% of total revenue, primarily due to higher personnel-related costs[69]. - General and administrative expenses rose by 3% to $26,504,000, maintaining 11% of total revenue, driven by higher stock-based compensation[70]. - Cyber vulnerability response expenses increased by 84% to $1,358,000, representing 1% of total revenue, related to costs from the MOVEit Vulnerability[72]. - Acquisition-related expenses dropped by 67% to $814,000, reflecting lower costs associated with business combinations compared to $2,490,000 in the prior year[74]. Tax and Other Financial Metrics - Provision for income taxes surged by 217% to $7,479,000, with an effective tax rate of 25%, up from 18% in the previous year[76]. - Total other expense, net, decreased by 15% to $16,173,000, primarily due to reduced interest expenses[75]. Cash Flow and Liquidity - Cash and cash equivalents increased by $18.4 million from the end of fiscal year 2025, totaling $113.2 million as of February 28, 2026, driven by cash inflows from operations of $98.6 million[87]. - Net cash flows provided by operating activities for the three months ended February 28, 2026, were $98.6 million, compared to $68.9 million for the same period in the previous year[89]. - The company plans to utilize worldwide cash based on the needs of the parent entity, with $69.0 million of cash and cash equivalents held by foreign subsidiaries[88]. - The company expects existing cash balances and funds generated from operations to be sufficient to finance operations and meet foreseeable cash requirements for at least the next twelve months[98]. - The company is continuously evaluating additional financing options to support general corporate purposes or repay outstanding indebtedness[99]. Shareholder Returns - The company repurchased $20.4 million of common stock in the first three months of fiscal year 2026, down from $30.1 million in the same period of the prior year[93]. - The Board of Directors approved the suspension of the quarterly dividend to redirect capital towards debt repayment and future M&A activities[95]. Accounts Receivable - As of February 28, 2026, gross accounts receivable decreased by $50.8 million, with days sales outstanding (DSO) improving to 52 days from 73 days in the previous fiscal quarter[91].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2025 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___ to ___ Commission File Number: 001-40386 ONEMEDNET CORPORATION (Exact name of registrant as specified in its charter) | Delaware | 86-2076743 | | --- | --- | | ...

Real World Data and Evidence - OneMedNet has established a network of 2,130 healthcare sites, enabling extensive access to regulatory-grade data for clinical imaging [26]. - The company launched its iRWDTM solution in 2019, becoming the first Real World Data solution for life science companies, leveraging its existing technology and customer base [25]. - Approximately 90% of healthcare data, by size, is associated with imaging, highlighting the significant role of imaging in patient diagnosis [33]. - In 2020, there were 28 oncology product submissions that included Real World Data, indicating a growing reliance on such data for regulatory decision-making [54]. - OneMedNet's data is fully de-identified and ready for use, eliminating the need for data manipulation by life science users [41]. - The company employs AI/ML technology for data curation, ensuring high accuracy and compliance with regulatory standards [36]. - Real World Evidence derived from OneMedNet's data can support regulatory submissions, enhancing the approval process for new medical products [50]. - The integration of AI in Real World Data processing is expected to improve the quality and speed of insights for pharmaceutical and biotech companies [55]. - OneMedNet's focus on regulatory-grade imaging RWD curation positions it as a leader in the field, addressing the complex needs of life science organizations [36]. - The global Real World Evidence solutions market size was estimated at USD $2.6 billion in 2023 and is expected to grow at a compound annual growth rate (CAGR) of 7.4% from 2024 to 2030 [86]. - The FDA launched the Real World Evidence Program in December 2022 to support regulatory decisions and develop consistent decision-making processes regarding Real World Evidence [87]. - The COVID-19 pandemic accelerated the adoption of Real World Evidence solutions, exemplified by the collaboration between ConcertAI and the FDA to generate Real World Evidence for cancer treatment [89]. - Real World Evidence is increasingly recognized by regulatory authorities, with the FDA expected to conduct its first full post-market safety approval using only Real World Evidence [71]. - Real World Evidence provides valuable insights into drug usage and safety, aiding life sciences companies in post-market surveillance and regulatory compliance [77]. - The FDA has emphasized the importance of Real World Evidence in monitoring post-market safety and adverse events, utilizing it to inform regulatory decisions [84]. - The demand for enhanced Real World Evidence capabilities is driving market growth, reflecting a shift from volume to value-based care in the life sciences industry [86]. - The global Real World Evidence solutions market is projected to grow from $2.62 billion in 2024 to $4.55 billion by 2030, at a CAGR of 8.2% [95]. - The global Real World Data market is estimated to be valued at $7.51 billion in 2024, with a forecasted CAGR of 9.1% from 2024 to 2031 [92]. - In 2021, the real world datasets segment accounted for 51.2% of the global Real World Evidence solutions market [92]. - Regulatory agencies like EMA and FDA are increasingly utilizing Real World Evidence in decision-making processes, driving demand for Real World Data solutions [95]. Financial Performance - The company generated net losses of $2.8 million and $10.1 million for the years ended December 31, 2025 and 2024, respectively, with an accumulated deficit of approximately $104.4 million as of December 31, 2025 [131][134]. - Total revenue for the year ended December 31, 2025, was $1.4 million, an increase of 111% compared to $0.6 million in 2024, primarily driven by a $1.0 million increase in data delivery revenue [220]. - Data delivery revenue (iRWD) increased by 329% to $1.3 million in 2025, while subscription revenue (BEAM) decreased by 70% to $0.1 million due to the platform's decommissioning in May 2025 [220]. - Cost of revenue rose to $1.9 million in 2025, a 102% increase from $0.9 million in 2024, primarily due to higher data and curation charges associated with increased data delivery revenue [221]. - Gross margin for 2025 was negative $503,000, compared to negative $281,000 in 2024, reflecting the impact of rising costs relative to revenue [219]. - General and administrative expenses decreased by 9% to $6.4 million in 2025, down from $7.0 million in 2024 [219]. - Sales and marketing expenses increased by 53% to $1.3 million in 2025, compared to $0.8 million in 2024, indicating a strategic push in marketing efforts [219]. - Research and development expenses were $1.5 million in 2025, a slight increase of 3% from $1.5 million in 2024, reflecting ongoing investment in product development [219]. - Interest expense decreased by 54% to $67,000 in 2025, down from $147,000 in 2024, indicating improved debt management [219]. Corporate Developments - A subsidiary of Data Knights merged with OneMedNet Solutions Corporation on November 7, 2023, changing its name to OneMedNet Corporation [100]. - The business combination completed on November 7, 2023, involved a total consideration of approximately $200 million, resulting in the rebranding of Data Knights to OneMedNet Corporation [201]. - The company plans to expand its sales network globally, focusing on Imaging AI, medical device companies, and pharmaceutical companies [95]. - The company aims to enhance its service offerings and expand its product portfolio into high-growth Real World Data and Real World Evidence solutions [96][98]. Risks and Challenges - The company faces significant risks related to competition in the Real World Data and Real World Evidence market, which is evolving and highly competitive [139]. - The company may encounter difficulties in managing growth, which could negatively impact operations and resource allocation [135]. - The company must continue to commit resources to develop its Real World Data and Real World Evidence technology to establish a competitive position [142]. - The company is increasingly dependent on information technology systems, and any security breaches could adversely affect its business and reputation [144][146]. - The company is subject to extensive government regulation and oversight, which could lead to increased costs and penalties if compliance is not maintained [150]. - The company has experienced significant legal scrutiny regarding privacy and security regulations, with potential severe penalties for violations [151]. - The company’s operations could be adversely affected by natural disasters and other catastrophic events, impacting service delivery and data integrity [153]. - The company faces risks related to bitcoin holdings, including potential loss due to security breaches and regulatory changes that could classify bitcoin as a security [159]. - The trading price of the company's common stock may be subject to extreme volatility, influenced by various market factors and operational performance [160]. - The company may face securities litigation following periods of market price volatility, which could divert management resources and incur substantial costs [162]. - The company’s ability to maintain its listing on Nasdaq is critical, as failure to meet listing requirements could impair stock liquidity and financing options [164]. - Principal stockholders hold significant influence over corporate actions, which could delay or prevent acquisitions or significant transactions [166]. - The company has identified material weaknesses in its internal control over financial reporting, which could lead to inaccuracies in financial statements and affect investor confidence [180]. - The company is in the process of remediating identified material weaknesses but cannot estimate when these efforts will be completed, posing risks to future financial reporting [181]. - The company faces significant increased expenses and administrative burdens as a public company, which could adversely affect its financial condition and results of operations [178]. - The company may not be able to raise additional capital on attractive terms, which could materially affect its operations and prospects [182]. Cybersecurity Measures - The company has implemented a comprehensive cybersecurity framework to protect its systems and sensitive information from unauthorized access [187]. - The company's cybersecurity program is overseen by the Audit Committee, which receives regular updates on critical issues related to information security risks [187]. - The company employs various data security technologies and practices, including multi-factor authentication and identity management, to safeguard its information infrastructure [188]. - The company has established global incident response procedures and training programs to enhance its cybersecurity posture and mitigate risks [190].

Product Development and Clinical Trials - Aspire plans to submit a 505(b)(2) NDA for its high-dose sublingual aspirin product by late 2026, following positive clinical trial results demonstrating faster bioavailability compared to standard oral aspirin [26]. - The successful clinical trial completed in July 2025 involved six healthy adult volunteers and showed that Aspire's sublingual delivery technology results in much faster aspirin bioavailability in the blood [26]. - Aspire's clinical trials for its aspirin product are designed to demonstrate a shorter time to clinically meaningful pharmacodynamic effect compared to standard oral aspirin, with the next trial expected to start in summer 2026 [36]. - Aspire has completed clinical trials for high-dose sublingual aspirin and plans to file an NDA (investigational new drug application) soon [204]. - Clinical development for Aspire's product candidates is lengthy and expensive, with uncertain outcomes that may delay or prevent regulatory approval [206]. - Delays in clinical trials can arise from various factors, including patient enrollment challenges and regulatory compliance issues [207]. - Aspire relies on third parties for conducting clinical trials, which may affect the timelines and costs associated with product development [219]. Intellectual Property and Patents - The company has developed a working formulation for sublingually administered melatonin and filed for patent protection, exploring licensing possibilities for this product [37]. - Aspire has also developed formulations for sublingually administered vitamins D, E, and K, and filed for patent protection under the Omnibus Patent [38]. - The company has filed patent applications for sublingual aspirin products, with a focus on improving delivery mechanisms to enhance patient outcomes [60]. - The company has a patent application for lower dose aspirin (63/456,290) filed on March 3, 2023, which is currently pending [54]. - The company intends to file a PCT application on October 1, 2025, claiming priority to U.S. Application No. 63/702,381, with a nominal expiration of October 1, 2045 [48]. - Aspire's new patent-pending formulation for its aspirin product is designed to facilitate rapid sublingual absorption, bypassing gastrointestinal issues associated with traditional aspirin [31]. - The company has filed multiple patent applications for its product candidates, indicating a focus on protecting its intellectual property as it moves towards commercialization [202]. Manufacturing and Supply Chain - Aspire has entered into a manufacturing agreement with Glatt for the production of its high-dose sublingual aspirin, with additional agreements in place for fill-and-finish processes and future clinical trials [25]. - The company has successfully completed cGMP manufacturing of its high-dose aspirin product for clinical trials, receiving positive feedback from the FDA regarding its Pre-IND meeting request [60]. - Aspire is subject to manufacturing and supply chain risks that could increase costs and limit product supply [159]. - The company relies on suppliers for components and services, and any failure in supply could adversely impact operations [172]. - Aspire's reliance on a limited number of suppliers poses risks of business interruptions and potential delays in product manufacturing [187]. Financial Position and Funding - Aspire has incurred net losses since inception and anticipates continuing to incur substantial losses in the foreseeable future [157]. - The Company requires substantial additional financing to achieve its goals, and failure to obtain necessary capital could delay or terminate product development [157]. - The company has issued two 20% original issue discount senior secured convertible debentures totaling $3,750,000, with a conversion price set at 92.5% of the lowest daily VWAP [72]. - Aspire Biopharma, Inc. entered into a Securities Purchase Agreement on August 19, 2025, selling convertible notes worth $9,687,500 for a subscription price of $7,750,000 [80]. - The company faced a compliance deficiency with Nasdaq regarding a minimum Market Value of Listed Securities of $50 million, with a 180-day period to rectify the issue [86]. - The company also received a Bid Price Notice for failing to maintain a minimum bid price of $1.00 per share for continued listing on Nasdaq [87]. - Aspire has retained experienced consultants to develop a plan for FDA approval of the sublingual aspirin delivery mechanism [117]. Market and Competition - The company faces competition from larger pharmaceutical and biotechnology companies with greater resources and experience in product development and commercialization [43]. - The company’s ability to compete may be affected by the pricing of its products, which are expected to be at a premium over generic alternatives [45]. - Aspire's business is highly dependent on the success of its lead product candidate, high-dose sublingual aspirin, which requires significant clinical testing [157]. - The ongoing military actions in Ukraine and the Israel-Hamas conflict may adversely affect Aspire's financial position and operations due to increased market volatility and financing challenges [184]. - Aspire's technology platforms are based on novel technologies, and the regulatory approval pathway for its product candidates is unproven, which may hinder market acceptance [188]. Corporate Governance and Compliance - Aspire Biopharma, Inc. stockholders received shares of New Aspire Common Stock valued at $350 million, adjusted for cash and indebtedness at closing [67]. - The Reverse Recapitalization was completed on February 17, 2025, with PowerUp Acquisition Corp. changing its name to Aspire Biopharma Holdings, Inc. [71]. - The Reverse Recapitalization was treated as a capital transaction, with Aspire Biopharma, Inc. recognized as the accounting acquirer [74]. - The Company regained compliance with the Bid Price Rule on February 3, 2026, and met the $2,500,000 stockholders' equity rule by February 18, 2026 [89]. - The Company has incurred and will continue to incur costs to comply with a wide range of federal, state, and local regulations, which are expected to increase [183]. - Aspire is classified as an "emerging growth company," allowing it to take advantage of certain exemptions from reporting requirements [149]. Product Portfolio and Future Plans - The company has initiated the marketing of its caffeine product, "Buzz Bomb," with 2,000,000 units manufactured and sales beginning on January 15, 2026 [40]. - Aspire is working on a sublingual erectile dysfunction (ED) medication, with an expected FDA approval timeline of at least 2-3 years [200]. - Aspire has developed a single serving sublingual pre-workout supplement and a "coffee or soda replacement" using patent-pending technology, with initial sales beginning in Q3 2025 [201]. - Aspire's scientists are working on formulations for various drugs, including anti-nausea products and anti-psychotic products, with several patents filed for these formulations [202]. - Aspire's high-dose sublingual aspirin product candidates are in development to treat heart attacks and strokes, with preliminary scientific evidence supporting their feasibility [189].

Product Development and Clinical Trials - Aspire plans to submit a 505(b)(2) NDA for its high-dose sublingual aspirin product by late 2026, following positive clinical trial results demonstrating faster aspirin bioavailability compared to standard oral aspirin [26]. - Aspire's recent clinical trial results showed that its sublingual aspirin product achieved faster therapeutic concentrations in the bloodstream, with significant pharmacodynamic effects compared to conventional aspirin [35]. - The company has received positive feedback from the FDA regarding its proposed next clinical trial for high-dose aspirin, which aims to evaluate its pharmacodynamic effects on platelet inhibition [36]. - Aspire has completed clinical trials for its high-dose aspirin, with final results provided on September 5, 2025, and plans to submit a 505(b)(2) NDA to the FDA for marketing approval [195]. - Clinical development for Aspire's product candidates is lengthy and expensive, with uncertain outcomes and a high rate of attrition in clinical trials [206]. - Delays in clinical trials can arise from various factors, including patient enrollment challenges and regulatory requirements, which could adversely affect Aspire's ability to generate product revenues [209]. - Aspire relies on third parties for conducting clinical trials, and any failure in their performance could delay regulatory approval and commercialization of product candidates [219]. - The company must comply with good clinical practices (GCPs) and current good manufacturing practices (cGMPs) to ensure the reliability of clinical data and successful regulatory approval [219]. Manufacturing and Supply Chain - The company has entered into a development and manufacturing agreement with Glatt to produce high-dose sublingual aspirin for clinical trials, with additional agreements for fill-and-finish services and future manufacturing needs [25]. - Aspire's manufacturing strategy relies on third-party contract manufacturers, with no current plans to develop in-house manufacturing capabilities [24]. - Aspire has entered into a manufacturing agreement with Desert Stream, Inc. to produce 2,000,000 units of its caffeine supplement marketed under the trademark "Buzz Bomb," with marketing and labeling starting on January 15, 2026 [201]. - The company is subject to manufacturing and supply chain risks that could increase costs and limit product supply [159]. - Aspire's reliance on a limited number of suppliers poses risks of business interruptions and potential delays in product manufacturing [187]. Intellectual Property and Technology - Aspire's patent-pending sublingual delivery technology is designed to improve drug efficacy and response time, with a focus on rapid absorption and high-dose delivery [31]. - The company has filed patent applications for sublingual aspirin products, with a focus on improving delivery mechanisms to avoid gastric issues, and has received positive feedback from recent clinical trials [60]. - The company’s intellectual property strategy includes filing U.S. and international patent applications to protect its drug candidates and formulations [47]. - Aspire has a pipeline of pending patent applications, including formulations for oral mucosal delivery of various substances, with key applications filed on January 9, 2026, and March 3, 2023 [54][55]. - Aspire's intellectual property rights may not provide a significant competitive advantage, and enforcement of these rights could be challenging [173]. Financial Performance and Capital Requirements - Aspire has incurred net losses since inception and anticipates continuing substantial losses in the foreseeable future, necessitating additional financing [157]. - The company relies on external financing for operations and may not secure necessary capital on favorable terms, jeopardizing its business plan [166]. - Aspire's future capital requirements depend on various factors, including the costs of research, regulatory approvals, and commercialization activities [168]. - The company has not recorded the assets from the asset purchase agreement due to the contingent nature of the transaction as of September 30, 2025 [64]. - Aspire's existing stockholders will hold over 64.4% of the voting interest in New Aspire under various redemption scenarios [76]. Market Competition and Challenges - The company is facing competition from larger pharmaceutical firms with greater resources and experience in drug development and commercialization [43]. - Aspire's business is highly dependent on the success of its lead product candidate, high-dose sublingual aspirin, which requires significant clinical testing before regulatory approval [157]. - The company faces significant competition from other biotechnology and pharmaceutical companies, which could adversely affect its operating results [159]. - Aspire has no marketing and sales organization and lacks experience in marketing products, which may hinder revenue generation [159]. - The ongoing military actions in Ukraine and the Israel-Hamas conflict may adversely affect Aspire's financial position and operations due to increased market volatility and financing challenges [184]. Regulatory Compliance - The company is subject to extensive regulatory compliance, which requires significant time and financial resources for product development and approval processes [118]. - Aspire has retained experienced consultants to assist in discussions with the FDA regarding the approval of its sublingual delivery mechanism [60]. - The company is required to evaluate its internal control procedures for the fiscal year ending December 31, 2025, as mandated by the Sarbanes-Oxley Act [148]. - Aspire's technology platforms are based on novel technologies, and the regulatory approval pathway remains unproven, posing risks to market acceptance [188]. - The company faces increasing regulatory compliance costs and risks associated with potential violations of federal, state, or local laws [183]. Product Pipeline and Future Developments - The company is developing additional products, including sublingual formulations for melatonin, vitamins D, E, and K, and ED medication, with patent applications filed for these formulations [37][38][39]. - Aspire's melatonin sleep-aid product has been developed in 3mg, 5mg, and 10mg doses, with patent protection filed under application 63/890,248 [198]. - The company is also developing sublingual formulations for vitamins D, E, and K, with patent protection filed in the Omnibus Patent [199]. - Aspire is working on a sublingual erectile dysfunction (ED) medication, with an expected FDA approval timeline of at least 2-3 years [200]. - Aspire has developed a single serving sublingual pre-workout supplement and a single dose "coffee or soda replacement" using patent-pending sublingual absorption technology, with trial runs and consumer testing conducted in Q2 2025 [201].

Financial Overview - HCIC completed its upsized initial public offering of 24.15 million units, generating gross proceeds of $241.5 million, with offering costs of approximately $9.67 million[23]. - The private placement of 671,000 units at $10.00 per unit generated additional gross proceeds of $6.71 million[24]. - The proceeds from the initial public offering and private placement are held in a trust account, invested in U.S. government treasury obligations or money market funds[25]. - HCIC has approximately $241.5 million available in its trust account for a business combination as of February 6, 2026, which includes deferred underwriting discounts and commissions of up to $4.83 million[60]. - HCIC's trust account held approximately $10.00 per public share as of February 6, 2026, net of accrued taxes[92]. - The per share redemption amount upon dissolution is expected to be approximately $10.00, but may be subject to claims from creditors[116]. - Only approximately $1,030,000 is available outside the trust account for HCIC's working capital requirements[182]. Acquisition Strategy - HCIC intends to focus on acquiring businesses in the industrial innovation and energy transition sectors, targeting an aggregate enterprise value of $500 million or greater[27]. - HCIC's acquisition criteria include targeting businesses with a large addressable market and a scalable growth platform, emphasizing sustainable growth due to shifting customer preferences[46]. - The company aims to partner with experienced management teams that share its strategic vision, enhancing operational capabilities post-acquisition[46]. - HCIC has identified over 1,600 potential acquisition targets since 2013, with meaningful reviews of over 40 targets for business combinations[44]. - The investment strategy focuses on industrial innovation and energy transition targets with an expected aggregate enterprise value of $500 million or greater[45]. Management and Experience - The management team has a strong track record, having executed or advised on 14 different business combinations across various industries since 2014[30]. - HCIC's management team has successfully executed or advised on 14 business combinations with a combined total enterprise value of approximately $8.8 billion[42]. - Daniel J. Hennessy, the CEO, has over 30 years of experience in private equity and over 10 years in the SPAC asset class[38]. - The board of directors includes members with extensive experience in mergers and acquisitions, with one director having led over $38 billion in closed transactions[39][40]. - The management team believes its relationships will generate attractive acquisition opportunities[38]. - Thomas D. Hennessy has successfully executed multiple SPAC business combinations, enhancing HCIC's credibility[35]. - HCIC's management team has extensive experience in evaluating and executing SPAC transactions, which is a core competency for selecting value-maximizing opportunities[44]. Business Combination Process - HCIC has a 24-month window from its IPO to complete an initial business combination, with provisions for shareholder votes to extend this period[48]. - If HCIC fails to complete its initial business combination within the specified timeframe, it will redeem public shares at a price based on the trust account balance[50]. - Nasdaq rules require HCIC to complete business combinations with an aggregate fair market value of at least 80% of the trust account value at the time of the agreement[51]. - HCIC's initial business combination requires shareholder approval, needing at least 6,393,244 public shares (26.5% of 24,150,000) to vote in favor for approval[101]. - The company must complete one or more business combinations with an aggregate fair market value of at least 80% of the trust account value at the time of the agreement[71]. - HCIC's initial business combination may be subject to negative economic, competitive, and regulatory developments that could adversely impact its industry[79]. Shareholder Rights and Redemption - Shareholders may redeem their public shares for cash upon completion of HCIC's initial business combination, with the redemption price based on the amount in the trust account divided by the number of outstanding public shares[92]. - HCIC's initial shareholders, officers, and directors have agreed to waive their redemption rights for any founder shares, private placement shares, and public shares in connection with the initial business combination[92]. - HCIC's shareholders are restricted from seeking redemption rights for more than 15% of the shares sold in its initial public offering without prior consent[104]. - The tender offer period for redemptions will be at least 20 business days, with a final proxy statement mailed at least 20 days prior to the shareholder vote[105]. - If HCIC's proposed business combination is not completed, public shareholders who elected to redeem their shares will not be entitled to any redemption[109]. - If HCIC does not seek shareholder approval, public shareholders' only opportunity to affect the investment decision is through redemption rights within a minimum of 20 business days[148]. Risks and Challenges - HCIC's lack of business diversification may pose risks, as its success may depend entirely on the performance of a single business post-combination[77]. - The company may face challenges in selecting a suitable business target and completing its initial business combination within the prescribed time frame[137]. - HCIC's financial performance post-business combination may be negatively affected by the lack of an established record of revenue and experienced management[137]. - The company is subject to risks related to market volatility and economic conditions that may hinder its ability to complete the initial business combination[138]. - HCIC's initial shareholders will lose their entire investment if the initial business combination is not completed, which may create conflicts of interest[138]. - The company may experience increased costs and difficulties in obtaining directors and officers liability insurance, which could impact its ability to negotiate and complete an initial business combination[141]. Regulatory and Compliance Issues - HCIC has filed a registration statement on Form 8-A with the SEC, making it subject to reporting obligations, including the requirement to file annual, quarterly, and current reports[129]. - Compliance with the Sarbanes-Oxley Act may increase costs and time for HCIC to complete its initial business combination[207]. - HCIC is classified as an "emerging growth company" and will remain so until it has total annual gross revenue of at least $1.235 billion or the market value of its Class A ordinary shares held by non-affiliates exceeds $700 million[133]. - HCIC's initial business combination may face regulatory review, including scrutiny from CFIUS, which could delay or prohibit the transaction[167]. Financial Obligations and Future Funding - The company does not currently anticipate needing additional funds for operations but may require financing for business combinations or to cover redemptions[54]. - HCIC may raise additional funds through private offerings or loans to complete its initial business combination[64]. - If HCIC's initial business combination agreement requires a minimum cash condition, it may need to reserve cash or seek third-party financing, which could lead to dilution for existing shareholders[151]. - The company may need to rely on loans from its sponsor or management team to fund its search for a target business[181]. - HCIC's obligation to indemnify its officers and directors may discourage shareholders from pursuing lawsuits against them[188]. Miscellaneous - HCIC's independent directors may choose not to pursue legal action against the sponsor for indemnification if the costs are deemed too high relative to recoverable amounts[119]. - The company intends to comply with Regulation 14A for any shareholder vote, even if it cannot maintain its Nasdaq listing[97]. - HCIC's management may not adequately assess all significant risk factors in potential business combinations, leading to potential shareholder value reduction[199]. - The control exerted by HCIC's initial shareholders will continue until the completion of the initial business combination[219].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 DATE OF REPORT (DATE OF EARLIEST EVENT REPORTED): March 30, 2026 THERAPEUTICSMD, INC. (Exact Name of Registrant as Specified in its Charter) Nevada 001-00100 87-0233535 (State or Other Jurisdiction of Incorporation) (Commission File Number) (IRS Employer Identification No.) 951 Yamato Road, Suite 220 Boca Raton, FL 33431 (Address of Principal ...

Sales Performance - Gross sales for the year ended December 31, 2025, reached $57.6 million, a 15.6% increase from $49.9 million in 2024[37] - The company’s net sales for 2025 reached approximately $49.89 million, with a 15.5% increase from $43.30 million in 2024[53] - E-commerce sales accounted for 50% of total net sales in 2025, while wholesale sales also represented 50%, showing a balanced revenue stream[53] - The wholesale channel sales grew by 41% in 2025 compared to 2024, driven by distribution expansion and higher shelf velocities[59] - Over 80% of direct-to-consumer net sales in both 2025 and 2024 came from subscribers or repeat users, indicating strong customer retention[58] Product Development and Market Trends - Coffee creamers accounted for 59% of total gross sales in 2025, generating $29.3 million, up from 53% and $23.1 million in 2024[37] - The company plans to expand its coffee creamer selection with additional flavors and functional ingredients, capitalizing on the growing U.S. creamer market valued at $7.1 billion in 2025, expected to grow at a 6.8% CAGR through 2030[40] - The U.S. instant coffee market generated approximately $859.3 million in revenue in 2025, indicating a strong demand for instant beverage products[45] - The U.S. greens powder market is projected to reach $338.5 million in 2025, with a CAGR of 10.7% from 2025 to 2032, highlighting growth potential in this segment[48] - The U.S. snack bar market is valued at $12.4 billion and is expected to grow at an 8.3% CAGR from 2026 to 2031, presenting opportunities for the company’s Protein Bars and Picky Bars[52] - The U.S. powdered electrolyte mix market is estimated at $2.7 billion in 2024, where the Hydrate product competes against established brands[51] - The North American coconut water market is projected to be $908 million in 2024, where the company’s Hydrate product competes[51] - The company’s new protein coffee product provides 10 grams of protein per serving and zero grams of sugar, targeting health-conscious consumers[44] Strategic Initiatives - The company aims to enhance its omnichannel distribution strategy, which includes e-commerce and wholesale, to maximize market penetration and customer engagement[26] - The company has a focus on new product development that aligns with its brand ethos of high-quality ingredients and nutritional density, aiming to diversify its revenue base[31] - The company plans to evaluate additional strategic transactions in the premium functional food market to further expand its product offerings and market presence[25] Regulatory Compliance - The company is subject to various labeling requirements at federal, state, and local levels, including compliance with FDA and FTC regulations[74] - The FDA mandates that all food products disclose net contents, identity, nutrition information, and manufacturer details, ensuring claims are truthful and not misleading[75] - The company believes it is in material compliance with existing food-related regulations, although future regulatory changes could impact capital expenditures and earnings[77] - The FTC regulates advertising for consumer products, requiring truthful and adequately substantiated claims, with potential investigations for non-compliance[80] Corporate Responsibility and Workforce - The company is committed to environmental, social, and governance (ESG) best practices, focusing on sustainable sourcing and reducing single-use plastics[33] - The company has a strong vision and values, employing 26 full-time and 2 part-time employees as of December 31, 2025, with no union representation[84] - An annual talent review process identifies top performers and informs development activities to meet future business needs[87] - The company offers competitive salaries and benefits, including employer-paid medical and vision insurance, dental insurance, and a retirement savings plan[88] - The company emphasizes diversity and inclusion to better understand customer needs and enhance innovation[89] Market Outlook - The U.S. grocery market is projected to grow at a 3.2% CAGR from 2024 to 2030, with the natural, organic, and functional food segment expected to grow at a 13.2% CAGR during the same period[23] - The North American Functional Mushroom Supplement Market was valued at $5.5 million in 2023, with a projected growth rate of 12% CAGR from 2024 to 2030[24] - The company completed the Navitas Acquisition on March 12, 2026, expanding its market presence[90]