UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ 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 UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _____________ to ________________ Commission file number: 001-41753 KEEN VISION ACQUISITION CORPORATION (Exact name of registrant as specified in its charter) British Virgin Island ...

IPO and Financial Proceeds - The company completed its IPO on July 27, 2023, raising gross proceeds of $149.5 million by selling 14,950,000 units at $10.00 per unit[27]. - A private placement with KVC Sponsor LLC generated an additional $6.78575 million from the sale of 678,575 private units at $1.00 each[28]. - The total net proceeds of $151.36875 million from the IPO and private placement were deposited into a trust account for public shareholders[29]. - The company incurred $6,597,980 in IPO-related costs, including $2,990,000 in underwriting fees[129]. - A total of $151,368,750 from the IPO and private placement was deposited in the Trust Account for the benefit of public shareholders[121]. - The company intends to use substantially all net proceeds from the IPO to acquire a target business and cover related expenses[130]. Merger and Acquisition Strategy - The company has entered into a merger agreement with Medera, with an aggregate consideration of $622.56 million, payable in newly issued shares valued at $10.00 each[33]. - The merger with Medera will result in the issuance of approximately 62,578,505 shares to Medera shareholders at closing[33]. - The company is targeting businesses in biotech, consumer goods, and agriculture, focusing on those with strong ESG imperatives and significant growth potential[30][40]. - The company aims to identify acquisition targets with a total enterprise value not exceeding $1 billion[40]. - The company has established a rigorous selection process for potential acquisitions, emphasizing due diligence to ensure sustainable shareholder value creation[32]. - The company has a binding letter of intent with Novoheart Group Limited, valuing NVH at $100 million, with a requirement for available cash of at least $10 million at closing[36]. - The company plans to leverage its management team's extensive networks and experience to enhance the likelihood of successful business combinations[34]. - The company intends to utilize cash from the IPO and private placement for business combinations, with no specific allocation for other purposes[42]. - Target businesses must have a fair market value of at least 80% of the Trust Account balance at the time of the business combination[49]. - The company aims to acquire 100% of the equity interests or assets of the target business, but may also consider less than 100% acquisitions[49]. - The management will focus on selecting target businesses with flexible operating models to adapt to market changes and sustainability concerns[43]. - The company will conduct extensive due diligence on prospective target businesses, including financial reviews and management assessments[47]. Shareholder Rights and Redemption - Shareholders may convert their shares into their pro rata share of the Trust Account or participate in a tender offer for their shares[55]. - Public shareholders have the right to redeem their shares for a pro rata share of the Trust Account, regardless of their vote on the proposed business combination[63]. - The company may require public shareholders to tender their shares to the transfer agent to exercise redemption rights, which could incur costs[66][67]. - If the initial business combination is not approved, public shareholders who exercised their conversion rights will not be entitled to convert their shares for the Trust Account[69]. - The company will assess all claims against it before distributing amounts from the Trust Account, as creditors may have priority over public shareholders[70]. Risks and Challenges - The company may face challenges in evaluating the management of target businesses and ensuring their capability to manage a public company[52]. - There is a risk of dependency on the performance of a single business due to the lack of diversification in acquisitions[51]. - The company anticipates sourcing target businesses from various unaffiliated financial community members, including investment bankers and venture capital funds[44]. - The company is considering acquiring a China-based company, which may involve risks related to PRC laws and regulations that are often vague and uncertain[75]. - Approval from Chinese authorities may be required for the company to continue listing on U.S. exchanges or issue securities to foreign investors post-business combination[76]. - There is uncertainty regarding future permissions from the PRC government, which could materially affect the company's ability to list on U.S. exchanges[78]. - If permission is denied or rescinded post-business combination, the company may incur increased costs for compliance or face penalties, adversely affecting its operations[79]. - New laws or regulations in China could require the company to change its business practices, potentially decreasing demand for its products or services and reducing revenues[80]. Corporate Governance and Management - The company is classified as an emerging growth company, allowing it to take advantage of certain exemptions from reporting requirements, which may affect the attractiveness of its securities[96]. - The company can delay the adoption of certain accounting standards until they apply to private companies, benefiting from an extended transition period[97]. - The company will remain an emerging growth company until it meets specific revenue or market value thresholds, including total annual gross revenue of at least $1.235 billion[98]. - The audit committee consists of independent directors, including Mr. Peter Ding, Mr. William Chu, and Prof. Albert Yu, ensuring financial literacy and oversight of financial statements[181]. - The compensation committee, chaired by Prof. Albert Yu, will review and recommend compensation arrangements related to initial business combinations, with no other compensation paid to existing shareholders prior to such arrangements[187]. - The nominating committee, also composed of independent directors, oversees the selection of board nominees, considering qualifications such as independence and relevant experience[184]. - The company will only enter into business combinations approved by a majority of independent directors, ensuring oversight and governance compliance[179]. - The audit committee is responsible for reviewing annual audited financial statements and discussing significant financial reporting issues with management and auditors[182]. - Mr. Ding is qualified as an "audit committee financial expert," enhancing the board's financial oversight capabilities[183]. - The company emphasizes the importance of independent directors in maintaining governance standards and ensuring unbiased decision-making[178]. Financial Position and Performance - For the year ended December 31, 2025, the company reported a net income of $1,910,263, which included dividend and interest earned on marketable securities of $2,653,771, offset by operating costs of $743,509[135]. - For the year ended December 31, 2024, the company had a net income of $7,409,180, with dividend income from marketable securities of $8,869,907 and operating costs of $1,460,753[136]. - As of December 31, 2025, the company had cash of $11,206 and investments held in the Trust Account of $57,003,115[127]. - As of December 31, 2025, the company had 4,822,346 ordinary shares subject to possible redemption, classified as temporary equity[145]. - The company has no long-term debt or off-balance sheet financing arrangements as of December 31, 2025[137]. - The company expects to incur increased expenses due to being a public company, particularly for legal, financial reporting, and due diligence expenses[134]. - The company is committed to pay a Deferred Discount of 2% of the gross offering proceeds of the Initial Public Offering, amounting to $2,990,000, to the underwriter upon consummation of a Business Combination[140]. - The company has not been subject to any market or interest rate risk as of December 31, 2025, with investments in U.S. government treasury obligations[147]. - The company began incurring a monthly fee of $10,000 for general and administrative services starting August 1, 2023[138]. - The company has identified critical accounting policies that may materially affect reported amounts in financial statements[141]. - The company has not experienced any changes in internal control over financial reporting that materially affected its operations during the most recent fiscal quarter[153]. Insider Ownership and Transactions - KVC Sponsor LLC holds 4,276,075 ordinary shares, representing 77.65% of the outstanding shares[210]. - Kenneth Wong owns 4,321,075 ordinary shares, accounting for 78.48% of the total[210]. - All executive officers and directors collectively own 4,416,075 ordinary shares, which is 80.20% of the outstanding shares[210]. - Karpus Investment Management and Wolverine Asset Management LLC own 294,134 (5.34%) and 297,589 (5.40%) ordinary shares, respectively[210]. - The company has not entered into any employment agreements with executive officers or provided benefits upon termination[203]. - The company will pay a $10,000 monthly administrative fee to the sponsor for up to 9 months, extendable to 21 months if necessary[204]. - No compensation will be paid to existing shareholders or their affiliates prior to the business combination[204]. - After the initial business combination, compensation for directors or management will be determined by a compensation committee of independent directors[205]. - The company has agreed not to consummate a business combination with any entity affiliated with its officers or directors without independent fairness opinions and disinterested director approval[198]. - All ongoing transactions with officers and directors will require prior approval by the audit committee and a majority of independent directors[197]. - In September 2021, a total of 3,737,500 insider shares were issued to the Sponsor for an aggregate contribution of $25,000[214]. - If the underwriters do not exercise the over-allotment option, up to 487,500 ordinary shares may be subject to forfeiture and cancellation[214]. - Initial shareholders, officers, and directors may loan funds to meet working capital needs, with loans evidenced by promissory notes[216]. - Up to $1,000,000 of the notes may be converted into private units at a price of $10.00 per unit upon consummation of the business combination[216]. - Conversion of notes could result in the issuance of units to acquire 100,000 ordinary shares and 100,000 warrants if $1,000,000 is converted[216]. - Shareholders have approved the issuance of units and underlying securities upon conversion of such notes[216]. - If a business combination is not completed, loans would be repaid from funds not held in the Trust Account[216].

Cash and Liquidity - As of January 31, 2026, the company had cash and cash equivalents of $428.8 million, excluding restricted cash of $0.6 million, and $250.0 million available under the Amended Credit Agreement[392]. - The company experienced a net increase in cash, cash equivalents, and restricted cash of $(13.5) million for fiscal 2026, compared to an increase of $293.9 million for fiscal 2025[396]. - The company’s liquidity is subject to various risks, including those outlined in the "Risk Factors" section of the Annual Report[392]. - The total borrowing capacity of the revolving credit facility was increased from $140.0 million to $250.0 million under the Amended Credit Agreement[394]. - The company may require additional equity or debt financing in the future, depending on various factors including capital requirements for acquisitions[393]. Operating Activities - Net cash provided by operating activities was $110.1 million for fiscal 2026, primarily due to non-cash charges of $324.9 million and a net loss of $159.9 million[397]. - The company reported a net cash provided by operating activities of $37.1 million for fiscal 2025, with a net loss of $239.1 million[398]. Investing Activities - Net cash used in investing activities was $44.8 million for fiscal 2026, including $19.9 million for investments in capitalized internal-use software and $19.8 million for the acquisition of Conduit[399]. Financing Activities - Net cash used in financing activities was $78.8 million for fiscal 2026, primarily due to the repayment of approximately $107.0 million in debt[401]. Valuation and Fair Value - The fair value of stock-based awards is determined based on the company's stock price on the Nasdaq at the grant date[407]. - Management makes judgments and estimates to determine the fair value of acquired assets and assumed liabilities during business combinations[408]. - Valuation of intangible assets, such as customer relationships and developed technology, relies on critical estimates including forecasted growth rates and customer retention rates[409]. Operational Risks - The company has incorporated traditional AI, machine learning, and generative AI into some of its products, which may present operational risks[19].

Financial Performance - Revenues for Park Dental Partners, Inc. were $244.5 million in 2025, up from $229.8 million in 2024, reflecting a growth of approximately 6.1% year-over-year[15]. - Same Practice Revenue increased by 5.8% for the year ended December 31, 2025, and 1.6% for the year ended December 31, 2024[34]. - Approximately 73% of total revenues for the years ended December 31, 2025, and 2024, were generated from 55 dental practice locations operated by Park Dental[41]. - The company generated 99.0% and 98.9% of its revenue from Minnesota locations for the years ended December 31, 2025, and 2024, respectively[126]. - Approximately 92% of total revenues for the years ended December 31, 2025 and 2024, were derived from patients with indemnity and preferred provider plans and government-sponsored programs[192]. - 22% and 16% of total revenues for the years ended December 31, 2025 and 2024, respectively, were derived from patients with government-sponsored plans including Medicare and Medicaid[193]. Market Position and Growth Strategy - The organization has acquired 43 practices and opened 12 de novo practices over the past 10 years, contributing to its steady growth strategy[16]. - Park Dental Partners, Inc. holds a leading market position in Minnesota, with over 330,000 active patients in the Minneapolis and St. Paul metro area[30]. - Park Dental Partners, Inc. aims to double the number of affiliated dentists it supports within a seven to ten-year timeframe, leveraging its growth strategy and market conditions[33]. - The company plans to expand primarily in medium and large Metropolitan Statistical Areas (MSAs), estimating approximately 230 such MSAs across the U.S. that meet their criteria[37]. - The company’s growth strategy depends on increasing the number of locations for affiliated dental groups, which involves various challenges[112]. - The company’s growth strategy relies on acquiring or affiliating with established dental practices and expanding existing practices, which requires significant capital resources and management time[145]. Patient and Customer Metrics - The patient retention rate for Park Dental Partners, Inc. was 89.9% in 2025, indicating strong customer loyalty and recurring revenue[30]. - Ongoing patient satisfaction surveys are conducted to gather feedback and promote continuous improvement in patient care[69]. - The company operates under a dyad leadership model, achieving a patient satisfaction score in the 92nd percentile for 2025 according to national Press Ganey Surveys[34]. Regulatory and Compliance Issues - Compliance with regulations such as HIPAA and OSHA is crucial for maintaining operational eligibility and avoiding legal consequences[75][84]. - The company’s affiliated dental practices are subject to complex laws and regulations, which may be costly and burdensome to comply with[119]. - Regulatory compliance and potential legal issues related to administrative resource agreements could impact the company's operational capabilities and revenue generation[131]. Operational Efficiency and Management - The company provides business support services to affiliated dental practices across 86 locations, ensuring operational efficiency and compliance with clinical decision-making[38]. - The company aims to improve operating margins by leveraging scalable infrastructure and streamlining administrative work, enhancing efficiency and productivity[39]. - Management information systems allow the company to track performance metrics across 86 affiliated practices, identifying growth opportunities[70]. - The company employs 990 hygienists, dental assistants, and patient care coordinators across 86 locations, facing increased labor costs due to market compensation rates rising approximately 16%[143]. Risks and Challenges - The company faces risks related to the performance of affiliated dental practices, which could negatively impact revenue generation[111]. - Rising inflation and interest rates may increase operating costs, potentially leading to higher dental service prices that could adversely affect patient demand[157]. - Labor shortages in the dental industry, with over 7,000 designated dental professional shortage areas in the U.S., are impacting the ability to attract and retain qualified staff[142]. - A significant cybersecurity incident could lead to unauthorized access to sensitive patient information, resulting in potential legal and financial repercussions[167]. - The healthcare industry has seen a rise in cyberattacks, with a notable breach in February 2024 affecting approximately 190 million individuals and incurring costs exceeding $2 billion[175][176]. Financial Management and Insurance - The management fee charged to affiliated dental practices is based on total net collections and is reviewed annually to align with fair market value[53]. - The company maintains professional liability insurance coverage limits of $2.0 million per occurrence and $3.0 million annual aggregate for general dentists[100]. - The current standard insurance policy provides coverage limits of $2.0 million per occurrence and $3.0 million annual aggregate, with higher limits for dental specialists providing sedation services[191]. - The company is self-insured for certain employee group medical costs, which may lead to increased financial risk if medical claims rise significantly[194]. Technology and Innovation - The company is increasingly adopting artificial intelligence technologies in dental care, which presents both competitive pressures and regulatory uncertainties[179]. - The regulatory framework for AI-enabled medical devices is evolving, creating potential liability exposure for the company[180]. - The company’s operations depend on integrated management information systems, which are critical for tracking financial and operational performance[159]. Brand and Intellectual Property - The company’s brand recognition is crucial for its business, and any negative events could materially affect patient relationships and demand for services[186]. - The company faces risks related to the protection of its intellectual property, which could impact brand value and operational success[182].

Financial Performance - Revenue for the year ended December 31, 2025, was $4.7 million, an increase of $0.4 million compared to $4.3 million in 2024, primarily due to higher consideration received for EsoGuard tests[354]. - Cost of revenue decreased to approximately $6.7 million in 2025 from $7.1 million in 2024, reflecting improved operational efficiencies[355]. - Sales and marketing expenses rose to approximately $17.7 million in 2025, up from $16.5 million in 2024, driven by expansion of commercial operations[355]. - General and administrative expenses increased to approximately $23.9 million in 2025 from $20.2 million in 2024, largely due to increased compensation and professional service costs[356]. - Research and development expenses were approximately $5.7 million in 2025, a decrease from $6.0 million in 2024, reflecting a focus on operational efficiency[357]. - The company experienced a net loss of approximately $58.0 million and used approximately $46.5 million of cash in operations during the year ended December 31, 2025[364]. - The company ended the year with cash on-hand of $34.7 million as of December 31, 2025[364]. Funding and Capital Raising - The Company closed a public offering in September 2025, raising approximately $27.0 million for working capital and corporate purposes[342]. - The company raised approximately $21.975 million in gross proceeds from the sale of 12.0% Senior Secured Convertible Notes due 2029 in November 2024[369]. - The company generated net proceeds of approximately $14.9 million from the sale of 13,939,330 shares of common stock at $1.10 per share in March 2025[371]. - The company raised approximately $16.2 million from the sale of 14,375,000 shares of common stock at $1.20 per share in April 2025[372]. - The company raised approximately $27.0 million from the September 2025 Offering after deducting estimated fees[373]. - The company sold 215,421 shares through its at-the-market equity facility for net proceeds of approximately $0.3 million in the year ended December 31, 2025[374]. - The company issued approximately 11,634 shares of Series B-1 Convertible Preferred Stock, raising gross proceeds of $11.6 million[367]. - The company recognized a deemed dividend of $7.5 million charged to accumulated deficit related to the exchange of Series A and Series A-1 Preferred Stock for Series B Preferred Stock[361]. Product Development and Market Expansion - EsoGuard demonstrated a positive predictive value of 30–33% and a negative predictive value of 99% for detecting Barrett's esophagus and esophageal adenocarcinoma[329]. - The Company submitted a clinical evidence package to secure Medicare coverage for EsoGuard, including six new peer-reviewed publications[332]. - The Company was awarded a contract by the U.S. Department of Veterans Affairs for EsoGuard, expanding access to testing for over nine million veterans annually[334]. - The company is focused on the commercialization of EsoGuard and expanding insurance reimbursement coverage while developing additional products and services[362]. Regulatory and Accounting Updates - In December 2023, the FASB issued ASU No. 2023-09, enhancing income tax disclosures, effective for the Company from January 1, 2025, with no material impact on financial statements[387]. - The Company is evaluating the impact of ASU No. 2024-03, which requires detailed disclosures about costs and expenses, effective after December 15, 2026[388]. - The FASB issued ASU No. 2023-06 in October 2023, modifying disclosure requirements, with the effective date contingent on SEC actions[389]. - The Company has no off-balance sheet arrangements[390]. - There are no applicable quantitative and qualitative disclosures about market risk[391]. Market Presence - The Company was added to the Russell 2000® and 3000® Indexes on June 27, 2025, enhancing its visibility in the market[338].

Financial Performance - The company reported a net income of $28.3 million in 2022, primarily due to a gain on divestiture of $94.7 million from the sale of TransOva, but has an accumulated deficit of $2.3 billion as of December 31, 2025[217]. - The company has incurred net losses since inception, with expectations of continued losses and negative cash flows for the foreseeable future[217]. - As of December 31, 2025, the company had net operating loss carryforwards of approximately $1.12 billion for U.S. federal income tax purposes, including $911.9 million generated after 2017[340]. - The company may require significant additional capital and financial resources to successfully commercialize Papzimeos and future products, impacting profitability[275]. - The company recorded a goodwill impairment charge of $3.9 million due to the shutdown of ActoBio's operations and the annual goodwill impairment test for Exemplar's reporting unit[339]. Regulatory Approvals and Compliance - The company received FDA approval for Papzimeos on August 14, 2025, for the treatment of recurrent respiratory papillomatosis (RRP) in adults, and is pursuing regulatory approval in other jurisdictions[218]. - The regulatory approval processes for product candidates are lengthy and unpredictable, often taking many years and subject to various factors[233]. - The company may face challenges in obtaining FDA approval for its product candidates, which could materially harm its business and revenue potential[236]. - The company must obtain regulatory approval for manufacturing processes and facilities before commercializing additional product candidates, which may involve extensive audits and inspections[266]. - Ongoing regulatory obligations after marketing approval may lead to significant additional expenses and compliance risks[268]. Market and Commercialization Risks - The company is heavily dependent on the successful commercialization of Papzimeos and the advancement of its product candidates through clinical trials, which may not occur[226]. - The market opportunity for Papzimeos may be smaller than estimated, as the prevalence of RRP is based on internal estimates and limited research, which could affect financial projections[230]. - The company anticipates significant commercialization expenses related to product sales, marketing, manufacturing, and distribution as it advances Papzimeos[218]. - The commercial success of Papzimeos and other product candidates will depend on acceptance by physicians, patients, and healthcare payers, which is influenced by public perception of gene and cell therapies[257]. - The success of product commercialization will depend on third-party payers providing adequate coverage and reimbursement, which is uncertain and may limit market potential[279]. Operational Challenges - The company faces risks related to macroeconomic conditions, including inflation and geopolitical conflicts, which could impact its ability to raise capital on favorable terms[220]. - Clinical trials for gene therapies have historically encountered significant technical problems, leading to high failure rates[237]. - The company may experience delays in clinical trials due to difficulties in patient enrollment, which could increase costs and hinder product development[244]. - Manufacturing processes for the company's product candidates are complex and may face interruptions due to various factors, impacting production and quality[247]. - The company faces risks related to maintaining a manufacturing supply chain for Papzimeos, which could adversely affect commercialization efforts[258]. Intellectual Property and Legal Risks - The company has adopted a strategy of seeking patent protection in the United States and abroad for its technologies and product pipeline[343]. - The company may face significant costs and time diversion due to potential litigation regarding intellectual property rights[350]. - The company relies on trade secrets to protect its technologies, which are difficult to safeguard[347]. - The company faces uncertainties in enforcing its intellectual property rights, which could impact its competitive position[361]. - The company is subject to potential regulatory actions and litigation due to data security breaches, which could materially affect its business and financial condition[325][326]. Corporate Governance and Management - The board of directors has overall oversight responsibility for the company's risk management, including cybersecurity risks[397]. - Effective internal controls over financial reporting are necessary to prevent fraud and ensure accurate financial reporting, with potential material weaknesses impacting investor confidence[308]. - The company has faced challenges in attracting and retaining key personnel, which could delay product development and commercialization efforts[320][321]. - Randal J. Kirk controlled approximately 34 percent of the company's common stock as of February 15, 2026, which may allow him to significantly influence management and operations[384]. - The company has historically been controlled by Randal J. Kirk and affiliates, which may lead to conflicts of interest with other shareholders[384]. Stock and Market Performance - The company's stock price has fluctuated significantly, trading as high as $5.23 and as low as $1.11 per share from January 1, 2024, to February 15, 2026[377]. - The company received a deficiency letter from Nasdaq on November 1, 2024, indicating that the bid price for its common stock had closed below the minimum $1.00 per share requirement for continued listing[372]. - On January 16, 2025, the company regained compliance with the Bid Price Rule after its common stock closed at or above $1.00 per share for ten consecutive business days[373]. - The company may face challenges in maintaining compliance with Nasdaq listing requirements, which could adversely affect its stock price and liquidity[374]. - The company does not anticipate paying cash dividends in the future, relying instead on stock appreciation for shareholder returns[382].

Company Transition and Product Launch - Precigen transitioned to a commercial-stage company with the FDA approval of PAPZIMEOS in August 2025, marking a significant milestone in its business evolution [5] - PAPZIMEOS generated $3.4 million in net product revenue in Q4 2025, reflecting the first partial quarter of US commercial sales [5] - The Centers for Medicare and Medicaid Services assigned a permanent J-code, J3404, to PAPZIMEOS, effective April 1, 2026, facilitating broader patient access [6] - Patient hub enrollment for PAPZIMEOS surpassed 300 patients, indicating strong demand from both patients and physicians [6] - The Marketing Authorization Application for PAPZIMEOS is under review by the European Medicines Agency, following validation in November 2025 [14] Financial Performance - Total revenues increased by $5.8 million in 2025 compared to 2024, primarily driven by PAPZIMEOS product revenue and higher collaboration and licensing revenue [11] - Total revenues for the year ended December 31, 2025, increased to $9,684,000, up from $3,925,000 in 2024, representing a growth of 147% [26] - Collaboration and licensing revenue reached $1,818,000 in 2025, compared to $0 in 2024, indicating the company has started generating revenue from collaborations [26] - Product revenues increased significantly to $3,975,000 in 2025 from $422,000 in 2024, showing a growth of 841% [26] Expenses and Losses - Research and development expenses decreased by $11.7 million, or 22.1%, compared to 2024, mainly due to reduced costs associated with ActoBio and strategic prioritization of the pipeline [12] - Selling, General and Administrative (SG&A) expenses increased by $28.8 million, or 69.8%, compared to 2024, primarily due to costs related to PAPZIMEOS commercial readiness [13] - Net loss attributable to common shareholders was $429.6 million, or $1.37 per share for 2025, compared to a net loss of $126.2 million, or $0.47 per share in 2024 [18] - The net loss for the year ended December 31, 2025, was $429,642,000, compared to a net loss of $126,235,000 in 2024, reflecting a significant increase in losses [26] - The company reported an operating loss of $110,507,000 for 2025, an improvement from the operating loss of $135,029,000 in 2024 [26] Asset and Liability Changes - Cash, cash equivalents, and investments totaled $100.4 million as of December 31, 2025, expected to fund operations to cash flow break-even by the end of 2026 [5] - Total operating expenses decreased to $120,191,000 in 2025 from $138,954,000 in 2024, a reduction of approximately 14% [26] - The total assets increased to $155,505,000 as of December 31, 2025, from $145,266,000 in 2024, marking a growth of approximately 7% [24] - Current liabilities rose significantly to $37,306,000 in 2025 from $21,518,000 in 2024, an increase of about 73% [24] - Shareholders' equity decreased to $20,911,000 in 2025 from $38,513,000 in 2024, a decline of approximately 46% [24]

Revenue and Sales Performance - SeaStar Medical recognized $1.2 million in revenue from the sale of its pediatric SCD therapy, QUELIMMUNE, for the year ended December 31, 2025, a significant increase from $0.1 million in 2024, representing an 814% growth [352][364]. - The company shipped its first commercial QUELIMMUNE units in July 2024 and had ten customers by December 31, 2025, up from three customers at the end of 2024 [352][364]. Expenses and Financial Performance - Research and development expenses for the year ended December 31, 2025, were $7.5 million, a decrease of 17% from $9.1 million in 2024 [363]. - General and administrative expenses decreased by 34% to $5.8 million in 2025 from $8.9 million in 2024 [363]. - The total operating expenses for 2025 were $13.4 million, down 26% from $18.0 million in 2024 [363]. - SeaStar Medical reported a net loss of $12.2 million for the year ended December 31, 2025, a 51% reduction compared to a net loss of $24.8 million in 2024 [363]. - Cash used in operating activities was $13.6 million in 2025, down from $16.0 million in 2024, a decrease of $2.4 million or 15% [378]. - Net cash provided by financing activities increased to $23.8 million in 2025 from $17.7 million in 2024, an increase of $6.1 million or 34% [379]. - As of December 31, 2025, the company had an accumulated deficit of approximately $151.7 million [348]. - The company expects existing cash of $12.0 million to be insufficient to fund operations for the next twelve months, raising substantial doubt about its ability to continue as a going concern [376]. Funding and Financial Obligations - The company raised approximately $14.4 million through registered direct offerings and $6.1 million through an At-The-Market Offering in 2025 [386]. - The total contractual obligations as of December 31, 2025, amount to $525,000, with all obligations due within one year [403]. - An insurance financing arrangement was entered into in October 2025 for $0.7 million, to be paid down in 10 monthly installments through August 2026 [404]. - The company has approximately $15.0 million remaining under the Standby Equity Purchase Agreement as of December 31, 2025 [385]. Clinical Trials and Product Development - The company is currently conducting a pivotal clinical trial for its adult SCD therapy, which is designed to integrate with existing continuous renal replacement therapy systems [347]. - SeaStar Medical's SCD therapy has received Breakthrough Device Designation for six therapeutic indications, facilitating a potentially expedited approval process [342]. - The NEUTRALIZE-AKI clinical trial is ongoing at multiple healthcare facilities, with costs incurred but not billed estimated at the end of each reporting period, impacting research and development expenses [395]. Company Classification and Compliance - The company is classified as an emerging growth company (EGC) under the JOBS Act, allowing for an extended transition period to comply with new accounting standards [399]. - The company will remain an EGC until the earliest of the last day of the first fiscal year following the fifth anniversary of the Business Combination, or total annual gross revenue of at least $1.235 billion [401]. - The company is classified as a smaller reporting company and is not required to provide certain market risk disclosures [405]. - The company is not required to provide certain disclosures and auditor's attestation reports due to its EGC status [400]. Valuation and Financial Instruments - A valuation allowance of $32.0 million was recorded for deferred tax assets as of December 31, 2025, compared to $28.5 million in 2024 [372]. - The company uses a Black-Scholes option pricing model to measure the fair value of liability classified warrants and stock options [396][397]. - The change in fair value of liability classified warrants is recorded in the consolidated statement of operations each reporting period [396].

Financial Performance - Total revenue for the year ended December 31, 2025, was $18.1 million, a decrease of 36% from $28.2 million in 2024, primarily due to a customer attrition rate of 28%[164][165] - Cost of revenue for 2025 was $13.3 million, down 30% from $19.1 million in 2024, reflecting the decrease in revenue[166] - General and administrative expenses decreased to $11.1 million in 2025 from $12.8 million in 2024, a reduction of $1.7 million due to operational streamlining[168] - Sales and marketing expenses fell to $1.1 million in 2025, down 38% from $1.8 million in 2024, as a result of streamlined efforts[169] - Net loss for 2025 was $16.6 million, a 25% improvement from a net loss of $22.1 million in 2024, attributed to cost reduction measures[182] - Loss per share improved to $0.95 in 2025 from $1.92 in 2024, reflecting the reduced net loss and additional common stock issuance[183] - The company reported a net loss of $16.6 million for the year ended December 31, 2025[208] Cash Flow and Financing - Net cash used in operating activities decreased to $7.5 million in 2025 from $15.2 million in 2024, reflecting a $7.7 million reduction[208] - Net cash provided by investing activities increased to $500 thousand in 2025 from $227 thousand in 2024, an increase of $273 thousand[209] - Financing activities provided net cash of $6.7 million in 2025, primarily from $7.0 million in private placements of common stock[210] - The company issued Senior Secured Convertible Debentures totaling $11.83 million, with $6.35 million purchased by JGB, and an additional $5.4 million in Debentures planned for sale[195] - A total of 730,000 shares of common stock were sold in a private placement at $1.00 per share on May 13, 2025[196] - The company issued 3,850,000 shares of common stock and warrants in a private placement at $1.00 per share on November 7, 2025[201] - The company issued a promissory note of $410,000 to the CEO with a 12.0% interest rate, due by April 11, 2026[203] Operational Changes and Future Plans - The company plans to consolidate claims processing operations onto a single cloud-based platform, expecting to achieve significant operational efficiencies and cost savings[184] - Estimated pre-tax restructuring charges of approximately $465 thousand are expected in the first half of 2026 due to the operational realignment[185][186] - Management is actively seeking additional funding alternatives to support operations and reduce capital resource drain[189] - The company expects to fund $465 thousand in restructuring-related cash payments through existing cash on hand, which is anticipated to improve future cash flow from operations[205] Accounting and Valuation - The company recognized impairments of goodwill during the year ended December 31, 2024[214] - The company estimates the expected term of stock options granted to employees using the simplified method, averaging the vesting term and the original contractual term[223] - For stock options granted to non-employees, the expected term is based on the contractual term of the option[223] - The fair value of stock options is calculated using the Black-Scholes option-pricing model, influenced by stock price, expected volatility, expected life, risk-free interest rate, and expected dividends[223] - Changes in assumptions for share-based compensation may significantly impact future results of operations[224] - Convertible notes and debentures are evaluated for embedded features that may require separate accounting as derivative financial instruments[225] - Bifurcated embedded derivatives are recorded at fair value and revalued at each reporting date, with changes reported as non-operating income or expense[225] - Recent accounting pronouncements are discussed in Note 3 of the consolidated financial statements[226] - There are no applicable quantitative and qualitative disclosures about market risk[227]

Financial Performance - Dakota Gold Corp. reported a significant increase in revenue, reaching $50 million for the fiscal year, representing a 25% year-over-year growth[10] - The company reported a significant increase in revenue, achieving $500 million in Q3 2023, representing a 25% year-over-year growth[15] - The company provided guidance for Q4 2023, expecting revenue to be between $520 million and $550 million, indicating a potential growth of 4% to 10%[15] - The company reported a net income of $5 million, a significant improvement compared to a net loss of $2 million in the previous year[10] User Growth - The company has successfully expanded its user base, with a 15% increase in active users, totaling 1.2 million users[10] - User data showed a 15% increase in active users, reaching 2 million by the end of Q3 2023[15] Future Projections - Future guidance indicates projected revenue growth of 30% for the next fiscal year, with expected revenues of $65 million[10] - The company anticipates a 10% increase in production capacity due to new operational efficiencies implemented in Q3 2023[15] Market Expansion - The company plans to expand its market presence by entering three new states, aiming for a 20% increase in market share[10] - The company is planning to expand its market presence in South America, targeting a 30% increase in market share by 2025[15] Product Development - Dakota Gold is investing in new product development, allocating $10 million towards research and development initiatives[10] - New product launches included a state-of-the-art mining technology that is expected to reduce operational costs by 20%[15] Acquisitions - Dakota Gold is exploring potential acquisition opportunities to enhance its portfolio, with a target of acquiring at least one new asset by the end of the fiscal year[10] - A strategic acquisition of a smaller mining firm was announced, which is projected to add $100 million in annual revenue[15] Operational Efficiency - The company has implemented new strategies to improve operational efficiency, aiming to reduce costs by 10% over the next year[10] - Exploration expenditures for the upcoming year are estimated at $50 million, focusing on high-potential mineral deposits[16] Sustainability - Dakota Gold is committed to sustainability, with plans to invest $2 million in environmentally friendly technologies over the next two years[10] Risks - Future risks include fluctuations in commodity prices, which could impact profitability and operational planning[16]