Financial Performance and Losses - The net loss attributable to common stockholders for the year ended December 31, 2025, was $22.4 million, with an accumulated deficit of $268.1 million[73]. - The company expects to incur additional losses while growing and expanding its business, which could negatively impact the market price of its common stock[73]. - The company may need to raise additional funds in the future to grow its business, which could result in dilution to existing stockholders if raised through equity[74]. Regulatory and Compliance Risks - As of December 31, 2025, the company's internal control over financial reporting was not effective, raising concerns about the reliability of financial reports[76]. - The company is subject to regulatory scrutiny regarding conflicts of interest, which could damage its reputation and business[112]. - The Company is subject to extensive securities regulation, and failure to comply could result in monetary penalties or sanctions that adversely affect its financial condition[142]. - Increased regulatory scrutiny in the financial services industry has raised the risk of financial liability and reputational harm due to adverse regulatory actions[147]. - New regulations, such as Regulation Best Interest, impose additional compliance costs and may limit revenue opportunities for the Company[150]. - The company may incur significant costs related to compliance with evolving laws and regulations, which could impact its business operations[151]. - The company is not in compliance with Section 404 of the Sarbanes-Oxley Act as of December 31, 2025, which could materially affect its business[155]. - The company incurs significant costs related to maintaining effective internal controls over financial reporting, which are subject to regulatory scrutiny[155]. Market and Economic Conditions - The performance in the financial services industry is heavily influenced by economic conditions, which are unpredictable and beyond the company's control[77]. - Changes in economic and political conditions, including tariffs and trade policies, could adversely affect global economic conditions and the stability of financial markets[81]. - Market fluctuations and global economic conditions may materially affect the company's results of operations, particularly in its Capital Markets business segment[113]. Competition and Industry Challenges - The financial services industry remains highly competitive, and the company faces challenges due to its relatively small size compared to larger firms, which have greater capital and technology resources[89]. - High turnover in the financial services industry increases competition for skilled professionals, potentially impacting the company's ability to retain key employees and maintain client relationships[102]. - The company faces significant competition for personnel, which may adversely affect its ability to manage growth effectively[106]. - The company's fixed income business is currently concentrated in investment grade products, potentially limiting growth opportunities compared to competitors offering non-traditional products[89]. Business Strategy and Growth - The company anticipates that its investment banking revenue will be directly related to the volume and value of transactions, which may decrease in unfavorable market conditions[84]. - The company may consider strategic acquisitions or joint ventures, which could result in unforeseen expenses and disrupt ongoing business[82]. - The company plans to expand into new investment strategies and geographic markets, which may introduce additional risks and uncertainties[98]. - The organic growth strategy focuses on achieving scale and profitability, but there is no assurance that new strategies and products will be successful[99]. - The company may pursue growth through acquisitions and strategic partnerships, which could involve various risks including integration challenges and regulatory approvals[100]. Operational and Technological Risks - The company may face increased operational, legal, and regulatory risks due to the adoption of artificial intelligence, which could disrupt business models and investment strategies[93]. - Regulatory scrutiny regarding artificial intelligence is increasing, with potential compliance obligations that could adversely affect the company's operations and strategies[96]. - The company may face operational risks due to reliance on complex technology and human error, which could adversely affect its business[124]. - Rapid technological changes in the financial services industry require the Company to adapt its technology systems to meet client needs and regulatory demands[136]. - The Company relies heavily on communications and information systems, and any failure or breach could adversely affect customer relationships and financial results[127]. - Cybersecurity incidents among financial services firms are increasing, although the Company has not yet experienced material losses from such breaches[130]. - The Company faces significant costs in maintaining its infrastructure to resist cybersecurity attacks, including regular briefings for senior management on preparedness[135]. Financial Position and Stock Performance - The common stock has experienced significant volatility, with a closing share price ranging from a high of $13.00 to a low of $1.03 from January 1, 2025, to December 31, 2025[161]. - Approximately 68.5% of the outstanding common stock is controlled by executive officers, directors, and advisory board members, potentially influencing significant corporate decisions[169]. - The company declared special cash dividends of $0.32, $0.22, and $0.432 per share on February 11, August 22, and December 11, 2025, respectively, but future dividends are not guaranteed[170]. - The common stock may be delisted from Nasdaq if continued listing standards are not met, which could adversely affect stock price and liquidity[160]. - Changes in tax laws in key jurisdictions could significantly increase the effective tax rate, adversely affecting cash flow and financial condition[156]. - The company’s common stock is thinly traded, which may limit stockholders' ability to sell shares at desired prices[162]. - The company is exposed to credit risk related to third parties, which could adversely affect its revenue and ability to borrow[119]. - The company may incur substantial costs in defending against claims related to employee misconduct, which could harm its reputation[109]. - The company is dependent on its senior executives, and the loss of their services could materially affect its operations[107]. - Liquidity is essential for the company's operations, and its ability to raise funding could be impaired by negative perceptions or market disruptions[121].

Revenue Performance - Full Year 2025 revenue reached a record $62.1 million, a 19% increase from $52.3 million in 2024[7] - Fourth Quarter 2025 revenue was $12.5 million, slightly down from $12.6 million in the same period of 2024[7] - Product revenue for Q4 2025 reached $12.425 billion, slightly up from $12.411 billion in Q4 2024, while total net revenue for the year increased to $62.064 billion from $52.347 billion in 2024, representing a year-over-year growth of 18.5%[23] Profitability - Gross profit for the full year 2025 was $16.1 million, with a gross margin of 26%, down from 31% in 2024[7] - The company reported a gross profit of $3.4 million in Q4 2025, compared to $2.8 million in Q4 2024[7] - Gross profit for Q4 2025 was $3.434 billion, compared to $2.766 billion in Q4 2024, indicating a significant increase of 24.1%[23] - Net income for the full year 2025 was $1.8 million, a decrease from $4.2 million in 2024[7] - Net income in Q4 2025 was approximately $0.2 million, compared to a net loss of approximately $0.6 million in Q4 2024[7] - Net income for Q4 2025 was $163 million, a recovery from a net loss of $558 million in Q4 2024, while the total net income for the year was $1.790 billion compared to $4.235 billion in 2024[23] Expenses - Research and development expenses for Q4 2025 totaled $1.035 billion, a decrease from $1.091 billion in Q4 2024, while total R&D expenses for the year rose to $4.090 billion from $3.837 billion in 2024[23] - Selling, general and administrative expenses for Q4 2025 were $2.213 billion, up from $1.898 billion in Q4 2024, reflecting an increase of 16.6%[23] - Interest expense for Q4 2025 was $328 million, up from $108 million in Q4 2024, indicating increased borrowing costs[23] Strategic Initiatives - The company launched a strategic initiative called Transform & Transcend to enhance operational execution and market position[3] - Solésence appointed Yoolie Park as Vice President of Brand Partnerships to strengthen commercialization strategy[7] - The company acquired 20 new brand partners in facial skincare and color cosmetics[7] - Expanded patent protection with 16 new U.S. and foreign patents, including for the Kleair™ technology[7] Other Financial Metrics - Adjusted EBITDA for Q4 2025 was $918 million, a significant increase from $26 million in Q4 2024, while the annual adjusted EBITDA decreased to $4.193 billion from $6.558 billion in 2024[23] - The company reported a provision for income taxes of $(317) million in Q4 2025, compared to a provision of $227 million in Q4 2024[23] - Other revenue for the year was $270 million, down from $457 million in 2024, indicating a decline in ancillary revenue streams[23] - The company’s cost of revenue for Q4 2025 was $9.049 billion, a decrease from $9.801 billion in Q4 2024, leading to improved gross margins[23]

Financial Results - MiNK Therapeutics, Inc. reported its financial results for the quarter and year ended December 31, 2025[6]. - A press release detailing the financial results was issued on March 31, 2026[6]. - The financial results include key metrics that will be detailed in Exhibit 99.1[6]. - The report does not provide specific financial figures or performance metrics in the available content[6]. Company Classification and Compliance - The company is classified as an emerging growth company under the Securities Act of 1933[5]. - The report is intended to be furnished and not deemed "filed" under the Securities Exchange Act of 1934[7]. - The filing is part of the company's compliance with the Securities Exchange Act of 1934[10]. Company Information - The company is headquartered at 149 Fifth Avenue, Suite 500, New York, New York[2]. - Jennifer S. Buell, Ph.D., serves as the Chief Executive Officer of the company[11]. - The company trades on The Nasdaq Stock Market under the symbol INKT[5].

Financial Performance - IMUNON reported a net loss of $14.5 million, or $6.83 per share, for the year ended December 31, 2025, compared to a net loss of $18.6 million, or $16.94 per share, for 2024[16]. - Net loss for 2025 was $14,495,000, compared to a net loss of $18,620,000 in 2024, indicating an improvement of 22.0%[29]. - Basic and diluted net loss per common share improved to $6.83 in 2025 from $16.94 in 2024[29]. Operating Expenses - Operating expenses decreased by 23% to $14.7 million in 2025, down from the previous year[16]. - Total operating expenses for the year ended December 31, 2025, were $14,651,000, a decrease of 23.0% from $19,132,000 in 2024[29]. - Research and development (R&D) expenses were $7.8 million for 2025, a 33% decrease compared to 2024, primarily due to lower costs associated with the OVATION 2 Study[17]. - Research and development expenses decreased to $7,781,000 in 2025 from $11,639,000 in 2024, representing a reduction of 33.0%[29]. Cash and Assets - Cash and cash equivalents as of December 31, 2025, were $8.8 million, with net cash used for operating activities at $13.9 million for the full year[20]. - Cash and cash equivalents increased to $8,781,000 as of December 31, 2025, up from $5,873,000 in 2024, reflecting a growth of 49.0%[31]. - Total assets rose to $12,288,000 in 2025, compared to $9,717,000 in 2024, marking an increase of 26.0%[31]. - Total liabilities decreased slightly to $5,226,000 in 2025 from $5,473,000 in 2024, a reduction of 4.5%[31]. - Stockholders' equity increased to $7,062,000 in 2025, up from $4,244,000 in 2024, representing a growth of 66.0%[31]. Clinical Developments - IMUNON achieved a median overall survival improvement of 14.7 months (45.1 vs. 30.4 months) in women treated with IMNN-001 compared to standard of care (SoC) chemotherapy alone[5]. - Women receiving IMNN-001 with SoC chemotherapy plus PARP inhibitors achieved a median overall survival increase of 24.2 months (65.6 vs. 41.4 months) compared to SoC alone[5]. - IMUNON's Phase 3 OVATION 3 Study for IMNN-001 is progressing ahead of plan, supported by strong interest from the medical community[2]. Strategic Actions - The company announced a strategic reorganization on February 5, 2026, to reduce operating expenses while focusing on the Phase 3 OVATION 3 clinical trial[14]. - IMUNON completed a $7.0 million registered direct offering, selling shares at a combined purchase price of $3.61[15]. - The company is advancing its PlaCCine DNA vaccine technology, with proof-of-concept data demonstrating safety and immunogenicity in human participants[12]. Investment Income - Investment income, net, decreased to $156,000 in 2025 from $512,000 in 2024, a decline of 69.5%[29].

Financial Performance - AquaBounty has incurred cumulative net losses of approximately $388 million from incorporation to December 31, 2025, and expects to incur additional losses in future periods[45]. - For the year ended December 31, 2025, the company reported a net loss of $18.5 million, a decrease of 88% compared to a net loss of $149.2 million in 2024[115]. - The loss from discontinued operations significantly decreased to $16.3 million in 2025 from $137.8 million in 2024, mainly due to the sale of the Indiana Farm and Canadian Farms[121]. - The company recorded impairment charges totaling $129.8 million for the years 2024 and 2025, with $14.4 million in 2025 and $115.4 million in 2024 attributed to discontinued operations[29][28]. - The company recorded an impairment charge of $26.3 million against the remaining Ohio Equipment Assets during its impairment analysis[96]. - The company incurred a net loss of $18.49 million for the year ended December 31, 2025, compared to a net loss of $149.19 million for the previous year, indicating a significant reduction in losses[189]. - The company has an accumulated deficit of $388 million and only $501 thousand in cash on its consolidated balance sheet as of December 31, 2025[102][122][130]. Liquidity and Cash Flow - As of December 31, 2025, AquaBounty had only $501 thousand in cash and cash equivalents, raising substantial doubt about its ability to continue as a going concern[46]. - Net cash used in operating activities was $8.7 million in 2025, a 37% improvement from $13.9 million in 2024[125]. - The company generated $7.1 million from asset sales in 2025, compared to $10.5 million in 2024[123][128]. - The company reported a loan forgiveness of $2.01 million in 2025, contributing positively to other income[184]. - The company’s cash and cash equivalents at the end of the period increased to $501,295 from $230,362 at the beginning of the period[189]. - The company plans to continue utilizing asset sales and debt/equity issuances to fund operations and improve liquidity[132]. Asset Management and Sales - Construction of the Ohio Farm Project was halted in June 2023 after spending roughly $145 million, with total estimated costs to complete now projected between $485 million and $495 million[38][39]. - The company sold its Indiana Farm for $22.5 million in July 2024 and its Canadian Farms, including Corporate IP, for an undisclosed amount in March 2025[25][27]. - The company is considering a potential sale of the Ohio Farm Project, which has received a non-binding Letter of Interest[32][40]. - The fair value of the Ohio Farm Project assets held for sale is recorded at expected net proceeds of $9.6 million[112]. - The company generated cumulative gross proceeds of $5.0 million from the sale of certain Ohio Equipment Assets and $2.1 million from the sale of its Canadian subsidiary during 2025[197]. Strategic Initiatives - The company has engaged an investment bank to explore funding and strategic alternatives, including potential joint ventures or other strategic transactions[47]. - The company is actively working with an investment bank to identify optimal paths for realizing the potential of its remaining assets, particularly the Ohio Farm Project[193]. - The company is currently working with an investment bank to explore funding and strategic alternatives for its remaining assets, particularly the Ohio Farm Project[94]. Risks and Compliance - The company is exposed to risks from security breaches and cyber-attacks, which could lead to significant financial and reputational damage[51]. - There are risks associated with issuing additional equity securities, which could dilute current stockholders' ownership and voting power[53]. - The company has periods of negative stockholders' equity, which could further jeopardize compliance with Nasdaq listing standards[63]. - The company received a notice from Nasdaq regarding non-compliance with minimum bid price requirements, with a compliance period until January 12, 2026[64]. - The company has recognized that if it cannot generate additional funds in a timely manner, it may exhaust its resources and be unable to maintain planned operations, risking significant losses for shareholders[134]. Operational Changes - The company has significantly reduced its headcount and ongoing operating costs following the exit from fish rearing operations[102]. - General and administrative expenses decreased by $5.0 million to $4.0 million in 2025, primarily due to reductions in personnel costs and legal fees[118]. - The company paused construction of its 10,000 metric ton Ohio Farm Project in June 2023 due to rising costs and inflation, which impaired its ability to pursue municipal bond financing[94]. Market Context - The aquaculture industry was valued at $296 billion in 2022, with salmon farming accounting for $22 billion[33]. - Global fish consumption is growing faster than all other animal protein foods, driven by population growth and increased demand for protein sources[34]. - Aquaculture production must nearly double by 2050 to meet the rising demand for fish protein, as traditional fisheries cannot satisfy this demand[35].

Revenue Performance - Fourth quarter 2025 net revenue was $140.7 million, representing growth of approximately 9.1% compared to the fourth quarter of 2024[3]. - Full year 2025 net revenue was $468.7 million, a decline of 3.9% compared to the full year 2024, primarily due to e-commerce headwinds[7]. - Revenues for the three months ended December 31, 2025, were $140.688 million, an increase of 9.3% from $128.975 million in the same period of 2024[25]. - For 2026, the company expects full year revenue to be in the range of $500 to $520 million and adjusted EBITDA in the range of $20 to $30 million[12]. Profitability Metrics - Adjusted EBITDA for the fourth quarter was $8.8 million, an improvement from $2.9 million last year, driven primarily by revenue growth and disciplined cost management[6]. - Full year adjusted EBITDA was $1.9 million, a significant improvement from $(20.8) million last year[10]. - Adjusted EBITDA for the year ended December 31, 2025, was $1.945 million, compared to an adjusted EBITDA loss of $20.825 million in 2024[31]. Gross Profit and Margin - Gross margin for the fourth quarter was 41.9%, compared to 42.9% in the prior-year period, reflecting sourcing initiatives and profitable inventory liquidation[4]. - Full year gross profit increased to $188.6 million, with a gross margin of 40.2%, up 310 basis points from last year[8]. - Gross profit for the year ended December 31, 2025, was $188.559 million, compared to $181.132 million in 2024, reflecting a gross margin improvement[25]. - Adjusted gross profit for the year ended December 31, 2025, was $189.554 million, with an adjusted gross profit margin of 40.4%[33]. Operating Expenses - Operating expenses for the fourth quarter were $61.2 million, down 2.9% from $63.0 million in the prior year quarter[5]. - Total operating expenses decreased to $231.588 million for the year ended December 31, 2025, down from $273.315 million in 2024, indicating a reduction of 15.3%[25]. - Adjusted operating expenses for the year ended December 31, 2025, were $212.926 million, down from $253.342 million in 2024, reflecting a 16% reduction[34]. Net Loss and Earnings Per Share - The company reported a net loss of $3.2 million for the fourth quarter, an improvement from a net loss of $(8.5) million in the prior year[6]. - The net loss for the year ended December 31, 2025, was $51.511 million, a significant improvement from a net loss of $98.098 million in 2024[27]. - The company reported a basic net loss per share of $0.48 for the year ended December 31, 2025, improving from a loss of $0.91 per share in 2024[25]. - For the three months ended December 31, 2025, the net loss attributable to Purple Innovation, Inc. was $3.226 million, compared to a net loss of $8.511 million for the same period in 2024, representing a 62% improvement[35]. - The adjusted net loss for the year ended December 31, 2025, was $34.339 million, a decrease from $55.079 million in 2024, indicating a 37% reduction year-over-year[38]. - The adjusted net loss per diluted share for the three months ended December 31, 2025, was $0.02, compared to $0.11 for the same period in 2024, reflecting an 82% improvement[37]. - The adjusted net loss per diluted share for the year ended December 31, 2025, was $0.32, down from $0.51 in 2024, marking a 37% decrease[38]. Cash and Financing - As of December 31, 2025, the company had cash and cash equivalents of $24.3 million, down from $29.0 million as of December 31, 2024[11]. - Cash flows from operating activities resulted in a net cash used of $33.830 million for the year ended December 31, 2025, compared to $17.850 million in 2024[27]. - The company raised $39 million from related party loans during the year ended December 31, 2025, compared to $61 million in 2024[27]. Other Financial Metrics - The total adjusted income tax benefit for the year ended December 31, 2025, was $12.002 million, compared to $19.252 million in 2024, showing a 37% decline[38]. - The revenue reduction due to SGI Contract for the year ended December 31, 2025, was $2.508 million, with no such reduction reported in 2024[35]. - The change in fair value of warrant liabilities for the year ended December 31, 2025, was a loss of $17.202 million, compared to a loss of $3.504 million in 2024, indicating a significant increase in losses[35]. - Restructuring related charges for the year ended December 31, 2025, amounted to $12.382 million, down from $35.415 million in 2024, representing a 65% decrease[35]. - Strategic alternative costs for the year ended December 31, 2025, were $7.275 million, with no such costs reported in 2024[35]. - The estimated effective tax rate for the three and twelve months ended December 31, 2025, was 25.9%[37].

Technology and Efficiency - AirJoule technology can produce pure distilled water at an energy requirement of less than 160 Wh/L, making it up to 4x more efficient than refrigerant-based systems and up to 8x more efficient than desiccant-based systems[41]. - The AirJoule Core system can generate up to 250 liters of pure distilled water per day, delivering up to 80% energy savings and 60% lower total cost of ownership compared to traditional desiccant-based systems[42]. - The AirJoule Prime system is designed for industrial-scale production, expected to deliver over 2,000 liters of water per day using low-grade waste heat[22]. - AirJoule technology can utilize low-grade waste heat, which is estimated to account for 50% of industrial energy input lost as waste heat, significantly improving efficiency[22]. - AirJoule technology significantly reduces energy requirements for dehumidification compared to conventional systems, potentially yielding substantial operating expense savings for customers[77]. - AirJoule's superior moisture removal capability is expected to significantly reduce power consumption in HVAC systems, addressing the pressure on building owners to improve energy efficiency[213]. Market Potential and Strategic Partnerships - The total addressable market for AirJoule's technology is estimated to be approximately $450 billion, targeting water, dehumidified air, and cooling demands[37]. - The company plans to leverage strategic partnerships to accelerate market penetration and scale manufacturing capabilities, enhancing its competitive position[39]. - The company entered into a joint venture with GE Vernova, forming AirJoule, LLC, with each party holding a 50% interest to develop water capture technology[46]. - The company signed a memorandum of understanding with Nexus Data Centers in June 2025 to integrate AirJoule technology into data center designs[58]. - Strategic partnerships with GE Vernova, Carrier Global, and TenX Investment are expected to accelerate market penetration and scale manufacturing capabilities[214]. Regulatory and Compliance Challenges - The company aims to achieve potable water certification with the Texas Commission on Environmental Quality, a key regulatory milestone for municipal and industrial applications[24]. - The company is subject to regulatory risks, including the need for various permits and compliance with environmental laws, which could increase operating costs[138]. - The regulatory environment is becoming more stringent, with potential new standards affecting operations, particularly regarding the Clean Water Act and the National Pollutant Discharge Elimination System permits[143]. - Future implementation of proposed rules redefining Waters of the United States (WOTUS) remains uncertain, which could impact operational compliance and costs[143]. Financial Performance and Projections - The company incurred a net loss of $215.7 million for the year ended December 31, 2024, and a loss of $9.0 million for the year ended December 31, 2025[87]. - The company expects to commence commercial sales of AirJoule systems in 2026, supported by partnerships including a joint venture with GE Vernova and an exclusive distribution agreement with TenX Investment in the Middle East[71]. - The company anticipates stable demand for its products across targeted industries, including data centers and advanced manufacturing, despite potential seasonal variations in moisture levels[81]. - The company may require additional financing to fund ongoing operations and achieve business objectives, as its ability to continue as a going concern depends on financial support and capital raising efforts[97]. Operational and Production Risks - The company may face challenges in scaling production and delivery capabilities, which could adversely impact commercialization of AirJoule systems[128]. - The company relies on sole-source suppliers for key components, such as MTMOF1, which is currently manufactured solely by BASF, posing risks to production and costs[124]. - The actual operating costs of manufacturing and commercializing AirJoule systems may exceed initial estimates due to various factors, which could adversely affect financing ability and profitability[103]. - The company has identified risks related to the adequacy of its disaster recovery and business continuity plans, which could impact operations during significant disruptions[159]. Intellectual Property and Competitive Landscape - The company is focused on optimizing AirJoule systems and protecting intellectual property, with several master patents and applications filed in relevant markets[73]. - The company relies on non-disclosure agreements to protect its intellectual property, facing risks related to the adequacy of patent protections[74]. - Patent applications may not result in issued patents, which could adversely affect the company's ability to protect its technology and maintain a competitive edge[160]. - The company faces significant competition from established firms with greater resources and market presence, which could negatively impact its ability to compete effectively[104]. Environmental, Social, and Governance (ESG) Considerations - The company is subject to increasing scrutiny regarding ESG matters, which could lead to reputational harm and impact assessments by ESG-focused investors[113]. - The company may face reputational damage due to penalties from Water Purchase Agreements, which could divert financial resources and inhibit growth opportunities[96]. Shareholder and Corporate Governance - The company holds approximately 52% of its outstanding common stock among executive officers and directors, allowing them significant control over corporate decisions[171]. - Anti-takeover provisions in the company's governing documents could make acquisitions more difficult and limit stockholder influence over management changes[176]. - The company does not intend to pay dividends on its common stock for the foreseeable future, focusing instead on funding business development and growth[174]. Funding and Investment Activities - The company issued 588,235 shares of Class A common stock at a purchase price of $8.50 per share, generating gross proceeds of $5.0 million from a PIPE investment[199]. - The company has the right to sell up to $30 million of shares of Class A common stock under an Equity Line Purchase Agreement, with 755,946 shares sold generating approximately $3.0 million in proceeds[204].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2025 ☐ 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 001-41151 AIRJOULE TECHNOLOGIES CORPORATION (Exact name of registrant as specified in its charter) Delaware 86-29622 ...

Financial Position - As of December 31, 2025, the company had cash and bank balances of S$2.10 million, down from S$4.97 million in 2024[757]. - As of December 31, 2025, the company had total contractual obligations of S$494,010 for bank borrowings and S$79,821 for lease liabilities[773]. Cash Flow - For the year ended December 31, 2025, net cash used in operating activities was S$3.70 million, primarily due to a loss of S$4.00 million[761]. - The company generated net cash from financing activities of S$208,648 in 2025, mainly from the issuance of ordinary shares[767]. - Total net cash used in investing activities for the year ended December 31, 2025, was S$929,283, primarily from proceeds of S$700,000 from dilution of interest in a subsidiary[764]. Revenue and Operations - The company has not generated any revenue from approved commercial sales and expects this to continue for the foreseeable future[756]. - The company plans to fund its operations through various sources, including net proceeds from its ATM offering and other equity and debt financings[757]. Research and Development - The company incurred R&D expenses that include employees' benefits and laboratory supplies, with estimates made for accrued expenses[777][778]. - The company anticipates increased costs associated with operating as a public listed company and ongoing R&D activities[768]. Compliance and Growth Status - The company is classified as an "emerging growth company" and has elected to delay the adoption of certain accounting standards[783]. - The Company will maintain its emerging growth status until it exceeds U.S.$1.235 billion in annual revenue or meets other specified criteria[784]. - The Company is classified as an "emerging growth company" under the JOBS Act, allowing it to delay compliance with certain accounting standards until they apply to private companies[783]. Share Issuance - On January 14, 2026, the Company issued 4,400 ordinary shares under its ATM offering program, generating gross proceeds of approximately U.S.$6,000[786].

Product Development and Regulatory Approval - The company is highly dependent on the success of its lead product candidate, tinlarebant (a/k/a LBS-008), which is currently in clinical development[39]. - The initial indication for tinlarebant is for the treatment of autosomal recessive Stargardt disease (STGD1), and failure to obtain approval could adversely affect the company's financial condition[40]. - All product candidates are in clinical or preclinical development, and significant delays in obtaining regulatory approval could harm the business[30]. - The regulatory approval processes for product candidates are time-consuming and may evolve, impacting the company's ability to commercialize its products[30]. - The company has no products approved for commercial sale, making it riskier compared to companies with multiple late-stage product candidates[39]. - The success of tinlarebant will depend on the completion of ongoing clinical trials and satisfactory safety and efficacy profiles for regulatory approval[41]. - The company relies on third parties for conducting clinical trials and manufacturing, and any issues with these relationships could impact product development[30]. - The company must maintain a continued acceptable safety profile for its product candidates following regulatory approval to ensure commercial success[54]. - The company may experience increased costs and delays if clinical trials do not produce positive results or if regulatory authorities require additional studies[58]. - The company is conducting clinical trials in multiple jurisdictions, including the US, UK, Germany, and Japan, which may lead to delays and increased expenses[60]. - The company has never obtained marketing approval for any product candidate, and the process may take years and require additional clinical trials, potentially delaying commercialization[72][74]. - The company expects to submit a New Drug Application (NDA) for its product candidate tinlarebant in Q2 2026, but there are risks associated with obtaining timely marketing approval[75]. - The manufacturing of biopharmaceutical products is complex and relies on third-party contractors, which could lead to significant delays if issues arise[70][71]. - The company faces risks related to patient enrollment in clinical trials, which could delay regulatory approvals and commercialization[55]. - The overall timeline for clinical trials remains uncertain due to various uncontrollable factors, which could impact the company's development plans[69]. - The company may not be able to obtain orphan drug exclusivity even if orphan drug designation is granted, as exclusivity is contingent on being the first to market[129]. - The FDA may require additional data to support approval, which could delay commercialization plans[120]. - Clinical trials conducted in one country may not be accepted by regulatory authorities in other countries, complicating the approval process[124]. - Regulatory approvals may come with limitations on marketing uses and conditions, potentially requiring costly post-marketing studies[134]. - Discovery of unknown issues post-approval could result in marketing restrictions, drug recalls, or fines[137]. Financial Condition and Funding - The company has recorded net cash outflow from operating activities since inception and will need additional financing to fund operations[30]. - The company recorded net cash outflows from operating activities of approximately US$29.8 million, US$29.2 million, and US$40.7 million for the years ended December 31, 2023, 2024, and 2025, respectively[104]. - The company anticipates significant annual net operating losses, projected at approximately US$31.6 million, US$36.1 million, and US$77.6 million for the years ended December 31, 2023, 2024, and 2025, respectively, leading to an accumulated deficit of approximately US$185.3 million by the end of 2025[112]. - The company has no products approved for commercial sale and has not generated any revenue from product sales[108]. - The company expects expenses to increase substantially as it continues to develop clinical trials and seeks regulatory approvals for its product candidates[113]. - The company will need to obtain substantial additional funding to support ongoing operations and may face challenges in raising capital due to market conditions[105]. - The company has incurred significant costs related to operating as a public company and expects these costs to continue to rise[105]. - The company may need to enter into collaborations or licensing arrangements to raise capital, which could result in unfavorable terms and dilution of ownership[116]. - Disruptions in financial markets could significantly impact the company's ability to raise capital on acceptable terms[210]. Competition and Market Dynamics - The company faces substantial competition from various biopharmaceutical companies, including major and specialty pharmaceutical companies, which may have greater resources and experience in drug development and commercialization[83]. - The NMPA has recently accelerated market approval for drugs addressing high unmet medical needs, potentially increasing competition for the company's product candidates[83]. - The company anticipates that the market opportunities for its product candidates may be smaller than initially estimated, particularly for the treatment of STGD1[95]. - The ability to compete with other therapies and obtain healthcare coverage and adequate reimbursement is critical for the commercial acceptance of approved products[54]. - The ultimate market opportunity for the company's product candidates will depend on regulatory approvals, acceptance by the medical community, and competition[96]. - The approval of generic versions of the company's products by regulatory authorities could adversely affect sales, as generic products are typically offered at lower prices[167]. - Competition from generic versions of products could negatively impact future revenue, profitability, and cash flows, limiting returns on investments in product candidates[169]. Intellectual Property and Legal Risks - The company holds a portfolio of 27 issued U.S. patents and 25 issued foreign patents, but the patent landscape remains uncertain and competitive[148]. - Patent applications may not result in effective protection, and challenges could narrow or invalidate patent rights[149]. - Competitors may develop similar technologies that circumvent existing patents, impacting the company's competitive advantage[151]. - The company is dependent on intellectual property licensed from third parties, including an exclusive license agreement with Columbia University, which imposes various obligations such as timely achievement of development milestones and payment of royalties[153]. - Failure to comply with obligations under the patent license could result in the conversion of the exclusive license to a nonexclusive license, significantly impacting the company's ability to develop or market products[157]. - The company may face challenges in maintaining and prosecuting in-licensed patents, which could affect the commercialization of product candidates[158]. - The company may encounter difficulties in enforcing intellectual property rights in jurisdictions with less favorable legal systems, potentially leading to increased competition[161]. - The company may face significant costs and time associated with defending against claims of patent infringement, which could adversely affect its financial condition and results of operations[187]. - Future intellectual property litigation may result in additional expenses and distractions, potentially exposing the company to significant liabilities or loss of proprietary position[182]. Management and Operational Challenges - The company must attract and retain qualified management and employees to ensure future success[30]. - The largest shareholder, Lin Bioscience International Ltd., has significant influence over corporate matters, which may lead to conflicts of interest[30]. - The company is in the process of building an in-house commercialization team and sales force to effectively market its product candidates, which requires significant capital expenditures and management resources[85]. - The company may face challenges in recruiting and retaining qualified personnel due to intense global competition in the biotechnology industry[201]. - The company currently does not have "key-man" insurance for any of its executive officers or key personnel, which could pose risks[199]. - The company may need to increase its workforce significantly to execute its business plans, particularly in research and development and regulatory affairs[206]. - The company may face difficulties in managing growth effectively, which could disrupt operations and adversely affect business performance[206]. - The company is exposed to risks associated with potential acquisitions or strategic collaborations, including increased capital requirements and operational challenges[213]. Compliance and Regulatory Obligations - Regulatory compliance requires substantial time and financial resources, with potential sanctions for non-compliance including withdrawal of approvals and fines[122]. - The company is subject to ongoing regulatory obligations and reviews, which may lead to significant additional expenses and potential penalties for non-compliance[133]. - Legislative changes may increase the difficulty and costs associated with obtaining marketing approvals and affect pricing strategies[141]. - The implementation of the "most favored nation" drug pricing policy could constrain global market entry strategies and affect sales[144]. - The company has limited experience in obtaining regulatory approval in international markets, which could hinder market potential[125].