Financial Reporting and Performance - Eni's consolidated financial statements are prepared in accordance with International Financial Standards (IFRS) as issued by the IASB[19]. - The company emphasizes the importance of forward-looking statements regarding future events and results, which are subject to risks and uncertainties[25]. - Eni's net borrowings are calculated as total finance debt less cash, cash equivalents, and certain very liquid investments, providing a measure of financial condition[31]. - The Total Shareholder Return (TSR) is assessed on a yearly basis, accounting for changes in market price and dividends distributed[32]. - Eni's market share estimates are based on management's assessments and independent market studies[27]. - The Group's financial performance is significantly affected by hydrocarbon price volatility, with lower prices leading to reduced revenues and cash flow, particularly in the Exploration & Production segment[54]. - Eni does not hedge its future expected cash flows from the sale of proved reserves, increasing exposure to commodity risk[54]. - The net present value of Eni's proved reserves was approximately €42.9 billion at December 31, 2025, a decrease of €12.6 billion from the previous year[128]. - Eni's operations are subject to high levels of income taxes and royalties, which may increase with rising oil prices, impacting net profits[124]. - Eni's compliance expenses may increase due to the adoption of carbon pricing mechanisms, with about half of its direct GHG emissions currently included in such schemes[82]. - Materialization of these risks could adversely affect Eni's financial condition, business prospects, and shareholder returns, including dividends and stock repurchases[169]. Production and Reserves - Eni's average reserve life index is calculated as the ratio between the amount of reserves at year-end and total production for the year[33]. - The Group's reported production and reserves increased by approximately 4 KBOE/d and 12 mmBOE, respectively, due to a decreased Brent reference price in 2025[55]. - Eni's production is estimated to vary by up to 1 KBOE/d for each one-dollar change in the price of Brent crude oil, highlighting the sensitivity of operations to commodity price fluctuations[55]. - Eni's future production levels are highly dependent on the success of exploration projects, with unsuccessful activities potentially leading to reduced oil and gas production[108]. - Approximately €45.3 billion in future development and decommissioning costs are associated with Eni's proved total reserves, indicating substantial financial commitments[121]. - As of December 31, 2025, about 44% of Eni's total estimated proved reserves by volume were undeveloped, requiring significant capital expenditures and successful drilling operations[121]. - Eni's ability to replace produced reserves is critical for future production and growth, with potential downward revisions in reserves impacting business prospects[116]. - Eni's production in Libya was 155 kboe/d in 2025, accounting for approximately 10% of the Group's total production[134]. Market and Economic Conditions - Crude oil prices have declined to a range of $60-70/bbl for the rest of the year, closing at a yearly average price of $69/bbl, down 14.5% year-on-year[50]. - The Brent crude oil price is estimated at $70/bbl in nominal terms for 2026, based on moderate global economic growth assumptions[50]. - Natural gas prices in Europe averaged in line with 2024, reflecting seasonal consumption rather than improving fundamentals[51]. - The price of natural gas in the United States was one fifth that of Europe in 2025, highlighting regional supply dynamics[51]. - OPEC+ decisions on production levels significantly influence short-term crude oil prices, with a recent resolution to unwind production cuts impacting supply[48]. - Global economic growth has slowed, influenced by trade disputes and high interest rates, affecting crude oil demand[50]. - The development of liquefaction capacity in the US, Qatar, and Australia has created a global liquid market for natural gas, increasing price volatility[51]. - Geopolitical tensions, particularly in the Middle East, have negatively affected investor confidence and economic activity, impacting oil prices[50]. Environmental and Regulatory Risks - Eni's GHG emissions are reported in CO2 equivalent, reflecting its commitment to environmental sustainability[34]. - Eni's management acknowledges that the transition to a low-carbon economy poses risks to long-term demand for hydrocarbons[49]. - Rising climate change concerns and regulatory pressures may lead to a decline in demand for hydrocarbons, potentially affecting prices and financial performance[78]. - Eni aims to increase the proportion of natural gas in its production mix while gradually reducing hydrocarbons in its portfolio, targeting net zero emissions of CO2 by 2050[79]. - In 2025, Eni accrued an expense of approximately €800 million for carbon allowances corresponding to 11.3 million tons of CO2 emissions, with a projected total expense of €850 million for 2024[82]. - Eni's operations are subject to regulatory risks, including potential stricter regulations on carbon emissions that could increase compliance costs and operational constraints[81]. - The company is expanding its portfolio of low or zero carbon products, including renewable electricity and biofuels, but faces challenges in achieving expected returns due to competition and regulatory uncertainties[99][101]. - Climate-related risks, including extreme weather events, could materially disrupt Eni's operations and negatively affect its financial condition and shareholder returns[98]. - Legal risks from climate-based litigation could result in significant financial liabilities for Eni, affecting its operations and business prospects[88][90]. Operational and Strategic Risks - The company is focused on enhancing recovery techniques to increase production from existing wells[33]. - Eni is actively involved in the development of new technologies to improve the commercial viability of its resources[33]. - The company anticipates that rising costs of capital and reduced access to financing may hinder its ability to invest in future oil and gas projects[95]. - Eni plans to invest approximately €29 billion in capital expenditures for the 2026-2030 period to explore and develop hydrocarbon reserves[123]. - The company faces significant operational risks in development projects, including potential cost overruns and delays due to complex activities and external factors[109]. - Eni is exposed to political risks, with 84% of its proved hydrocarbon reserves located in non-OECD countries, which may affect operational stability[129]. - The company is not fully insured against all potential HSE risks, which could lead to substantial liabilities in the event of a major environmental disaster[152]. - Eni has invested heavily in upgrading safety and reliability measures, but risks remain that could adversely affect operations and financial results[153]. - The Group faces potential environmental liabilities from past operations, with ongoing remediation efforts at several industrial sites in Italy[155]. - Eni is involved in various legal proceedings that could result in significant financial losses due to environmental claims and compliance issues[158]. - The Company is actively seeking acquisition opportunities to achieve growth targets, but such acquisitions carry integration and financial risks[159]. - Eni's crisis management systems may be ineffective, potentially prolonging disruptions and adversely impacting financial results[160]. Financial and Credit Risks - Eni is exposed to credit risk, which may lead to loss provisions and cash flow shortfalls if counterparties default or fail to meet obligations[167]. - Liquidity risk could hinder Eni's ability to secure funding or sell assets, negatively impacting operations and cash flows[168]. - In 2025, the Euro appreciated by 4.4% against the U.S. dollar, negatively impacting reported results by an estimated €0.5 billion[166]. - The Group is exposed to treasury and trading risks, including commodity price volatility, which could lead to substantial losses[165]. - The ongoing geopolitical tensions and macroeconomic risks could negatively impact global demand for hydrocarbons, affecting Eni's results of operations[63].

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 001-40133 ENVOY MEDICAL, INC. (Exact name of registrant as specified in its charter) | Delaware | 86-1369123 | | --- | --- ...

Financial Performance and Losses - The company has incurred net losses of approximately $23.8 million and $20.8 million for the years ended December 31, 2025 and 2024, respectively, with accumulated deficits of approximately $313.4 million and $284.7 million as of December 31, 2025 and 2024[192]. - The company has not generated any revenue from the sale of the Acclaim CI and anticipates continuing to incur significant operating losses until it receives necessary regulatory approvals[194]. - Future operating losses will depend on the rate of expenditures and the ability to obtain funding through equity or debt financings, strategic collaborations, or grants[194]. - The company has historically generated limited revenue from its legacy product, Esteem FI-AMEI, and has not yet achieved profitability[196]. - The company has a history of net losses and negative cash flow from operations, which are expected to continue, with anticipated increases in costs related to business development[224]. - The company may not achieve sustainable profitability, which would materially affect its financial condition and the value of its securities[225]. Funding and Financial Risks - The company may need to raise substantial additional funding, potentially $48 million from the exercise of Class A Warrants, but there is no guarantee that these warrants will be exercised[202]. - The company faces risks related to design or manufacturing defects in the Acclaim CI, which could adversely affect its business and financial results[199]. - The company is subject to various risks from global economic conditions, including inflationary pressures and increased interest rates, which could impact its financial condition and liquidity[211]. - The company has experienced rising costs in employee compensation and third-party vendor pricing, which could further affect its financial condition if inflation persists[212]. - Recent increases in interest rates may adversely affect the company's ability to finance the development and commercialization of the Acclaim CI, potentially impacting results of operations and growth prospects[213]. - The company has substantial doubt about its ability to continue as a going concern, which could limit its ability to raise additional funds[220]. Product Development and Market Risks - The company expects to incur significant expenses related to clinical trials and commercialization efforts for the Acclaim CI, which may include sales, marketing, and manufacturing costs[193]. - The successful commercialization of the Acclaim CI will depend on obtaining adequate reimbursement levels from governmental and private payors, which is uncertain[227]. - The company faces intense competition from large medical device companies and smaller firms, which may impact its market position and profitability[234]. - The company is vulnerable to fluctuations in demand for the Acclaim CI, which could materially affect its financial condition and results of operations[238]. - If healthcare professionals do not recommend the Acclaim CI, it may not achieve market acceptance, impacting profitability[239]. - The company anticipates needing to significantly increase production rates for the Acclaim CI to meet clinical trial demands and eventual commercialization, targeting FDA approval by late 2027 or early 2028[244]. - The addressable market for the Acclaim CI has not been precisely established and may be smaller than estimated, affecting potential market share capture[247]. Supply Chain and Operational Risks - Supply chain disruptions from unforeseen events could delay the FDA trial process for the Acclaim CI, adversely affecting financial condition[215]. - The reliance on third-party suppliers for critical materials may expose the company to risks such as supply shortages and increased costs, which could delay production[245]. - The company relies on third-party vendors for clinical trials, which may lead to costs and delays beyond its control, impacting regulatory approval timelines[248]. Intellectual Property Risks - The company has 40 issued patents in the United States and 48 in other countries as of March 2, 2026, but uncertainties exist regarding the protection of its intellectual property[260]. - The patent prosecution process is expensive and time-consuming, and the company may not be able to maintain or enforce all necessary patents effectively[261]. - The company faces potential litigation risks that could divert management's attention and resources, adversely affecting its financial condition and operations[252]. - The company may face challenges in obtaining method patents outside the United States due to differing patent laws, which could limit patent protection and its value[262]. - There is a risk of third-party submissions challenging the company's patent rights, which could lead to reduced scope or invalidation of patents, allowing competitors to commercialize similar technologies[263]. - The company’s existing patents may be challenged in courts, potentially resulting in loss of exclusivity or enforceability, impacting the ability to prevent others from using similar products[264]. - The company’s pending patent applications may not result in issued patents, and existing patents may not provide competitive advantages if challenged[265]. - The company relies on trade secrets and unpatented technology, but there is no guarantee that these can be adequately protected from independent development by competitors[267]. - Compliance with various procedural requirements is necessary to maintain patent protection, and failure to comply could result in loss of patent rights[268]. - The company may face significant costs and resource diversion from lawsuits involving intellectual property, which could negatively impact business operations[269]. - If the company is found to infringe on third-party intellectual property rights, it may be required to obtain licenses on potentially unfavorable terms, which could harm business operations[271]. - The company may encounter difficulties in enforcing intellectual property rights in foreign jurisdictions, where protections may be weaker than in the United States[277]. - The company could be subject to claims of misappropriation of intellectual property from former employees, which may lead to costly litigation and operational disruptions[279]. Regulatory and Compliance Risks - The company is classified as an "emerging growth company," allowing it to take advantage of reduced disclosure requirements, which may affect the attractiveness of its Class A Common Stock to investors[282]. - The company may face increased legal and financial compliance costs as it transitions from being an "emerging growth company," potentially diverting management's attention from other business concerns[284]. - The company is subject to the reporting requirements of the Exchange Act and the Sarbanes-Oxley Act, which may strain resources and increase operational costs[284]. - The choice of forum provision in the company's Charter may limit stockholders' ability to bring claims in favorable judicial forums, potentially increasing costs for investors[280]. Market and Currency Risks - The company is exposed to various market risks, including currency risk, credit and counterparty risk, and inflation risk, which are monitored to ensure timely and effective measures are implemented[391]. - The company operates primarily in the United States and Germany, with most transactions settled in U.S. dollars, exposing it to foreign currency risk due to certain bank balances and payables in Euros[392]. - There have been no material losses on accounts receivable, and no customers accounted for 10% or more of sales for the years ended December 31, 2025, and 2024[394]. - The company has not experienced any losses on cash deposits with accredited financial institutions, indicating a low exposure to unusual credit risk[393]. - Inflationary factors may adversely affect operating results, although the company does not believe inflation has materially impacted its financial position to date[395].

Cancer Therapy Development - The company is focused on developing therapies for lung cancer, specifically targeting Non-Small Cell Lung Cancer (NSCLC), which accounts for 85% of all lung cancers [560]. - In January 2025, the company announced a clinical supply agreement with BeiGene to assess ateganosine in combination with tislelizumab for three cancer indications, with MAIA sponsoring the trials [564]. - The company plans to initiate a Phase 3 pivotal trial (THIO-104) in 2025, enrolling up to 300 patients to evaluate ateganosine in combination with a checkpoint inhibitor for third-line NSCLC patients [564]. - The THIO-101 trial expansion will enroll up to 48 patients, assessing overall response rates in advanced NSCLC patients resistant to previous treatments [565]. - The company plans to initiate Phase 2 trials for hepatocellular carcinoma, colorectal cancer, and small cell lung cancer in 2026, using ateganosine in combination with tislelizumab [562]. - The FDA granted Fast Track designation for ateganosine for the treatment of NSCLC, supporting its ongoing clinical trials [566]. - The company plans to conduct clinical trials for ateganosine in various cancer indications, including breast and pancreatic cancers [569]. - As of September 17, 2025, a patient treated with ateganosine showed a survival of 30 months, highlighting the treatment's potential [567]. Financial Performance - Total operating costs and expenses for the year ended December 31, 2025, were $24,269,686, a 43% increase from $16,957,210 in 2024 [570]. - Research and development expenses rose by approximately $4.5 million (45%) to $14.5 million in 2025, primarily due to increased clinical trial costs [571]. - General and administrative expenses increased by approximately $2.8 million (40%) to $9.7 million in 2025, driven by higher investor relations and payroll expenses [572]. - Other income increased by approximately $8,171,000 (or approximately 130%) from a net expense of $6,297,000 in 2024 to a net income of $1,874,000 in 2025, primarily due to changes in the fair value of warrant liabilities [573]. - The consolidated net loss for 2025 was approximately $22.396 million, slightly lower than the $23.255 million loss in 2024 [594][595]. - For the year ended December 31, 2025, net cash used in operating activities was approximately $18.845 million, compared to $15.704 million in 2024, reflecting an increase of 13.6% [594][595]. - Net cash provided by financing activities for 2025 was approximately $17.907 million, a decrease from $18.177 million in 2024 [596][597]. - The company reported a net decrease in cash of approximately $943,267 for 2025, contrasting with a net increase of $2.451 million in 2024 [593]. Capital Raising Activities - The company raised approximately $2.72 million from a private placement of 1,810,000 shares at $1.50 per share in February 2025 [565]. - The company issued and sold 463,332 shares at $1.50 per share, raising approximately $0.7 million in gross proceeds on June 3, 2025 [566]. - The company sold 3,274,360 shares of Common Stock at an average price of approximately $3.09 per share, resulting in net proceeds of approximately $9,453,195 from February 14, 2024 to December 31, 2024 [575]. - On March 14, 2024, the company issued 2,496,318 shares at a price of $1.17 per share, receiving gross proceeds of approximately $2.92 million [576]. - From January 1, 2025 to December 31, 2025, the company sold 3,782,335 shares at an average price of approximately $1.90 per share, resulting in net proceeds of approximately $6,874,401 [583]. - On February 24, 2025, the company issued 1,810,000 shares at a price of $1.50 per share, receiving gross proceeds of approximately $2.7 million [584]. - On October 1, 2025, the company issued 1,733,766 shares at a price of $1.30 per share, receiving gross proceeds of approximately $2.3 million [589]. - On December 22, 2025, the company issued 1,233,488 shares at a price of $1.224 per share, receiving gross proceeds of approximately $1.5 million [591]. Research and Development Updates - A new dimer form of ateganosine was published in a peer-reviewed journal, showing potential to enhance chemotherapeutic efficacy by targeting GSTP1, a key enzyme in cancer progression [565]. - Updated data from the THIO-101 Phase 2 clinical trial indicated a median overall survival of 17.8 months for 22 NSCLC patients, with a 95% confidence interval lower bound of 12.5 months [566]. - The company received a $2.3 million grant from the NIH for the expansion of the THIO-101 Phase 2 clinical trial [567]. - The National Institutes of Health (NIH) awarded the company a $2.3 million grant for the THIO-101 Phase 2 clinical trial for advanced non-small cell lung cancer (NSCLC) treatment [592]. Asset and Liquidity Management - As of December 31, 2025, cash decreased to $8,658,031 from $9,601,298 in 2024, while total assets decreased from $10,155,279 in 2024 to $9,704,656 in 2025 [574]. - Working capital decreased from $6,322,441 in 2024 to $3,865,458 in 2025, indicating a significant reduction in liquidity [574]. - Stock-based compensation for 2025 included approximately $2.631 million, contributing to the overall non-cash charges of $2.052 million [594]. - Total changes in operating assets and liabilities for 2025 were approximately $1.499 million, driven by increases in accounts payable and accrued expenses [594]. - The company estimates its prepaid and accrued research and development expenses based on contracts and services performed, which may lead to adjustments in financial reporting [601]. - The company is classified as a smaller reporting company and is not required to provide certain market risk disclosures [602].

Financial Performance - YUPELRI net sales increased by 12% to $266.6 million in 2025 compared to 2024, with customer demand growing by 7%[19] - For the year ended December 31, 2025, Theravance Biopharma recognized a net income of $105.9 million, primarily driven by a one-time net gain from the sale of TRELEGY royalties and sales-related milestones for YUPELRI and TRELEGY[132] - The cumulative net loss since the spin-off from Innoviva, Inc. as of December 31, 2025, was $859.6 million[133] - YUPELRI operations have been profitable on a brand basis since Q3 2020, but ongoing commercialization costs may hinder significant profit generation in the near future[134] Strategic Initiatives - The company expects to reduce operating expenses by approximately 60%, translating to cost savings of about $70 million starting in Q3 2026[18] - The sale of the remaining royalty interest in TRELEGY to GSK for $225 million was part of the strategic review to maximize shareholder value[20] - The Strategic Review Committee is exploring various alternatives, including a potential sale of the company, to maximize shareholder value[17] - The TRELEGY Royalty Sales Agreement is part of the company's strategic review to unlock shareholder value, with a focus on disciplined capital allocation[44][45] Clinical Development - The ampreloxetine Phase 3 clinical study did not meet its primary endpoint, leading to the decision to wind down the program[16][36] - The company announced the decision to wind down the ampreloxetine program after the Phase 3 CYPRESS study did not meet its primary endpoint[192] Regulatory and Compliance - The company is subject to extensive regulatory requirements for the development and commercialization of pharmaceutical products, including rigorous FDA approval processes[55][63] - The company must comply with FDA regulations regarding the promotion of drugs, including restrictions on off-label use communications[67] - The company is subject to various laws and regulations regarding laboratory practices and the use of hazardous substances in drug development[65] - The company faces potential delays in clinical studies or product development due to reliance on third-party manufacturers and suppliers[136] Intellectual Property - The company owns a total of 119 issued US patents and 666 granted foreign patents as of December 31, 2025[78] - The last to expire patent for YUPELRI (revefenacin) inhalation solution is set to expire on October 23, 2039[79] - The company has multiple patents for YUPELRI, expiring between 2025 and 2039, but faces competition from generic applicants who may challenge these patents[148] - The company relies on its collaboration partner, Viatris, to enforce its Orange Book patents, which may limit the company's control over litigation outcomes[211] Market and Competition - Theravance Biopharma faces substantial competition from companies with greater resources, which may impact the development and commercialization of its products[127] - The acceptance of YUPELRI by physicians and patients is critical for revenue growth, and any decline in acceptance could materially harm financial results[120] - The company is responsible for marketing and sales of YUPELRI in the US, which involves risks related to maintaining an effective sales force and marketing organization[122] Employee and Workplace Culture - As of December 31, 2025, the company had 90 employees, with 79 based in the US and 11 in Dublin, Ireland[100] - The company’s employee engagement survey achieved a participation rate of 98% in 2025, with an average score of 4.4 out of 5[102] - The company emphasizes a culture of empowerment and ethical conduct, encouraging employees to report violations of its Code of Business Conduct[103] - The company is committed to maintaining a positive workplace culture and eliminating discrimination in all forms[104] Financial Risks and Uncertainties - The company may require additional funding if its current operating plans or financial forecasts change, potentially through public or private equity offerings, debt financings, or collaborations[188] - The strategic business plan is subject to uncertainties, including unplanned expenses and lower-than-anticipated revenue, which could lead to substantial future losses[135] - The company may face challenges in obtaining regulatory approvals, which could delay or prevent the commercialization of product candidates[196] - The company’s ability to commercialize products successfully depends significantly on adequate financial coverage and reimbursement from third-party payers[70] Legal and Litigation - The company has initiated litigation against seven companies seeking to market a generic version of YUPELRI, with ongoing lawsuits based on newly issued patents[210] - Product liability lawsuits pose inherent risks that could divert resources, result in substantial liabilities, and reduce the commercial potential of the company's medicines[213] - The likelihood of product liability lawsuits increases once a product is approved for sale, potentially harming the company's reputation and commercial efforts[213] Economic and Environmental Factors - Global economic conditions remain uncertain due to challenges such as war, inflation, and instability in the banking sector, which may negatively affect stock price[168] - The facility is located near earthquake fault zones, making it vulnerable to significant disasters that could impair operations[173] - Development and regulatory approval of product candidates may be delayed due to political events and government budget constraints, impacting the FDA's operations[169]

Token Holdings - As of March 16, 2026, the company holds approximately 2.06 billion SKY tokens, reflecting its engagement in SKY-related on-chain activities, including staking[3] Corporate Name Change - The company will change its name to "Stablecoin Development Corporation," with trading under the new name expected to begin on April 3, 2026[5] Stock Ticker Change - The company's common stock will cease trading under the ticker symbol "NBY" and will commence trading under the ticker symbol "SDEV" effective April 3, 2026[7]

Clinical Study Progress - Talphera achieved 50% enrollment in the NEPHRO CRRT clinical study, reaching a milestone of 35 patients[2] - The NEPHRO CRRT study is designed to enroll 70 adult patients and is expected to complete later in 2026[12] Financial Performance - Cash and investments totaled $20.4 million as of December 31, 2025, compared to $8.9 million in 2024[18] - Combined R&D and SG&A expenses for Q4 2025 were $3.5 million, an increase from $3.0 million in Q4 2024[8] - The net loss for Q4 2025 was $3.8 million, or $0.06 per share, compared to a net loss of $1.9 million, or $0.07 per share, in Q4 2024[8] - Total operating expenses for the year ended December 31, 2025, were $13.5 million, down from $15.3 million in 2024[19] - Talphera expects cash operating expenses in the range of $17 million to $18 million for 2026, up from approximately $13 million in 2025[5] Product Development - Talphera's lead product candidate, Niyad, has received Breakthrough Device Designation from the FDA[9] Investor Relations - The company plans to host a virtual investor and analyst day on March 23, 2026, to provide business updates[1] Financing Activities - The company closed a financing tranche of $4.1 million upon achieving the 35-patient enrollment milestone[8]

Clinical Study Progress - Talphera achieved 50% enrollment in the NEPHRO CRRT clinical study, reaching a milestone of 35 patients[2] - The NEPHRO CRRT study is designed to enroll 70 adult patients and is expected to complete later in 2026[12] Financial Performance - Cash and investments totaled $20.4 million as of December 31, 2025, compared to $8.9 million in 2024[18] - Combined R&D and SG&A expenses for Q4 2025 were $3.5 million, an increase from $3.0 million in Q4 2024[8] - The net loss for Q4 2025 was $3.8 million, or $0.06 per share, compared to a net loss of $1.9 million, or $0.07 per share, in Q4 2024[8] - Total operating expenses for the year ended December 31, 2025, were $13.5 million, down from $15.3 million in 2024[19] - Talphera expects cash operating expenses in the range of $17 million to $18 million for 2026, up from approximately $13 million in 2025[5] Product Development - Talphera's lead product candidate, Niyad, has received Breakthrough Device Designation status from the FDA[9] Investor Relations - The company plans to host a virtual investor and analyst day on March 23, 2026, to provide business updates[1] Financing Activities - The company closed a financing tranche of $4.1 million upon achieving the 35-patient enrollment milestone[8]

Financial Performance and Challenges - The company anticipates increased operating expenses due to the costs associated with being a public entity, which may lead to future net losses and challenges in achieving profitability [32]. - The company faces significant competition from various retailers, which may impact its ability to compete effectively and maintain profitability [44]. - The company may require additional debt financing to support operations and expansion, which could be affected by rising interest rates and market conditions [46][50]. - The ability to secure adequate debt financing is contingent on financial strength and external economic conditions, with no assurance of favorable terms [49]. - The company faced significant inflationary pressures in Asia, which could lead to decreased profitability due to rising costs in procurement, wages, and freight charges [98]. - Economic downturns may lead to increased competition and pressure to reduce selling prices, negatively impacting financial condition and profitability [85]. - Uncertain global economic conditions have led to lower net sales and reduced consumer spending, impacting overall financial performance [84]. - The company experienced significant disruptions during the COVID-19 pandemic, affecting supply chains and logistics, which could recur in future public health emergencies [97]. Business Operations and Structure - The company operates through three core divisions: export, leather trading, and consumer retail, with direct operations in Singapore and Korea, but historical growth rates may not be sustainable [33]. - The acquisition of HTL Marketing, completed on May 19, 2025, is expected to provide growth opportunities, but there are no guarantees of realizing anticipated benefits such as increased revenue or market share [38]. - The company plans to expand its sales network and product offerings, but execution of these plans is subject to uncertainties and potential challenges [34]. - The company operates four retail stores in Singapore and two in South Korea, with plans for future expansion dependent on various factors including location availability and construction costs [122]. - HomesToLife's export sales business accounted for 92.5% of total revenue for the year ended December 31, 2025 [194]. - The leather trading business contributed 5.1% to total revenue for the year ended December 31, 2025 [195]. - The retail division, primarily in Singapore and South Korea, accounted for 2.4% of total revenue for the year ended December 31, 2025 [196]. Management and Personnel - Retaining key management personnel is critical for the company's performance, and losing such personnel could adversely affect business operations [54]. - Competition for skilled personnel is intense, which may lead to increased costs or challenges in attracting and retaining qualified employees [55]. - Directors and executive officers have significant time commitments to other companies, with the CEO dedicating 80% of their time to the company and 20% to others, while the Chairman allocates only 10% to the company [58]. - The company may face difficulties in recruiting and retaining experienced personnel, which could impact its operational capabilities [136]. Legal and Regulatory Risks - The company has limited experience managing a public company listed in the U.S., which may affect its compliance with complex regulations and oversight [62]. - Legal disputes with customers or suppliers could divert resources and negatively impact the company's financial condition and operations [63]. - The company is subject to various anti-corruption laws, and violations could result in significant legal and financial penalties [70]. - The company must comply with Singaporean laws and regulations, and any failure to do so could adversely affect its operations and financial condition [75]. - Existing insurance coverage may not be sufficient to cover all potential liabilities, which could negatively impact the company's financial results [79]. - Cybersecurity threats pose a significant risk to the company's operations and data security, potentially leading to substantial harm and regulatory actions [81]. Market and Competitive Landscape - Seasonal trends have historically resulted in variability in financial results, with higher order volumes typically recorded in January, April, August, September, and October [45]. - The company relies heavily on consumer spending and housing market conditions, with any decline in discretionary spending adversely affecting business results [93]. - Disruptions in supplier relationships could materially affect operations, as the company heavily relies on stable supply chains for furniture [100]. - The company has a foreign currency hedging policy, but residual exposure to exchange rate fluctuations could adversely affect profitability [95]. - Any adverse changes in government trade policies or tariffs could disrupt supply chains and limit market access, negatively impacting business operations [87]. Brand and Marketing Strategy - The company aims to enhance its "HomesToLife" brand, which may require substantial investments that could impact financial condition if unsuccessful [111]. - Customer acquisition efforts are primarily through online advertising, which may not always result in cost-effective customer growth [115]. - The company is increasing marketing investment in Asia, reflecting confidence in HomesToLife's growth potential amid evolving regional demographics [214]. - The brand Domicil continues to perform strongly in established markets, supported by rising average order values and increasing engagement among affluent buyers [215]. - HTL Marketing leads a Group-wide marketing framework to ensure brand consistency and strategic coherence across export, leather trading, and retail segments [218]. Shareholder and Corporate Governance - The company has 89,687,500 Shares outstanding, and substantial sales of Shares could adversely affect their market price and impair future capital-raising efforts [154]. - Major shareholders, including founders, own approximately 94.79% of the issued and outstanding shares, allowing them to exercise significant voting power [169]. - The company may lose its foreign private issuer status if more than 50% of voting securities are owned by U.S. residents, which would result in increased reporting requirements [168]. - The rights of shareholders to inspect corporate records are limited under Cayman Islands law, potentially hindering transparency [161]. - The concentration of ownership among major shareholders may lead to conflicts of interest and affect the value of shares [170].

Acquisition and Transition - The Company acquired all outstanding units of AGIG on July 1, 2025, transitioning to a low-carbon energy solutions focus[190]. Financial Performance - For the fiscal year ended December 31, 2025, the Company reported a net loss of approximately $29,460,935, compared to a net loss of approximately $3,621,948 in 2024[206]. - The Company reported a net loss of $29,460,935 for the year ended December 31, 2025, compared to a net loss of $3,621,948 for the year ended December 31, 2024, reflecting an increase in net loss of $25,838,987 primarily due to higher general and administrative expenses and impairment charges totaling $1,546,900[233]. - Total consolidated general and administrative expenses were $10,584,333 for the year ended December 31, 2025, an increase of $8,144,183 from $2,440,150 in 2024, driven by professional fees related to the Share Exchange and increased public company compliance costs[228]. - Cash used in operating activities was $7,505,203 for the year ended December 31, 2025, compared to $1,924,700 used in 2024, primarily due to professional fees related to the Share Exchange[238]. - Cash raised from financing activities was $15,177,110 for the year ended December 31, 2025, compared to $2,395,100 raised in 2024, attributed to registered direct offerings and ELOC drawdowns[239]. Capital Investments and Expenses - Capital investments in 2025 included $8,572,523 for the acquisition of the Cedar Port site and $630,830 for the Abundia Innovation Center build-out[198]. - The Company incurred impairment charges of $1,546,900 in 2025, with $1,115,000 related to a technology license and $431,900 for legacy oil and gas assets[205]. - Operating expenses in the Renewables segment increased by $7,245,300 for the year ended December 31, 2025, totaling $10,584,333 compared to $2,440,150 for the year ended December 31, 2024[220]. - Research and development expenses in the Renewables segment were $752,287 for the year ended December 31, 2025, down from $1,651,170 in 2024, reflecting a decrease of $898,883 due to reduced development-stage research activities[221]. - The Company recorded an impairment charge of $1,115,000 in the Renewables segment for the year ended December 31, 2025, compared to a $1,000,000 impairment charge in 2024[222]. Stock and Financing Activities - The Company issued 868,000 shares of Common Stock under the ELOC Agreement, generating total gross proceeds of $2,569,097 since December 31, 2025[193]. - The ELOC Agreement allows for up to $100,000,000 in Common Stock purchases, with a purchase price set at 96% of the lowest daily VWAP[199]. - The Company issued 646,149 shares under the ELOC Agreement during 2025, resulting in total gross proceeds of $3,925,972[201]. - The Company received approximately $20.0 million in gross proceeds from a registered direct offering that closed on February 23, 2026[195]. Going Concern and Future Outlook - The Company has substantial doubt about its ability to continue as a going concern for at least the next twelve months[207]. - The Renewables segment did not generate any revenue during the years ended December 31, 2025 or 2024, as commercial production has not commenced[219]. - The Company is focused on decarbonizing the energy sector by converting waste products into renewable alternatives, responding to growing demand due to regulatory requirements[192]. Balance Sheet and Working Capital - The Company had a cash balance of $4,618,621 and working capital of $(1,043,785) at December 31, 2025, compared to a cash balance of $525,809 and working capital of $(5,340,035) at December 31, 2024[235]. - Long-term liabilities increased to $6,439,464 at December 31, 2025, compared to $0 at December 31, 2024, due to the extension of the AGIG Convertible Note and the long-term portion of the operating lease[241].