Revenue and Financial Performance - Volato generated over $1.5 million in annual recurring revenue (ARR) from its Vaunt platform, which has surpassed 190,000 app downloads and completed 1,145 flights in 2025[18]. - The company sold its former subsidiary, GC Aviation, Inc., for $2.0 million, with $1.8 million recorded as a note receivable[27]. - A merger with M2i Global, Inc. is expected to result in M2i's stockholders owning approximately 85% of the combined company upon completion[28]. Software Development and Platforms - The company has committed to developing proprietary software solutions to meet the unique needs of private aviation operators, including the launch of its Vaunt and Mission Control platforms[20]. - Volato's proprietary flight management system, Mission Control, was developed to address operational challenges in private aviation, enhancing efficiency and fleet utilization[21]. - Volato's Parslee platform combines document intelligence with autonomous workflow agents, targeting enterprise applications within Microsoft 365[29]. - Mission Control, a cloud-based software developed by Volato, aims to streamline operations for Part 135 operators, enhancing data transparency and customer engagement[32]. - The platform includes key modules such as Flight Scheduling and Optimization, Integrated Crew Management, and Real-Time Analytics, which collectively improve operational efficiency and service quality[33][37]. - Mission Control's omnichannel communication system consolidates customer interactions, improving service consistency and reducing response times[35]. - The platform has been commercialized with flyExclusive as the first third-party user, addressing gaps in the aviation software market[41]. - Vaunt, a new platform targeting empty leg flights, aims to attract a broader market segment, providing affordable access to private aviation[46]. - Vaunt members pay an annual fee for access to empty leg flights, with a proprietary algorithm determining waitlist priority based on various factors[48][49]. - Parslee, an enterprise AI platform, is currently in beta and entered its first paying pilot programs in Q3 2025, featuring integrations with Microsoft 365[53]. - Volato's flexible subscription model for Mission Control enhances customer engagement and operational tools, setting a new standard in private aviation software[43]. Operational Changes and Management - Volato's aircraft ownership program transitioned management to flyExclusive, resulting in substantial cost savings and allowing the company to focus on high-growth areas[23]. - The company signed an amendment to its Aircraft Management Services Agreement with flyExclusive, which included a $2,000,000 payment in shares for asset options[25]. - The company has 13 full-time employees as of March 3, 2026, all located in the United States, with no current labor organization representation[61]. Intellectual Property and Technology Strategy - Volato employs various strategies to protect its intellectual property, including trademarks and confidentiality agreements, while also evaluating technology development initiatives[64].

Revenue Generation and Contracts - In 2025, the company generated over 46% of its revenue from patients covered by value-based contracts, predominantly in the form of capitated contracts[34]. - More than 50% of revenue in 2025 was generated from value-based contracts where payors designated affiliated providers as their preferred oncology group[67]. - The capitation arrangements involve a fixed per member per month (PMPM) payment model, aligning provider incentives with quality and efficiency of care[63]. - The TOI PCs' revenue for 2025 included approximately 16% derived from fixed fees under capitation agreements with payors[126]. - A significant portion of Patient Services revenue is dependent on a limited number of health insurance payors, with no single non-government payor accounting for more than 10% of revenue in 2025[131]. - A significant decrease in the number of capitation or fee-for-service arrangements could adversely affect revenues and results of operations[155]. Patient Care and Services - The company focuses on delivering personalized, evidence-based care while managing costs for patients and payors[31]. - The High Value Cancer Care (HVCC) program demonstrated over 25% lower median total healthcare costs from diagnosis to death[48]. - The company aims to provide access to world-class oncology care in an affordable manner to underserved populations[36]. - The average patient rating based on over 3,500 Google reviews is 4.6 out of 5 stars, indicating high patient satisfaction[52]. - The company operates specialty and retail pharmacies across five states to fill medication orders related to oncology care[28]. Growth and Expansion - The company managed a population of approximately 2.0 million patients under value-based agreements as of December 31, 2025[25]. - The company is expanding its value-based arrangements, particularly in areas with a demand for full delegation of oncology services[35]. - The company anticipates adding more TOI PC clinics through acquisitions and de novo clinic builds, enhancing market presence and capacity[56]. - The company has a robust pipeline for acquisitions, focusing on practices aligned with its value-based care philosophy[70]. - The growth strategy relies on building or acquiring new clinics to service contracts and treat patients, which involves significant risks and uncertainties[107]. Financial Performance and Risks - The Oncology Institute incurred a net loss of $60,606,000 in 2025, with a loss from operations of $36,083,000[113]. - The company anticipates increasing expenses in the future as it invests heavily in expanding its patient base and operations[113]. - A significant portion of revenue is derived from a limited number of health insurance payors, which could impact revenue if relationships are disrupted[105]. - The company faces competition for payor relationships with other healthcare organizations, which may increase costs due to ongoing consolidation in the healthcare industry[108]. - The transition from volume to value-based reimbursement models may adversely affect operations and financial results[105]. Regulatory Compliance and Legal Risks - The company is subject to various state healthcare regulations, including California Assembly Bill 1415, which requires at least 90 days' written notice before closing certain material transactions[77]. - The company is subject to federal and state healthcare regulatory laws, including the Anti-Kickback Statute and Stark Law, which impose strict compliance requirements[78][79][80]. - The company is subject to potential legal proceedings and litigation, which could materially harm its business and results of operations[173]. - The company may face significant costs and operational disruptions due to medical malpractice claims, which could strain financial resources and harm its reputation[175]. - The company is required to comply with complex fraud, waste, and abuse laws, which could lead to federal and state audits and investigations[197]. Cybersecurity and Data Privacy - Cybersecurity incidents could compromise the confidentiality and integrity of sensitive data, potentially resulting in significant costs and reputational harm[171]. - The company experienced temporary cash flow impacts due to delays in claim submissions caused by the Change Healthcare cyberattack, but does not believe the impact was material[172]. - The company collects and processes sensitive personal information, making it subject to various federal and state privacy laws, which are rapidly evolving[203]. - Violations of HIPAA can result in significant civil and criminal penalties, as well as additional oversight obligations[205]. - The company must navigate numerous state and federal laws regarding personal information processing, which complicates compliance efforts[206]. Market and Competitive Landscape - The competitive landscape includes traditional oncology practices and specialty benefit managers, with the company distinguishing itself through its integrated value-based care approach[72]. - The healthcare industry is experiencing consolidation, leading to fewer but larger payors with significant bargaining power, which may result in declining reimbursement rates[156]. - The TOI PCs' growth strategy depends on attracting new patients and retaining existing payor contracts, facing competition from other oncology providers[121]. Tax and Financial Reporting - As of December 31, 2025, the company had federal income tax NOLs of $227,510,540 and state income tax NOLs of $220,729,030 available to offset future taxable income[214]. - The deferred tax asset associated with the company's federal and state net operating losses is fully offset by a valuation allowance, limiting its impact on the effective tax rate[214]. - Future changes in tax laws or their interpretation could adversely affect the company's business, financial condition, and results of operations[215]. Operational Challenges - The company has experienced rapid growth, which has placed significant demands on management and operational resources[111]. - Increased labor costs may not be offset by rate increases due to the fixed nature of a significant percentage of revenue[159]. - The company is substantially dependent on a single source of drug supplies, which poses risks related to supply disruptions and price increases[166]. - The company must continue to invest in information technology systems to enhance patient experience and maintain competitive advantage[170].

Business Performance - OppFi has facilitated over $8.6 billion in gross loan issuance covering more than 4.7 million loans since inception through December 31, 2025[21]. - As of December 31, 2025, OppFi served more than 1.6 million unique customers and maintained a net promoter score (NPS) of 78[29]. - OppFi maintained a 4.4/5.0 star rating on Trustpilot and a Net Promoter Score (NPS) of 78 for the year ended December 31, 2025, reflecting strong customer satisfaction[54]. - Approximately 15.7% of new loans originated in 2025 were generated through SEO, email marketing, and customer referrals, while 80.6% came from strategic partners[53]. - The company anticipates leveraging both organic and inorganic growth strategies, including potential acquisitions to diversify its business and reach underbanked consumers[55]. Market Opportunity - Approximately 48 million everyday Americans are underbanked, representing about 14.2% of U.S. households, highlighting a significant market opportunity[33]. Technology and Innovation - Approximately 93.7% of credit decisions on the OppFi platform were automated during the year ended December 31, 2025[25]. - OppFi's tech stack utilizes machine learning and real-time data analytics to generate credit decisions, moving away from traditional credit scores[39]. - OppFi's proprietary underwriting platform uses machine learning models, including Model 6.1, to enhance risk assessment and pricing precision, with full implementation expected in the second half of 2026[51]. - OppFi's technology investments include the development of the Loan Origination Lending Application (LOLA), aimed at improving operational efficiency and integrating AI tools[49]. - OppFi's digital platform provides significant scalability and cost efficiency, allowing the company to serve consumers without physical store costs[42]. Customer Service and Support - OppFi's Customer Advocate team focuses on providing customer service and collections, ensuring compliance with regulations such as UDAAP and TCPA[43]. - The OppFi TurnUp Program helps eligible applicants find more affordable credit options with an APR of less than 36.0%[39]. - OppFi's loans have no fees, including origination, late, or insufficient funds fees, and allow for flexible repayment options[26]. - The company has established relationships with social impact organizations to provide customers with free resources and education, enhancing its commitment to financial health[43]. Regulatory Compliance - Regulatory compliance is critical for OppFi, as it operates under extensive federal and state regulations, with oversight from agencies like the CFPB and FDIC[60]. - OppFi assists with compliance to the Truth in Lending Act (TILA) by providing required disclosures such as the annual percentage rate and finance charge for loans facilitated through its platform[65]. - The Equal Credit Opportunity Act (ECOA) prohibits discrimination against credit applicants based on various factors, and OppFi ensures compliance by providing timely adverse action notices to denied applicants[66]. - Under the Fair Credit Reporting Act (FCRA), OppFi accurately reports loan payment information to credit bureaus and provides timely adverse action notices when required[67]. - OppFi has implemented an identity theft prevention program as required by FCRA and maintains processes for consumers to opt-out of sharing personal information[69]. - The Fair Debt Collection Practices Act (FDCPA) guides OppFi's internal collection team and third-party agents in collecting delinquent accounts while ensuring compliance with applicable laws[70]. - OppFi's privacy policies comply with the Gramm-Leach-Bliley Act (GLBA), ensuring the confidentiality and security of consumers' personal information[71]. - The Dodd-Frank Act established the Consumer Financial Protection Bureau (CFPB), which has regulatory authority over OppFi and its bank partners, ensuring compliance with consumer protection laws[72]. - OppFi's loan servicing activities are designed to comply with the Electronic Fund Transfer Act (EFTA), ensuring necessary consumer consents are obtained for electronic transfers[77]. - The Servicemembers Civil Relief Act (SCRA) requires OppFi to adjust interest rates on loans for qualifying military personnel to a maximum of 6.0% during active duty[82]. - OppFi ensures compliance with the Military Lending Act, which includes a limit on the Military Annual Percentage Rate of 36.0% for certain active duty members and their dependents[83]. - The company is required to maintain compliance with various federal, state, and local laws, which could impact its business operations if not adhered to[91]. - OppFi's compliance management system is designed to minimize compliance-related risks, although no program can guarantee complete avoidance of violations[95]. Human Resources - OppFi has approximately 410 full-time employees as of December 31, 2025, with no employees represented by a labor union[102]. - The company has built a strong company culture and has received numerous awards as a best place to work, emphasizing its focus on attracting talented employees[100]. Financial Impact - As of December 31, 2025, a hypothetical increase of 10% to the expected default rate would decrease the fair value of finance receivables by $25.9 million[467]. - Conversely, a hypothetical decrease of 10% to the expected default rate would increase the fair value of finance receivables by $25.5 million[467]. Intellectual Property - The company has trademark registrations in the U.S. and continues to pursue additional registrations to protect its intellectual property[97]. Business Model - The bank partner model allows OppFi to facilitate loan products funded directly by banks, operating in 40 states as of December 31, 2025[45]. - OppFi's business model may be affected by potential changes in the enforcement of the Small Dollar Loan Rule, which could require additional borrower consents[89]. - The company has implemented an anti-money laundering (AML) program to comply with U.S. regulations and mitigate risks associated with money laundering and terrorist financing[84]. - OppFi's bank partners are subject to state usury laws, which may limit the interest rates and fees charged on loans originated through its platform[90].

Financial Performance - Total revenues for 2025 were CHF 0, a decrease from CHF 5.0 million in 2024, primarily due to the conclusion of revenue recognition from the Novartis collaboration agreement[37]. - R&D expenses decreased to CHF 40.2 million in 2025 from CHF 48.6 million in 2024, reflecting a reduction of CHF 8.4 million[35]. - The net cash outflow from operating activities was CHF 51.3 million in 2025, an improvement from CHF 59.2 million in 2024[35]. - The Group generated an operating loss of CHF 58.1 million in 2025, an improvement from a loss of CHF 61.2 million in 2024[41]. - The net loss for 2025 was CHF 61.7 million, compared to a net loss of CHF 54.0 million in 2024[43]. - Total operating expenses for 2025, including depreciation and amortization, were CHF 58.1 million, down from CHF 66.1 million in 2024[35]. - In 2025, total operating expenses decreased by CHF 7.9 million to CHF 58.1 million, with personnel expenses accounting for CHF 34.7 million (60% of total operating expenses) and external research costs totaling CHF 11.2 million (19% of total operating expenses)[39]. - The company expects full-year 2026 operating expenses to be between CHF 45 million and CHF 55 million[12]. - For 2026, the Group expects total operating expenses to be between CHF 45-55 million, including approximately CHF 6 million in non-cash effective costs[53]. Cash and Liquidity - Cash and cash equivalents, including short-term deposits, amounted to CHF 93.1 million as of December 31, 2025, providing a financial runway until 2028[36]. - As of December 31, 2025, cash and cash equivalents decreased by CHF 56.3 million to CHF 93.1 million, representing 91% of total assets[44]. - The Group's liquidity position is strong, with CHF 93.1 million in cash, estimated to fund operations until 2028[56]. Research and Development - The company initiated a Phase 1/2a study of its lead Radio-DARPin candidate MP0712 targeting DLL3 for small cell lung cancer, with recruitment now open[6]. - MP0726, the second Radio-DARPin candidate targeting mesothelin, has been nominated and proof-of-concept data was presented at SNMMI 2025[11]. - The company presented encouraging imaging and dosimetry data for MP0712 at TWC 2026, supporting its clinical development[11]. - The pipeline includes clinical-stage candidates targeting oncology, with a focus on Radio-DARPin Therapy for small cell lung cancer and a tetraspecific T cell engager for acute myeloid leukemia[72]. - The company has initiated a Phase 1/2a trial for MP0712, targeting DLL3 in small cell lung cancer, with initial clinical data expected in 2026[81]. - MP0726, targeting MSLN in ovarian cancer, is progressing towards first-in-human imaging, with preclinical data presented in June 2025[86]. - MP0317 has completed a Phase 1 dose-escalation study, showing tumor-localized CD40 activation and TME remodeling in 46 patients[93]. - MP0533 is currently in a Phase 1/2a trial for relapsed/refractory AML, with data indicating tolerability and improved serum exposure[98]. - The company plans to present preclinical data on Radio-DARPins' suitability with multiple isotopes at the 3rd Global Radiopharmaceuticals Development Summit in March 2026[88]. - The company is evaluating various radionuclides to tailor Radio-DARPin candidates to patient needs, enhancing therapeutic applications[88]. - The Switch-DARPin technology aims to improve the safety and potency of T cell engagers by enabling conditional activation in specific biological contexts[102]. - The company intends to nominate a lead Switch-DARPin candidate for development in H1 2026, with updates expected at the AACR Annual Meeting in April 2026[107]. - Molecular Partners' MP0621 program is designed to enhance the efficacy of hematopoietic stem cell transplantation, with pre-clinical proof-of-mechanism data presented at major conferences[110]. Corporate Governance - The company has established a Quality Management System to ensure compliance with regulations and maintain product quality and patient safety[129]. - The company emphasizes the importance of corporate governance, with detailed responsibilities outlined for each committee[184]. - The organizational rules and powers of the CEO are available for reference, indicating a structured governance framework[185]. - The Board of Directors consists of eight members as of December 31, 2025, and is responsible for the ultimate direction of the company's business[169][171]. - The Board of Directors met two times in person and conducted six telephone conference meetings in 2025[174]. - The Audit and Finance Committee reviews the financial statements and reports from the external auditor prior to their public release[181]. - The company has not reported any changes in the membership of the Board of Directors during 2025[187]. - The Board of Directors consists of non-executive members, with Patrick Amstutz serving as the CEO since the company's inception[187]. Shareholder Information - The company has a market capitalization of CHF 137 million as of December 31, 2025[134]. - Significant shareholders include Mark N. Lampert with 21.54% and Suvretta Capital with 10.62% of voting rights[136]. - The issued share capital of the company amounted to CHF 4,037,464.10, divided into 40,374,641 fully paid registered shares as of December 31, 2025[140]. - The conditional share capital amounted to CHF 363,419, equating to approximately 9% of the existing share capital[148]. - The share capital may be increased by up to CHF 226,087 through the issuance of 2,260,870 fully paid registered shares, representing about 6% of the existing share capital[149][151]. - The company has not issued participation certificates or dividend-right certificates[154]. - The company has not paid dividends since its inception and does not anticipate doing so in the foreseeable future[163]. - Shareholders must be registered in the share register at least six business days prior to the general meeting to be entitled to vote[158]. Employee and Social Responsibility - The company is focusing its ESG efforts on five priority areas, including human capital management and diversity, equity, and inclusion[115]. - The company offers flexible working arrangements and training programs to support employee growth and well-being[118][119]. - The company has waived future royalties from ensovibep in developing regions as part of its corporate social responsibility commitment[127]. - The company has implemented cutting-edge IT systems for data protection and cybersecurity, ensuring high standards of data security[124]. - The board of directors includes seven male directors and one female director, with two members identifying as underrepresented individuals[130].

Sales Performance - In 2025, the company sold 1,703 units, a decrease of 20% from 2,129 units sold in 2024[102] - Total net revenue decreased by $19.6 million, or 10.7%, from $184.2 million in 2024 to $164.6 million in 2025[128] - Product sales declined by $12.4 million, or 9.6%, primarily due to a decrease in unit volumes shipped, with total units sold dropping from 2,129 in 2024 to 1,703 in 2025, a decrease of 20.0%[129][130] - Texas accounted for 52% of product sales in 2025, down from 54% in 2024[106] - Approximately 44% of 2025 product sales were from independent retail distributors, while 35% were direct sales to manufactured housing community owners[105] Financial Performance - Inflation and increased tariffs on imported goods have pressured gross margins, impacting profitability[115] - Selling, general and administrative expenses rose by $6 million, or 26%, driven by increases in warranty costs, consulting fees, and legal costs[135] - Consumer, MHP, and dealer loans interest income increased by $2.5 million, or 6.1%, due to growth in loan portfolios, with the consumer loan portfolio increasing by $24.7 million[132] - Other revenue decreased by $9.7 million, or 71.0%, primarily due to an $8.8 million decrease in land sales[133] Cash Flow and Investments - Net cash provided by operating activities was $37.2 million in 2025, compared to $36.0 million in 2024, reflecting cash generated from net income of $41.8 million[145] - Net cash used in investing activities totaled $22.1 million, primarily due to $19.0 million related to the AmeriCasa acquisition[146] - The company maintained approximately $8.5 million in cash and cash equivalents as of December 31, 2025, up from $1.1 million in 2024[143] Assets and Equity - Book value per share increased from $20.45 in 2024 to $22.20 in 2025, reflecting total stockholders' equity growth from $493.96 million to $528.61 million[142] - The company acquired properties for developing manufactured housing communities, with total land and improvements valued at $44.612 million as of December 31, 2025[108] Financing and Obligations - The company offers three types of financing solutions, including inventory financing for independent retailers and consumer financing for end-users[107] - The company entered into a four-year senior secured revolving credit facility with an initial commitment of $50.0 million, maturing on July 28, 2027[148] - The maximum contingent obligations under repurchase agreements were approximately $841,000 and $805,000 as of December 31, 2025 and 2024, respectively[153] - The company has no off-balance sheet arrangements likely to affect its financial condition or liquidity[153] - The company considers its obligations on current contracts to be immaterial and has not recorded any reserve for repurchase commitments as of December 31, 2025[153] Production Capacity - The company operates three manufacturing facilities and can produce up to approximately 70 home sections or 60 fully-completed homes per week[104] - The company is exploring opportunities to increase production capacity in attractive regions to meet future demand[115]

Market Conditions and Financial Performance - The company experienced significant fluctuations in the refinance market, leading to decreased loan volumes and substantial revenue declines, resulting in net losses for fiscal years 2022, 2023, 2024, and 2025[157]. - As mortgage interest rates rose in 2022 and 2023, loan volumes decreased, and rates remained high in 2024 and 2025, contributing to ongoing revenue challenges[157]. - The interest rate environment has adversely affected the company's business, financial condition, and results of operations, with higher rates reducing demand for mortgage loans[159]. - Increased mortgage loan delinquencies and defaults may lead to lower revenue from servicing loans, as servicing fees are primarily collected from performing loans[165]. - The company incurred losses in fiscal years 2023, 2024, and 2025, necessitating amendments to certain warehouse lines and secured credit facilities related to financial covenants[220]. Regulatory and Compliance Risks - Regulatory changes and uncertainties in the mortgage industry may negatively impact the company's operations and result in increased compliance costs[175]. - Compliance with Agency and Ginnie Mae guidelines is critical; failure to meet these could lead to penalties and adversely affect business operations[181]. - The company is subject to significant compliance costs due to state licensing and operational requirements, which could increase with regulatory changes[194]. - Potential changes in state regulations could significantly raise compliance costs or limit revenue-generating fees, impacting business viability[196]. - The company is subject to various federal and state laws regarding predatory lending, which could adversely impact its financial condition and operations[199]. - The company faces potential compliance costs and penalties related to fair lending laws, including the Fair Housing Act and ECOA[200]. - The company must comply with privacy and information security regulations, which could increase compliance costs and impact its business operations[206]. - Regulatory investigations and inquiries could result in fines and increased costs, damaging the company's reputation and financial condition[186]. Market Position and Competitive Landscape - The competitive landscape is intensifying, with larger institutions having greater access to capital, which may disadvantage the company in terms of pricing and operational efficiency[161]. - The company faces challenges in maintaining relationships with traditional market participants, which are crucial for growing its purchase money mortgage loan volume[158]. - The company relies heavily on the programs of government-sponsored enterprises (GSEs) like Fannie Mae and Freddie Mac, which significantly reduce credit exposure and financing costs for mortgage loans[178]. - Any changes to the roles or practices of the GSEs could materially and negatively affect the company's operations and competitive ability[179]. - The company faces uncertainty regarding future reforms in the GSEs and home mortgage market, complicating business planning and potentially impacting operational results[180]. Financial Structure and Debt Obligations - The company has eleven warehouse lines providing an aggregate available mortgage loan lending facility of $4.2 billion as of December 31, 2025[214]. - The company relies on two warehouse line providers for 39% of its aggregate available residential mortgage loan funding capacity[215]. - The company's existing indebtedness imposes financial covenants that limit its ability to incur additional debt and maintain liquidity[217]. - The company’s ability to finance operations and repay obligations is contingent on its ability to borrow money and secure investors for loan purchases[214]. - As of December 31, 2025, the company had $5.0 billion in outstanding indebtedness, including $2.9 billion in secured short-term debt, $1.3 billion in secured debt obligations, and $807.1 million in unsecured debt obligations[222]. - The company has $340.6 million of senior secured notes due in November 2027 and $600.0 million in unsecured senior notes due in April 2028[223]. - The company's high level of debt may limit its ability to obtain additional financing, which could adversely affect its operations and financial condition[224]. - The company relies primarily on cash generated from operations to meet its debt obligations, and insufficient cash flows could hinder its ability to repay debt or fund liquidity needs[225]. Shareholder and Stock Market Considerations - The Hsieh Stockholders and Parthenon Stockholders collectively hold approximately 62.7% of the voting power of the company's capital stock, potentially limiting other shareholders' influence on corporate matters[232]. - The company has entered into a tax receivable agreement that requires it to pay 85% of cash savings from tax benefits to certain stockholders, which could result in substantial payments[235]. - Payments under the tax receivable agreement may exceed the actual tax benefits realized, negatively impacting the company's liquidity[236]. - The market price of the Class A Common Stock has fluctuated between $1.02 and $31.48 since the IPO in February 2021, indicating high volatility[240]. - The company has not declared a regular cash dividend since Q2 of fiscal 2022, and future dividends will depend on various factors including financial condition and capital requirements[250]. - The obligation under the tax receivable agreement could lead to significant lump sum payments that may adversely affect liquidity and deter potential acquirers[238]. - Future offerings of debt or equity securities may dilute existing stockholders' rights and adversely affect the market price of Class A Common Stock[246]. - The trading market for Class A Common Stock is influenced by analyst coverage; downgrades or lack of coverage could lead to a decline in stock price[252]. Anti-Takeover Provisions - Certain provisions in the company's bylaws may hinder unsolicited acquisition proposals, potentially affecting stockholder interests[255]. - The company has implemented anti-takeover provisions that may hinder third parties from pursuing tender offers or takeover attempts opposed by management[256]. - These provisions could prevent stockholders from participating in transactions that may be favorable to them[256]. - The anti-takeover measures may significantly impede stockholders' ability to benefit from changes in control or management[256]. - As a result of these provisions, the market price of the company's Class A Common Stock may be adversely affected[256]. - Stockholders may not realize any potential change of control premium due to these anti-takeover provisions[256].

Growth Direct Platform - The Growth Direct platform is the only fully automated, high-throughput and secure microbial quality control (MQC) solution, designed to meet the challenges of increasing scale and regulatory scrutiny in pharmaceutical manufacturing [24]. - The platform delivers results in half the time or less compared to traditional methods, significantly increasing operational efficiency and accuracy [27]. - The Growth Direct method reduces MQC testing to a simple two-step workflow, eliminating up to 85% of the manual steps of traditional MQC [45]. - The Growth Direct platform integrates with existing LIMS, enabling a fully paperless workflow and eliminating human error in data entry, thus enhancing efficiency and data integrity [60][71]. - The Growth Direct platform has been adopted by 49 global customers across 107 manufacturing facilities, targeting top 50 pharmaceutical companies and leading CDMOs for further adoption [76]. - The Growth Direct platform reduces MQC testing steps by 85%, leading to significant operational and cost savings for customers [72]. - The Growth Direct system is designed to comply with industry data integrity standards, ensuring trustworthiness and accessibility of data for authorized users [71]. - The Growth Direct system has demonstrated accuracy and reliability comparable to traditional methods, with studies showing it can identify and count colonies that technicians missed [49]. - The Growth Direct system is a fully automated, high throughput system capable of processing 700 samples, delivering test results in half the time compared to traditional methods [53][71]. - The new rapid sterility test can detect organisms in as little as 12 hours and provide final results within one to three days, significantly reducing the time required for final product release [58]. - The company aims to establish Growth Direct as the trusted global standard in automated MQC, focusing on speed, accuracy, security, and regulatory compliance [31]. Market Potential and Strategy - The total addressable market for MQC testing is estimated to be approximately $5.0 billion for system sales and another $5.0 billion for annual recurring sales of consumables and services [41]. - The MQC market is expected to grow due to increasing regulatory scrutiny, the rise of biologics and cell and gene therapies, and the need for efficient automated processes [44]. - The company aims to expand its Growth Direct platform into new drug manufacturing areas, including biologics and cell and gene therapies, to capture a greater share of the MQC testing value chain [131]. - The company has a strong intellectual property portfolio with at least 162 granted and pending patents globally, supporting its competitive advantage in the market [72]. - The company plans to launch new consumables for MQC testing applications, including sterility testing available for commercial sale in 2024, enhancing the platform's capabilities [79]. - The company aims to position the Growth Direct platform as the industry standard for automated MQC testing through strategic growth initiatives [74]. Financial Performance - The company achieved positive gross margins for the first time in its history in Q3 and Q4 of 2024, with gross margins remaining positive for the 12 months ended December 31, 2025 [84]. - The gross margin improved from (0.4)% for the 12 months ended December 31, 2024 to 3.1% for the 12 months ended December 31, 2025, although quarterly gross margins declined from 12% to (3%) during the same periods [114]. - For the years ended December 31, 2025 and 2024, the company incurred net losses of $47.1 million and $46.9 million, respectively, with an accumulated deficit of $522.4 million as of December 31, 2025 [109]. - The company has $38.3 million in cash, cash equivalents, and short-term investments as of December 31, 2025, expected to fund operations for at least 12 months [128]. - Revenue generation heavily relies on the sale of Growth Direct systems and consumables, with a significant portion expected from a small number of customers each year [123]. Operational Challenges - The company faces competition from established manufacturers and emerging companies in the MQC testing market, necessitating continuous innovation and customer integration [96][97]. - The company may need to raise additional capital to fund operations and product development, which could dilute existing shareholders' interests [129]. - The company recognizes revenue upon delivery of its systems to customers, which is influenced by factors beyond its control, including customer manufacturing capabilities [121]. - The company faces significant fluctuations in operating results due to various factors, including customer demand and the timing of sales cycles [114]. - The company has limited experience in marketing and sales, relying on a small team for direct sales globally, which poses risks in effectively expanding its customer base [143]. - The company may face challenges in integrating acquisitions or partnerships, which could disrupt ongoing operations and require management resources [183]. Regulatory and Compliance Issues - The company has a robust regulatory strategy, having defined the Growth Direct Technology as "automated compendial validation," which aids in customer regulatory acceptance [77]. - The company’s ability to meet regulatory compliance standards is critical, as failure to do so could result in loss of customers and harm to its reputation [138]. - Compliance with evolving data privacy laws, such as the California Consumer Privacy Act (CCPA) and the EU General Data Protection Regulation (GDPR), is increasingly complex and resource-intensive [175][177]. - The company faces potential legal and financial liabilities due to non-compliance with data protection regulations, which could impact revenue and operational strategies [178]. Human Resources and Management - The company had 171 full-time employees as of December 31, 2025, with 34 in sales and marketing, 34 in research and development, 74 in manufacturing and service, and 29 in general and administrative [102]. - The company is highly dependent on its management and directors, including the CEO, Robert Spignesi, and the loss of any key personnel could materially harm the business [165]. - Future success will depend on the ability to attract and retain qualified personnel, with competition for talent being intense in the technology sector [166]. - The company emphasizes internal mobility opportunities and provides competitive employment benefits, including a comprehensive 401k retirement plan with employer match [104]. Risks and Uncertainties - The company faces risks related to inventory management and the ability to support demand for existing and future products on the Growth Direct platform [140]. - The complexity of the company's products necessitates extensive customer training, which can be expensive and time-consuming, potentially deterring some customers [162]. - Product liability claims could expose the company to substantial liabilities, impacting its business reputation and commercialization efforts [163]. - The company may evaluate strategic opportunities including acquisitions, joint ventures, or investments, which could negatively affect operating results and dilute stockholder ownership [183]. - The company relies on information technology systems for critical operations, and any failure could adversely affect business performance [167]. - Cybersecurity incidents and data breaches pose significant risks, potentially compromising sensitive information and damaging the company's reputation [170]. Economic and Market Conditions - High inflation rates could negatively impact revenues and profitability, potentially leading to decreased demand for products and increased operating costs [203]. - Global economic and political instability could adversely affect the company's business and financial condition, particularly due to potential government shutdowns and trade policy changes [205]. - The U.S. administration imposed new tariffs in 2025 on a broad range of imports, which may lead to retaliatory tariffs from other countries, impacting international trade relations [206]. - Political tensions from trade policies could reduce trade volume and investment, adversely affecting global economic conditions and financial market stability [207]. - Supply chain disruptions and volatile demand could arise from a weak economy, impacting the company's ability to meet customer needs and maintain operations [209].

Financial Performance - Opus Genetics reported a net loss of $49.6 million for the year ended December 31, 2025, compared to a net loss of $57.5 million for 2024, with an accumulated deficit of $188.6 million as of the same date[583]. - License and collaborations revenue increased to $14.2 million for the year ended December 31, 2025, up from $11.0 million in 2024, representing a growth of approximately 29.9%[602]. - Total operating expenses decreased to $52.8 million in 2025 from $73.1 million in 2024, a reduction of $20.3 million or approximately 27.8%[601]. - Research and development expenses rose to $30.8 million in 2025, compared to $26.9 million in 2024, an increase of $3.9 million or approximately 14.6%[604]. - General and administrative expenses increased to $22.0 million in 2025 from $18.2 million in 2024, a rise of $3.8 million or approximately 20.9%[605]. - For the year ended December 31, 2025, the net cash used in operating activities was $35.3 million, attributed to a net loss of $49.6 million, adjusted by non-cash operating income of approximately $16.5 million[650]. - The net cash provided by financing activities for the year ended December 31, 2025 was $50.0 million, primarily from a Registered Direct Offering of $23.0 million and a March 2025 Offering of $21.5 million[654]. Clinical Trials and Product Development - The FDA granted OPGx-LCA5 multiple designations, including Rare Pediatric Disease and Regenerative Medicine Advanced Therapy, and the program is currently in a Phase 1/2 clinical trial with six participants showing clinically meaningful vision improvements[559][560][561]. - OPGx-BEST1 received FDA clearance for an Investigational New Drug application, with the first participant dosed in a Phase 1/2 trial, and initial data expected in mid-2026[568][569]. - The Phase 3 trial for OPGx-LCA5 is expected to begin dosing in the second half of 2026, with topline clinical data anticipated approximately one year later[565]. - RYZUMVI® was approved by the FDA in September 2023, triggering a $10 million milestone payment under the Viatris License Agreement, and was commercialized in April 2024[576]. - In the VEGA-3 trial for presbyopia, 27.2% of participants treated with PS achieved a significant improvement in near visual acuity, compared to 11.5% in the placebo group (p<0.0001)[577]. - The LYNX-2 trial for treating night driving impairment met its primary endpoint, with 17.3% of participants achieving a significant improvement in low contrast distance visual acuity[578]. Funding and Cash Management - The company has funded operations primarily through equity financings, convertible notes, and milestone payments from the Viatris License Agreement, with total anticipated revenue from this agreement capped at $50 million[582][584]. - As of December 31, 2025, the company had cash and cash equivalents of $45.1 million, which is expected to fund operations for at least twelve months[614]. - The company received gross proceeds of approximately $25.0 million from a private placement in February 2026[614]. - The company plans to use proceeds from a registered direct offering, which raised approximately $23.0 million, to advance gene therapy programs and for working capital[617]. - A total of 3,827,751 shares of common stock were sold at a price of $2.09 per share, along with pre-funded warrants for 7,177,033 shares at a purchase price of $2.0899 per warrant, closing on November 7, 2025[618]. - The August 2025 Private Placement raised approximately $3.5 million by issuing 3,138,338 shares of common stock, closing on August 25, 2025[619]. - Net proceeds from the August 2025 Private Placement will be used to expedite manufacturing process development for gene therapy candidates OPGx-LCA5 and OPGx-BEST1[620]. - The combined gross proceeds from the March 2025 Offering and Private Placement were approximately $21.5 million, with 862,684 warrants exercised for cash amounting to $0.8 million as of December 31, 2025[625]. - As of December 31, 2025, the company had cash and cash equivalents of $45.1 million, with total equity offerings amounting to $118.1 million and convertible notes of $8.5 million[656]. Future Outlook and Strategic Plans - The company expects higher development costs for LCA5, BEST1, and PS during later stages of clinical development due to increased trial sizes and durations[591]. - The company expects to generate significant revenue primarily from RYZUMVI® sales and regulatory approvals for LCA5 and BEST1, with no assurance of profitability or positive cash flow from operating activities[657]. - The company has budgeted research and development expenses related to the Viatris License Agreement, which are fully reimbursed, but uncertainties remain regarding the development of LCA5 and BEST1[660]. - The company anticipates satisfying its obligations through cash on hand, future equity and debt financings, and reimbursement payments until it generates adequate revenue from commercial sales[675]. Accounting and Financial Reporting - License and collaborations revenue is recognized based on the fair value of performance obligations, utilizing a discounted cash flow approach[679]. - The company has issued warrants related to March 2025 financings, recorded as liabilities at fair value, with adjustments for changes in fair value recognized in comprehensive loss[680]. - A full valuation allowance has been provided on net deferred tax assets due to uncertainty regarding future taxable income[681]. - The acquisition of in-process research and development (IPR&D) was recorded at fair value using the Multi-Period Excess Earnings Method, sensitive to changes in revenue growth rate and projected EBITDA margin[682]. - Royalties on future sales of licensed products will be expensed in the period related revenues are recognized[682]. - The company believes that recently issued accounting standards that are not yet effective will not materially impact its financial position or results of operations upon adoption[684].

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 pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934. For the transition period from _____ to _____ Commission File No. 001-34079 Opus Genetics, Inc. (Exact name of registrant as specified in its charter) Delaware 11-3516358 (State or other jurisdiction of ...

Financial Performance and Backlog - As of December 31, 2025, the company had approximately $9.1 million in system backlog, with an expectation that about 78% will be recognized as revenue in 2026[26] - The company reported a system backlog of approximately $14.4 million as of December 31, 2024, indicating growth in demand for its products[26] Acquisitions and Product Development - The company completed the acquisition of Access Point Technologies EP, Inc. on July 31, 2024, enhancing its in-house catheter development capabilities[28] - The acquisition of Access Point Technologies EP, Inc. on July 31, 2024, provides the company with the Map-iT portfolio, enhancing its offerings in traditional cardiac ablation procedures[43] - The MAGiC Sweep catheter received FDA 510(k) clearance in July 2025, marking a significant advancement in the company's product lineup[52] - The company has developed a proprietary MAGiC ablation catheter expected to receive regulatory clearance in Europe by 2025 and in the U.S. by early 2026, which will replace the currently used J&J catheters[67] Clinical Focus and Market Potential - The primary clinical focus is on electrophysiology, specifically cardiac ablation procedures, which represent a multi-billion-dollar market with significant growth potential[19] - The market for cardiac ablation procedures has grown rapidly, with an annualized procedure growth rate of approximately 10%[57] - The company estimates that approximately 4 million interventional cardiology procedures are performed annually in the U.S., with 10-15% classified as complex, requiring longer procedure times and potentially sub-optimal outcomes[63] Technology and Innovation - The GenesisX RMN System is designed to improve accessibility and reduce installation time compared to previous generations[22] - The Odyssey Solution and its next-generation counterparts, Synchrony and SynX, aim to enhance procedure efficiency and lab integration[23] - The robotic technology is expected to enable more complex procedures with improved patient outcomes and reduced x-ray exposure[33] - The robotic technology has been demonstrated in over 500 publications and more than 150,000 procedures, showing significant reductions in major complications and patient radiation exposure[36] - The Odyssey Solution integrates multiple diagnostic and imaging sources into a single user interface, improving clinical workflow and efficiency in interventional labs[39] Regulatory and Compliance - The company’s medical devices are subject to extensive regulation by the FDA, requiring 510(k) clearance or pre-market approval (PMA) for commercial marketing in the U.S.[99][101] - Most of the company's current products are classified as Class II devices requiring 510(k) clearances, while certain therapeutic devices are classified as Class III and require PMA[102] - The 510(k) clearance process typically takes between four to twelve months, but can take longer depending on the complexity of the device[104] - The company must comply with various international regulations, including obtaining CE Mark certification for marketing in the European Economic Area[110] - The company is subject to anti-kickback and false claims laws, which impose significant penalties for violations related to healthcare fraud and abuse[112] Competition and Market Position - The company faces competition from traditional catheter-based electrophysiology approaches and new products in the market, including next-generation mapping systems and non-RF ablation devices[94] - The company faces competition from four companies with FDA-cleared endovascular catheter navigation systems for electrophysiology procedures and two companies with CE Mark approved electromagnetic catheter navigation systems in Europe[95] - The company has developed its own line of robotically enabled medical devices, competing with other manufacturers of traditional interventional devices and magnetically enabled catheters[96] - The Odyssey/Synchrony Solution faces direct competition from established imaging companies and dedicated solution providers, with expectations of continued competitive pressure due to rapid technological advancements[97] - Key competitive factors in the market include capability, safety, efficacy, ease of use, price, quality, reliability, and effective sales support[98] Workforce and Employee Relations - As of December 31, 2025, the company had 131 employees, with 40 in research and development, 47 in sales and marketing, 26 in manufacturing and service, and 18 in general administrative activities[125] - The company emphasizes the importance of attracting and retaining top talent to succeed in the competitive medical device industry[122] - The company provides a comprehensive total rewards package, including annual bonuses, sales commissions, and a 5% discount on stock purchases for eligible employees[128] - The company emphasizes employee health and wellness, offering programs that support mental health, family care, and financial well-being[126] - The company engages in ongoing training and development, requiring compliance training and offering professional development courses[129] - The company maintains a positive relationship with employees, with a significant majority not covered by collective bargaining agreements[125] - The company operates in 11 different countries, reflecting a diverse global workforce[124] - The company is committed to fostering a culture of mutual respect and dignity among employees[124] - The company conducts annual global performance reviews to assess employee performance and compensation[129] - The company invests in employee safety and wellness programs, adhering to regional and local regulations[127] Transparency and Communication - The company makes SEC filings available on its website, ensuring transparency and accessibility of financial information[130]