Financial Performance - For the year ended December 31, 2025, the company reported a net income of $1,637,488, which includes a loss of $908,002 from formation and operating costs, offset by interest earned of $2,535,846 from the Trust Account [315]. - The company generated gross proceeds of $60,000,000 from its IPO at $10.00 per Unit, along with an additional $2,300,000 from the sale of 230,000 Private Placement Units [319]. - The company incurred transaction costs of $3,722,527 related to the IPO, which included $1,200,000 in cash underwriting fees and $2,100,000 in deferred underwriting fees [320]. Cash and Liquidity - As of December 31, 2025, the cash held in the Trust Account amounted to $64,487,925, which is intended for completing a Business Combination [326]. - Cash used in operating activities for the year ended December 31, 2025, was $401,584, with changes in operating assets and liabilities using $496,774 of cash [321]. - The company has a working capital deficit of $1,157,343 as of December 31, 2025, indicating potential liquidity challenges [327]. - The company has no long-term debt or capital lease obligations, but incurs $10,000 per month for office space and administrative support [335]. Going Concern - Management has raised substantial doubt about the company's ability to continue as a going concern within one year after the financial statements are issued [333]. Investment Activities - Cash used in investing activities for the year ended December 31, 2025, was $1,200,000, related to an extension payment deposited into the Trust Account [323]. - The company expects to incur significant costs in pursuit of its financing and acquisition plans for a Business Combination [332].

Financial Performance - For the year ended December 31, 2025, the company reported a net income of $1,637,488, which includes a loss of $908,002 from formation and operating costs, offset by interest earned of $2,535,846 from the Trust Account[315]. - The company generated gross proceeds of $60,000,000 from its IPO at $10.00 per Unit, along with an additional $2,300,000 from the sale of 230,000 Private Placement Units[319]. - The company incurred transaction costs of $3,722,527 related to the IPO, which included $1,200,000 in cash underwriting fees and $2,100,000 in deferred underwriting fees[320]. Cash and Liquidity - As of December 31, 2025, the company had cash held in the Trust Account amounting to $64,487,925, intended for completing a Business Combination[326]. - Cash used in operating activities for the year ended December 31, 2025 was $401,584, with changes in operating assets and liabilities using $496,774 of cash[321]. - The company has a working capital deficit of $1,157,343 as of December 31, 2025, indicating potential liquidity challenges[327]. - The company has no long-term debt or capital lease obligations, but incurs $10,000 per month for office space and administrative support[335]. Management Concerns - Management has raised substantial doubt about the company's ability to continue as a going concern within one year after the financial statements are issued[333]. Investment Activities - Cash used in investing activities for the year ended December 31, 2025 was $1,200,000, related to an extension payment deposited into the Trust Account[323]. - The company plans to use funds held outside the Trust Account primarily for operational expenses and due diligence related to potential business combinations[328].

Financial Position - As of December 31, 2025, the company had $5.1 million in cash and cash equivalents, and completed PIPE Financing in January 2026 for net proceeds of approximately $18.6 million [253][260]. - The company incurred a net loss of $7.6 million for the year ended December 31, 2025, with an accumulated deficit of $1.2 billion [256]. - The company expects to continue incurring substantial losses for the foreseeable future and may never generate significant revenue or achieve profitability [256][268]. - The company’s ability to raise additional funds will depend on various factors, including market conditions and operational milestones [260]. Capital Raising and Funding Challenges - The company has faced substantial difficulties in raising capital and may need to delay or reduce its research and development program for emavusertib if sufficient funds are not available [254]. - The company has entered into a 2024 Sales Agreement to sell up to $100.0 million of common stock, but sold no shares under this agreement during the twelve months ended December 31, 2025 [264]. - The company may seek strategic alternatives, including partnerships or asset sales, but there is no assurance of timely or favorable terms [262]. Drug Development and Commercialization Risks - The company has not completed the development of any drug candidate and may never achieve commercialization [256]. - The company is dependent on the successful development and commercialization of emavusertib, which is subject to various risks and uncertainties [266][270]. - Emavusertib's therapeutic efficacy in humans remains unproven, and its development may be abandoned if significant side effects are identified [272]. - The company has never obtained marketing approval for any drug candidate, which may delay or prevent the commercialization of emavusertib [282]. - The approval of emavusertib may be contingent on conducting additional clinical trials or studies as required by the FDA, which could delay commercialization [284]. - The company currently has no sales, marketing, or distribution experience, which may hinder its ability to commercialize emavusertib effectively [291]. Clinical Trial and Regulatory Challenges - Delays in patient enrollment for clinical trials could significantly impact the timeline for obtaining regulatory approvals and increase development costs [278]. - The company may face challenges in enrolling sufficient patients due to competition from other clinical trials and existing therapies [277]. - The design and execution of clinical trials can significantly influence the results, and flaws may not be apparent until later stages [279]. - Regulatory authorities may impose additional restrictions or require changes to the drug's administration, impacting its marketability [288]. - The company is dependent on companion drugs for clinical trials, and any unavailability could lead to significant delays in emavusertib development [323][324]. Competition and Market Dynamics - Emavusertib faces substantial competition from existing and new technologies, with competitors potentially developing drugs targeting the same molecular pathways [292]. - Key competitors include companies pursuing oncology indications in IRAK4, CLL, PCNSL, and AML with FLT3 mutations, highlighting a competitive landscape [293]. - Market acceptance of emavusertib is uncertain, and failure to achieve adequate acceptance could hinder revenue generation and profitability [287]. Intellectual Property and Legal Risks - Patent protection for technologies and drugs is uncertain, which could impact the company's competitive position [332][333]. - The company faces risks related to patent rights, including potential overlaps with third-party patents that may hinder the development and commercialization of drug candidates [334]. - The enforcement of intellectual property rights in China and India may not be as effective as in the U.S., posing risks to the company's proprietary technology [343]. - The company may incur substantial costs and distractions from potential patent litigation or other intellectual property disputes [340]. Regulatory Environment and Compliance - The company must comply with advertising and promotion regulations for emavusertib, which restrict marketing to approved indications only [372]. - Non-compliance with regulatory requirements can lead to significant financial penalties and restrictions on product marketing and distribution [377]. - The FDA may grant accelerated approval for drug candidates that provide meaningful therapeutic benefits, but this process is subject to stringent requirements [380]. - The company is subject to various healthcare laws and regulations that could expose it to significant penalties and operational disruptions if non-compliance is found [428]. Market Access and Pricing Challenges - The company anticipates that ongoing legal challenges and Congressional actions regarding the Affordable Care Act (ACA) will create uncertainty affecting its operations and market conditions [412]. - Legislative changes, including the Inflation Reduction Act, may increase the difficulty and cost for the company to obtain reimbursement for drug candidates, materially impairing revenue generation [410]. - The company may face significant competition from generic drug manufacturers once regulatory exclusivity periods expire, adversely affecting future revenue and profitability [409]. Data Privacy and Security Compliance - The company is subject to stringent privacy laws and regulations, with potential fines and penalties that could materially affect its business and financial condition [431]. - Compliance with HIPAA privacy and security standards is complex and may involve significant internal resources, with potential civil and criminal penalties for non-compliance [433]. - The California Consumer Privacy Act (CCPA) imposes requirements on businesses processing personal information of California residents, with significant penalties for violations [435]. International Trade and Export Challenges - The company must navigate complex international trade regulations affecting product availability [451]. - Delays in product introduction could hinder competitive positioning in the market [451]. - The company’s financial results may be sensitive to changes in international trade policies [451].

Company Overview - The company is a blank check company formed to pursue a business combination with a target having an enterprise value exceeding $500 million[15]. - The focus will be on sectors such as asset management, hospitality, travel, entertainment, and gaming, leveraging next-generation technologies like AI and digital assets[15][16]. - The management team aims to identify private companies with sound business models and growth prospects, targeting those that have been underinvested in by prior ownership[21]. - The company has not yet selected a business combination target and is focusing on technology and software infrastructure companies in financial services, real estate, and asset management[42]. Acquisition Strategy - The company intends to pursue targets with strong free cash flow characteristics and predictable revenue streams, aiming for superior risk-adjusted returns compared to publicly traded companies[20]. - The acquisition process will involve due diligence, including meetings with management, document reviews, and financial assessments, although costs and timelines are currently uncertain[23]. - The company may structure the business combination to acquire less than 100% of the target, provided it maintains a controlling interest[25]. - The management team has developed a broad network of contacts that provides access to numerous potential business combination targets[32][33]. - The company anticipates that target business candidates will be sourced from various unaffiliated sources, including investment bankers and private investment funds[44]. Financial Considerations - The company intends to complete its initial business combination using cash from its initial public offering and private placement warrants, along with potential debt and other securities[40]. - The company may need additional financing to complete its initial business combination, which could lead to significant dilution for public shareholders[43]. - The anticipated amount in the trust account is initially expected to be $10.00 per public share, which will be used for redemptions upon completion of the initial business combination[67]. - Public shareholders will have the opportunity to redeem their Class A ordinary shares at a per-share price equal to the aggregate amount in the trust account, calculated as of two business days prior to the consummation of the initial business combination[67]. - If the aggregate cash consideration required for redemptions exceeds the cash available, the initial business combination will not be completed, and all shares submitted for redemption will be returned[71]. Shareholder Rights and Redemption - Shareholder approval may be required for the initial business combination under certain conditions, such as significant changes in ownership or control[56]. - The company may conduct redemptions without a shareholder vote, but will seek approval if required by law or stock exchange rules[56]. - If shareholder approval is not required, the company may conduct redemptions through a tender offer, which must remain open for at least 20 business days[77]. - Public shareholders are restricted from seeking redemption rights for Excess Shares without prior consent, limiting the ability of large shareholders to block business combinations[84]. - The per-share redemption amount upon dissolution is expected to be approximately $10.00, but may be less due to creditor claims[95]. Competition and Market Risks - The company may face intense competition from other SPACs and private investors seeking similar business opportunities, which could complicate the acquisition process[19]. - Competition for target businesses includes established entities with greater resources, which may limit the company's ability to acquire larger targets[102]. - The company may face significant competition from other entities for business combination opportunities, which could limit its ability to complete acquisitions[142]. - Ongoing geopolitical conflicts, such as the Russia-Ukraine conflict, may adversely affect the company's search for an initial business combination and the operations of potential target companies[171]. Regulatory and Compliance Issues - Nasdaq rules require that the initial business combination must have an aggregate fair market value of at least 80% of the assets held in the trust account[24]. - The company is required to file periodic reports with the SEC, including annual, quarterly, and current reports[104]. - The company is classified as an "emerging growth company," allowing it to take advantage of certain reporting exemptions[109]. - The company is considered a "controlled company" under Nasdaq standards, which may exempt it from certain corporate governance requirements[114]. - Compliance with new SEC SPAC Rules may increase costs and time needed to complete initial business combinations, potentially constraining the company's operations[159]. Management and Governance - The company cannot assure that key personnel will remain in senior management positions after the business combination[54]. - The company currently has one officer, Orestes Fintiklis, who is not obligated to devote specific hours until the initial business combination is completed[103]. - The company may engage in business combinations with affiliated entities, which could raise potential conflicts of interest[198]. - The company’s directors may choose not to enforce indemnification obligations, potentially reducing funds available for public shareholders[150]. Risks of Business Combination - There is a risk that the target business may not meet the company's general criteria and guidelines, potentially affecting the success of the business combination[185]. - Shareholders may face a reduction in the value of their securities if the business combination does not perform as anticipated[183]. - The company may face claims from third parties if it enters into an insolvent liquidation, which could impact shareholder distributions[178]. - If the initial business combination is unsuccessful, shareholders may have to wait for liquidation to redeem their shares, potentially suffering material losses[125]. Funding and Financial Structure - The net proceeds from the initial public offering and private placement of warrants amount to $220,200,000, which will be used to complete the initial business combination[205]. - The company may incur substantial debt to complete a business combination, which could negatively impact its financial condition and shareholder value[204]. - The company may only be able to complete one business combination, leading to a lack of diversification that could negatively affect operations and profitability[205]. - The company may issue additional Class A ordinary shares or preference shares to complete its initial business combination, which could dilute existing shareholders[189].

Foreign Exchange and Financial Risks - The company reported net foreign exchange gains of $71 million in fiscal year 2025, compared to net losses of $43 million in fiscal year 2024 and gains of $31 million in fiscal year 2023[167]. - The company is exposed to foreign exchange risks due to a significant amount of debt and long-term financial commitments denominated in U.S. dollars[166]. - The company faces potential risks from foreign exchange controls that could restrict its ability to receive funds from operations[168]. - The company may experience delays in cash upstreaming from subsidiaries due to limited liquidity in foreign exchange markets[170]. - As of December 31, 2025, the company's consolidated indebtedness excluding lease liabilities was $6,886 million, with total indebtedness including lease liabilities amounting to $9,472 million[195]. - The company funded acquisitions in Panama and Nicaragua primarily through additional indebtedness, including a $750 million bond issued in March 2019 and a $600 million bond issued in November 2019[197]. Legal and Compliance Issues - A ruling against the company on March 28, 2022, resulted in a $16.2 million penalty primarily related to taxes on incoming international calls and interest expense deductibility[172]. - The company incurred a $60 million fine and forfeited $58.2 million in benefits as part of a Deferred Prosecution Agreement with the U.S. Department of Justice in November 2025[177]. - The company is subject to complex anti-money laundering laws, which could expose it to fines or legal actions if not fully complied with[183]. - The company may lose its foreign private issuer status, which could result in significant additional costs and expenses[237]. - The Company is subject to significant legal, accounting, and compliance costs due to its status as a public company in the United States[228]. Operational and Safety Risks - The company reported a fatality in 2024 among its employees and contractors, highlighting risks associated with health and safety in its operations[190]. - The company’s operations in Nicaragua are affected by international sanctions, which may restrict its business activities[187]. - The company’s operations are significantly impacted by its ability to protect intellectual property rights, which are difficult to enforce in many markets[192]. - The company’s central functions provide essential support to its subsidiaries, and any disruption in these services could adversely affect operations[211]. - The company may face challenges in managing unauthorized access to its services, which could harm relationships with content providers and result in revenue loss[193]. Financial Performance and Revenue - For the year ended December 31, 2025, the company's revenue was $5,819 million and net profit attributable to the owners was $1,316 million[279]. - As of December 31, 2025, the company provided services to 49.3 million mobile customers and 4.6 million customer relationships with fixed services[278]. - Mobile service revenue for 2025 was $3,286 million, an increase of 4% from $3,159 million in 2024[363]. - The average revenue per user (ARPU) for mobile customers increased to $6.3 in 2025 from $6.2 in 2024, reflecting a 1.6% growth[363]. - Fixed and other service revenue accounted for 38% of consolidated service revenue in 2025, down from 40% in 2024[288]. Market Presence and Acquisitions - The company is pursuing an acquisition of 67.5% of Telefónica Colombia, with an expected aggregate investment of approximately $1 billion, subject to various external factors[201]. - The company completed the acquisition of operations in Uruguay and Ecuador in 2025, enhancing its market presence[352]. - The company is expanding its market presence through acquisitions, including the purchase of Otecel, S.A. in Ecuador, which added 5.1 million mobile subscribers[307]. - The company served 3.0 million mobile subscribers in El Salvador, making it the largest mobile service provider in that market[309]. - As of December 31, 2025, the company served 1.1 million mobile subscribers in Uruguay after acquiring Telefónica Móviles de Uruguay S.A.[323]. Organizational Changes and Strategy - The company has implemented significant organizational changes to streamline its structure, with all General Managers reporting directly to the CEO[277]. - The company has redefined its operating segments to align with its countries of operation, including Guatemala, Colombia, Panama, Bolivia, Honduras, Paraguay, and others[277]. - The company recognizes that risk is linked with opportunity and aligns its risk management focus with strategic goals[252]. - The company’s strategy focuses on expanding network reach and capacity, with low penetration rates for mobile and fixed broadband services in its markets[280]. - The company implemented significant organizational changes in 2023 to drive profitable growth and streamline decision-making processes[356]. Shareholder and Market Dynamics - The concentration of voting power held by Xavier Niel may adversely affect the market value of the Company's common shares[241]. - Future sales of common shares may depress the share price and could be dilutive to existing shareholders[227]. - The Company is not required to pay dividends, and its ability to do so may be restricted by existing debt agreements[222]. - The trading price of the Company's common shares has been volatile, influenced by market conditions and operational results[224]. - The Company may adopt share repurchase programs, but there is no assurance that these will be fully executed[223]. Infrastructure and Technology - The company operates a portfolio that includes around 2,000 towers, 12 Tier III data centers, and over 200,000 kilometers of fiber[276]. - The company deployed over 200,000 kilometers of fiber in its markets, enhancing its product portfolio with cloud and security solutions[293]. - The company holds various spectrum licenses across multiple countries, with expiration dates ranging from 2025 to 2047, including significant holdings in Colombia and Ecuador[327][328]. - The company has entered into a mobile network sharing agreement in Colombia, transferring spectrum licenses to joint operations, enhancing operational efficiency[329]. - The company has licenses to provide telecommunication services in Bolivia until 2051, with various spectrum licenses expiring between 2028 and 2031[331]. Cost Management and Economic Factors - Cost-reduction measures, including a broad-based efficiency program, resulted in severance and restructuring costs of approximately $87 million in 2023 and $115 million in 2024[357]. - Changes in macroeconomic factors, such as inflation and foreign currency exchange volatility, continue to impact profitability and service affordability[351]. - Supplier finance arrangements increased significantly from $29 million in 2024 to $163 million in 2025, indicating a shift in working capital management[355].

Financial Performance - Total sales for Q3 FY2026 reached $845.1 million, a 25% increase from $678.2 million in Q3 FY2025[10] - Adjusted EBITDA increased by 26% to $102 million, with adjusted EBITDA margin rising to 12.1% from 12.0% year-over-year[4][6] - Adjusted diluted EPS for Q3 FY2026 was $1.25, a 26% increase compared to $0.99 in the same quarter last year[12] - Operating income for Q3 FY2026 was $65.8 million, compared to $71.1 million in the prior year quarter[26] - Net income for the three months ended February 28, 2026, was $68.0 million, a significant recovery from a net loss of $8.9 million in the same period of 2025[32] - Adjusted net income for the three months ended February 28, 2026, was $49.6 million, compared to $35.4 million in the same period of 2025, reflecting a growth of 40.5%[38] - Adjusted diluted earnings per share for the three months ended February 28, 2026, was $1.25, compared to $0.99 for the same period in 2025, reflecting a significant increase[39] - The company reported a net income margin of 8.0% for the three months ended February 28, 2026, compared to a loss margin of (1.3)% in the same period last year, highlighting a turnaround in profitability[42] Sales Growth - Sales to commercial customers grew by 27%, contributing an additional $130 million, while sales to government customers increased by 19%[10] - The Parts Supply segment experienced a 45% growth, driven by a 36% organic growth in new parts Distribution activities[3] - The company expects total sales growth of 19% to 21% for Q4 FY2026 and approximately 19% for the full year FY2026[17][18] - Organic adjusted sales growth for the three months ended February 28, 2026, was 14.1%, driven by a GAAP sales growth of 24.6%[41] Cash Flow and Debt Management - Cash from operations was $75 million, reducing net leverage to 2.17x, comfortably within the target range of 2.0x to 2.5x[7][16] - Cash flows provided by operating activities were $74.7 million for the three months ended February 28, 2026, compared to a cash outflow of $18.7 million in the same period of 2025[32] - Long-term debt decreased to $888.3 million as of February 28, 2026, down from $968.0 million on May 31, 2025, indicating a reduction of 8.2%[30] - Total debt decreased to $895.0 million as of February 28, 2026, down from $1,032.0 million in the previous year, indicating improved financial stability[43] - Net debt as of February 28, 2026, was $816.5 million, a reduction from $947.6 million in the prior year, reflecting effective debt management[43] - The net debt to adjusted EBITDA ratio improved to 2.17 as of February 28, 2026, compared to previous periods, suggesting enhanced leverage metrics[43] Asset Growth - Total assets increased to $3,332.5 million as of February 28, 2026, up from $2,844.6 million on May 31, 2025, representing a growth of 17.2%[30] - Total current assets rose to $1,763.7 million, compared to $1,510.6 million in the previous year, marking an increase of 16.7%[30] - The company reported a total of $1,643.4 million in equity as of February 28, 2026, an increase from $1,211.6 million in the previous year, representing a growth of 35.6%[30] Operational Efficiency - Adjusted operating income for the three months ended February 28, 2026, was $86.2 million, up from $81.2 million in the previous year, indicating a positive trend in operational efficiency[40] - Adjusted operating margin for the three months ended February 28, 2026, was 10.2%, consistent with the previous quarter, indicating stable operational performance[40] - Operating income for the Integrated Solutions segment was $9.4 million for the three months ended February 28, 2026, slightly down from $9.6 million in the same period of 2025[34] Strategic Developments - The company is on track to close the acquisition of A-R-T in Q4 FY2026, with integration of HAECO Americas progressing ahead of schedule[5] - Recent contracts include a multi-year agreement with the U.S. Air Force worth up to $450 million for repair and new pallet construction[11]

Financial Performance - BioCardia reported a net loss of approximately $8.2 million for the year ended December 31, 2025, compared to a net loss of approximately $7.9 million in 2024[13]. - The company had no revenues in 2025, down from $58,000 in 2024, primarily due to the fulfillment of performance obligations for several business partners[13]. - Cash and cash equivalents at the end of 2025 totaled approximately $2.5 million, compared to $2.4 million at the end of 2024[21]. - Total assets decreased to approximately $3.4 million in 2025 from $3.7 million in 2024, while total stockholders' equity increased to $895,000 from $837,000[21]. Research and Development - Research and development expenses increased to approximately $5.0 million in 2025, up from approximately $4.4 million in 2024, due to activities related to the CardiAMP Heart Failure Trial and regulatory efforts in Japan[13]. - The CardiAMP HF II Trial has begun enrollment at four clinical sites, with positive clinical results presented at a major conference indicating decreased left ventricular remodeling in treated patients[4]. - The company plans to file a Q-Sub request with the FDA for the CardiAMP System's approvability based on safety and efficacy data from three clinical trials[7]. - The Helix™ Biotherapeutic Delivery System received FDA acceptance for a Pre-Submission, with a meeting scheduled for Q2 2026 to discuss its approval[12]. - The company anticipates a formal clinical consultation with Japan's PMDA regarding the CardiAMP System in Q2 2026[19]. Clinical Outcomes - The average increase in exercise tolerance for patients in the CardiAMP study for chronic myocardial ischemia was 107 seconds, with an 82% reduction in angina episodes at the six-month follow-up[5].

Drug Development and Innovation - The company has advanced its first two programs from AI design to IND in approximately two years with a total investment of around $15 million per program, compared to an industry average of 4–6 years at a cost exceeding $50 million[22]. - The Integrated Drug Creation platform allows the company to design antibody-based therapeutics targeting underexplored biological mechanisms, enhancing the precision of therapeutic designs[30]. - The company aims to leverage its Integrated Drug Creation platform to create differentiated therapeutics for both its own pipeline and partners' pipelines[29]. - The company’s lab-in-a-loop approach enables rapid innovation, allowing the transition from AI designs to wet lab-validated product candidates in as little as six weeks[31]. - The company aims to leverage its AI models to evaluate billions of unique protein variants, increasing the probability of finding promising product candidates[49]. - The strategy focuses on advancing programs that address underexplored biological mechanisms in areas of significant unmet medical need[46]. - The company focuses on using its Integrated Drug Creation platform to enhance the speed and success of biologic product discovery and development efforts[94]. Clinical Trials and Product Candidates - The lead product candidate, ABS-201, is being developed for androgenetic alopecia and endometriosis, targeting large populations with significant unmet needs[23]. - ABS-201 is currently in the HEADLINE™ Phase 1/2a clinical trial for androgenetic alopecia, which affects approximately 80 million people in the U.S., with interim proof-of-concept data expected in the second half of 2026[25]. - The company plans to initiate a Phase 2 clinical trial of ABS-201 for endometriosis in Q4 2026, a condition affecting about 10% of women of reproductive age worldwide[25]. - The ABS-201 program for androgenic alopecia has initiated a Phase 1/2a clinical trial, with preliminary safety and tolerability data expected in the first half of 2026[55]. - The Phase 1/2a clinical trial of ABS-201, HEADLINE™, is expected to enroll up to 227 healthy volunteers, with interim safety and tolerability data anticipated in the first half of 2026[71][73]. - ABS-201 is planned for a Phase 2 clinical trial in endometriosis, anticipated to start in Q4 2026, with proof-of-concept data expected in the second half of 2027[80]. Research and Development - The company is advancing five wholly-owned, internally developed programs targeting significant unmet medical needs as of December 31, 2025[53]. - The Origin-1 platform has successfully validated four targets, demonstrating binding, developability, and approximately 100nM functional potency across 5+ assays[39]. - ABS-201 demonstrated significant hair regrowth in a preclinical mouse study, achieving full hair growth after 22 days, while minoxidil achieved only approximately one-third hair growth in the same period[67]. - In a preclinical study with aged stump-tailed macaques, ABS-201 treatment nearly doubled the number of terminal hairs after six months, showing sustainable impact even four years post-treatment[69]. - ABS-201 increased key hair growth factors like IGF1 and FGF7, promoting hair matrix keratinocyte proliferation and protecting hair follicle stem cells[66]. - ABS-201's mechanism of action involves blocking prolactin receptor signaling, which may influence lesion growth and pain perception in endometriosis[76]. Regulatory and Compliance - Regulatory compliance is critical, with extensive regulations governing the research, clinical development, and commercialization of biotherapeutics, requiring substantial time and financial resources[95]. - The process for obtaining marketing approvals in the U.S. involves multiple phases, including preclinical testing, IND submission, and clinical trials[96]. - Human clinical trials are typically conducted in three phases, with Phase 1 focusing on safety, Phase 2 on preliminary efficacy, and Phase 3 on expanded patient populations[106]. - The FDA aims to review standard Biologics License Applications (BLAs) within ten months and priority reviews within six months after acceptance[108]. - Approval of a BLA requires compliance with current good manufacturing practices (cGMPs) and successful completion of all required testing[109]. - The FDA may withdraw product approval if compliance with pre- and post-marketing requirements is not maintained[112]. - Fast track designation allows for expedited review of product candidates intended to treat serious diseases, with a determination made within 60 days of request[113]. - Breakthrough therapy designation provides more intensive FDA interaction and guidance, potentially starting as early as Phase 1[114]. - Priority review aims for FDA action on marketing applications within six months for products showing significant improvement over existing therapies[115]. - Accelerated approval may be granted if a product shows meaningful advantages over existing therapies and meets certain endpoint criteria[116]. - Orphan drug designation is available for products intended to treat rare diseases affecting fewer than 200,000 individuals in the U.S.[119]. - Orphan exclusivity prevents FDA approval of similar products for seven years post-approval, with exceptions for clinical superiority[120]. - Pediatric exclusivity can add six months to existing exclusivity periods if pediatric trials are completed as per FDA requests[123]. - The FDA requires ongoing compliance with regulations post-approval, including record-keeping and reporting of adverse experiences[124]. - The Hatch-Waxman Amendments allow for patent term restoration of up to five years for products lost during development and FDA review[128]. - The approval of a biosimilar product by the FDA may not be made effective until 12 years from the date the reference product was first licensed[130]. Business Model and Partnerships - The business model includes generating internally developed programs and partnering or out-licensing them at various development stages[42]. - The company has a track record of partnerships with leading biopharmaceutical companies, including Merck and AstraZeneca[45]. - The company is positioned to execute on near-term catalysts while building long-term pipeline value through potential partnerships or out-licensing arrangements[24]. Employee and Corporate Culture - As of December 31, 2025, the company had 140 employees, many with advanced post-graduate degrees, primarily in research and development[158]. - The company offers competitive cash compensation, an all-employee equity program, and a wide range of benefits, including a short-term incentive cash bonus program[159]. - The company emphasizes diversity, equity, inclusion, and belonging (DEIB) to drive innovation and address significant unmet medical needs[164]. - The company has established a reporting hotline for ethical concerns and requires all employees to acknowledge the Code of Business Conduct and Ethics annually[162]. - The company provides numerous educational resources and development opportunities, including an annual monetary stipend for continuing education[161]. - The company is committed to promoting employee health, safety, and well-being, with regular safety training and a dedicated Employee Safety Committee[165]. - The company has a paid internship program aimed at providing real-world experience to university or graduate students[161]. - The company holds monthly company-wide meetings and utilizes employee surveys to gauge engagement and refine programs[163]. Financial and Market Considerations - Adequate coverage and reimbursement from governmental healthcare programs and commercial payors are crucial for the acceptance of any product commercialized by the company[144]. - The company is subject to various healthcare regulations that may constrain business operations and relationships with partners and payors[147]. - Legislative changes, such as the Affordable Care Act, have introduced potential competition from lower-cost biosimilars and increased minimum Medicaid rebates[149]. - The Inflation Reduction Act of 2022 allows for negotiation of maximum prices for certain drugs under Medicare, impacting pricing and reimbursement dynamics[150]. - The company must navigate complex pricing and reimbursement environments, both domestically and internationally, which may affect the commercial viability of its products[155]. - Anti-Corruption Laws impose strict regulations on interactions with government officials and healthcare professionals, which the company must comply with to avoid legal repercussions[156]. Company History and Information - The company was originally formed in August 2011 and converted to a Delaware corporation in October 2020[166]. - The company maintains an investor relations website where periodic and current reports are available free of charge[169].

Wine Production and Sales - The Company produced and sold wines under various labels, with Pinot Noir being the flagship varietal priced between $25 to $120 per bottle[20] - The winery produced approximately 158,707 cases (377,333 gallons) of wine in 2025, down from 253,974 cases in 2024[59] - The Company sold approximately 173,014 cases of wine in 2025, a decrease of 13,405 cases, or 7.2%, compared to 186,419 cases in 2024[144] - Total wine case sales decreased by approximately 13,405 cases, or 7.2%, to 173,014 cases in 2025 compared to 186,419 cases in 2024[169] - The Company operates vineyards, wineries, and tasting rooms, focusing on premium wines such as Pinot Noir and Chardonnay[217] Financial Performance - The Company reported a net loss of $917,685 for the year ended December 31, 2025, compared to a net loss of $117,894 for 2024, representing an increase in net loss of $799,791[147] - Net sales revenues decreased by $2,585,320, or 6.5%, to $37,197,122 in 2025 from $39,782,442 in 2024, primarily due to lower direct sales and sales to distributors[149] - The gross profit for 2025 was $22,492,520, down $1,702,936, or 7.0%, from $24,195,456 in 2024, attributed to lower sales revenues[156] - Selling, general and administrative expenses increased by $305,094, or 1.3%, to $23,928,692 in 2025 from $23,623,598 in 2024, mainly due to higher selling costs[158] - The gross margin percentage slightly decreased to 60.5% in 2025 from 60.8% in 2024, reflecting higher discounts offered[157] - The Company had cash balances of $410,886 and a working capital balance of $24.6 million as of December 31, 2025[184] - Total net sales for the year ended December 31, 2025, were $37,197,122, a decrease of 6.6% from $39,782,442 in 2024[209] - The company reported a net loss of $917,685 for 2025, compared to a net loss of $117,894 in 2024, indicating a significant increase in losses[209] Market Trends and Competition - The U.S. wine volume decreased by approximately 2% to 329 million cases, with revenue declining by 1.6% to around $74.3 billion in 2025 compared to 2024[26] - Direct-to-consumer wine shipping volume dropped by 15% year-over-year to 5.4 million cases, with value down 6% to $3.7 billion in 2025[27] - The wine industry is highly competitive, with significant competition from larger California wineries that have greater resources[77] - A reduction in consumer demand for premium wines could harm the Company's business, influenced by economic conditions and health concerns[102] Production Capacity and Facilities - The Company owns and leases approximately 1,018 acres of land, with 801 acres suitable for vineyard planting, aiming to grow approximately 69% of the grapes needed for its production capacity of 654,000 gallons (275,000 cases)[41] - The Company's Estate Winery has a production capacity of up to 275,000 cases (654,000 gallons) of wine per year, with approximately 158,707 cases (377,333 gallons) produced in 2025[118] - The Tualatin Estate Winery adds approximately 28,000 cases (66,000 gallons) of wine production capacity to the Company[119] - The Company has an estimated aggregate production capacity of 720,000 gallons (303,000 cases) per year, providing significant competitive advantages over most Oregon wineries[78] Sales and Distribution - Direct sales accounted for approximately 54.4% of the company's net sales in 2025, compared to 53.4% in 2024[72] - In 2025, sales to distributors and wine brokers contributed approximately 45.6% of the Company's revenue from operations, compared to 46.6% in 2024[73] - Direct-to-consumer sales accounted for 54.4% of total revenue in 2025, up from 53.4% in 2024[170] Employee and Operational Insights - The Company employs approximately 158 full-time and 141 part-time employees as of December 31, 2025[84] - The Company has expanded its culinary offerings, including daily food pairings and community-style wine dinners[69] - The Company operates seven additional tasting rooms across various locations, enhancing its market presence[71] Debt and Financial Obligations - As of December 31, 2025, the Company's outstanding long-term debt was approximately $15.0 million, with $3.1 million drawn under its short-term line of credit[94] - The company incurred an aggregate principal balance of $15,184,395 on four mortgages for its winery facilities as of December 31, 2025[62] - Interest expense increased by $151,542, or 14.9%, to $1,167,722 for the year ended December 31, 2025, primarily due to higher average loan balances[160] Regulatory and Risk Factors - The Company is subject to extensive regulation by various authorities, which could negatively affect its financial condition and operations[104] - The Company faces risks from agricultural factors, including diseases and weather conditions that could adversely affect grape supply and profitability[87] - The Company is subject to a federal alcohol tax of $1.07 per gallon for wines up to 16.0% alcohol content, with higher alcohol wines taxed at $1.57 per gallon[80] - The Company pays a state excise tax of $0.67 per gallon for wines with alcohol content at or below 14.0% and $0.77 per gallon for wines above 14.0% sold in Oregon[81] Shareholder and Stock Information - The Company's common stock is thinly traded, resulting in lower liquidity compared to other investments[106] - The Company may face liabilities associated with the offer and sale of its Preferred Stock, which could impact its financial condition[107] - The Company's ability to pay dividends on its Preferred Stock is contingent upon available funds and may be limited by existing credit facilities[108] - Preferred stock dividends remained constant at $2,252,941 for both 2025 and 2024[209] Other Financial Metrics - The Company had total liabilities of $41,547,424 in 2025, up from $39,783,410 in 2024, marking an increase of 4.4%[206] - Shareholders' equity decreased to $66,188,175 in 2025 from $69,233,730 in 2024, a decline of 4.4%[207] - Total current assets increased to $39,005,575 in 2025 from $36,919,057 in 2024, reflecting a growth of 5.9%[204]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION (Mark One) x 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 Washington, D.C. 20549 FORM 10-K o 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: 000-21522 WILLAMETTE VALLEY VINEYARDS, INC. (Exact name of registrant as specified in its char ...