Financial Position - As of December 31, 2025, the accumulated deficit was $501.5 million, with expectations of continued losses for the foreseeable future[280]. - The company may face challenges in raising additional capital, which could lead to dilution of stockholder interests and impact product development efforts[375]. - Innoviva, the principal stockholder, owns 68.8% of the company’s outstanding shares, which may limit other shareholders' influence and affect stock price[369]. - The company’s stock price has shown volatility, with a range between $0.90 and $16.34 per share from January 1, 2025, to December 31, 2025[372]. Funding and Financial Support - The company received a total of $26.2 million in funding through the MTEC Agreement, with the latest modification extending the term to March 31, 2026[281]. - Changes in U.S. government policies could impact the availability of government funding for grants, which are crucial for the company's operations and could materially harm its business[326]. Regulatory Approval and Compliance - The company is developing antibacterial agents using bacteriophage and synthetic phage technology, which has not yet received regulatory approval from the FDA or equivalent agencies[284]. - The company must demonstrate safety and efficacy through well-controlled clinical trials to obtain FDA approval, a process that is lengthy and uncertain[302]. - Delays in clinical trials could result in increased costs and hinder the ability to obtain regulatory approval for product candidates[293]. - The company has not received FDA approval for any bacteriophage products, which complicates the commercialization process[284]. - Compliance with FDA regulations is complex and costly, with potential sanctions for non-compliance[299]. - The regulatory review process for product candidates is lengthy and may vary significantly based on product complexity[302]. - The FDA has significant discretion in the approval process, which may delay or prevent the approval of product candidates, potentially requiring additional studies that could take several years and require more resources than available[303]. - Regulatory approval processes are expensive and time-consuming, with no assurance that any product candidates will gain approval, which could delay revenue generation and profitability[308]. - Changes in regulatory policies or additional regulations could lead to delays or rejections of applications for regulatory approval[309]. - If regulatory approval is obtained, it may come with limitations on marketing uses, which could adversely affect potential product revenues[310]. - The company relies on third parties for clinical trials and manufacturing, and any failure by these parties could delay development and commercialization of product candidates[311]. - Compliance with healthcare regulatory laws is complex and may expose the company to penalties, including fines and exclusion from government-funded healthcare programs[312]. - The company faces potential liability related to privacy laws concerning health information obtained from clinical trial patients, which could result in significant penalties[314]. - The EU GDPR imposes strict requirements on the processing of personal data, including potential fines of up to 4% of global revenues for violations, which could adversely affect the company[323]. Intellectual Property and Competition - The company emphasizes the importance of obtaining and maintaining patent protection for its technology and product candidates to prevent competitors from commercializing similar products[329]. - The patent application process is costly and time-consuming, and there is a risk that necessary patents may not be filed or prosecuted effectively[331]. - Changes in patent laws and interpretations may diminish the value and enforceability of the company's patents, particularly in foreign jurisdictions[333]. - The company faces significant competition from major pharmaceutical and biotechnology firms, which may develop or commercialize products more successfully[351]. - The company may not be able to protect its intellectual property rights globally, which could allow competitors to exploit its technologies in jurisdictions without patent protection[341]. - There is a high rate of failure in drug discovery and development, which can occur at any stage and may result in substantial financial losses[349]. - The company relies on trade secrets and confidentiality agreements to protect its competitive position, but breaches could harm its business[346]. - Monitoring unauthorized use of intellectual property is challenging, and the effectiveness of protective measures remains uncertain[347]. - Competitors may gain regulatory approval from the FDA or EMA faster, establishing a strong market position before the company can enter the market[352]. - The company faces competition from larger firms with greater financial resources and expertise in R&D, which may intensify due to mergers and acquisitions in the industry[354]. - The company’s commercial opportunity could be diminished if competitors develop safer, more effective, or less expensive products, potentially leading to delays in product approval[356]. Operational Risks - Company operations could be disrupted by failures in information systems or successful cyber-attacks, which could adversely affect business operations and financial condition[382]. - The company has experienced various forms of cyber-attacks, including phishing, but none have resulted in material adverse impacts on business operations or financial condition[382]. - A system failure or security breach could lead to significant delays in regulatory approval efforts and increase costs to recover or reproduce clinical trial data[384]. - The company's information technology operations are spread across multiple platforms, posing operational difficulties in maintaining data integrity[385]. - Any breach of security measures could result in financial, legal, and reputational harm, adversely affecting the company's business position and stock price[386]. - The company is subject to laws and regulations that require measures to protect the privacy and security of information, with potential substantial liability for any breaches[384]. - Delays in receiving regulatory approvals and difficulties in enrolling patients in clinical trials could impact product development timelines[383]. - Constraints in the supply chain may disrupt the ability to conduct clinical trials and develop products[383]. Market Acceptance and Pricing - Market acceptance of the company’s product candidates is uncertain, and failure to achieve adequate acceptance could hinder revenue generation and profitability[361]. - Legislative and regulatory changes in healthcare reform may significantly influence how the company’s products are prescribed, purchased, and reimbursed, adversely affecting operations[362]. - Pricing of pharmaceuticals in the EU is subject to government control, which can delay reimbursement and pricing approval, potentially harming the business[368].

Financial Performance - Net earnings attributable to common shareholders for Q1 2026 were $155.7 million, up 22% from $127.8 million in Q1 2025[2] - Total net revenues for Q1 2026 reached $2.02 billion, a 26.6% increase from $1.59 billion in Q1 2025[2] - Investment banking net revenues were $1.02 billion, reflecting a 45% growth compared to the prior year quarter[8] - Capital markets net revenues increased to $779 million, up 12% from the previous year, with equities net revenues rising 37%[9] - Asset management fees and investment return revenues surged 91% year-over-year to $159 million[10] - Total revenues for the quarter were $2.87 billion, compared to $2.47 billion in the prior year, reflecting a significant growth in various segments[19] Shareholder Returns - The company declared a quarterly cash dividend of $0.40 per share, payable on May 29, 2026[3] - Jefferies repurchased 3.0 million shares for $174 million, averaging $58.18 per share, with a total buyback authorization increased to $250 million[3] - The company repurchased 3.0 million shares of common stock for $174 million, at an average price of $58.18 per share[18] Operational Efficiency - The return on adjusted tangible shareholders' equity was 10.9%, up from 8.0% in the prior year[2] - Compensation and benefits expenses amounted to $1,085,890,000, slightly up from $1,080,779,000, indicating a compensation ratio of 53.8%[13] - Compensation and benefits expense as a percentage of net revenues was 53.8%, compared to 52.8% in the prior year quarter[18] - The compensation ratio, which measures total compensation expense as a percentage of total net revenues, is an important indicator of operational efficiency[27] Taxation - The income tax expense for the period was $52,870,000, resulting in an income tax rate of 24.9%[13] - Effective tax rate from continuing operations was 24.9%, up from 9.4% in the prior year quarter, influenced by the resolution of certain tax matters[18] Asset Management - Total asset management net revenues were $220,262,000, an increase from $186,998,000 in the previous period[13] - The company is winding down its legacy merchant banking portfolio, with the sale of Tessellis expected to close in Q1 2027[6] Financial Position - The company reported total assets of $778,756,000, compared to $914,698,000 in the previous period[13] - Total assets as of February 28, 2026, were $74.38 billion, a slight decrease from $76.01 billion in the previous quarter[20] - Book value (GAAP) increased to $10,610,845 thousand as of February 28, 2026, up from $10,204,228 thousand in 2025, representing a growth of 3.98%[24] - Adjusted tangible book value (non-GAAP) rose to $8,747,132 thousand in 2026, compared to $8,281,261 thousand in 2025, reflecting an increase of 5.64%[24] - Common shares outstanding decreased slightly to 204,423 thousand in 2026 from 206,250 thousand in 2025[24] - The total number of fully diluted shares outstanding (non-GAAP) was 255,468 thousand in 2026, a slight increase from 254,287 thousand in 2025[24] Goodwill and Leverage - The company reported a $35.5 million after-tax write-down of goodwill associated with Tessellis, which was reclassified to assets held for sale during Q1 2026[27] - The leverage ratio, defined as total assets divided by total equity, is a key metric for assessing the company's financial health[27] - The tangible gross leverage ratio, which excludes goodwill and intangible assets, is utilized by rating agencies to evaluate the company's leverage[27] - The company emphasizes the importance of tangible shareholders' equity for valuation purposes, as it is often used by investors to assess financial companies[27] Management Outlook - Management aims to build upon the momentum in core business activities throughout fiscal 2026 and beyond[12]

Revenue Growth - Fourth quarter revenue grew 35% year-over-year to $178 million, with usage revenue at $161 million and subscription revenue at $17 million[1] - Full year revenue reached $702 million, a 31% increase year-over-year, with usage revenue at $640 million and subscription revenue at $62 million[3] - For Q1 FY'27, total revenue is expected to be in the range of $204 - $206 million, representing year-over-year growth of 30% at the midpoint[13] - For FY'27, total revenue is projected to be in the range of $866 - $874 million, indicating year-over-year growth of 24% at the midpoint[13] - Revenue for the three months ended January 31, 2026, was $177,918,000, representing a 34.7% increase from $131,992,000 in the same period of 2025[23] Gross Profit and Operating Income - Gross Booking Volume (GBV) increased 42% year-over-year to $2.3 billion in Q4, while payment volume grew 19% year-over-year to $1.0 billion[3] - Gross profit for the year ended January 31, 2026, was $500,471,000, up from $367,022,000 in 2025, indicating a 36.3% growth[23] - GAAP gross profit for Q1 2026 was $125,787,000, up from $89,244,000 in Q1 2025, representing a 41% increase[30] - Non-GAAP gross profit for Q1 2026 was $127,546,000, compared to $90,360,000 in Q1 2025, reflecting a 41% growth[30] - Non-GAAP income from operations for FY'26 was $37 million, compared to a non-GAAP loss of $25 million in FY'25, resulting in a non-GAAP operating margin of 5%[5] Net Loss and Cash Flow - GAAP net loss for Q4 was $73 million, compared to a net loss of $47 million in Q4 FY'25, while non-GAAP net income was $5 million, compared to a non-GAAP net loss of $33 million in Q4 FY'25[5] - Net loss for the three months ended January 31, 2026, was $72,761,000, compared to a net loss of $46,652,000 in the same period of 2025, showing a 55.8% increase in losses[23] - The company achieved its first full year of positive cash flows from operating activities, reaching $34 million in FY'26[1] - The company reported a net cash provided by operating activities of $34,982,000 for the three months ended January 31, 2026, compared to a net cash used of $8,938,000 in the same period of 2025[28] - Free cash flow for Q1 2026 was $29,736,000, compared to a negative free cash flow of $12,900,000 in Q1 2025[33] Expenses and Liabilities - Total operating expenses for the three months ended January 31, 2026, were $215,277,000, compared to $122,054,000 in 2025, reflecting a 76.4% increase[23] - The company incurred research and development expenses of $35,282,000 for the three months ended January 31, 2026, up from $31,602,000 in 2025, reflecting an increase of 11.8%[23] - The company’s total liabilities decreased to $500,700,000 as of January 31, 2026, from $969,732,000 in 2025, a reduction of 48.3%[25] Shareholder Information - The weighted-average shares outstanding used to compute net loss per share attributable to common stockholders increased to 248,835,778 in 2026 from 45,454,277 in 2025[23] - Weighted-average shares outstanding for GAAP net loss per share in Q1 2026 were 248,835,778, significantly higher than 45,454,277 in Q1 2025[32] - Non-GAAP net income per share for Q1 2026 was $0.02, compared to a loss of $0.73 per share in Q1 2025[32] Product Development and Partnerships - Launched Navan Edge, a hyper-personalized AI travel assistant, and announced plans to integrate Reed & Mackay customers into the Navan platform[5] - Navan continues to expand its enterprise market presence, partnering with companies like Yahoo and Simon-Kucher to modernize travel and expense programs[5]

Trading Volume and Stock Performance - The average daily trading volume of the company's ADSs in 2025 was approximately 80,000, with a high and low bid price of $3.45 and $8.50, respectively, for the fiscal year ended December 31, 2025[258]. - The average daily trading volume in December 2025 was 62,959, compared to 235,289 for the same period in 2024, indicating a significant decline[258]. - The high and low bid price of the company's ADSs for the fiscal year ended December 31, 2024, was $1.21 and $2.12, respectively[258]. - The company’s securities may experience significant price and volume fluctuations, which could adversely affect the market price of its ADSs[258]. Dividend Policy and Profit Allocation - The company intends to retain future earnings to finance business development and does not plan to pay cash dividends in the foreseeable future[251]. - Under French law, the company must allocate 5% of its unconsolidated net profit to a legal reserve fund before paying dividends until the reserve equals 10% of the aggregate nominal value of issued share capital[252]. Regulatory and Compliance Issues - The company became a U.S. Domestic Issuer and a smaller reporting company on January 1, 2026, which will likely result in significant additional costs and expenses[253]. - As a smaller reporting company, the company is not required to include a compensation discussion and analysis section and will provide only two years of audited financial statements[254]. - The company may face increased operational costs and compliance costs due to potential new trade restrictions and regulatory changes related to climate change and geopolitical instability[271][270]. Foreign Exchange and Market Risks - The company is exposed to foreign currency exchange rate risk, particularly between the euro and the U.S. dollar, which could materially affect operating profitability[244]. - Global inflation is expected to adversely affect the company's business, with potential difficulties in raising prices for devices and services amid rising costs[271]. Strategic Developments and Financing - The company plans to issue up to 20 million new shares to fund developments and strategic opportunities, with no shares issued as of December 31, 2025[273]. - The company has outstanding 4,889,380 subscription options as of December 31, 2025, with new resolutions allowing for the issuance of additional shares and options to motivate employees[276]. - The company has requested Tranche A borrowings under the Credit Facility and issued 2,624,421 Tranche A Warrants to EIB, with plans for Tranche B borrowings[275]. Legal and Litigation Risks - The company may face securities class action litigation, which could incur substantial costs and divert management resources[279][280]. Revenue and Market Presence - Net sales in Russia represented approximately 1.0% of consolidated revenues in 2024 and 0.5% in 2025, with no material disruptions impacting financial results due to the closure of the Moscow office[266].

Financial Performance - The company has incurred significant losses since inception and expects to continue incurring losses for the foreseeable future, with no guarantee of achieving profitability[23]. - The company believes its cash and cash equivalents will be sufficient to fund operating expenses into 2029[37]. Product Development - The company plans to complete the preclinical and clinical development of EQ504, with a Phase 1 initiation anticipated in mid-2026 and data expected approximately six months thereafter[30]. - EQ504 targets ulcerative colitis (UC) and other gastrointestinal diseases, with a total addressable market for UC estimated at approximately $12 billion by 2030 in the U.S.[39]. - EQ302, a preclinical-stage product candidate for celiac disease, is ready for IND-enabling studies, with potential for further advancement[27]. - EQ504 is an investigational AhR modulator designed for the treatment of ulcerative colitis (UC) and other gastrointestinal diseases, with a Phase 1 study planned to start in mid-2026[43]. - EQ302 is a first-in-class, orally delivered selective inhibitor of IL-15 and IL-21, showing potential for treating various gastrointestinal diseases, including celiac disease[44][45]. - The company has conducted preclinical development of EQ302, including in vivo pharmacology studies and formulation development, to support a potential IND filing[51]. Acquisitions and Rights - The company acquired exclusive worldwide rights to EQ504 for up to $55 million in regulatory approval milestones[33]. - The acquisition of Bioniz Therapeutics provided exclusive rights to EQ302, with potential payments of up to $57.5 million in regulatory milestones[34]. Intellectual Property - The patent portfolio includes four families related to selective AhR modulators, with patents set to expire between 2037 and 2047[53][57]. - The company aims to protect its intellectual property through patent applications covering compositions of matter and methods of use for its product candidates[52]. - The patent application family for EQ302 includes claims directed to its use in treating various T cell mediated diseases, with patents expected to expire in 2038[61]. - The company recognizes the uncertainty in obtaining patent protection and the potential challenges to its patents by third parties[66]. - The company relies on third-party proprietary technologies for product development, which may require alterations in strategies if patents are issued[67]. - Patent terms generally last 20 years from the filing date, with potential extensions available under specific conditions, such as FDA regulatory review delays[67]. - The company plans to seek patent term extensions for products upon receiving FDA approval, although there is no guarantee of approval for such extensions[67]. Regulatory Environment - The FDA requires a comprehensive process for drug approval, including submission of an IND and completion of clinical studies[77]. - The NDA review process typically takes up to 10 months for standard applications and 6 months for priority reviews, with potential delays due to additional information requests[83]. - Approval from the FDA may come with specific limitations on marketing and may require post-marketing studies to monitor safety and effectiveness[87]. - The company may pursue expedited development and review programs from the FDA to accelerate the approval process for new therapeutic products[88]. - The company is eligible for priority review if the product offers safe and effective therapy where no satisfactory alternative exists, with a six-month FDA review goal compared to ten months under standard review[89]. - Fast track designation allows for expedited development and review, with opportunities for rolling review of NDA sections if agreed upon by the sponsor and FDA[90]. - Breakthrough therapy designation indicates substantial improvement over existing therapies, with eligibility for accelerated approval and expedited FDA actions[91]. - Accelerated approval may be granted based on effects on surrogate endpoints likely to predict clinical benefit, with post-marketing studies required to verify anticipated effects[92]. - The FDA may withdraw approval if regulatory compliance is not maintained, leading to potential revisions in labeling or additional studies[96]. - The company must comply with ongoing FDA regulations regarding quality control, adverse experience reporting, and product promotion post-approval[94]. Market and Competition - The biotechnology and pharmaceutical industries are highly competitive, with significant competition from larger companies that have greater financial resources and expertise[70]. - Coverage and reimbursement from third-party payors are critical for product acceptance, with uncertainty regarding their availability and levels[114]. Compliance and Legal - The Hatch-Waxman Act provides five-year exclusivity for new chemical entities, limiting ANDA submissions during this period[99]. - The company must report price metrics like average sales price and best price to the government, with penalties for inaccurate submissions[110]. - The federal Physician Payments Sunshine Act requires reporting of certain payments to healthcare professionals, with penalties for non-compliance[111]. - Compliance with state laws for drug and biological product distribution is essential, including registration of manufacturers and distributors[112]. - Significant penalties may arise from violations of federal and state healthcare laws, impacting operations and financial results[113]. - The Foreign Corrupt Practices Act mandates compliance with accounting provisions and internal controls for international operations[129]. - Environmental laws govern the handling and disposal of hazardous substances, with potential liabilities for non-compliance[130]. - Economic sanctions enforced by the U.S. Treasury Department may restrict activities with embargoed countries and entities[131]. - Compliance with numerous federal, state, and local laws may incur significant costs for the company[132]. Company Overview - As of December 31, 2025, the company employed 14 employees, with 13 being full-time engaged in various activities including research and development[133]. - The company was incorporated in March 2017 and changed its name to Equillium, Inc. in May 2017[134]. - The principal executive offices are located in La Jolla, CA, and the company has three wholly-owned subsidiaries[134]. - The company qualifies as a "smaller reporting company" under the Exchange Act and has opted for scaled disclosures available to such companies[135]. - All brand names or trademarks mentioned in the report are the property of their respective holders, with no implied endorsements[136]. - Quantitative and qualitative disclosures about market risk are not required for smaller reporting companies[499].

Exhibit 99.1 GCT Semiconductor Holding, Inc. Provides Business Update and Reports Fourth Quarter and Full Year 2025 Financial Results Commercial Shipments of 5G Chipsets Exceeded 1,900 Units in Q4, Reflecting Continued Progress Toward Volume Production Ramp Company Expects Sequential Quarterly Growth in Revenue and 5G Chipset Shipments Throughout 2026 SAN JOSE, CA – March 25, 2026 – GCT Semiconductor Holding, Inc. ("GCT" or the "Company") (NYSE: GCTS), a leading designer and supplier of advanced 5G and 4G s ...

Revenue Performance - Total revenue for Q4 2025 was $0.8 million, a 57.5% decrease from $1.8 million in Q4 2024, while total operating expenses increased by 35.0% to $10.7 million[9] - Total net revenues for the year ended December 31, 2025, were $2.866 billion, a decrease from $9.128 billion in 2024[21] - The net loss for 2025 was $43.372 billion, compared to a net loss of $12.379 billion in 2024[21] - Basic and diluted net loss per common share for 2025 was $0.82, up from $0.30 in 2024[21] Operating Expenses - Total operating expenses increased significantly to $34.723 billion in 2025 from $18.198 billion in 2024[21] - Research and development expenses were $14.005 billion in 2025, down from $17.329 billion in 2024[21] - Sales and marketing expenses rose to $4.243 billion in 2025, compared to $3.920 billion in 2024[21] - General and administrative expenses increased to $16.475 billion in 2025 from $10.798 billion in 2024[21] Financial Position - Total liabilities increased to $98.9 million in 2025, up from $79.2 million in 2024, while stockholders' deficit grew to $83.3 million from $59.3 million[19] - GCT entered into a $20 million convertible note financing facility to support working capital and strategic growth initiatives, with an initial advance of $1 million[4] 5G Chipset Developments - GCT Semiconductor shipped over 1,900 5G chipsets in Q4 2025, marking a significant step towards increased production capacity and revenue growth in 2026[3] - The company expects sequential quarterly growth in both revenue and 5G chipset shipments throughout 2026, driven by increased demand and production readiness[11] - GCT secured a licensing agreement with a major satellite communications provider, enabling new capabilities for global connectivity and paving the way for 5G product shipments expected in H2 2026[4] - GCT's first network operator, Gogo, successfully launched a broadband air-to-ground service using GCT's 5G chipset, marking a key milestone in its commercialization efforts[4] Operational Outlook - GCT's gross margin for Q4 2025 is currently negative, reflecting lower product revenue insufficient to cover production overhead costs, but operational efficiencies are expected to improve as 5G sales ramp up[9] - The company anticipates that Q3 2025 marked the bottom of its revenue cycle due to the transition to 5G, with expectations for recovery starting in 2026[5] - The company is focused on scaling operations and maintaining financial flexibility to convert its growing 5G pipeline into tangible revenue[5]

Financial Performance - Full-year revenue for 2025 increased by 10% to $56.7 million, with Q4 revenue rising 27% year-over-year to $15.6 million[1][6] - Full-year Adjusted EBITDA reached $2.9 million, a 209% increase from $0.9 million in 2024; Q4 Adjusted EBITDA was $1.7 million compared to a loss of $0.5 million in Q4 2024[1][9] - The net loss for 2025 decreased to $3.1 million from $12.6 million in 2024, reflecting improved operational performance[7][6] - Revenues for 2025 reached $56.7 million, an increase of 9.8% from $51.7 million in 2024[27] - Adjusted EBITDA for 2025 was $2.9 million, compared to $922,613 in 2024, indicating a substantial increase in operational performance[32] - The company reported a basic loss per share of $0.27 in 2025, an improvement from a loss of $1.22 per share in 2024[27] Expenses and Liabilities - Operating expenses for 2025 were $56.7 million, down from $62.2 million in 2024, with non-cash expenses remaining consistent at $2.4 million[5][4] - Total expenses decreased to $56.7 million in 2025 from $62.2 million in 2024, reflecting a reduction of 8.7%[27] - Total liabilities increased to $48.6 million in 2025 from $46.8 million in 2024, representing a rise of 3.9%[25] - Stockholders' equity decreased to $9.7 million in 2025 from $11.6 million in 2024, a decline of 16.8%[25] - Payroll and benefits expenses rose to $41.9 million in 2025, up from $38.1 million in 2024, an increase of 7.3%[27] - Acquisition costs increased to $416,171 in 2025 from $164,044 in 2024, reflecting a rise of 154.3%[27] Future Outlook - The company anticipates continued revenue growth and significant Adjusted EBITDA margin expansion in 2026, supported by strategic partnerships and AI capabilities[2][6] - Expected annual savings of approximately $2.2 million from bank debt maturity and $1 million from lease terminations will enhance operational leverage and free cash flow[3][6] - Dolphin's infrastructure and team are positioned to support a larger revenue base, allowing incremental revenue to flow disproportionately to the bottom line[2][6] Strategic Initiatives - The company has unveiled a new division, Dolphin Intelligence, to enhance AI-driven marketing strategies for partners[11] - Dolphin's strategic partnership with DealMaker is expected to unlock community capital for celebrity and influencer brands, serving as a growth catalyst[11] - The company celebrated significant achievements, including Oscar wins and multiple nominations for clients at major award events, enhancing its market visibility[11] Other Notable Events - The company reported a gain of $756,574 from the sale of Always Alpha Sports Management LLC in 2025[27]

Financial Performance - Total revenue for 2025 decreased to $3.09 million from $3.50 million in 2024, primarily due to a $638,000 reduction in research and development revenue[20] - Grant revenue increased to $1.86 million in 2025, compared to none in 2024, partially offsetting the decline in total revenue[20] - Loss from operations increased to $7.19 million in 2025, compared to $5.90 million in 2024, primarily due to lower license and milestone revenue[23] - Net loss for 2025 was $7.36 million or $(0.23) per share, compared to a net loss of $5.81 million or $(0.20) per share in 2024[23] Cash and Assets - Cash position as of December 31, 2025, was approximately $8.59 million, down from $9.29 million as of December 31, 2024[18] - Total current assets increased slightly to $9,896,653 from $9,827,668, reflecting a growth of 0.7% year-over-year[33] - The company reported a total asset value of $9,945,725, a slight increase from $9,930,275, reflecting a growth of 0.2%[33] Liabilities and Equity - Total liabilities rose to $8,713,315, up from $7,459,985, representing an increase of 16.8%[33] - Current liabilities increased substantially to $3,687,271 from $2,448,017, marking a growth of 50.7%[33] - The accumulated deficit widened to $(93,451,108) from $(86,086,480), reflecting a decrease in retained earnings[33] - Total stockholders' equity decreased to $1,232,410 from $2,470,290, a decline of 50%[33] - Additional paid-in capital rose to $113,564,991 from $107,444,595, an increase of 5.2%[33] - Convertible notes, net of issuance costs, decreased to $2,962,304 from $3,911,471, a reduction of 24.2%[33] Business Development - Dyadic launched AlbuFree™ DX recombinant human albumin in February 2026, with profit-sharing from sales[5] - Dyadic entered into an OEM distribution agreement with IBT Bioservices to commercialize recombinant DNase I and transferrin[6] - A development and commercialization agreement was signed with BRIG Bio to produce animal-free bovine alpha-lactalbumin for global nutrition markets[8] - The company anticipates expanding its pipeline of non-animal dairy proteins and related enzyme applications[9] - Dyadic is participating in a $4.5 million CEPI-funded program to advance recombinant vaccine development using its C1 platform[14] Accounts Receivable - Accounts receivable surged to $1,090,297, a significant increase from $237,027, indicating a growth of 359%[33] Shares - The number of outstanding shares increased to 36,187,798 from 29,835,799, representing a growth of 21%[33]

Business Transition and Strategy - Dyadic International, Inc. is transitioning to Dyadic Applied BioSolutions, focusing on commercial biotechnology solutions through its Dapibus™ and C1 gene expression platforms[32]. - The company is transitioning to a commercially focused enterprise, emphasizing applied biotechnology solutions through C1 and Dapibus™ technologies[109]. - Dyadic's strategic collaborations are aimed at expanding its product pipeline and enhancing its capabilities in both pharmaceutical and non-pharmaceutical markets[66]. - The company is pursuing commercialization of recombinant transferrin and fibroblast growth factor (FGF) for cell culture media and diagnostics[51][52]. - The company plans to pursue acquisitions, investments, and strategic alliances, but these efforts may require significant resources and could lead to unforeseen liabilities[147]. Product Development and Platforms - The Dapibus™ platform enables the production of high-value, non-animal proteins and enzymes, targeting life sciences, food and nutrition, and bio-industrial markets[38]. - Dyadic has commercialized AlbuFree™ DX recombinant human albumin and recombinant DNase I, generating revenue through partner collaborations and internal production[32]. - Dyadic's C1 platform is designed for cost-effective, large-scale production of proteins, with applications in vaccines, monoclonal antibodies, and diagnostics[42]. - Dyadic's C1 platform has demonstrated the ability to produce complex glycoproteins and monoclonal antibodies with comparable properties to traditional systems, supporting future pharmaceutical licensing opportunities[71]. - The company has developed high-yield production strains for various proteins, including human and bovine serum albumin and vaccine antigens, demonstrating significant advancements in biopharmaceutical capabilities[80]. Financial Performance and Market Potential - Dyadic's total addressable market is estimated to exceed $25 billion across life sciences, food and nutrition, and bio-industrial segments, with specific markets including $5 billion for cell culture media and $11 billion for food and nutrition[81][87]. - The company had an accumulated deficit of approximately $93.5 million as of December 31, 2025[115]. - For the years ended December 31, 2025 and 2024, the company generated revenue from 14 and 19 customers, respectively, with two significant customers accounting for approximately $1,859,000 or 60.1% and $1,915,000 or 54.8% of revenue[114]. - The company anticipates substantial future capital requirements to further develop its microbial protein production platforms and proprietary technologies[129]. Regulatory and Compliance Challenges - The company has no prior experience submitting applications to the FDA, which may hinder obtaining regulatory approval for products developed using the C1 platform[177]. - Compliance with FDA and EPA regulations may lead to increased expenses and delays in product development, potentially affecting commercialization[163]. - Regulatory compliance failures could result in significant fines, product recalls, or delays in product approvals, adversely impacting the company's reputation and financial results[180]. - The market for developing pharmaceutical proteins from filamentous fungi is not yet established and faces regulatory hurdles[111]. Risks and Uncertainties - The company faces significant competition in the biotechnology sector, with competitors having greater capital resources and R&D capabilities, which may hinder the company's ability to develop technologies and products effectively[126]. - The company may face challenges in managing growth, including balancing cash burn with technology and product development[118]. - The company is exposed to adverse market conditions, including high-interest rates and inflation, which could negatively impact its operations and financial condition[131]. - The company may face challenges in raising additional capital due to unfavorable market conditions, which could limit its ability to fund operations and execute its business strategy[133]. Intellectual Property and Market Position - Dyadic has a total of six patent families, with two patents and four pending applications in the United States, indicating a strong focus on intellectual property protection[102]. - The patent positions of biotechnology companies are uncertain, and failure to protect intellectual property could harm the company's competitive advantage[181]. - The company faces risks related to intellectual property infringement claims, which could lead to significant costs and delays in product commercialization[186]. Corporate Governance and Structure - As of December 31, 2025, Dyadic had 5 full-time employees, all located in the United States, reflecting a lean operational structure[100]. - The company has approximately 36,187,798 shares of common stock outstanding as of December 31, 2025, with about 24.2% controlled by executive officers, directors, and principal stockholders[203]. - The concentration of ownership among existing officers and directors may limit other stockholders' influence on corporate decisions[197]. Cybersecurity and Operational Risks - The company has not experienced any material cybersecurity incidents to date, although it acknowledges the potential risks associated with cybersecurity threats[216]. - The company's board of directors oversees cybersecurity risk management, with regular updates from senior management on cybersecurity matters[217]. - The company relies heavily on information technology, and any cybersecurity incidents could disrupt operations and lead to significant costs for recovery[149]. Market Perception and Stock Performance - The trading price of the company's common stock is likely to be volatile, influenced by factors such as public perception of biotechnology companies and announcements of new technologies or products[189]. - The company does not expect to pay cash dividends in the foreseeable future, which may affect the perceived value of its stock[194]. - The company received a deficiency notice from Nasdaq on December 19, 2025, indicating that its common stock did not maintain a minimum bid price of $1.00 for 30 consecutive trading days[208].