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 CALIDI BIOTHERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware 86-2967193 (State or other jurisdiction of (I.R.S. Employer incorporation or organization) Identification Number) 4475 Executive Drive, Suite 200, San Diego, California 92121 (Address of principal executiv ...

(Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15 OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2025 OR UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (State or other jurisdiction of incorporation or organization) New York 11-3474831 (I.R.S. Employer Identification No.) 60 Cutter Mill Road, Suite 205, Great Neck, NY 11021 (Address of Principal Executive Office) (Zip Code) (516) 444-3400 (Registrant's telephone number, including area co ...

Company Classification and Stock Information - The company is classified as a "smaller reporting company," which subjects it to reduced disclosure requirements, potentially making its common stock less attractive to investors [298]. - As of March 27, 2026, the company has 60,759,711 shares of common stock issued and outstanding, with an authorization to issue up to 200,000,000 shares [308]. - The company has no plans to pay dividends on its common stock for the foreseeable future, intending to retain earnings for operations and growth [313]. Financial Performance and Risks - The company has incurred losses in each year since its inception and will require significant additional financing to continue operations, which may involve dilution of existing shareholders [309]. - The company has previously failed to comply with Nasdaq continued listing requirements and may face delisting if it cannot maintain compliance [302]. - A delisting from Nasdaq could materially affect the liquidity and market price of the common stock, reducing visibility and credibility in capital markets [304]. - The common stock price is subject to rapid and substantial volatility, which may not correlate with the company's actual operating performance [305]. Cybersecurity and Operational Risks - The company plans to develop and implement information security policies and incident response plans to handle material risks associated with cybersecurity threats [300]. - Cybersecurity-related attacks could damage the company's reputation and adversely affect its business and financial results [299]. - The market for "penny stocks" has suffered from patterns of fraud and abuse, which the company aims to mitigate within practical limitations [317].

Product Development and Regulatory Approvals - Company is focused on developing therapies for unmet medical needs, including HT-001 for cancer treatment side effects, HT-KIT for mast-cell derived cancers, and HT-ALZ for Alzheimer's disease[26] - HT-001 received FDA approval for a Phase 2a clinical trial in December 2022, with positive interim results reported[27] - HT-KIT has received Orphan Drug Designation from the FDA for mastocytosis treatment and is currently preparing for IND submission[32] - A patent for HT-ALZ was granted in November 2024, with plans to develop it under the FDA's Section 505(b)(2) regulatory pathway[33][34] - The BioLexa Platform, licensed from the University of Cincinnati, is aimed at treating eczema and is in Phase 1b clinical trials[36][37] - HT-004 is under investigation for asthma and allergies, with preclinical proof-of-concept data supporting its efficacy[38][39] - HT-VA, licensed from the Department of Veterans Affairs, is being developed for obesity treatment, with positive initial results from preclinical studies[40][41] - The FDA announced a policy shift to a "one-trial requirement" for marketing authorization of novel product candidates, moving from the historical requirement of two pivotal clinical trials[55] - The FDA's goal for completing substantive reviews of standard NDAs is ten months from receipt, although this timeline may be extended due to requests for additional information[62] - The submission of an NDA or BLA is subject to a substantial user fee, with potential waivers under limited circumstances[61] - Five years of marketing exclusivity may be granted for drugs approved under a 505(b)(1) or 505(b)(2) application containing a new active moiety[70] - Pediatric exclusivity can provide an additional six months of marketing exclusivity if clinical trials in children are conducted in response to an FDA request[71] - The FDA may require Phase 4 clinical trials to further assess drug safety and effectiveness post-approval[65] - The FDA will conduct pre-approval inspections of manufacturing facilities to ensure compliance with current good manufacturing practices (cGMP)[64] - A 505(b)(2) application allows reliance on data not developed by the applicant, potentially expediting the approval process[66] - The FDA may audit clinical trial data to ensure compliance with good clinical practice (GCP) requirements before approving an NDA[64] - The issuance of a non-compliance letter may occur if a sponsor fails to submit required pediatric assessments under the Pediatric Research Equity Act (PREA)[60] - The FDA marketing approval process is lengthy, costly, and uncertain, with no product candidates currently having gained marketing authorization[96] - Regulatory agencies may require extensive data and additional clinical trials, which can delay the approval process[100] - The company has not submitted any NDA applications to the FDA or comparable applications to other regulatory authorities[111] - Regulatory approval is uncertain and may be impacted by changes in policies or additional requirements from regulatory authorities[116] - The company may need to conduct additional research and development activities if required data for approval is insufficient[117] - Failure to obtain regulatory approval will materially impair the company's ability to generate revenue from product candidates[114] - The company faces risks related to the design and implementation of clinical trials, which may not meet regulatory standards[112] - The outcome of pre-clinical studies and early clinical trials may not predict later success, leading to potential delays or failures in obtaining approval[107] - The company may face delays in obtaining regulatory approvals due to potential changes in approval policies or the need for additional clinical data[118] - The FDA may require a Paragraph IV Certification for 505(b)(2) applications, which could lead to a patent infringement action and a stay of up to 30 months[119] - The company has received orphan drug designation from the FDA for HT-KIT for the treatment of mastocytosis, which may provide financial incentives but does not guarantee regulatory exclusivity[122] - Orphan drug exclusivity may last for seven years if the product receives FDA approval, but this exclusivity can be challenged or lost under certain conditions[125] Financial Performance and Capital Needs - The company reported net losses of $12.5 million and $8.2 million for the years ended December 31, 2025 and 2024, respectively, with an accumulated deficit of $72.9 million as of December 31, 2025[88] - The company has generated no revenue from commercial sales to date, and future profitability remains uncertain[88] - The company may need to raise substantial additional capital to fund operations and product development, with no assurance that future revenues will be sufficient[89] - The company has incurred recurring losses and negative cash flows, leading to substantial doubt about its ability to continue as a going concern[94] - The company is dependent on the clinical success of its licensed products and technologies, with no current revenues from product candidates[95] - The commercial success of products is heavily dependent on third-party reimbursement, which is uncertain and may be limited by cost containment efforts from payors[150] - Legislative changes, such as the Medicare Modernization Act and the Health Care Reform Law, could restrict pricing and reimbursement, adversely impacting profitability[152][153] - The company anticipates needing significant additional capital for operations, which may lead to dilution of existing shareholders if equity securities are issued[224] - The company does not intend to pay cash dividends on its common stock, limiting returns to shareholders to potential increases in share price[225] - The global credit and financial markets have experienced extreme volatility, which may adversely impact the company's financial condition and stock price[221] Manufacturing and Supply Chain Risks - Company relies on contract manufacturing organizations for production, as it currently lacks manufacturing capabilities[45] - The company relies on third-party manufacturers for clinical supplies, which exposes it to risks that could delay clinical trials and commercialization[138] - The company does not have the infrastructure to manufacture its clinical supplies internally and relies on third-party vendors, which could lead to production delays[138] - The company currently relies on foreign CROs and CDMOs, including WuXi, for the manufacturing of HT-KIT, which may increase costs and affect supply due to potential U.S. legislation and trade restrictions[142] - There is a risk of supply shortages or increased manufacturing costs if the CMO fails to meet specifications or scale production adequately[178] - The company may face delays or increased costs in the development of product candidates if there is a change in Contract Manufacturing Organizations (CMOs) due to the need for re-validation of manufacturing processes[177] Regulatory Compliance and Legal Risks - The company is subject to healthcare regulations that may affect its ability to operate, including anti-kickback and false claims laws[81] - Regulatory compliance is critical; failure to meet FDA regulations could result in enforcement actions, affecting product sales and profitability[146] - Non-compliance with healthcare regulations could result in substantial penalties and adversely affect business operations and financial condition[167] - The company may need to conduct costly post-market testing and comply with adverse event reporting requirements, which could lead to additional regulatory scrutiny[149] - The company faces risks related to third-party manufacturers, including potential inability to meet clinical and commercial needs, which could negatively impact the development of HT-KIT[144] Market and Competitive Landscape - The biopharmaceutical industry is characterized by intense competition, with larger companies having greater resources and expertise[44] - The company faces significant competition from larger pharmaceutical companies and institutions, which may have greater financial resources and development capabilities[164] - Factors affecting market acceptance include physician willingness to prescribe, efficacy compared to competitors, pricing, and reimbursement coverage[165] - There is a risk that proposed product candidates may not achieve acceptance from patients, healthcare providers, and insurance companies, affecting commercialization efforts[159] - Even with regulatory approval, the commercial success of product candidates depends on acceptance by the medical community, which is influenced by clinical safety, efficacy, and convenience[161] - If product candidates do not achieve adequate acceptance, the company may not generate sufficient revenue or sustain profitability, requiring significant resources for education efforts[162] Cybersecurity and IT Risks - Cybersecurity threats pose significant risks to the company's operations, potentially leading to data breaches and increased operational costs[189] - The company is enhancing its cybersecurity measures to mitigate risks, but vulnerabilities remain that could adversely affect its financial condition[190] - The company is increasingly dependent on complex information technology systems, which may expose it to vulnerabilities such as IT system breakdowns and data security breaches[212] - Significant disruptions to information technology systems could adversely affect product production and key business processes, potentially leading to legal proceedings and damage to the company's reputation[215] - Data security breaches could lead to the loss of sensitive information and result in demands for ransom or other forms of blackmail[213] - The company is subject to frequent cyberattacks, which may affect its systems and operations, especially given its global presence[213] Intellectual Property and Licensing - The company holds licenses to five U.S. patents and has multiple pending patent applications in various jurisdictions[50] - The company relies on licenses from various licensors for its product candidates, and any failure by these licensors to defend their intellectual property could harm the business[194] - The company emphasizes obtaining patent and trade secret protection for new technologies, but the future protection of proprietary rights remains uncertain[195] - Patent positions in the industry are complex and uncertain, which may hinder the company's ability to enforce its patents or secure new ones[196] - The company has applied for patents for certain products, but there is no guarantee that these applications will result in issued patents or provide adequate protection from competition[197] - The cost of enforcing patent rights against infringers could be significant, potentially diverting resources from normal operations[198] - The company relies on trade secrets and confidentiality agreements to protect proprietary information, but breaches could lead to competitive disadvantages[202] Operational Challenges and Human Resources - The company employs a total of 6 individuals, including 2 full-time employees, as of March 26, 2025[83] - The company may face challenges in hiring and retaining key employees, which could adversely affect its operations and growth[206] - The company may face challenges in attracting new customers and securing necessary resources for clinical trials, impacting its growth strategy[218] Strategic Growth and Acquisitions - The company formed a new subsidiary, merveille.ai, on October 4, 2023, expanding its operational footprint[84] - The company plans to expand its business through acquisitions, which may involve substantial cash expenditures and risks of dilution for current shareholders[203] - Future acquisitions may divert management's attention and could result in dilution to shareholders, as well as challenges in integrating acquired businesses[219]

Financial Performance - For the year ended December 31, 2025, net income was $9,022,000, an increase of $1,078,000 from $7,944,000 in 2024, resulting in earnings per share of $1.99 compared to $1.75 in 2024 [244]. - Net interest income rose to $32,807,000 in 2025, up from $29,236,000 in 2024, reflecting a growth of $3,571,000 or 12.2% [245]. - Noninterest income increased to $15,852,000 in 2025, compared to $15,137,000 in 2024, indicating a growth of 4.7% [244]. - The efficiency ratio improved to 77.17% in 2025 from 79.11% in 2024, reflecting revenue growth of 9.7% outpacing expense growth of 7.0% [246]. - Return on average equity for 2025 was 12.68%, slightly down from 12.70% in 2024, despite a 23.4% increase in stockholders' equity [247]. Asset and Loan Growth - Total assets as of December 31, 2025, were $1,039,024,000, an increase of $59,780,000 or 6.10% from $979,244,000 at the end of 2024 [236]. - Net loans increased to $661,357,000 as of December 31, 2025, from $636,552,000 in 2024 [236]. - Total loans increased to $661,357,000 on December 31, 2025, from $636,552,000 in 2024, representing a growth of 3.9% [276]. - The Mortgage Division originated 659 mortgage loans totaling approximately $199,563,000 in 2025, an increase from 633 loans totaling $190,669,000 in 2024, reflecting a growth of 4.1% in loan volume [263]. Interest Income and Margin - Interest income increased to $46,655,000 for the year ended December 31, 2025, from $44,643,000 in 2024, driven by a 3.14% growth in average earning assets [251]. - The net interest margin improved by 28 basis points to 3.39% in 2025, compared to 3.11% in 2024 [236]. - The average rate on earning assets increased modestly by 7 basis points from 4.75% in 2024 to 4.82% in 2025 [253]. Credit Losses and Allowances - The allowance for credit losses is based on management's estimates of lifetime expected losses in the loan portfolio [241]. - The provision for credit losses was a net recovery of $35,000 for the year ended December 31, 2025, down from a net recovery of $655,000 in 2024, a decrease of $620,000 [248]. - The allowance for credit losses as a percentage of total loans was 0.97% at December 31, 2025, compared to 1.09% at December 31, 2024 [249]. - The allowance for credit losses decreased by 8.4% from $7,044,000 in 2024 to $6,450,000 in 2025, representing 0.97% of total loans outstanding [333]. Deposits and Liquidity - Total deposits increased by 6.2%, from $882,404,000 at December 31, 2024, to $937,129,000 at December 31, 2025, representing growth of $54,725,000 [282]. - Cash and cash equivalents increased from $73,309,000 on December 31, 2024, to $84,475,000 on December 31, 2025 [287]. - Liquid assets totaled $298,603,000 at December 31, 2025, compared to $261,225,000 at December 31, 2024, reflecting an increase in liquidity [307]. Capital and Ratios - Stockholders' equity rose by $15,183,000 or 23.4%, reaching $80,048,000 as of December 31, 2025, primarily due to a record net income of $9,022,000 [327]. - The total risk-based capital ratio was 12.54% in 2025, compared to 12.84% in 2024, remaining above the regulatory benchmark of 10.5% [323]. - The Bank's capital ratios exceeded the minimum requirements for well-capitalized institutions, indicating a strong capital position [321]. Noninterest Income and Expenses - Noninterest expense rose to $37,549,000 in 2025 from $35,105,000 in 2024, driven by increases in salaries, employee benefits, and professional expenses [271]. - Noninterest income, excluding securities gains and losses, consists of income from mortgage originations, service fees, and wealth management fees, which are critical for profitability [261]. Market and Economic Conditions - The Federal Reserve's target rate was reduced to a range of 3.50% to 3.75% as of December 31, 2025, following a series of rate cuts [238]. - Management monitors interest rate levels daily and meets quarterly with the board to assess the impact on earnings and liquidity [351]. Miscellaneous - The acquisition of Pettyjohn, Wood & White, Inc. was completed for a total consideration of $10.5 million, enhancing the company's asset management capabilities [299]. - The bank has no current plans to open additional branches but may consider expansion based on market conditions and strategic priorities [362].

Financial Position - The company has approximately $220 million from its initial public offering to pursue its initial business combination [363]. - As of December 31, 2025, the company reported approximately $92,000 in cash and cash equivalents and $1,471,000 in negative working capital [366]. - The Company had cash and cash equivalents of approximately $92,000 and working capital of approximately $1,471,000 as of December 31, 2025 [395]. - The net proceeds from the initial public offering were approximately $222,500,000, with $221,100,000 deposited in the trust account [391]. - The Company drew down $250,000 under a working capital loan in November 2025, with an additional $290,000 drawn in January 2026 [397]. - The Company has concluded that conditions raise substantial doubt about its ability to continue as a going concern within one year after the financial statements are issued [395]. Business Combination - A business combination agreement was entered into on September 8, 2025, involving CoinShares and SPAC Merger Sub [367]. - Each SPAC Class A Share will be converted into one Holdco Ordinary Share as part of the merger [371]. - The acquisition of CoinShares will be valued at $1.2 billion, with the equity value per share determined by the number of fully diluted CoinShares equity securities [371]. - The business combination is subject to customary conditions, including shareholder approvals and regulatory approvals [376]. - The business combination agreement allows for termination if the transactions are not consummated by June 8, 2026 [380]. - The Company intends to use substantially all funds in the trust account to complete its initial business combination [392]. - The company intends to target businesses with enterprise values greater than what can be acquired with the net proceeds from the initial public offering and private placement warrants [398]. Costs and Expenses - The company expects to incur significant costs in pursuing its acquisition and financing plans [366]. - The operating costs for the year ended December 31, 2025, were approximately $449,000, with significant costs incurred for professional fees and executive compensation totaling around $1,308,000 [389]. - The company has incurred and expects to continue to incur increased expenses due to being a public company, including legal and compliance costs [389]. - The company will compensate its CEO and CFO $33,000 per month prior to the initial business combination, with $16,500 payable currently and the remainder upon completion [401]. - The company has agreed to pay its Executive Director $33,000 per month prior to the initial business combination, all payable upon completion [401]. Financing and Capital Needs - The Company expects to incur significant costs in pursuit of its financing and acquisition plans, indicating a need for additional working capital [395]. - The company may need to seek additional financing if the cash portion of the purchase price exceeds the amount available from the trust account after redemptions by public shareholders [398]. - If the company cannot complete its initial business combination due to insufficient funds, it will be forced to cease operations and liquidate the trust account [399]. - The company may need additional financing to meet obligations following the initial business combination if cash on hand is insufficient [399]. - There is no limitation on the company's ability to raise funds through equity or debt in connection with its initial business combination [398]. - The company may incur significant dilution for public shareholders if additional funds are raised through equity or convertible debt issuances [398]. Operations and Accounting - As of December 31, 2025, the company had not commenced operations and all activities related to its formation and initial public offering [388]. - Management does not believe the company has any critical accounting estimates as of December 31, 2025 [402]. - As of December 31, 2025, the company had no long-term debt, capital lease obligations, operating lease obligations, or long-term liabilities, except for an Administrative Support Agreement costing $10,000 per month [400].

Financial Position - The company has approximately $220 million from its initial public offering to pursue its initial business combination [363]. - As of December 31, 2025, the company reported approximately $92,000 in cash and cash equivalents and $1,471,000 in negative working capital [366]. - The Company raised approximately $222,500,000 from its initial public offering, with $221,100,000 deposited in the trust account [391]. - As of December 31, 2025, the Company had cash and cash equivalents of approximately $92,000 and working capital of approximately $1,471,000 [395]. - The Company has incurred significant costs in pursuit of financing and acquisition plans, indicating a need for additional working capital [395]. - The Sponsor made a working capital loan of $290,000 in January 2026, following a $250,000 drawdown in November 2025 [397]. - As of December 31, 2025, the company had no long-term debt or long-term liabilities, except for an Administrative Support Agreement costing $10,000 per month [400]. Business Combination - A business combination agreement was entered into on September 8, 2025, involving CoinShares and SPAC Merger Sub [367]. - Each SPAC Class A Share will be converted into one Holdco Ordinary Share as part of the merger [371]. - The acquisition of CoinShares will be valued at $1.2 billion, with the equity value per share determined by the number of fully diluted CoinShares equity securities [371]. - The business combination is subject to shareholder approvals from both SPAC and CoinShares [376]. - The obligations to consummate the transactions are contingent upon various regulatory approvals and the absence of any adverse effects on SPAC's business [378]. - The business combination agreement allows for termination if the transactions are not completed by June 8, 2026 [380]. - The funds in the trust account will be used to complete the initial business combination and may also finance operations of the target business [392]. Operational Costs - The operating costs for the year ended December 31, 2025, were approximately $449,000, with significant costs incurred for professional fees and executive compensation totaling around $1,308,000 [389]. - The company expects to continue incurring increased expenses due to being a public company and efforts to identify target businesses [389]. Income and Financial Health - Other income for the year ended December 31, 2025, included approximately $9,434,000 in interest income primarily from the trust account [390]. - The company has substantial doubt about its ability to continue as a going concern within one year after the financial statements are issued [395]. Management Compensation - The company will compensate its CEO and CFO $33,000 per month prior to the initial business combination, with $16,500 payable currently and the remainder upon completion [401]. Accounting Estimates - The company has no critical accounting estimates as of December 31, 2025, indicating management's confidence in the accuracy of reported financials [402].

Technology Development - Verde Clean Fuels has developed the STG+® technology, which converts syngas from various feedstocks into fully finished liquid fuels without additional refining [30]. - The STG+® technology has been validated through a demonstration plant that has completed over 10,000 hours of operation [30]. - The STG+® process is designed to produce RBOB gasoline that is free of sulfur and benzene, making it a drop-in substitute for petroleum-derived gasoline [32]. - The company holds patents related to the STG+® technology, with validity extending through 2031 and 2033 for different aspects [46]. - The company is exploring opportunities to deploy the STG+® technology through modular units designed to reduce construction complexity and improve schedule predictability [39]. Strategic Initiatives - The company aims for a 50% reduction in costs in 2026 compared to 2025 as part of its aggressive cost savings initiatives [28]. - Verde Clean Fuels is shifting its strategy to capitalize on capital-lite opportunities, including licensing technology and providing engineering services [47]. - The company has appointed George Burdette as CEO and engaged Roth Capital Partners as a financial advisor to evaluate strategic alternatives [29]. - The company has shifted its strategy to focus on licensing its STG+® technology and providing engineering services, moving away from capital-intensive commercial production plants [112]. Financial Performance - Total proceeds raised from the Business Combination amounted to $51,122,970, including $32,000,000 from PIPE Financing and $19,031,516 from the CENAQ trust [57]. - As of the completion of the Business Combination, there were 31,858,620 shares of Common Stock issued and outstanding, comprising 9,358,620 shares of Class A Common Stock and 22,500,000 shares of Class C Common Stock [57]. - The Company has not generated any revenue to date and does not expect to do so until it can commercialize its STG+® technology, which has been under development since 2007 [121]. - The Company has incurred significant operating losses and negative cash flows, which are expected to continue until the technology is commercialized [123]. - The company is exploring financing options, including debt financing and equity issuance, but there is no assurance that favorable terms will be available when needed [128]. Market and Regulatory Environment - The regulatory environment for renewable fuels is subject to change, which may impact the company's operations and profitability [81]. - The RFS program mandates a minimum volume of renewable fuel in transportation fuel sold in the U.S., with the EPA establishing biofuel volume requirements for 2023 to 2025 [75]. - The Inflation Reduction Act of 2022 provides tax credits for clean hydrogen production, sustainable aviation fuel, and carbon capture, which could benefit the company's renewable gasoline products [80]. - The company believes its renewable gasoline will qualify for a D3 RIN under the RFS program, potentially providing significant value [85]. - The EPA has approved various fuel pathways under the RFS program, and the company’s renewable gasoline may qualify for Pathway M, allowing it to be used as a drop-in replacement for petroleum-based fuels [91]. Operational Challenges - The company faces significant risks related to regulatory changes affecting renewable fuels, technological advancements, and competition from other fuel producers [114]. - The company is subject to risks related to obtaining necessary permits and approvals for commercial production plants, which could impede growth [112]. - The complexity of customer procurement processes may result in lengthy timelines for revenue recognition from new commercial production plants [137]. - The company may face challenges in securing financing for commercial production plants, which could affect supply agreements and financial performance [167]. - The company is vulnerable to supply chain disruptions, which could increase costs and affect operations [179]. Competition and Market Dynamics - The company faces substantial competition from both the petroleum-based industry and emerging renewable fuels, which may hinder growth [146]. - Competitors may have greater resources and financial strength, making it challenging for the company to develop proprietary products and technologies [147]. - The company has limited experience in marketing and selling renewable gasoline, which may hinder its ability to compete effectively in the market [138]. - Future revenue will heavily depend on the ability to license STG+® technology and secure long-term supply agreements for renewable gasoline [171]. Environmental and Compliance Risks - Compliance with environmental, health, and safety laws may result in increased costs and operational restrictions [188]. - Changes in regulations could lead to additional expenditures and delays in operations [189]. - The company may face challenges in obtaining necessary permits for future operations, impacting growth and financial performance [190]. - Transition risks related to climate change could have material adverse effects on the company, potentially increasing operating costs and reducing access to financial markets [192]. Leadership and Workforce - The company has not experienced any work stoppages and maintains a good relationship with its employees [102]. - As of March 27, 2026, the workforce consisted of 9 employees and 3 contractors, down from 12 employees and 4 contractors as of December 31, 2025 [102]. - The appointment of George Burdette as CEO on March 20, 2026, follows the departure of Ernie Miller, who will remain as a senior advisor [217]. Future Outlook - The company expects carbon credits to be a significant source of future revenue, but market development may not occur as anticipated [186]. - The renewable and low-carbon fuels industry is rapidly evolving, and failure to keep pace with technological advancements may result in a competitive disadvantage [180]. - The company may not be able to obtain government grants or incentives, limiting opportunities for business expansion [200].

Technology Development - Verde Clean Fuels has developed the STG+® technology, which converts syngas from various feedstocks into fully finished liquid fuels without additional refining [30]. - The STG+® technology has been validated through over 10,000 hours of operation at a demonstration plant [30]. - The STG+® process is designed to produce RBOB gasoline that meets ASTM specifications and is a drop-in substitute for petroleum-derived gasoline [32]. - The company holds patents related to the STG+® technology, with validity extending through 2031 and 2033 for different aspects [46]. - Verde Clean Fuels entered into a joint development agreement with Cottonmouth for the development of a natural gas-to-gasoline plant in the Permian Basin utilizing Verde's STG+® technology [66]. Financial Performance and Projections - The company aims for a 50% reduction in costs in 2026 compared to 2025 as part of its aggressive cost savings initiatives [28]. - The total proceeds raised from the Business Combination amounted to $51,122,970, consisting of $32,000,000 from PIPE Financing and $19,031,516 from the CENAQ trust [57]. - The Company has not generated any revenue to date and does not expect to do so until it can commercialize its STG+® technology, which has been under development since 2007 [121]. - The Company has incurred significant operating losses and negative cash flows, which are expected to continue until the technology is commercialized [123]. - Future revenue will heavily depend on the ability to license STG+® technology and secure long-term supply agreements for renewable gasoline [171]. Market Strategy and Operations - The company has suspended the development of the Permian Basin Project due to changing market conditions [27]. - Verde Clean Fuels is shifting its strategy to capitalize on capital-lite opportunities, including licensing technology and providing engineering services [47]. - The company has shifted its strategy to focus on licensing its STG+® technology and providing engineering services, moving away from capital-intensive commercial production plants [112]. - The Company completed a FEED study for the Permian Basin Project in December 2025, which will inform future opportunities for deploying its technology [131]. - The company plans to grow by deploying its STG+® technology through licensing and potentially building commercial production plants, which may require significant upfront investment [153]. Regulatory Environment and Compliance - The regulatory environment surrounding renewable fuels is subject to change, which may impact the company's operations and profitability [81]. - The RFS program mandates a minimum volume of renewable fuel in transportation fuel sold in the U.S., with the EPA establishing biofuel volume requirements for 2023 to 2025 [75]. - The Inflation Reduction Act of 2022 provides tax credits for clean hydrogen production, sustainable aviation fuel, and carbon capture, which could benefit the company's renewable gasoline products [80]. - Compliance with environmental, health, and safety laws may result in increased costs and operational restrictions [188]. - Changes in regulations could lead to additional expenditures and delays in operations [189]. Risks and Challenges - The company faces significant risks related to regulatory changes affecting renewable fuels, technological advancements, and competition from other fuel producers [114][115]. - The Company faces risks related to obtaining necessary permits and authorizations for commercial production plants, which could delay operations and impact revenue [136]. - The company may face challenges in obtaining financing for commercial production plants, which could impact its growth strategy [115]. - The company is subject to various operational risks, including disruptions from global health crises and environmental factors [115]. - The renewable and low-carbon fuels industry is rapidly evolving, and failure to keep pace with technological advancements may result in a competitive disadvantage [180]. Leadership and Governance - The company has appointed George Burdette as CEO and engaged Roth Capital Partners as a financial advisor to evaluate strategic alternatives [29]. - The company is streamlining its Board of Directors as part of its restructuring efforts [28]. - The appointment of George Burdette as CEO on March 20, 2026, follows the stepping down of Ernie Miller, who will remain as a senior advisor [217]. Environmental Impact and Sustainability - In 2023, gasoline accounted for over 20% of the U.S.'s energy-related CO2 emissions, with transportation representing approximately 39% of total emissions (1,856 million tons of CO2) in the U.S. [70]. - An ICE vehicle using renewable gasoline produced with the STG+® process could account for approximately negative 81 tons of CO2 over a 200,000-mile life, resulting in over 200% less CO2 emissions compared to traditional gasoline [74]. - Concerns regarding the environmental impact of renewable gasoline production could impair public policy support, affecting profitability and operating margins [205]. Shareholder and Market Considerations - Future sales of Class A Common Stock could lead to dilution of existing stockholders' ownership and potentially decrease share price [221]. - Substantial sales of Class A Common Stock could occur at any time, which may reduce the market price of the stock [222]. - The SEC's final rules on climate-related disclosures are currently under judicial review, creating uncertainty about their implementation [100].

Product Launch and Approvals - Humacyte, Inc. commenced the U.S. commercial launch of its first FDA-approved product, Symvess, in Q1 2025, targeting vascular trauma indications[16]. - The FDA granted full approval for Symvess on December 19, 2024, for use as a vascular conduit in urgent revascularization cases[20]. - The FDA granted full approval for ATEV on December 19, 2024, for use in adults with extremity vascular trauma, broadening its indication beyond previous restrictions[113]. - ATEV received RMAT designation from the FDA in May 2023 for urgent arterial repair following extremity vascular trauma, with a BLA filed in December 2023[81]. - The company expects to file a BLA with the FDA in the second half of 2026 for ATEV use in AV access for hemodialysis, targeting high-risk patients[48]. - The FDA is expected to receive a supplemental BLA submission in the second half of 2026, targeting subgroups with the best results from the ATEV[169]. Clinical Trials and Results - As of December 31, 2025, approximately 636 patients have received ATEVs in clinical trials and post-launch[19]. - The company is conducting a Phase 3 trial for a 6mm ATEV in AV access for hemodialysis, with plans to submit a supplemental BLA in H2 2026[21]. - ATEV has been implanted in over 85 clinical sites across seven countries with zero instances of clinical rejection in the past ten years[66]. - The longest ATEV use for dialysis has been more than ten years, with no evidence of clinically relevant immunologic reactions observed[65]. - In the V005 trial, the primary patency rate for ATEVs was 84.3%, compared to 78.9% for synthetic grafts, while secondary patency was 90.2% versus 78.9%[86]. - ATEV demonstrated a primary patency rate of 93.8% and a secondary patency rate of 93.8% in the V017 trial, with no conduit infections or amputations reported[99]. - The combined results from the V005 and V017 trials showed a primary patency of 87.1% and a secondary patency of 91.5%, significantly outperforming the synthetic graft benchmark of 78.9%[110]. - The V006 trial enrolled 355 subjects, with ATEV subjects trending older (mean age 62.6 years) and having a higher prior stroke rate (12.4%) compared to ePTFE subjects (5.6%)[138]. - ATEV demonstrated secondary patency rates of 92% at 6 months and 67% at 24 months, while ePTFE showed 87% and 74% respectively, indicating ATEV's initial advantage[142]. - The V007 trial enrolled 242 patients, comparing ATEV to autogenous AV fistulas, with ATEV showing functional patency of 81.3% at 6 months versus 66.4% for AVF[157]. - ATEV demonstrated a secondary patency rate of 68.3% at 12 months compared to AVF's 62.2%, with a duration of use of 7.5 months versus 6.1 months[157]. - The V012 trial has enrolled 113 patients, with an interim analysis planned after one year of follow-up, expected to report results in Q2 2026[168]. Manufacturing and Capacity - Humacyte's manufacturing facility spans 83,000 square feet and can accommodate over 40 LUNA200 systems, currently operating eight systems[35]. - The LUNA200 system can produce up to 200 ATEVs (42cm in length) per batch, with the ability to generate 400 ATEVs (13cm in length) per batch[36]. - The LUNA200 manufacturing system can produce up to 200 ATEVs per batch, with an annual gross capacity of approximately 900 ATEVs per system[215]. - The FDA inspected the manufacturing facility in April 2024, which is set to support the commercial launch of ATEVs in the first quarter of 2025[214]. Patient Population and Economic Impact - The estimated annual eligible patient population for ATEVs in the U.S. is approximately 26,000, based on trauma injury analysis[43]. - An estimated $5 to $6 billion per year is spent on hospital admissions for hemodialysis patients with infection and access complications, with over 555,000 patients receiving hemodialysis in the U.S. in 2024[46]. - Hemodialysis patients average 1.8 hospital admissions and four days hospitalized for infections each year, with infection and access complications being the two most common causes[47]. - The ATEVs are projected to be cost-saving for trauma centers and third-party payors, primarily due to reductions in costs related to amputations and conduit infections[45]. - A Budget Impact Model published in March 2025 projected cost savings for trauma centers and third-party payers due to reduced rates of amputations and conduit infections associated with ATEV[114]. Safety and Efficacy - The average infection rate for ATEVs in AV access trials is approximately 1.0% or less per patient-year, with rates in trauma and PAD trials ranging from 0% to 2%[67]. - ATEV showed a low infection rate of less than 1% per patient-year in hemodialysis access trials, indicating a significant improvement over traditional methods[129]. - ATEV had a significantly lower rate of vascular access site infections (0%) compared to ePTFE (2.8%), highlighting a safety advantage[148]. - ATEVs maintained an infection-free rate of 92.9% from months 3 to 36 in long-term follow-up studies[92]. - The company has observed consistent durability and a strong tolerability profile for ATEVs across various trials and programs[65]. - ATEV has shown strong patency rates and no reported infections in clinical studies for peripheral artery disease (PAD)[171]. Future Developments - The company plans to support an IND application for CABG using a small diameter ATEV in 2025, following preclinical testing[56]. - The company is planning to commence human clinical testing of the CTEV in CABG in the second half of 2026, pending FDA IND clearance[202]. - The engineered lung technology is being scaled up for human-sized organs, with gas exchange observed in studies with rodent models[212]. - The BVP product candidate can accommodate approximately 800,000 human pancreatic islets, potentially reversing diabetes and restoring glucose control[194]. - Preclinical studies showed that insulin-producing cells in the BVP survived for months post-implantation and continued to produce measurable insulin in the bloodstream[197]. - The CTEV demonstrated sustained patency in a baboon model of CABG, with all CTEVs maintaining blood flow throughout a six-month follow-up[199]. - The CTEV is being evaluated for use in pediatric heart surgery, with promising results published in October 2023 showing patency and blood flow for up to six months[205].