Sales Performance - For the year ended December 31, 2025, direct-to-consumer (DTC) sales accounted for 55.8% of net revenues, down from 58.1% in both 2024 and 2023, while wholesale sales increased to 44.2% from 41.9% in the previous two years[26]. - DTC net revenues decreased by $22.3 million, or 7.9%, while wholesale net revenues increased by $3.2 million, or 1.6% compared to 2024[217]. - E-commerce net revenues decreased by $23.4 million, or 11.4%, while Purple showroom net revenues increased by $1.1 million, or 1.5% compared to 2024[217]. - In 2025, the company experienced a 9.1% increase in fourth quarter revenue compared to the previous year, driven by strategic priorities[181]. - Wholesale revenue grew by 39.8% in the fourth quarter of 2025, attributed to expanded placements with Mattress Firm and Costco[181]. Product Development and Innovation - The acquisition of Advanced Comfort Technologies, Inc. in 2022 allowed the company to expand into the luxury mattress segment and launch two new collections in Q2 2023, increasing product offerings to three collections[31]. - The Rejuvenate 2.0 collection exceeded performance expectations in 2025, with strong traction in both showrooms and wholesale channels[38]. - The company launched three new premium mattress collections in 2023, including a new line of luxury mattresses[55]. - The proprietary Hyper-Elastic Polymer technology differentiates its products by providing pressure relief, temperature neutrality, and durability, which are not addressed by traditional foam mattresses[36]. - The proprietary Hyper-Elastic Polymer material can stretch up to 15 times its original size and returns to shape without losing its properties, enhancing comfort and support[42]. Financial Performance - The company reported negative cash flow from operating activities of $33.8 million and $17.9 million for the years ended December 31, 2025, and 2024, respectively[86]. - As of December 31, 2025, the company had unrestricted cash and cash equivalents of $24.3 million and borrowings of $111.3 million under the Amended and Restated Credit Agreement, which is due on April 30, 2027[86]. - The company recognized $12.4 million in costs related to its Restructuring Plan during 2025, including $9.5 million for equipment write-offs[185]. - Net revenues decreased by $19.2 million, or 3.9%, to $468.7 million in 2025 compared to $487.9 million in 2024, primarily due to industry-wide demand softness for home-related products and e-commerce channel weakness[217]. - Gross profit increased by $7.4 million, or 4.1%, to $188.6 million in 2025, with a gross profit percentage improvement to 40.2% from 37.1% in 2024[218]. Operational Strategy - The company plans to open seven new stores in 2025 after closing four underperforming locations, reflecting a disciplined approach to fleet optimization[38]. - The company operates 55 Purple showrooms, a decrease from 58 in 2024 and 60 in 2023, with plans for future expansion[27]. - The manufacturing facility in McDonough, Georgia, provides 844,000 square feet of space for mattress production and distribution, consolidating operations after the closure of two Utah facilities[50]. - The company has a dedicated 61,000 square foot innovation center in Draper, Utah, to facilitate research and development of new comfort technologies[55]. - The company is focusing on cost savings through supply chain initiatives and manufacturing efficiency to improve gross margins[181]. Market and Competitive Landscape - The company faces significant competition in the sleep products industry, which is fragmented and includes both established and new entrants[98]. - Changes in economic conditions, such as the housing market and tariffs, have negatively impacted demand for the company's products[108]. - Recent U.S. trade policy changes, including tariffs, may adversely affect the company's operations and financial results[109]. - Increased competition for search terms has driven up marketing costs, impacting advertising efficiency and brand awareness[115]. - Expansion into wholesale distribution carries risks of unpaid invoices and lower gross profit compared to direct-to-consumer sales[116]. Financial Risks and Liabilities - The company faces substantial doubt about its ability to continue as a going concern due to recurring losses and negative cash flows[82]. - The Amended and Restated Credit Agreement imposes various affirmative and negative covenants that could limit operational and financial flexibility[78]. - The company may need to raise additional funds to support operations and business initiatives, which may not be available on acceptable terms[84]. - The company has mandatory prepayment obligations under the Amended and Restated Credit Agreement, which could divert resources from operating expenses[81]. - The company estimates a liability of approximately $137.5 million related to the Tax Receivable Agreement, which could be accelerated upon a change of control, potentially discouraging acquisitions[141]. Corporate Governance and Shareholder Matters - Coliseum Capital Management, LLC owns 61.1 million shares of Common Stock, representing a significant influence over the company's Board and strategies[92]. - The company has anti-takeover provisions that may limit stockholder participation in favorable transactions and affect share price[139]. - The market price of the company's common stock is highly volatile and may decline regardless of operational results, affecting stockholder resale opportunities[138]. - The company has issued warrants to purchase 20.0 million shares at $1.50 per share, which could dilute existing stockholders' interests[147]. - The company is a holding company and relies on Purple LLC for distributions to meet financial obligations, which may not be sufficient[149]. Risk Management and Compliance - The company has implemented processes to assess and manage cybersecurity risks, with no material breaches identified in 2025[159][161]. - The Audit Committee of the Board of Directors oversees cybersecurity risk management and receives regular updates from management[162]. - The company is facing increasing counterfeit goods and patent/trademark infringements, leading to higher enforcement costs and potential harm to its intellectual property value[133]. - The company has licensed certain intellectual property to EdiZONE, which may limit its ability to innovate and expand product offerings due to existing third-party obligations[135]. - The company has engaged in related-party transactions totaling $100.0 million under the Amended and Restated Credit Agreement, which may lead to conflicts of interest[95].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 20-F ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☐ SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the ...

Financial Position and Trust Account - The company has approximately $953,750 available outside the trust account to fund working capital requirements, with offering expenses estimated at $600,000[98]. - The trust account is intended to hold funds pending the completion of the initial business combination or the return of funds to public shareholders if no combination occurs within the prescribed timeframe[108]. - If the initial business combination is not completed within the required time period, public shareholders may receive only approximately $10.10 per share upon liquidation of the trust account[97]. - If the company is required to liquidate, public shareholders may lose the opportunity to invest in a target business and may receive only approximately $10.10 per share[111]. - The trust account may be subject to claims from third parties, potentially reducing the per-share redemption amount below $10.10[149][151]. - If the company does not complete its initial business combination by July 16, 2026, it will distribute the trust account funds to public shareholders, which may delay redemption[153]. - Shareholders may not have rights to funds from the trust account except under specific circumstances, potentially forcing them to sell shares at a loss[144]. Business Combination Risks - The company may incur significant costs in pursuit of acquisition plans, and may depend on loans from sponsors or management to fund operations if net proceeds are insufficient[98]. - The company may seek acquisition opportunities with early-stage companies or financially unstable businesses, which could introduce numerous operational risks[115]. - The company may face challenges in assessing the management capabilities of prospective target businesses, potentially impacting the success of the business combination[119]. - The company may not be able to diversify its operations if it completes its initial business combination with a single target, exposing it to various economic and regulatory risks[124]. - The company may face challenges in completing the initial business combination due to potential litigation involving management team members[161]. - The company may pursue business combinations with affiliated entities, subject to independent director approval[199]. - The company may face additional risks and costs associated with acquiring and operating a business in foreign countries, including regulatory approvals and currency fluctuations[213][214]. Shareholder Rights and Governance - Public shareholders will not have voting rights on director appointments prior to the initial business combination, limiting their influence on company management[112]. - The company has approximately 25% of its ordinary shares held by initial shareholders, which may influence the voting process for amendments[134]. - The company may amend its governing instruments, including warrant agreements, to facilitate the completion of its initial business combination, requiring at least a two-thirds approval from shareholders[131]. - The company may require holders of public warrants to exercise on a cashless basis if certain conditions are not met, affecting the number of shares issued[158]. - The company’s amended and restated memorandum and articles of association may inhibit a takeover, potentially limiting the price investors are willing to pay for Class A ordinary shares[186]. - The company may be classified as a "controlled company" by Nasdaq due to voting rights being held solely by holders of founder shares, potentially qualifying for exemptions from corporate governance requirements[235]. - The board includes a majority of independent directors, a compensation committee comprised entirely of independent directors, and independent directors recommend nominees for the board[236]. Market and Regulatory Environment - The company is subject to new SEC rules regarding SPACs, which may increase costs and time needed to complete a business combination[222]. - The Inflation Reduction Act of 2022 imposes a 1% U.S. federal excise tax on stock repurchases, which could affect the company if it engages in redemptions post-business combination[229]. - The company may reincorporate in another jurisdiction during its initial business combination, potentially resulting in tax liabilities for shareholders[228]. - The company may be classified as a Passive Foreign Investment Company (PFIC), which could lead to adverse U.S. federal income tax consequences for U.S. investors[224][225]. - The company must comply with various laws and regulations, and failure to do so could adversely affect its ability to complete a business combination and its overall operations[221]. Financial Projections and Share Issuance - The gross proceeds from the initial public offering and the sale of private placement securities amount to approximately $179.2 million, which includes up to $6.9 million of deferred underwriting commissions held in the trust account[123]. - The company believes that the net proceeds from its initial public offering will be sufficient for its initial business combination, but it may need additional financing if the proceeds are insufficient[135]. - The company has authorized the issuance of up to 200,000,000 Class A ordinary shares, with 181,507,125 Class A shares available for issuance immediately after the IPO[163]. - The company may issue additional Class A ordinary shares or preference shares to complete the initial business combination or under an employee incentive plan[164]. - The potential issuance of additional Class A ordinary shares upon exercise of warrants could make the company a less attractive acquisition vehicle[176]. Management and Operational Challenges - The company’s management team may not be able to identify a suitable candidate for the initial business combination, as past performance is not indicative of future results[187]. - The company’s operations are dependent on a small group of individuals, and the unexpected loss of key personnel could adversely affect operations[189]. - The personal interests of the sponsor and directors may misalign with public shareholders' interests during the business combination process[207]. - Conflicts of interest may arise due to overlapping affiliations of directors and officers with other entities[195]. - The company may face conflicts of interest as directors and officers allocate their time between various business activities[188].

Financial Position and Capital Requirements - The company has approximately $953,750 available outside the trust account to fund working capital requirements, with offering expenses estimated at $600,000[98]. - The company may incur significant costs in pursuit of acquisition plans, and may depend on loans from affiliates to fund operations if necessary[98]. - The company believes that the net proceeds from its initial public offering will be sufficient for its initial business combination, but it may need additional financing if the proceeds are insufficient[135]. - As of December 31, 2025, the company had $296,249 in cash and a working capital deficit of $70,710, indicating a weak cash position[219]. - The company has a working capital deficiency and expects to incur significant costs in pursuit of acquisition plans, raising concerns about capital raising success[219]. Trust Account and Shareholder Rights - The trust account is intended to hold funds pending the completion of the initial business combination or the return of funds to public shareholders if no combination occurs[108]. - Public shareholders will not have voting rights on director appointments prior to the initial business combination[112]. - Shareholders may not have rights to funds from the trust account except under specific circumstances, potentially forcing them to sell shares at a loss[144]. - The trust account may be subject to claims from third parties, potentially reducing the per-share redemption amount below $10.10[149]. - If the company is unable to complete the initial business combination, public shareholders may lose their opportunity for investment appreciation and receive only approximately $10.10 per share[111]. Business Combination Risks and Challenges - If the initial business combination is not completed within the required time, public shareholders may receive only approximately $10.10 per share upon liquidation of the trust account[97]. - The company may incur substantial debt to complete a business combination, which could adversely affect its financial condition and shareholder value[122]. - The company may face challenges in assessing the management capabilities of prospective target businesses, potentially impacting the success of the business combination[119]. - The company may seek acquisition opportunities with early-stage companies or financially unstable businesses, which could introduce numerous operational risks[115]. - The company may not be able to maintain control of a target business post-transaction, affecting operational management[211]. Regulatory and Compliance Issues - Compliance with the Sarbanes-Oxley Act may increase the time and costs associated with completing an acquisition, particularly if the target business is not compliant[138]. - The company is subject to new SEC rules regarding SPACs, which may increase costs and time needed to complete business combinations[222]. - The Inflation Reduction Act of 2022 imposes a 1% U.S. federal excise tax on stock repurchases, which could affect the company if it engages in redemptions post-business combination[229]. - The company is classified as an "emerging growth company" and may take advantage of exemptions from certain disclosure requirements, which could affect the attractiveness of its securities to investors[232]. - The company is also classified as a "smaller reporting company," which allows it to provide only two years of audited financial statements until certain market value or revenue thresholds are met[234]. Shareholder Influence and Governance - Initial shareholders own approximately 25% of the issued and outstanding ordinary shares, which may influence the voting process for amendments[134]. - The company’s initial shareholders may exert substantial influence over actions requiring shareholder votes, potentially affecting corporate governance[166]. - The company’s board of directors will generally serve a three-year term, with current directors continuing until the business combination is completed[167]. - The board includes a majority of independent directors, and there is a compensation committee comprised entirely of independent directors[236]. - The company intends to comply with Nasdaq corporate governance requirements despite being eligible for exemptions[235]. Market and Economic Conditions - Economic and political conditions in the country of operation could significantly impact the company's ability to find and complete a business combination[139]. - The COVID-19 pandemic and other public health crises could adversely affect the company's search for a business combination and the operations of any target business[140]. - There is currently no market for the company's securities, which may affect liquidity and price[142]. - Nasdaq may delist the company's securities if it fails to meet minimum listing standards, including maintaining an average global market capitalization and a minimum of 400 public holders[145]. - The company must ensure its share price remains at least $4.00 per share to comply with Nasdaq's initial listing requirements[145]. Conflicts of Interest - Conflicts of interest may arise as directors and officers may have affiliations with other entities engaged in similar business activities[195]. - The personal financial interests of the sponsor and directors may misalign with public shareholders, especially as the deadline for business combination approaches[207]. - The company has not adopted a policy to prohibit directors and officers from having financial interests in transactions, potentially leading to conflicts[196]. - Founder shares may provide substantial profit to holders even if public shareholders incur losses post-business combination[207]. - The company may pursue business combinations with affiliated entities, although no specific opportunities are currently identified[199].

Financial Performance - Dominari reported a revenue of $123.1 million in 2025, representing a 487% increase from $21.0 million in 2024[3] - Underwriting revenues surged to $79.0 million, a 596% increase compared to $11.4 million in 2024[3] - The company experienced a loss from operations of $55.7 million, an increase of $47.0 million from a loss of $8.7 million in 2024, primarily due to $55.0 million in non-cash stock-based compensation[3] - Other income rose to $42.6 million, an increase of $48.6 million compared to a loss of $6.0 million in 2024, driven by the market value increase of its investment in American Bitcoin Corp.[3] - Non-GAAP adjusted net income (loss) improved to $32.6 million, compared to a net loss of $13.1 million in 2024, reflecting a $45.6 million year-over-year increase[3] - For the year ended December 31, 2025, Dominari Holdings reported a loss from operations of $55,726, compared to a loss of $8,702 in 2024[13] - The adjusted loss from operations for 2025 was $719, significantly improved from an adjusted loss of $7,069 in 2024[13] - The net loss attributable to common stockholders for 2025 was $22,435, compared to a net loss of $14,703 in 2024[13] - Dominari Holdings achieved an adjusted net income attributable to common stockholders of $32,572 in 2025, contrasting with an adjusted net loss of $13,070 in 2024[13] - The basic net income per share for 2025 was $2.28, a recovery from a loss of $2.11 per share in 2024[13] - The weighted average number of shares outstanding increased to 14,285,097 in 2025 from 6,183,397 in 2024[13] Assets and Equity - Liquid assets totaled $94.3 million at the end of 2025, a 248% increase from $27.1 million at the end of 2024[3] - Total assets increased by 140% to $112.9 million, up from $47.1 million in 2024[3] - Total stockholders' equity rose by 74% to $69.4 million, compared to $39.9 million in 2024[3] Dividends - Dominari declared $22.2 million in dividends during the year, marking the first time in its history that dividends were paid[3] Future Outlook - The company expects continued growth in 2026, emphasizing prudent management and exceptional customer service[2] - Dominari Holdings is engaged in wealth management, investment banking, sales and trading, and asset management, aiming to enhance shareholder value through organic growth and opportunities in AI and Data Center sectors[14] - Dominari Securities LLC focuses on capitalizing on emerging trends in financial services to create wealth for stakeholders[15] Risk Management - The company emphasizes the importance of forward-looking statements and the associated risks and uncertainties in its financial outlook[17] - Dominari Holdings maintains a commitment to updating stakeholders as required by law regarding any significant changes in its financial position[17]

Debt and Interest Rates - As of December 31, 2025, the company had $389.5 million in principal debt outstanding with a weighted average interest rate of approximately 12.2%[386] - A 1% increase or decrease in the assumed weighted average interest rate would impact interest expense by approximately $3.9 million per year[386] Foreign Currency Risks - The company is exposed to foreign currency risks from intercompany loans and transactions in currencies other than the functional currency[387] Stock Volatility - The price of the company's common stock has been volatile, posing risks for future equity funding[388] Inflation Impact - Inflation has materially affected the company's business, particularly increasing costs of labor and supplies[389]

Debt and Interest Rates - As of December 31, 2025, the company had $389.5 million in principal debt outstanding with a weighted average interest rate of approximately 12.2%[386] - A 1% increase or decrease in the assumed weighted average interest rate would impact interest expense by approximately $3.9 million per year[386] Foreign Currency Risks - The company is exposed to foreign currency risks from intercompany loans and transactions in currencies other than the functional currency[387] Stock Volatility - The price of the company's common stock has been volatile, posing risks for future equity funding[388] Inflation Impact - Inflation has materially affected the company's business, particularly increasing costs of labor and supplies[389]

Financial Performance - Total revenue for the year ended December 31, 2025, was $16.3 million, an increase from $9.6 million in 2024, primarily driven by ATEC sales of $14.5 million compared to $7.9 million in 2024[166] - The company incurred a net loss of $34.2 million for the year ended December 31, 2025, compared to a net loss of $31.1 million for the year ended December 31, 2024[164] - Operating income (loss) for the Land and Water Resources segment was $(28.1) million in 2025, compared to $(25.0) million in 2024, while the Water Filtration Technology segment reported an operating income of $2.5 million in 2025[164] - Cost of sales for the year ended December 31, 2025, totaled $11.2 million, with a gross margin of 48.4% for ATEC, up from 45.5% in 2024[167] Expenses and Costs - General and administrative expenses increased to $24.2 million in 2025 from $19.7 million in 2024, primarily due to higher legal and consulting fees[168] - Interest expense increased to $8.6 million in 2025 from $7.9 million in 2024, primarily due to increased borrowing under the Lytton Credit Agreement[170] Investments and Acquisitions - The company completed the acquisition of ATEC Water Systems, enhancing its water filtration technology capabilities[151] - The company has established a new special purpose business entity, Mojave Water Infrastructure Company LLC, to finance the Mojave Groundwater Bank project, with estimated capital costs of $1.5 billion[155] - Agreements have been made for the purchase of 21,275 acre-feet per year of water supply, with an estimated market price starting at approximately $850 per acre-foot[154] Cash Flow and Financing Activities - Cash used for operating activities totaled $18.9 million for the year ended December 31, 2025, a decrease from $21.5 million in 2024, primarily due to reduced working capital needs[190] - Cash used for investing activities increased to $12.6 million in 2025 from $1.2 million in 2024, mainly for securing an exclusive option for steel pipeline purchase and other project-related costs[191] - Cash provided by financing activities was $25.4 million for the year ended December 31, 2025, compared to $35.5 million in 2024, with proceeds primarily from share issuance and initial borrowing under the Lytton Credit Agreement[192] - The company entered into the Lytton Credit Agreement, allowing for up to $51 million in unsecured term loans for the Mojave Groundwater Bank construction, with an interest rate of 8% per annum[183] - The company made an initial draw of $15 million from the Lytton Credit Agreement for project expenses in November 2025 and a second draw of $15 million in March 2026[186] - The company expects to meet short-term working capital needs through proceeds from the Lytton Credit Agreement and cash on hand[193] - Long-term capital needs will depend on the progress of the Mojave Groundwater Bank and other development activities, with potential additional capital raises anticipated[194] - The company is evaluating cash requirements and potential financing methods, including equity or debt placements, to minimize dilution for existing shareholders[195] Asset Management and Valuation - The company conducts a quantitative assessment using the present value (discounted cash flow) method to determine the fair value of reporting units with goodwill[202] - In the fourth quarter of 2025, the goodwill of all reporting units in the water and land resources and water filtration technology segments was tested, and it was determined that their fair values were more-likely-than-not greater than their carrying values, indicating no impairment[203] - Long-lived assets, including property, plant, and equipment, are depreciated or amortized over their useful lives, which are based on management's estimates of revenue generation periods[204] Regulatory and Reporting Status - The company is classified as a smaller reporting company and is not required to provide certain market risk disclosures[206]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 OR 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): March 31, 2026 MASSIMO GROUP (Exact name of registrant as specified in its charter) | Nevada | 001-41994 | 92-0790263 | | --- | --- | --- | | (State or other jurisdiction | (Commission | (IRS Employer | | of incorporation) | File Number) | Identification No.) | 3101 W Miller Road Garland, TX 75 ...

Drug Development and Clinical Trials - The company is advancing CAD-1005, a first-in-class selective 12-LOX inhibitor for treating heparin-induced thrombocytopenia (HIT), with a Phase 3 pivotal trial planned following a successful End-of-Phase 2 meeting with the FDA on March 26, 2026[24][40]. - CAD-1005 has received orphan drug designation (ODD) and Fast Track designation from the FDA for the treatment and prevention of HIT, indicating its potential significance in addressing this life-threatening condition[32][41]. - The Phase 1 clinical studies of CAD-1005 demonstrated good tolerability with no serious adverse events reported among 96 healthy subjects[38]. - A Phase 2 pilot study of CAD-1005 showed a high rate of thrombotic events (>75%) in the placebo group compared to 50% in the CAD-1005 group, although it did not meet its primary endpoint of platelet count recovery[39]. - The company plans to secure sufficient financing to commence the pivotal Phase 3 clinical trial for CAD-1005, which is crucial for its development[29][40]. - The company is focused on addressing the underlying pathophysiology of HIT, which existing therapies do not adequately target, potentially positioning CAD-1005 as a transformative treatment[34][36]. - The company is currently focused on the development of CAD-1005, having shifted from its previous focus on tecarfarin[165]. - The company has not yet received the final minutes from its EOP2 meeting with the FDA, which may contain additional comments affecting the Phase 3 trial protocol[176]. - The Phase 2 trial of CAD-1005 in patients with HIT enrolled only 24 patients out of a planned 60 and was terminated early, indicating challenges in patient recruitment[205]. - The company faces significant clinical risks that could impede the advancement of CAD-1005 and its second-generation oral candidates[177]. Financial Position and Funding - The company had an accumulated deficit of approximately $39.0 million as of December 31, 2025, and a net loss of approximately $13.2 million for the fiscal year ended December 31, 2025[160]. - The company expects to incur significant expenses and continued losses from operations for the foreseeable future, indicating a need for additional financing to support its business strategy[160]. - The company plans to raise additional capital to fund its planned clinical trials and support development and commercialization efforts for its product candidates[171]. - The company may need to relinquish significant rights to its technologies or grant licenses on unfavorable terms if it raises funds through partnering or licensing arrangements[160]. - The company anticipates that future capital requirements will be funded through a combination of private and public equity offerings, debt financings, and strategic collaborations[173]. - The company will require additional financing prior to commencing any clinical trial and to meet anticipated cash requirements for at least the next twelve months[171]. - The company faces risks related to its financial position and need for capital, which could adversely affect its ability to continue as a going concern[160]. Regulatory Environment - The company is subject to extensive regulatory requirements, which require significant time and financial resources for compliance and approval processes[103][104]. - The FDA requires two adequate and well-controlled Phase 3 clinical trials to demonstrate drug efficacy, with trials typically involving several hundred to several thousand patients[109]. - The FDA has 60 days to determine if an NDA is accepted for filing, with standard review applications typically reviewed within 10 to 12 months and priority review applications within 6 to 8 months[114]. - Orphan drug designation can provide a seven-year exclusive marketing period in the U.S. for drugs treating rare diseases affecting fewer than 200,000 individuals, along with potential grant funding of up to $500,000 per year for four years[121]. - Accelerated approval allows for early drug approval based on surrogate or intermediate clinical endpoints, significantly shortening the time required for clinical trials[124]. - The cost of preparing and submitting an NDA is substantial, with manufacturers potentially assessed up to five program fees for a fiscal year for prescription drug products identified in a single approved NDA[113]. - The FDA may impose sanctions or discontinue a clinical trial if it believes the trial is not compliant with requirements or poses unacceptable risks to patients[110]. - The company has never submitted a New Drug Application (NDA) to the FDA and relies on third-party contract research organizations (CROs) for assistance in the approval process[214]. Market Potential and Competition - The estimated peak annual market revenue potential for CAD-1005 in patients with HIT is approximately $825 million, while the combined peak annual U.S. market revenue potential for tecarfarin and frunexian is estimated at $2 billion[96][97]. - The company faces substantial competition from major pharmaceutical companies and other entities in the development and commercialization of its product candidates[91][95]. - The commercial success of product candidates will depend on obtaining favorable labeling from regulatory authorities, which may not align with the company's expectations[206]. - The commercial success of the company's product candidates will depend on market acceptance by physicians, patients, and healthcare payors, which is influenced by factors such as efficacy, safety, and pricing[211]. Manufacturing and Supply Chain - The company has completed the manufacturing of tecarfarin drug product in accordance with cGMP and has contracts with third-party CDMOs for development and supply, but lacks long-term supply agreements[87][88]. - The company does not have any long-term supply agreements or commercialization partnerships with manufacturers for its product candidates, which may expose it to risks in production and distribution[218]. - The company anticipates that if approved by the FDA, it will be able to enter into agreements with third parties for the manufacturing and distribution of its product candidates[220]. - The company faces risks related to supply disruptions, regulatory compliance, and loss of key manufacturing partners that could delay product development and commercialization[223]. Intellectual Property and Agreements - The company acquired the Veralox assets, including CAD-1005 and related compounds, on December 10, 2025, enhancing its pipeline and intellectual property portfolio[26][27]. - The company has acquired intellectual property from Veralox and eXIthera, including U.S. and foreign patents for 12-LOX inhibitors and Factor XIa inhibitors, with various expiration dates for these patents[98][100]. - The company entered into a Veralox Purchase Agreement for $200,000 in cash, with contingent milestone payments not exceeding $15 million based on clinical and regulatory achievements[75]. - The eXIthera Purchase Agreement involved acquiring assets for $50,000 in transaction costs and up to $15 million in milestone payments based on clinical and regulatory events[83][84]. - The company is obligated to pay eXIthera a 2% royalty on annual net sales of pharmaceutical products containing compounds from the eXIthera Purchase Agreement, payable from the first commercial sale until the expiration of patent claims[84]. Employee and Corporate Structure - The company has five full-time employees and approximately thirty-five consultants and contractors as of March 27, 2025[146]. - The corporate headquarters are leased with a monthly rent of $2,346, under a lease agreement that commenced on November 1, 2025[148]. - The company qualifies as an "emerging growth company," allowing it to take advantage of reduced reporting requirements until certain revenue or debt thresholds are met[152]. - The company has opted for an extended transition period to comply with new accounting standards, potentially delaying compliance compared to other public companies[153].