IPO and Fundraising - The company completed its initial public offering on February 20, 2026, raising gross proceeds of $230 million from the sale of 23 million units at $10.00 per unit[25]. - An additional private placement of 695,000 units was completed simultaneously, generating gross proceeds of $6.95 million[25]. - The total proceeds of $230 million from the IPO and private placement, including $8.05 million of underwriters' deferred commission, were placed in a U.S.-based trust account[25]. - The company has deposited $230,000,000 in a U.S. based trust account, with an initial investment in U.S. government treasury obligations[65]. - The trust account includes up to $8,050,000 in deferred underwriting commissions, which will be available for public share redemptions if necessary[65]. - The company has $221.95 million available from its initial public offering and private placement units to complete its initial business combination, after accounting for $8.05 million in deferred underwriting commissions[167]. Business Combination Strategy - The company intends to pursue an initial business combination with target businesses having an enterprise value of approximately $750 million to $1.5 billion or more[24]. - The acquisition strategy focuses on businesses with strong market positions, attractive growth potential, and experienced management teams[36]. - The company anticipates structuring its initial business combination to acquire 100% of the equity interests or assets of the target business, but may acquire less than 100% under certain conditions[47]. - The company may pursue business combinations with affiliated companies, but will obtain an independent valuation opinion to ensure fairness[60]. - The management team will evaluate business combination opportunities across various industries, but there is no guarantee of success due to the lack of specific target selection[145]. - The company has not selected a specific business combination target but intends to target businesses with enterprise values greater than the net proceeds from its initial public offering and the sale of private placement units[180]. Timeframe and Redemption - The company has a 24-month period from the closing of the IPO to complete its initial business combination, with the possibility of seeking shareholder approval for extensions[42]. - If the initial business combination is not completed within the 24-month period, the company will redeem 100% of public shares at approximately $10.00 per share[44]. - If the initial business combination is not completed within the specified period, the company will redeem 100% of public shares at a price equal to the amount in the trust account[68]. - The per-share redemption price for public shareholders will be calculated based on the aggregate amount in the trust account, including interest earned[70]. - If the company does not seek to extend the period for consummating the initial business combination, it will cease operations and redeem public shares within ten business days[99]. - If too many public shareholders exercise their redemption rights, the company may not meet cash requirements for a business combination, potentially leading to an unsuccessful transaction[90]. Management and Conflicts of Interest - The management team has raised over $10 billion in capital through public and private markets, enhancing their ability to evaluate financing alternatives for potential business combinations[32]. - The company may face conflicts of interest due to management's ownership of founder shares and private placement units, which could affect decision-making[61]. - The company is not prohibited from pursuing business combinations with entities that have existing fiduciary obligations to other companies[50]. - Officers and directors may have fiduciary or contractual obligations to other entities, leading to conflicts in presenting business opportunities[223]. - Conflicts of interest may arise if officers and directors pursue business combinations for other blank check companies they are involved with[223]. Regulatory and Compliance Issues - Nasdaq rules require that the aggregate fair market value of the business combination must be at least 80% of the value of the assets held in the trust account[46]. - The SEC adopted new SPAC Rules on January 24, 2024, requiring additional disclosures related to business combination transactions and potential conflicts of interest[123]. - Compliance with the SPAC Rules may increase costs and extend the time needed to negotiate and complete an initial business combination[125]. - The company is required to provide public shareholders with the opportunity to redeem their shares for cash if amendments to the governing documents are proposed[179]. - The company may face regulatory review and approval requirements for its initial business combination, particularly from CFIUS, which could limit the pool of potential targets[186]. Financial Risks and Liabilities - There are no commitments to issue shares or incur debt as of the report date, but the company may choose to incur substantial debt in connection with a business combination[56]. - The company may incur substantial debt to complete a business combination, which could negatively impact its financial condition and shareholder value[166]. - The company may face excise tax implications on redemptions if it engages in a business combination with a U.S. entity[115]. - Any excise tax payable due to redemptions would be the company's responsibility, potentially reducing cash available for business combinations[117]. - The company may need to seek additional financing if the cash portion of the purchase price exceeds the amount available from the trust account, which could compel it to restructure or abandon a business combination[180]. Market and Economic Conditions - Ongoing geopolitical conflicts, such as the U.S.-Iran military escalation and the Russia-Ukraine conflict, may adversely affect market conditions and the search for business combinations[138]. - The number of SPACs has risen significantly, resulting in fewer available attractive targets for business combinations[189]. - Tariffs and changes in international trade policies could adversely affect the search for initial business combination targets and the performance of post-business combination companies[194][195]. - The economic and political conditions in the country of operation could significantly affect the company's business and profitability post-combination[218]. Operational Challenges - The company may face challenges in completing desirable business combinations due to the potential for significant shareholder redemptions[93]. - Key personnel from an acquisition candidate may resign after the business combination, potentially affecting operations and profitability[199]. - The company may face challenges in obtaining necessary financial statements from target businesses, limiting potential acquisition opportunities[192]. - The company may pursue complex business combinations that require significant operational improvements, which could delay achieving desired results[203]. - The company may not maintain control of a target business after the initial business combination, potentially leading to management challenges[201].

Interest Rate Risk - The company is exposed to interest rate risk with fixed-rate debt instruments bearing interest rates of approximately 7-23% as of December 31, 2025[351]. - A hypothetical 100 basis point increase in market interest rates would not have materially impacted the company's results for the year ended December 31, 2025[352]. - The company does not utilize derivative instruments or hedging strategies, believing that current market risk exposures did not materially affect its financial condition for the year ended December 31, 2025[364]. Raw Material and Logistics Costs - The company sources approximately one-third of its raw materials domestically, one-third from China, and the remainder from other international sources[357]. - A 10% increase in raw material or logistics costs could have a material adverse effect on gross margins if not offset through pricing or cost controls[357]. - The company is subject to commodity and input cost risks associated with changes in the cost and availability of raw materials[356]. Foreign Currency Exposure - The company does not currently hedge foreign currency exposures, and a 10% adverse movement in foreign currency exchange rates could increase input costs[354]. Market Conditions - The market price of the company's common stock has been volatile since listing, influenced by factors beyond its control[358]. - The company faces risks from inflation and broader macroeconomic conditions that may increase costs and reduce consumer demand[360]. - The company has ongoing monitoring of input costs and pricing strategies to manage market risks[362].

IPO and Fundraising - The company completed an initial public offering (IPO) on February 9, 2026, raising gross proceeds of $172.5 million from the sale of 17,250,000 public units at a price of $10.00 per unit[22]. - A private placement generated an additional $2.79 million from the sale of 279,465 private placement units and 768,529 restricted Class A ordinary shares[23]. - The total net proceeds of $172.5 million from the IPO and private placement are held in a trust account, invested only in U.S. government treasury bills or money market funds[24]. - As of February 9, 2026, the company has $160,425,000 in the Trust Account available for a business combination, net of a deferred underwriting fee of $12,075,000[44]. - The company intends to use substantially all funds held in the trust account to acquire target businesses and pay related expenses, with the expectation that interest earned will cover any income taxes[105]. - The proceeds from the private placement units were added to the net proceeds from the Offering held in the trust account[176]. Business Combination Strategy - The company has 15 months from the closing of the offering to complete its initial business combination, with the possibility of extending this period by up to 6 months[34]. - The initial business combination must involve a target with a fair market value of at least 80% of the assets held in the trust account[33]. - The company aims to acquire 100% of the equity interests or assets of the target business, but may acquire less than 100% under certain conditions[36]. - The target company should have a defensible market position, a capable management team, and potential for growth, among other criteria[30]. - The company has not yet identified a specific target for its initial business combination and has not taken steps to secure third-party financing[44]. - The company may seek to raise additional funds through private offerings of debt or equity securities in connection with the initial business combination[47]. Management and Governance - The management team has extensive experience in sourcing and executing business combinations, leveraging a broad network of contacts[29]. - Bala Padmakumar has been the Chief Executive Officer since June 2025, with extensive experience in SPACs and clean energy sectors[125]. - Soumen Das, the Chief Financial Officer since June 2025, has initiated and launched seven SPAC IPOs, with the latest business combination closing in July 2024[126]. - Kathleen Cuocolo, chairperson of the audit committee, has a background in managing financial services with over $1.2 trillion in assets during her tenure at State Street Corporation[127]. - The company has established a compensation committee composed solely of independent directors[134]. - The audit committee includes independent directors who oversee the integrity of financial statements and compliance with legal requirements[135]. Financial Performance - As of December 31, 2025, the company reported a net loss of $110,178, which consisted solely of general and administrative expenses[101]. - The company has not generated any revenue to date and has relied on the sale of securities and loans from sponsors to fund operations[92][100]. - The company has a shareholder's deficit of $85,178, with accumulated deficit totaling $110,178[205]. - The company incurred a net loss of $110,178 for the period from June 18, 2025, through December 31, 2025, resulting in a basic and diluted net loss per share of $0.02[208]. - Total liabilities amounted to $679,243, including accrued expenses of $60,417 and a promissory note related party of $217,513[205]. Shareholder Rights and Approvals - Public shareholders will have the opportunity to redeem their shares at approximately $10.00 per share upon the completion of the initial business combination[56]. - If the company fails to complete its initial business combination within 15 months from the closing of the Offering, it will redeem public shares at a per-share price equal to the amount in the trust account[58]. - Shareholder approval may be required for the initial business combination under certain conditions, including significant changes in ownership or control[54]. - The company’s amended and restated memorandum and articles of association require at least two-thirds approval from ordinary shares holders for any amendments related to shareholder rights[68]. Risks and Challenges - The company may face risks associated with a lack of business diversification, as its success may depend entirely on the performance of a single business post-combination[49]. - The company may face intense competition from other blank check companies and private equity groups, which may limit its ability to acquire larger target businesses[69]. - The company has incurred significant costs in pursuit of its financing and acquisition plans, raising substantial doubt about its ability to continue as a going concern[199]. - The company has not adopted a formal policy for the review of related party transactions, which may lead to conflicts of interest[168]. Compliance and Regulations - The company is classified as an "emerging growth company" and will remain so until it has total annual gross revenue of at least $1.235 billion or the market value of its ordinary shares held by non-affiliates exceeds $700 million[42]. - The company is also a "smaller reporting company," which allows it to provide only two years of audited financial statements until its market value exceeds $250 million or annual revenues exceed $100 million[43]. - The company is required to evaluate its internal control procedures for the fiscal year ending December 31, 2026, as mandated by the Sarbanes-Oxley Act[76]. - The company has adopted insider trading policies to promote compliance with relevant laws and regulations regarding securities transactions by directors and officers[141]. - A code of ethics has been established, applicable to all executive officers, directors, and employees, governing business and ethical principles[142]. Future Outlook - Future strategies may include further market expansion and potential mergers or acquisitions, leveraging the expertise of the board members in various sectors[125][126][127]. - The company has not commenced any operations and will not generate operating revenues until after completing its initial Business Combination[218]. - The company has not selected any specific Business Combination target and has not engaged in substantive discussions regarding potential targets[217].

Clinical Developments - PAVmed's subsidiary Lucid Diagnostics submitted a clinical evidence package to secure Medicare coverage for EsoGuard, including six new peer-reviewed publications[299]. - Lucid was awarded a contract by the U.S. Department of Veterans Affairs for EsoGuard, expanding access to esophageal precancer testing for over nine million enrolled veterans annually[305]. - PAVmed entered a license agreement with Duke University for technology that combines angle-resolved low coherence interferometry with optical coherence tomography for advanced esophageal precancer detection[303]. - Lucid's real-world experience study evaluated EsoGuard and EsoCheck in approximately 12,000 patients, demonstrating high technical success rates and rapid procedure times[306]. - A recent update to the NCCN Guidelines® now references EsoGuard as an acceptable alternative for detecting esophageal precancer[310]. Financial Performance - Revenue for the year ended December 31, 2025, was $0.1 million, a decrease of $2.9 million compared to $3.0 million in the prior year, primarily due to the deconsolidation of Lucid Diagnostics[340]. - Cost of revenue for the year ended December 31, 2025, was $0.2 million, down from $4.8 million in the prior year, reflecting the absence of Lucid's results[341]. - Sales and marketing expenses decreased to approximately $0.9 million in 2025 from $11.6 million in 2024, mainly due to the deconsolidation of Lucid[342]. - General and administrative expenses were approximately $16.3 million in 2025, down from $24.5 million in the prior year, attributed to the deconsolidation of Lucid[343]. - Research and development expenses were approximately $4.5 million in 2025, a decrease from $5.9 million in 2024, also due to the deconsolidation of Lucid[344]. - The company experienced a net loss of approximately $2.5 million and used about $5.2 million in cash for operations for the year ended December 31, 2025[355]. Financing Activities - PAVmed completed a Series D offering, raising $30 million and converting all Series D Preferred Stock into common stock, resulting in the issuance of 4,615,393 shares[312][314]. - Veris Health raised approximately $2.5 million from the sale of 1,800,000 shares of common stock and warrants to fund the development of its implantable physiological monitor[321]. - The Company generated gross proceeds of $2.37 million from the Offering of 85,812 shares and pre-funded warrants, priced at $21.345 per share[323]. - Lucid Diagnostics closed on the sale of 28,750,000 shares at $1.00 per share, generating approximately $27.0 million in net proceeds for working capital[327]. - The company issued 40,553 shares of common stock for net proceeds of approximately $0.8 million through its at-the-market equity facility[357]. - The company refinanced the September 2022 Senior Secured Convertible Note, generating gross proceeds of approximately $7.6 million from the February 2026 Financing[360]. - The company entered into a Securities Purchase Agreement for the purchase of 2,653 shares of Series C Preferred Stock, satisfied through the cancellation of $2.6 million in unsecured debt[363]. - The February 2025 Offering generated gross proceeds of $2.37 million from the sale of 85,812 shares of common stock and pre-funded warrants[369]. - The June 2025 Offering generated approximately $2.5 million in gross proceeds for Veris from the sale of 1,800,000 shares of common stock[371]. - The Series D Warrants allow for the purchase of 30,000 shares of Series D Preferred Stock at an exercise price of $1,000 per share, potentially generating an additional $30 million if fully exercised[365]. Compliance and Regulatory - The company regained compliance with Nasdaq's $1 minimum bid price requirement for continued listing on the Nasdaq Capital Market[319][320]. - Lucid was added to the Russell 2000® and 3000® Indexes following the 2025 annual reconstitution[309]. - The fair value of the Company's investment in Lucid was $34.1 million as of December 31, 2025, with an unrealized gain of $8.5 million recognized for the year[351]. Accounting and Standards - The company anticipates recurring losses and negative cash flows, raising substantial doubt about its ability to continue as a going concern within one year after the issuance of the financial statements[355]. - The estimated fair values of financial instruments are based on common stock prices and Level 3 inputs, utilizing models such as Monte Carlo simulations and discounted cash flow analyses[379]. - The fair value adjustments for the April 2022, September 2022, and March 2023 Senior Convertible Notes are recognized as other income (expense) in the consolidated statement of operations[378]. - The adoption of ASU No. 2023-09 regarding income tax disclosures is effective from January 1, 2025, and did not materially impact the consolidated financial statements but resulted in new disclosures[381]. - ASU No. 2024-03, effective after December 15, 2026, will require public entities to disclose specified information about costs and expenses, including inventory purchases and employee compensation[382]. - The company has no off-balance sheet arrangements[384]. - Recent accounting standards updates are being evaluated for their potential impact on the company's consolidated financial statements and disclosures[383].

Financial Performance - The company incurred a net loss of approximately $46.4 million on revenues of approximately $1 million for the year ended December 31, 2025, compared to a net loss of approximately $49.3 million on revenues of approximately $0.8 million for 2024, and a net loss of approximately $43.5 million on revenues of approximately $1.5 million for 2023[36]. - The company anticipates that its losses may continue to be significant as it shifts its R&D focus and expands production capabilities[39]. - The product mix sold during a period can significantly impact financial performance, with lower-gross margin products adversely affecting overall results[95]. - The company may incur significant legal claims related to product liability and breach of contract, which could adversely affect financial condition[82]. - The company is experiencing increased costs due to inflationary pressures and supply chain delays, which may impair gross margins and profitability[74]. - The company may face claims for remuneration or royalties for assigned service invention rights, which could lead to litigation and negatively impact business[164][165]. Research and Development - Research and development expenses were approximately $34.8 million in 2025, $35.1 million in 2024, and approximately $34.1 million for 2023, with expectations for continued significant investment in future R&D[44]. - The company is investing in research and development, collaborating with Tier-1 suppliers, and expanding sales efforts to attract new customers in various industries[60]. - The development cycle for the company's products can take several years, particularly in the automotive market, which may delay revenue generation[45]. Market Strategy and Operations - The company plans to transition to production of its radar chip for sale to customers during 2026, although there is no assurance that this timetable will be met[36]. - The company has broadened its focus to seek contracts with Tier 1 suppliers and OEMs for orders in commercial quantity, in addition to sales of radars for testing purposes[41]. - The company is pursuing market opportunities beyond the automotive sector, but these markets may develop more slowly than anticipated[65]. - The company anticipates significant growth in operations, requiring improvements in execution, operational controls, and compliance programs[62]. Risks and Challenges - The company faces risks related to market adoption of its products, which may develop more slowly than expected, impacting business performance[50]. - The company is subject to various risks including international conflicts, economic conditions, and customer trends that could adversely affect its business[46]. - The company faces challenges in accurately estimating supply and demand, which could lead to inefficiencies and hinder revenue generation[51]. - The company is vulnerable to geopolitical risks, including conflicts involving Israel, which may disrupt operations and affect financial stability[93]. - The complexity of the company's products may lead to unforeseen delays or expenses due to defects, which could adversely affect market adoption and reputation[79]. Compliance and Regulatory Environment - The company must comply with numerous laws and regulations concerning the manufacturing and sale of its products, which may vary significantly across different jurisdictions[115]. - The company is subject to stringent reporting requirements and civil penalties for violations related to safety defects and product recalls, which could adversely affect its financial condition[130]. - The introduction of the proposed Self Drive Act of 2026 could impose significant compliance costs and restrict the company's ability to sell its radar chipsets in the U.S.[123]. - The company is subject to cybersecurity risks that could lead to unauthorized access to proprietary information, impacting its competitive advantage[109]. - The company is required to pay royalties from sales of products developed with IIA-funded grants, which could amount to up to 300% of the IIA grants received[169]. Financial Position and Funding - The company raised gross proceeds of $18.5 million in an underwritten registered direct public offering on January 26, 2026, with working capital of approximately $38.9 million as of December 31, 2025[48]. - The company may need to raise additional funds in the future to execute its business plan, and there is no assurance that such funds will be available on acceptable terms[48]. - The company’s ability to incur additional debt may be restricted due to covenants associated with its convertible bonds[145]. - The company has cash and cash equivalents of not less than $5 million as of the last day of one quarter, and shareholders' equity shall not fall below $5 million as of the last day of two consecutive quarters[152]. Intellectual Property - The company relies on a combination of patent, copyright, and trade secret laws to protect its intellectual property, but these protections may be limited[104]. - The company may face challenges in enforcing its intellectual property rights internationally, which could adversely affect its competitive position[106]. - The company has filed for patents and trademarks in Israel, the United States, Europe, and China, but not all applications have resulted in granted patents[104]. Shareholder and Market Considerations - The company may issue additional ordinary shares or securities without shareholder approval, potentially diluting existing ownership interests[201]. - The market price of the company's ordinary shares has been volatile and subject to wide fluctuations, which could adversely affect investor confidence[212]. - The company may face delisting from Nasdaq if the closing bid price of its ordinary shares remains below $1.00 for 30 consecutive business days[208]. - The dual listing of the company's ordinary shares on Nasdaq and the Tel Aviv Stock Exchange may lead to price discrepancies due to differences in trading currencies and hours[184].

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ___________________________________________________________ FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2025 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ________ to ________ Commission file number 001-34049 Presidio Property Trust, Inc. ...

Model Homes and Properties - As of December 31, 2025, the company owned 80 model homes with a net book value of approximately $36.7 million[26] - In 2025, the company acquired 22 Model Home Properties for approximately $9.4 million, consisting of $2.8 million in cash and $6.6 million in mortgage notes[22] - The company disposed of 20 model homes for approximately $9.8 million in 2025, recognizing a gain of approximately $1.0 million[24] - The company operates four limited partnerships related to its model home business, with two partnerships dissolved in 2025[28] - The Company plans to refinance a significant portion of mortgage notes payable or sell model home properties to repay $4.5 million in principal payments due in 2026[41] Commercial Properties - The company recognized a net gain of approximately $4.5 million from the sale of two commercial properties for approximately $15.9 million in 2025[24] - The company’s commercial properties tenant base consists of approximately 131 individual tenants, with the largest tenant representing 6.90% of annualized base rent[20] - As of December 31, 2025, the ten largest tenants represented approximately 37.69% of the company’s annualized base rent[20] - The Company’s commercial properties and Model Homes adequately covered their debt servicing needs during the year ended December 31, 2025[42] Financial Performance and Debt - Total debt as of December 31, 2025, included $22.6 million with recourse to the Company, of which $5.5 million was related to model homes properties[39] - The Company uses non-recourse financing for seven of its nine commercial mortgage loans, limiting exposure to equity invested in each property[39] Stock and Dividends - The company repurchased 16,080 shares of Series A Common Stock at an average price of $4.79 per share, totaling $77,092 in 2025[30] - A Tender Offer in 2025 resulted in the purchase of 214,412 shares of Series A common stock for approximately $1.458 million[32] - Series D Preferred Stock has a cumulative cash dividend rate of 9.375% per annum, equating to $2.34375 per share annually[36] - As of January 28, 2026, the Company suspended the monthly dividend on Series D Preferred Stock, with unpaid dividends accruing at $0.19531 per share each month[38] Company Structure and Employment - As of December 31, 2025, the Company had a total of 15 full-time employees[55] - The Board of Directors consists of six members, four of whom are independent directors[51] Market Focus - The company focuses on regionally dominant markets with strong employment growth and low unemployment rates to maximize returns[21] Office Space - The Company reduced its office space from approximately 9,224 square feet to 6,570 square feet in September 2024[54] REIT Qualification - The Company qualified as a REIT for federal income tax purposes for the fiscal year ended December 31, 2025[52]

Financial Performance and Viability - The company has incurred significant operating losses since inception and anticipates continuing substantial operating losses for the foreseeable future[20] - The company has identified substantial doubt about its ability to continue as a going concern, necessitating additional funding[20] - The company has a limited operating history and has not generated substantial product revenues to date, complicating the evaluation of its business success and future viability[20] Cash and Financial Resources - The company has $28,862 in cash, cash equivalents, and restricted cash as of March 26, 2026, primarily held in U.S. Government money market funds[813] - The loans under the Credit Agreement bear interest at a fixed rate of 13%, exposing the company to material interest rate risk if market rates drop[815] Product Development and Commercialization - The company is dependent on the success of its lead product candidate, BXCL501, and the commercialization of IGALMI®[20] - The company relies on third parties for the manufacture of clinical supplies and commercial supplies of IGALMI®, which could impact its ability to commercialize products[20] - The regulatory approval processes for the company's product candidates are lengthy and unpredictable, posing risks to business operations[20] Market and Compliance Risks - The company faces risks related to maintaining compliance with Nasdaq listing standards, which could lead to delisting if not adhered to[20] - The company’s estimated total addressable market for its products is subject to inherent challenges and uncertainties, which could affect revenue and profitability[20]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ________ to _________ Commission File Number: 001-42953 Alussa Energy Acquisition Corp. II (Exact name of Registrant as specified in its charter) Cayman Islands N/ ...

Financial Condition - As of December 31, 2025, the company had an accumulated deficit of approximately $141.6 million and reported net losses of approximately $20.1 million and $22.2 million for the years ended December 31, 2025 and 2024, respectively [207]. - The company has approximately $5.6 million in cash and working capital of approximately $2.3 million, raising substantial doubt about its ability to continue operations for the next 12 months without additional capital [208]. - The company has experienced recurring losses from operations since inception, raising substantial doubt about its ability to continue as a going concern [351]. Product Development and Regulatory Challenges - The company has no products approved for commercial sale and has not generated any revenue from product sales to date, with expectations of continued losses for the foreseeable future [214]. - The company is advancing its product candidates through preclinical testing and clinical development, including a Phase 1 clinical trial for its product candidate CLD-201, which utilizes an allogeneic adipose-derived mesenchymal stem cell line [220]. - The company anticipates significant increases in research and development expenses as it continues its clinical trials and seeks marketing approvals for its product candidates [211]. - The company faces challenges in obtaining regulatory approvals and successfully commercializing its product candidates, which could materially harm its business [215]. - The company anticipates that obtaining regulatory approval for its novel product candidates will be complex and lengthy, potentially increasing development costs and delaying commercialization [239]. - The company’s clinical trials may fail to demonstrate the necessary safety and efficacy for regulatory approval, which could prevent or delay commercialization [230]. - The regulatory approval process is lengthy and unpredictable, which may materially impair the ability to commercialize current and future product candidates [263]. - The company may need to abandon or limit the development of product candidates associated with serious adverse events or undesirable side effects [267]. Funding and Financial Risks - The company must raise substantial additional funding to support its operations and product development programs, with potential delays or reductions in programs if capital is not secured [220]. - The company may face significant challenges in securing additional financing due to disruptions in financial markets, which could adversely affect its ability to develop and commercialize product candidates [225]. - The company’s reliance on additional financing may divert management from day-to-day activities, adversely affecting product development and commercialization efforts [225]. - Access to adequate funding sources for current and future operations could be impaired by liquidity constraints or failures in the financial services industry [383]. Market and Competitive Landscape - The company faces substantial competition from major pharmaceutical and biotechnology companies, which may have greater resources and expertise [260]. - Market acceptance of product candidates will depend on their efficacy, safety, and the awareness among the medical community and patients [254][257]. - The commercial success of adenovirus-based product candidates will depend on public acceptance of immuno-oncology therapies, particularly oncolytic viral immunotherapy [246]. Legal and Regulatory Compliance - The company must comply with strict advertising and promotion regulations, and failure to do so could result in significant penalties and harm to its reputation [292]. - The company is subject to the U.S. Foreign Corrupt Practices Act and other anti-corruption laws, with potential civil or criminal penalties for non-compliance [360]. - Employee misconduct or noncompliance with regulatory standards could materially affect the company's business and financial condition [378]. Manufacturing and Supply Chain Issues - The company faces challenges in establishing manufacturing relationships, with limited qualified manufacturers available [399]. - Delays in preparing for commercial scale manufacturing could impair clinical development and commercialization timelines, affecting financial performance [400]. - Regulatory non-compliance could result in severe penalties, including fines and suspension of production, affecting commercialization efforts [404]. Healthcare and Legislative Environment - Legislative changes, such as the ACA, could impose competition from lower-cost biosimilars and affect pricing and reimbursement strategies [303]. - Future healthcare reform measures may impose more rigorous coverage criteria and downward pressure on product pricing, adversely affecting demand [339]. - The company is facing potential adverse effects on its operations due to proposed drug price control measures at the federal level, which may include allowing Medicare to negotiate drug prices and eliminating cost sharing for low-income patients [307]. Human Resources and Management - The company is highly dependent on retaining key executives and qualified personnel, which is critical for its success [343]. - The company’s ability to attract and retain key personnel is critical for pursuing its growth strategy, amid intense competition in the industry [344]. - The company expects significant growth in employee numbers and operational scope, particularly in drug development and regulatory affairs [345].