Financial Performance - As of March 31, 2025, SuRo Capital's net asset value is estimated to be between $6.50 and $7.00 per share, compared to $6.68 per share at December 31, 2024[9]. - The total net assets increased from approximately $157.6 million at December 31, 2024, to approximately $181.7 million at March 31, 2025[9]. - The preliminary financial estimates provided are unaudited and subject to change, with actual results potentially differing materially[13]. Investment Activities - The company held positions in 37 portfolio companies as of March 31, 2025, including 32 privately held and 5 publicly held[11]. - During Q1 2025, SuRo Capital invested a total of $1.3 million in Orchard Technologies, Inc. and $1.0 million in Whoop, Inc.[11]. - Subsequent to the quarter-end, the company invested $5.0 million in Plaid Inc. on April 4, 2025[12]. Shareholder Information - There are 23,551,859 shares of common stock outstanding as of March 31, 2025[10]. Future Outlook - The company expects to announce its first quarter results for the period ended March 31, 2025, in May 2025[14]. - The company cautions that forward-looking statements regarding future performance involve risks and uncertainties that could cause actual results to differ materially[15]. - The company is not classified as an emerging growth company under the Securities Act[5].

Business Expansion and Market Strategy - The company operates six physical retail stores in Singapore and plans to expand into new markets, including Taiwan, Korea, Indonesia, and Malaysia within the next six months [44][48]. - Expansion into new geographic markets may involve significant upfront investments and face challenges such as local competition and regulatory compliance [46][49]. - The company targets the premium mass market and middle to upper-class consumers, relying heavily on consumer spending and housing market conditions [50]. - The company aims to enhance its "HomesToLife" brand through high-quality products and superior customer service, which may require substantial investments [40][41]. - HomesToLife Singapore intends to open additional retail stores in high-demand areas within Singapore to strengthen its market presence [200]. - The company has identified opportunities in the wholesale upholstered furniture market across various Asia-Pacific countries, including Japan, Korea, and Indonesia [195]. - HomesToLife Singapore's management team has over 40 years of experience in the furniture industry, providing a competitive edge in market understanding and supplier relationships [194]. - The company plans to explore mergers and acquisitions to deepen connections with local furniture suppliers in the Asia-Pacific region [201]. Financial Performance and Challenges - The company anticipates increased operating expenses due to growth efforts and public company status, which may lead to future net losses and challenges in achieving profitability [31]. - Revenue decreased from US$6.0 million in fiscal year ended December 31, 2022 to US$5.1 million in fiscal year ended December 31, 2023 due to the impact of COVID-19 [120]. - The ongoing COVID-19 pandemic has significantly disrupted global supply chains, affecting suppliers' ability to provide products in a timely manner, which may continue into 2025 [112]. - Economic conditions in Singapore have led to significant economic contraction and high unemployment rates during the years ended December 31, 2023 and 2022, although recovery appears to have begun in 2024 [121]. - The company incurs significant expenses due to public company obligations, which negatively impacts financial performance [135]. - The company may require additional debt financing to support business operations and future strategies [77]. - Rising interest rates could increase operational costs and limit financial flexibility, potentially affecting profitability [79]. Operational Risks and Management - The company faces risks related to managing growth effectively, including hiring and retaining qualified personnel [32][34]. - Increased competition from various retailers, including online marketplaces, poses a risk to the company's market position [54]. - Cybersecurity threats pose risks to the company's data and operations, necessitating robust cybersecurity measures [51]. - Cybersecurity incidents could lead to significant legal and financial exposure, adversely affecting the company's reputation and operations [53]. - The company is subject to risks related to product liability claims, which could harm its reputation and financial performance [68]. - Legal disputes and claims could divert resources and adversely affect the company's financial condition and operations [86]. - The company may face liabilities under anti-corruption laws, which could lead to significant legal and financial repercussions [99]. Supply Chain and Product Management - The company has experienced surges in orders during peak months, particularly in March, April, June, August, November, and December, which may strain operations [70]. - The company relies on third parties for payment processing, and any failure in compliance or data breaches could materially affect financial results [72]. - HomesToLife Singapore transitioned its major supply source from HTL Marketing to HTL Furniture (China) Co., LTD effective January 1, 2025, under a new supply agreement [62]. - The company relies on a limited number of key suppliers for leather and fabric upholstered furniture, making it vulnerable to negative publicity affecting these suppliers [113]. - Supply chain disruptions experienced during the COVID-19 pandemic may impact the ability to fulfill customer orders in a timely manner [104]. Customer Engagement and Sales Strategy - The company’s success depends on increasing net revenue per active customer and maintaining high levels of customer engagement [38]. - Customer acquisition costs are significant, with marketing expenses varying as the company tests new channels and refines strategies [35][36]. - HomesToLife Singapore offers free delivery for orders above SGD1,200, enhancing customer service for larger purchases [223]. - The average cycle time for custom furniture orders is approximately 8 to 12 weeks, which is faster than competitors, providing a competitive advantage [226]. - HomesToLife Singapore's sales staff follow up with potential customers after initial contact, emphasizing time-limited offers to close sales [222]. - Online sales contribute less than 1% of total sales for the fiscal years ended December 31, 2024, 2023, and 2022, indicating a strong preference for in-store purchases [206]. Regulatory and Compliance Issues - The management team has limited experience managing a public company listed in the U.S., which may impact compliance with regulatory obligations [85]. - The company is subject to evolving regulatory measures, which may increase compliance costs and divert management attention from revenue-generating activities [170]. - The company cannot assure compliance with Nasdaq's continued listing standards, which could lead to significant adverse consequences if delisted [172]. - Shareholders may face difficulties in enforcing judgments against the company or its directors due to the company's operations being primarily outside the United States [168]. - The company may be classified as a passive foreign investment company (PFIC) for U.S. federal income tax purposes, which could lead to adverse tax consequences for U.S. investors [161]. Market Conditions and Economic Factors - Inflationary pressures in Asia may lead to government actions that could significantly decrease profitability in the future [123]. - The company faces risks related to inflationary pressures on product procurement costs, wages, rental rates, and freight charges, which could adversely affect profit margins [107]. - Uncertain global economic conditions have resulted in lower net sales due to weakened demand and unfavorable changes in product price/mix [117]. - Any adverse changes in the Singapore market, such as economic recession or pandemic, could materially affect the company's business and financial condition [115]. - The company is exposed to foreign exchange fluctuations, particularly as purchases are settled in USD while sales are in Singapore dollars [89].

Financial Transactions - Zevra Therapeutics completed the sale of its Rare Pediatric Disease Priority Review Voucher for gross proceeds of $150.0 million on April 1, 2025[4][5]. - The company received the Priority Review Voucher when MIPLYFFA (arimoclomol) was approved by the FDA for treating neurological manifestations of Niemann-Pick disease type C[4]. - The Asset Sale was executed under a PRV Transfer Agreement dated February 26, 2025[5]. - The press release related to the Asset Sale was issued on April 7, 2025[6][11]. Financial Position - As of March 31, 2025, the company's cash, cash equivalents, and investments totaled approximately $68.7 million[6][8]. - The cash and investment figures are based on preliminary unaudited information and management estimates for the quarter ended March 31, 2025[9]. - The company has not yet completed its financial closing procedures for the quarter ended March 31, 2025, and the figures are subject to change[9]. - The independent registered public accounting firm has not reviewed the preliminary estimates provided[9]. Forward-Looking Statements - Forward-looking statements regarding the company's financial position are subject to various risks and uncertainties[10]. - The company may update forward-looking statements in the future but disclaims any obligation to do so unless required by law[10].

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, 2024 ☐ 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: 001-41293 Aspire Biopharma Holdings, Inc. (Exact name of registrant as specified in its charter) Delaware 33-3467744 (State or other jurisd ...

Clinical Trials and Product Development - Aspire plans to conduct clinical trials for its high-dose sublingual aspirin product, with the first trial scheduled for April 2025, involving at least eight healthy adult volunteers[32]. - The company has entered into a development and manufacturing agreement with Glatt to produce sufficient quantities of its high-dose sublingual aspirin for clinical trials[24]. - Aspire aims to submit a section 505(b)(2) New Drug Application (NDA) for its aspirin product to the FDA, seeking approval for treatment of suspected acute myocardial infarction[35]. - The company has developed a working formulation for sublingually administered melatonin and plans to conduct a pharmacokinetic study in May 2025[36]. - Aspire is also developing sublingually administered vitamins D, E, and K, with plans for manufacturing process validation and pharmacokinetic studies in the first half of 2025[37]. - A formulation for sublingually administered testosterone is in development, with plans for clinical testing and NDA submission anticipated in 2026[38]. - Aspire's scientists are finalizing a working formulation for a sublingual semaglutide product, with a timeline to market similar to that of testosterone[39]. - The company has developed a single-dose sublingual pre-workout supplement and plans consumer and safety testing in Q2 2025, aiming for a launch in Q2 or Q3 2025[40]. - Aspire plans to conduct various clinical trials in April 2025 to support its FDA approval process for high-dose aspirin products[59]. - Aspire's melatonin sleep-aid product is in formulation development, with plans for a pharmacokinetic study in May 2025[114]. - The company is also developing sublingual formulations for vitamins D, E, and K, with plans for manufacturing validation in early 2025[115]. - Aspire aims to submit an NDA for its testosterone product in Q2 2026, following Phase One clinical testing[116]. - The development of semaglutide and caffeine products is underway, with expected market readiness in Q2 or Q3 2025[117][118]. Financial Performance and Capital Requirements - Aspire has incurred net losses in every year since its inception and anticipates continuing substantial and increasing net losses in the foreseeable future[80]. - Aspire requires substantial additional financing to achieve its goals, and failure to obtain necessary capital could delay, limit, reduce, or terminate product development or commercialization efforts[84]. - Aspire has no products approved for commercial sale and has not generated any revenue from product sales to date[80]. - Aspire will remain an emerging growth company until it has total annual gross revenue of at least $1.07 billion or the market value of its Class A ordinary shares held by non-affiliates equals or exceeds $700 million[68]. - The company had $0 in its operating bank account and a working capital deficit of $15,570,205 as of December 31, 2024[193]. - The company completed its initial public offering (IPO) on February 23, 2022, raising gross proceeds of $250,000,000 from the sale of 25,000,000 units[191]. - For the year ended December 31, 2024, net cash used in operating activities was $11,160,534, while net cash provided by investing activities was $13,781,323[192]. - The company has never declared or paid any cash dividends on its common stock and does not expect to do so in the foreseeable future[182]. - Future capital stock issuances could dilute existing shareholders' ownership and influence over company matters[166]. - The market price of Aspire's common stock may experience significant volatility, influenced by various operational and market factors[164]. Intellectual Property and Competitive Landscape - Aspire acquired all intellectual property of Instaprin Pharmaceuticals for a purchase price of $3,628,325 plus interest, to be paid from product sales[44]. - The acquisition includes a contingent purchase price obligation of 20% from the first $5,000,000 of sales and 10% thereafter until fully satisfied[44]. - Aspire's management intends to build upon the acquired intellectual property assets to enhance patent protections and develop new products[54]. - Aspire's primary patent properties for aspirin formulation technology are pending with nominal expirations in March 2024 and October 2024[50][56]. - Aspire's aspirin products will compete with established products like Bayer aspirin, Advil, and Tylenol, with no current sublingual aspirin products on the market[49]. - The company has filed for a new trademark for "Instaprin," which is currently pending[53][56]. - Aspire's technology platforms and product candidates are based on novel technologies, and the development and regulatory approval pathway is unproven[74]. - Aspire's intellectual property rights may not provide a significant competitive advantage, and enforcement of these rights could be challenging[90]. Regulatory and Operational Risks - Aspire is subject to extensive regulatory requirements for drug development, which require significant time and financial resources[57]. - Aspire's ability to compete may be affected by competitors obtaining FDA approval more rapidly and offering safer or more effective products[48]. - Aspire is subject to a multitude of manufacturing and supply chain risks that could substantially increase costs and limit the supply of its product candidates[76]. - The company is dependent on key personnel, and the loss of these individuals could harm its business and operations[93]. - Aspire has not purchased key person life insurance policies, increasing the risk associated with the loss of key personnel[94]. - The company's reputation is critical to its success, and negative publicity could significantly reduce its brand value[96]. - Cybersecurity threats and attacks pose risks to Aspire's information infrastructure, potentially leading to data breaches and operational disruptions[97]. - Aspire's business could be negatively impacted by ongoing military actions and international trade disputes, affecting its financial condition and operations[101][102]. - The company relies on a limited number of suppliers, which subjects it to risks of business interruptions and delays in product delivery[104]. - Aspire's product candidates may face market acceptance issues if undesirable side effects are identified post-approval[131]. - The company plans to seek regulatory approval for its product candidates internationally, which introduces additional operational risks[148]. - Aspire faces significant risks related to potential misconduct by employees and third parties, which could lead to substantial fines and operational disruptions[152]. - The company is exposed to product liability risks, which may result in decreased demand, reputational harm, and significant financial liabilities[154]. - Aspire relies on third-party manufacturers for clinical supplies and commercial production, which could impact the ability to meet regulatory requirements and maintain product quality[157]. - The cost of commercial manufacturing for Aspire's product candidates is currently uncertain, potentially affecting their commercial viability[159]. Management and Corporate Governance - Aspire's management team possesses extensive experience in financial acumen and value creation, led by CEO Kraig Higginson[62]. - The company has identified critical accounting policies that require management to make estimates and assumptions affecting reported amounts of assets and liabilities[213]. - The company accounts for warrants as either equity-classified or liability-classified instruments based on specific terms and applicable guidance, determining that Public Warrants and Private Placement Warrants qualify for equity accounting treatment[214]. - Ordinary shares subject to possible redemption are classified as temporary equity due to certain redemption rights considered outside of the company's control[215]. - The company applies the two-class method in calculating earnings per share, with net income per share for Class A and Class B shares calculated based on specific income allocations[216]. - The FASB issued ASU 2023-09, effective for fiscal years beginning after December 15, 2024, which requires expanded disclosures of income taxes paid, but the company does not expect a material impact on its financial statements[217]. - ASU 2023-07, effective for fiscal years beginning after December 15, 2023, mandates additional segment reporting disclosures, which the company will need to comply with[218]. - The company has no long-term debt or significant liabilities, only incurring a monthly fee of $10,000 for administrative support services since February 23, 2022[219].

Financial Performance and Funding - The company has generated no revenues to date and has incurred significant losses since inception, with expectations of continued losses over the next several years[42]. - The company may need to raise substantial additional funding to continue operations, which could lead to dilution of existing shareholders[49]. - The market price of the company's ordinary shares is likely to be highly volatile, and there is no current intention to pay dividends[42]. - Significant shareholders beneficially owned approximately 56.41% of the outstanding ordinary shares as of April 1, 2025[229]. - The company does not currently intend to pay cash dividends on its ordinary shares in the foreseeable future[231]. - An active trading market for the company's ordinary shares may not be sustainable, potentially impairing future capital raising efforts[228]. Product Development and Clinical Trials - The company is heavily dependent on the success of its product candidates, specifically the extended-release and immediate-release formulations of deucrictibant, which are in late-stage development[42]. - Topline data from the RAPIDe-1 study demonstrated efficacy in the Phase 2 clinical trial for treatment of HAE attacks on demand using deucrictibant IR[42]. - The company has established proof-of-concept for deucrictibant in Phase 2 trials for both treatment and prophylaxis of HAE attacks, but future clinical trials may not replicate these results[63]. - The FDA lifted clinical holds on deucrictibant for on-demand and prophylactic treatment of HAE in June 2023 and January 2024, respectively, but future challenges may arise[64]. - The company has completed Phase 2 trials for on-demand and prophylactic settings, providing critical data for late-phase clinical trials[86]. - The company is developing an extended-release formulation for deucrictibant, with plans for multiple dose studies to assess pharmacokinetics and safety[79]. - The company has not yet received regulatory approval for any drugs and may face significant delays in the commercialization of its product candidates[71]. - The company has not submitted any marketing authorization applications for its product candidates, which must include extensive nonclinical and clinical data to establish safety and effectiveness[72]. - The company faces risks in clinical trials, including failure to obtain necessary approvals and potential negative results, which could lead to additional trials or abandonment of product development[73]. - The company may experience setbacks in clinical trials, including delays in commencing or completing trials, which could materially affect its business[42]. Regulatory and Compliance Risks - The company identified material weaknesses in its internal control over financial reporting as of December 31, 2023, which were concluded to be remediated by December 31, 2024[52]. - The company is subject to taxation in multiple jurisdictions, including the Netherlands, Switzerland, and the United States, which may lead to variable effective income tax rates[57]. - The OECD's Global Anti-Base Erosion Model Rules aim to impose a global minimum tax of 15% on multinational enterprises with revenue exceeding €750 million, which could impact the company if revenue thresholds change[60]. - The EU Pillar II Directive, adopted on December 15, 2022, requires member states to implement minimum tax measures starting from fiscal years beginning on or after December 31, 2023[61]. - The company is subject to extensive regulations for clinical trials and marketing, requiring authorization from appropriate regulatory authorities[89]. - Regulatory disruptions at agencies like the FDA and EMA could hinder the approval process for new products[78]. - The company acknowledges that clinical trials may not uncover all possible adverse effects, leading to potential safety concerns post-approval[83]. - The company may face significant delays in obtaining marketing approvals in the United Kingdom due to Brexit, which could restrict revenue generation and profitability[94]. - The company faces challenges in conducting animal testing due to regulatory and public pressures, potentially impacting research and development activities[88]. - The company may experience delays in patient enrollment for clinical trials, which could increase development costs and delay regulatory approvals[81]. Manufacturing and Supply Chain Risks - The company does not own manufacturing facilities and relies on third-party CDMOs, which may affect its ability to supply sufficient product candidates[110]. - The company currently relies on a small number of CDMOs for production, which poses risks to manufacturing operations and could adversely affect business and financial results[111]. - Manufacturing process changes may require repeating trials or conducting additional trials, potentially delaying marketing approval[112]. - Development of in-house manufacturing facilities could enhance control over material supply, but the company lacks experience in this area[113]. - Dependence on third-party manufacturers may adversely affect future profit margins and timely commercialization of products[114]. - Manufacturing challenges may arise during scale-up, leading to increased costs or delays in regulatory approval[115]. - The company relies on third-party manufacturers who are also subject to environmental and safety regulations, which could impact business operations[221]. Competition and Market Risks - The company faces substantial competition from major pharmaceutical and biotechnology companies, which may hinder its ability to commercialize its product candidates successfully[137]. - The commercial success of the company's product candidates will depend significantly on market acceptance among physicians, patients, and healthcare payors[135]. - Market opportunities for product candidates may be smaller than anticipated, potentially lowering revenue projections[130]. - The company anticipates pricing pressures due to the increasing availability of generic products and cost-containment initiatives by insurers[138]. - The insurance coverage and reimbursement status for newly approved products remains uncertain, which could limit the company's ability to generate revenue[145]. - Governments and pricing authorities, especially in the European Union, impose strict price controls that may adversely affect future profitability[143]. Intellectual Property Risks - The company is exposed to risks related to the enforcement of its intellectual property rights, which could lead to potential litigation and impact its ability to protect its technologies[172]. - The patent protection for the company's products may not be sufficiently broad, which could allow competitors to develop similar products and adversely affect the company's market position[170]. - The company may not be able to secure necessary patent rights or maintain existing patents, which could limit its ability to compete effectively in the market[175]. - The duration of patent protection is limited, with U.S. patents generally expiring 20 years after the effective filing date, which could impact the company's long-term competitive advantage[178]. - The company faces risks related to the expiration of patents for product candidates, which may leave it vulnerable to competition from biosimilars or generics[181]. - Future patents may be challenged in court, potentially leading to loss of exclusivity or invalidation, which could adversely affect the company's competitive position[182]. - The company may not be able to protect its intellectual property rights in all jurisdictions, limiting its ability to prevent third parties from using its inventions[184]. - Changes in patent laws, such as those introduced by the America Invents Act, could weaken the company's ability to obtain and enforce patent protection[189]. - The company may face significant costs and distractions from potential litigation regarding intellectual property rights, which could impact its financial condition[197]. - There is a risk of infringing third-party intellectual property rights, which could result in costly litigation and affect the company's ability to commercialize its product candidates[194]. Operational and Management Risks - The company may encounter ownership disputes related to intellectual property, which could result in litigation and loss of valuable rights[196]. - The company faces challenges in attracting and retaining qualified management and scientific personnel, which is crucial for the successful development and commercialization of its product candidates[162]. - The company may struggle to enter into or maintain strategic alliances necessary for the commercialization of its product candidates, facing competition from other companies and institutions[167]. - The company may face significant product liability claims, which could result in substantial financial liabilities[151]. - The company’s business operations may be subject to significant costs associated with compliance with health care laws, which could lead to penalties and impact financial results[213]. - Rapid technological changes in the pharmaceutical industry could render the company’s product candidates obsolete, adversely affecting financial condition and prospects[215]. - The company’s international operations are subject to various economic, political, and regulatory risks, including differing drug approval requirements and intellectual property protections[216]. - Failure to achieve projected development goals may delay product commercialization, potentially leading to a decline in stock price[219]. Environmental and Legal Risks - The company is subject to extensive environmental, health, and safety laws and regulations, which may lead to significant compliance costs and liabilities[222]. - Misconduct by employees or third parties could result in significant administrative, civil, and criminal fines, adversely affecting the company's reputation and financial condition[224]. - The company may face increased restrictions and compliance costs related to changing legal or regulatory requirements, impacting production and development efforts[222]. - There is no certainty that all employees and collaborators will comply with applicable laws, potentially leading to significant legal and financial repercussions[227]. - The company faces risks related to the handling of sensitive patient data, which is subject to stringent privacy laws[121]. - Non-compliance with GDPR could result in fines up to €20 million or 4% of total worldwide annual turnover, whichever is higher[124].

Financial Performance - The company incurred a net loss of $11,752,000 and used cash in operations of $4,929,000 for the year ended December 31, 2024[22]. - Net sales increased by $3.1 million, or 887%, to approximately $3.5 million for the year ended December 31, 2024, compared to $349,000 for the year ended December 31, 2023[209]. - The net loss for the year ended December 31, 2024, was $11.8 million, a 154% increase from a net loss of $4.6 million in 2023[208]. - Gross profit for the year ended December 31, 2024, was $2.3 million, representing a 1,764% increase from $122,000 in 2023[208]. - Total operating expenses increased by 53% to $7.3 million in 2024, up from $4.8 million in 2023[208]. - Financing costs were reported at $6.9 million in 2024, reflecting a 100% increase as compared to the previous year[208]. - Interest income increased significantly to $161,000 in 2024 from $8,000 in 2023, marking a 1,900% rise[208]. - Gross margin improved to 66% in 2024 from 35% in 2023 due to changes in product mix and inventory reserves[210]. Cash and Liquidity - The company had cash and cash equivalents of $7,650,000 as of December 31, 2024, which is expected to last for at least the next 12 months[23]. - The company has sufficient cash on hand for current operations for a minimum of 12 months, but may need to raise additional funds to execute its growth strategy[141]. Market and Competition - The golf equipment market size is estimated at USD 13.32 billion in 2023 and is expected to reach USD 17.64 billion by 2028, growing at a CAGR of 5.78%[24]. - The company faces competition from established brands like TaylorMade, Ping, and Acushnet, which have been in the market longer and possess greater resources[64]. - The company faces intense competition in the golf market, with four major competitors holding the majority of U.S. market share[78]. Product Development and Innovation - The company expanded its shaft offerings into fairway wood/hybrid replacement shafts in 2024[30]. - The company has developed patented Ultra-Low Balance Point technologies to enhance putting performance[37]. - The company introduced the "Newton" division, marking its first entry into golf club shafts, with the Newton Motion driver shaft designed to enhance performance by promoting straighter and longer shots[43]. - The Newton Motion shaft features a unique DOT system for flex categorization, ranging from one to six dots, optimizing performance based on individual golfer abilities[44]. - The proprietary Kinetic Storage Construction of the Newton Motion shaft allows for improved club speed and exit velocity, addressing inconsistencies in flex and spin rates[47]. - The company plans to launch multiple new or enhanced putter designs in 2025, leveraging advanced metals to potentially outperform existing market models[42]. - The company intends to expand its product line to include high-quality soft goods such as golf apparel and accessories, with plans to begin manufacturing in 2025[49]. Operational Challenges - The company has experienced recurring operating losses and negative operating cash flows since inception, raising substantial doubt about its ability to continue as a going concern[101]. - The company is dependent on a limited number of suppliers for key components, and the loss of any of these suppliers could significantly disrupt operations[118]. - The company faces significant price fluctuations and shortages in raw materials such as aluminum, magnesium, and carbon fiber, which could adversely affect its financial condition and results of operations[122]. - Transportation costs are volatile due to shortages in shipping capacity and fuel price fluctuations, potentially impacting the company's ability to pass on costs to customers[123]. - The company must manage the introduction of new products effectively to meet changing consumer preferences and avoid significant adverse impacts on financial performance[84]. Regulatory and Compliance - The company is subject to various environmental laws and regulations, ensuring compliance in its manufacturing processes[50]. - The company has implemented procedures to maintain the confidentiality of proprietary information, crucial for its competitive advantage[57]. - Compliance with evolving data privacy laws, such as the GDPR, poses challenges and could result in increased costs and operational restrictions[137]. Shareholder and Market Issues - The company's common stock is traded on the Nasdaq Capital Market under the symbol "NWTG"[159]. - The company received a notice from Nasdaq for not complying with the minimum bid price requirement, as its stock did not maintain a closing bid price of at least $1.00 for 30 consecutive business days[160]. - The company was not eligible for a compliance period due to a reverse split within the prior year, but has requested a hearing for an extension[161]. - Any capital raised through equity sales will dilute the percentage ownership of existing shareholders, while debt financing may impose restrictive covenants[142]. - Increases in interest rates could raise the cost of servicing debt, adversely affecting profitability and cash flows[143]. - The company does not anticipate paying cash dividends in the foreseeable future, limiting returns to shareholders to potential increases in share price[152]. Strategic Growth Initiatives - The company plans to grow distribution centers in or near Tokyo, Japan, Seoul, South Korea, and Mexico City based on market needs[30]. - The company plans to expand its international business into Asia, Latin America, and Europe, which requires significant investment and poses risks if not managed effectively[117]. - The company has invested significantly in upgrading manufacturing facilities, including a new golf shaft manufacturing facility in St. Joseph, MO, to remain competitive[80]. Risks and Uncertainties - Economic downturns could adversely affect wholesale customers' financial conditions, impacting their ability to pay trade obligations[77]. - Changes in U.S. trade policies, including increased tariffs, could adversely affect the company's ability to obtain components and impact sales[99]. - Adverse publicity or legal actions could damage the company's brand image and consumer confidence, negatively impacting sales[89]. - The company relies on endorsements from professional athletes, and any loss of these endorsements could materially affect sales[97]. - Fluctuations in foreign currency exchange rates could significantly impact the company's financial results, as transactions are conducted in various currencies[109]. - The company may face significant costs or damages from intellectual property claims or lawsuits, which could affect its ability to sell products[103]. - Integration of newly acquired businesses or partnerships could strain resources and disrupt ongoing operations, potentially harming financial performance[113]. - Information systems are critical for operations, and any failure or cyber security breach could disrupt business and adversely affect financial performance[128].

Acquisition and Expansion - The Company acquired a 60% interest in three existing linear accelerator facilities in Rhode Island for a purchase price of $2,850,000, closing the transaction on May 7, 2024[22][28]. - The Company began treating patients at a stand-alone radiation therapy facility in Puebla, Mexico in July 2024[37]. - The Company has established a joint venture in Puebla, Mexico, with an 85% ownership interest, to treat public- and private-paying cancer patients[29]. - The Company expects to construct a linear accelerator facility in Bristol, Rhode Island, with a purchase price of $1,185,000 for the property, anticipating patient treatment to begin in approximately 18 to 24 months[33]. - The Company completed the acquisition of 60% of the equity interests of the RI Companies on May 7, 2024, which operate three radiation therapy facilities in Rhode Island[168]. - The Company acquired real property in Bristol, Rhode Island for $1,185,000 on February 6, 2025[150]. Revenue and Financial Performance - Total revenue for 2024 was $28,340,000, representing a 32.9% increase from $21,325,000 in 2023, driven by new facilities in Puebla, Mexico, and the acquisition of RI Companies[192]. - Revenue from Gamma Knife services in 2024 was $9,716,000, representing 34.3% of total revenue, down from $10,992,000 and 51.5% in 2023[45]. - PBRT revenue decreased by 1.8% to $9,952,000 in 2024, with the number of fractions down 4.3% to 5,139, while average revenue per fraction increased by 2.6% to $1,937[194]. - Gamma Knife revenue fell 11.6% to $9,716,000, with the number of procedures decreasing by 9.3% to 1,084 due to contract expirations[196]. - For the year ended December 31, 2024, 56% of the Company's revenue was derived from the leasing segment, while 44% came from the retail segment[191]. - Revenue sharing arrangements accounted for approximately 47% of total revenue for the year ended December 31, 2024, down from 70% in 2023[175]. - The Company recognized retail revenues of approximately $12,556,000 for the year ended December 31, 2024, compared to $3,553,000 in 2023[179]. Debt and Financing - The Company entered into a $22 million credit agreement in April 2021, which includes a $7 million revolving line of credit for future projects[54]. - A Supplemental Term Loan of $2.7 million was added to the credit agreement in January 2024, maturing on January 25, 2030, to finance capital expenditures in Puebla, Mexico[55]. - A Second Supplemental Term Loan of $7 million was added in December 2024, maturing on December 18, 2029, for capital expenditures related to domestic Gamma Knife leasing operations[56]. - The Company has incurred additional debt through various amendments to its credit agreements, including a $2,700,000 term loan and a $7,000,000 term loan[102]. - As of December 31, 2024, the Company's combined long-term debt, net, totaled $20,182,000, with a $7,000,000 Revolving Line available for future projects[103]. Operational Challenges and Risks - The Company is not in compliance with certain covenants of the DFC Loan as of December 31, 2023, but has received waivers and amendments to address these issues[57]. - The integration of the RI Companies poses risks, including potential disruptions to existing operations and added costs for regulatory compliance[110]. - The Company is addressing a material weakness in internal controls over financial reporting, which could impact its ability to report financial results accurately[114]. - The Company has experienced equipment impairment, with its Gamma Knife portfolio determined to have no remaining salvage value as of December 31, 2024[131]. - The Company faces competition from conventional neurosurgery and radiation therapy, with Gamma Knife radiosurgery being an alternative due to its favorable morbidity outcomes[59]. - The Company is not in compliance with certain debt covenants, but has received waivers to avoid default, which could adversely affect financial condition if future waivers are not granted[107]. Market and Regulatory Environment - The repeal of the Affordable Care Act's individual mandate could lead to a decrease in the number of insured patients seeking Gamma Knife or radiation therapy treatment[78]. - The Company believes it is in compliance with the federal anti-kickback statute, which has been subject to evolving interpretations and could impact its operations[77]. - The Company is subject to various federal civil and criminal laws targeting false claims and fraudulent billing activities, and it believes it is in compliance with the Federal False Claims Act[81]. - The Federal reimbursement rate for outpatient Gamma Knife treatment has been significantly reduced, potentially impacting the Company's return on investment[98]. - The average Medicare reimbursement delivery rate for Gamma Knife is projected to decrease from $7,691 in 2023 to $7,420 in 2024, before rising to $7,645 in 2025[71]. Employee and Operational Structure - The Company has a workforce of 43 full-time employees in the United States and additional staff in Peru, Ecuador, and Mexico, with no union representation[88]. - The Company maintains general and professional liability insurance in the United States, which it believes is adequate for its business operations[87]. - The Company has long-term leases for many facilities, and failure to renew these leases could require relocation or closure of facilities, impacting operations[119]. Technology and Equipment - The Company has begun the process to upgrade its Gamma Knife unit in Peru with an Esprit, expected to be completed around April 2025[42]. - The Company upgraded its Gamma Knife unit in Ecuador to the Esprit, enhancing procedure efficiency[167]. - The Company completed two Esprit upgrades and began installation at a third site during 2024, indicating ongoing investment in technology[219]. Cash Flow and Liquidity - The Company had cash and cash equivalents of $11,275,000 at December 31, 2024, down from $13,808,000 at December 31, 2023, a decrease of $2,533,000[215]. - Operating activities generated $167,000 in cash in 2024, driven by net income of $1,532,000 and non-cash charges for depreciation and amortization of $6,174,000[216]. - Trade accounts receivable increased by $7,267,000 to $11,610,000 at December 31, 2024, with days sales outstanding (DSO) rising to 150 days from 74 days[217]. - The increase in DSO was attributed to the addition of four retail sites during 2024, which generally have longer collection periods[217]. Cybersecurity and Macroeconomic Factors - The Company has established cybersecurity guidelines to protect its IT infrastructure, but there is no guarantee against evolving cyber threats[137]. - The Company has established a comprehensive cybersecurity governance framework overseen by the IT Manager and the Board of Directors to manage cybersecurity risks[144]. - Macroeconomic conditions, including inflation and geopolitical tensions, could negatively impact the Company's business and capital investment decisions[129].

Product Development and Clinical Trials - The lead product candidate, nebokitug, is in early clinical development for primary sclerosing cholangitis (PSC) and systemic sclerosis (SSc) [40]. - A Phase 1a safety study and a Phase 1b multiple ascending dose study of nebokitug have been completed, along with a Phase 2a safety study in metabolic dysfunction-associated steatohepatitis (MASH) patients [40]. - Nebokitug was generally well-tolerated in clinical studies with about 120 participants, with only minor adverse events reported [57]. - The Phase 3 trial for nebokitug in PSC is designed to enroll approximately 350 patients, focusing on moderate to advanced disease, with a primary endpoint of time-to-first clinical event [193]. - The Phase 2 SPRING trial enrolled 76 patients, demonstrating that nebokitug is well tolerated and effective in improving multiple disease-related secondary endpoints over 15 weeks [226]. - The open-label extension of the Phase 2 SPRING trial confirmed continued improvements in liver biomarkers over 48 weeks, with significant reductions in liver stiffness and total serum bile acids [228]. - The Phase 2a trial in MASH patients showed that nebokitug was well tolerated and demonstrated favorable pharmacokinetics and biomarker activity [222][224]. - The clinical development plan for nebokitug is designed to maximize clinical information and support future advancement to registration trials, thereby reducing overall risk [233]. Financial Position and Funding - The company has no products approved for commercial sale and has not generated any revenue to date [38]. - The company expects substantial efforts and expenditures on nebokitug over the next few years, requiring significant investment and marketing efforts before generating any revenues [41]. - The company will need to raise substantial additional funds through public or private equity or debt transactions to complete the development of nebokitug [42]. - Cash and cash equivalents as of December 31, 2024, are expected to fund operations through the first quarter of 2026 [43]. - As of December 31, 2024, the company had incurred an accumulated deficit of $102.6 million and expects to continue incurring significant operating losses for the foreseeable future [81]. - The company had gross proceeds of approximately $1.2 million from sales of equity and grants from the Israel Innovation Authority as of December 31, 2024 [81]. - The company's cash, cash equivalents, and deposits were approximately $14.3 million as of December 31, 2024, which are expected to fund operations through the end of the first quarter of 2026 [81]. - A private placement in July 2024 raised approximately $10 million, extending Chemomab's financial runway through early 2026 [201][211]. - The company may need to raise additional capital, which could lead to dilution or restrictions on operations if financing is not obtained on acceptable terms [163][164]. Regulatory and Market Challenges - The company faces risks related to the lengthy and complex clinical development process, which may result in delays or additional costs [55]. - The approach to treating fibrotic diseases is novel and unproven, with no assurance of developing marketable products [47]. - The company may experience significant setbacks in advanced clinical studies due to lack of efficacy or safety issues [50]. - Regulatory approval processes for product candidates are lengthy and unpredictable, with no guarantee of success, which could significantly harm the company's business [106]. - The company has not yet obtained regulatory approval for any product candidate, including nebokitug, which may hinder market entry [108]. - The FDA may approve product candidates for more limited indications than requested, affecting commercial prospects [112]. - Compliance with extensive regulatory requirements post-approval is necessary, and failure to do so could lead to loss of marketing approval [117]. - The lengthy and unpredictable nature of regulatory approval processes may result in significant resource expenditure without guaranteed outcomes [111]. - The commercialization of product candidates may be delayed if projected development goals are not achieved [128]. Market Opportunity and Competition - The potential market opportunity for nebokitug may be smaller than anticipated, with estimates based on various sources that could prove incorrect [69]. - The company faces substantial competition from major biopharmaceutical and biotechnology companies, which may hinder its product development efforts [130]. - The market acceptance of approved product candidates is uncertain and depends on various factors, including pricing and reimbursement policies [144]. - The inability to obtain adequate reimbursement rates from payors could adversely affect the company's financial condition and ability to raise capital [146]. Operational and Management Considerations - The company anticipates significant growth in employee numbers and operational scope, particularly in product candidate development, regulatory affairs, and sales and marketing [79]. - The company may face difficulties in managing growth, which could disrupt operations and lead to increased expenses and reduced productivity [79]. - The company relies on third-party suppliers for manufacturing clinical drug supplies and lacks internal manufacturing capabilities [135]. - Establishing sales, marketing, and distribution capabilities is crucial for the successful commercialization of products, but the company currently lacks this infrastructure [139]. - The executive team has extensive experience in inflammation, fibrosis, and biologics drug discovery, with key members having over 25 years of relevant experience [232]. Risks Related to External Factors - The ongoing war has led to a downgrade in Israel's credit rating by agencies such as Moody's, S&P Global, and Fitch, indicating a deterioration in economic conditions [153]. - The company is exposed to financial risks due to longer payment cycles and difficulties in collecting accounts receivable, which may be impacted by local and regional financial crises [152]. - The trading price of the company's American Depositary Shares (ADSs) has been highly volatile, with a closing price of $2.46 on September 3, 2024, and $0.51 on January 22, 2024 [166]. - The company is subject to currency fluctuation risks as some expenses are incurred in currencies other than the U.S. Dollar, which may affect operational results [159]. - The company’s commercial insurance does not cover losses from war and terrorism, which could materially affect its business if damages occur [156]. - The global perception of Israel may lead to increased sanctions and boycotts against Israeli companies, potentially impacting business operations [157]. - The company’s ability to operate may be affected by proposed changes to Israel's judicial system, which could lead to political instability or civil unrest [158]. Intellectual Property and Compliance - The company has received Orphan Drug Designation for nebokitug in connection with three indications, which may provide market exclusivity benefits [74]. - The transition to a "first-to-file" patent system in the U.S. may increase uncertainties and costs related to patent applications and enforcement [99]. - The AIA allows third parties to challenge patent validity, potentially impacting the company's patent rights and competitive position [100]. - Non-compliance with patent maintenance requirements could result in abandonment or loss of patent rights, impacting competitive position [105]. - The company has secured new patents for nebokitug in Europe, Brazil, and Israel, covering its use in treating liver diseases like PSC [207]. Strategic Focus and Future Directions - Chemomab has developed nebokitug, a monoclonal antibody targeting CCL24, with a market opportunity exceeding $1 billion for primary sclerosing cholangitis (PSC) and over $1.5 billion for systemic sclerosis (SSc) in the U.S., EU, and Japan [188][189]. - Chemomab's innovative approach targets the dual mechanisms of fibrosis and inflammation, addressing high unmet needs in rare diseases [188][189]. - The company is exploring nebokitug's potential in other fibrotic-inflammatory diseases, including idiopathic pulmonary fibrosis and MASH, based on promising preclinical results [220][230]. - Chemomab completed its End-of-Phase 2 Meeting with the FDA, aligning on a Phase 3 study design for nebokitug in PSC, which aims for regulatory approval based on a single pivotal trial without liver biopsies [199].

Distribution Announcement - MV Oil Trust announced its quarterly distribution for the payment period ended March 31, 2025[5] - The press release regarding the quarterly distribution was issued on April 4, 2025[5] - The financial statements and exhibits related to the quarterly distribution are included in the filing[7] Company Classification - MV Oil Trust is classified as an emerging growth company[4] Trading Information - The Trust's units of beneficial interest are traded under the symbol MVO on The New York Stock Exchange[3]