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PowerUp Acquisition (PWUP) - 2024 Q4 - Annual Report
PWUPPowerUp Acquisition (PWUP)2025-04-07 11:30

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 1.07billionorthemarketvalueofitsClassAordinarysharesheldbynon−affiliatesequalsorexceeds1.07 billion or the market value of its Class A ordinary shares held by non-affiliates equals or exceeds 700 million[68]. - The company had 0initsoperatingbankaccountandaworkingcapitaldeficitof0 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 250,000,000fromthesaleof25,000,000units[191].−FortheyearendedDecember31,2024,netcashusedinoperatingactivitieswas250,000,000 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].−Thecompanyhasneverdeclaredorpaidanycashdividendsonitscommonstockanddoesnotexpecttodosointheforeseeablefuture[182].−Futurecapitalstockissuancescoulddiluteexistingshareholders′ownershipandinfluenceovercompanymatters[166].−ThemarketpriceofAspire′scommonstockmayexperiencesignificantvolatility,influencedbyvariousoperationalandmarketfactors[164].IntellectualPropertyandCompetitiveLandscape−AspireacquiredallintellectualpropertyofInstaprinPharmaceuticalsforapurchasepriceof13,781,323[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 5,000,000ofsalesand105,000,000 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].