Business Combination and Corporate Structure - Aspire Biopharma Holdings, Inc. completed its Business Combination on February 17, 2025, transitioning from a privately held corporation to a publicly traded entity[130]. - The Business Combination with PowerUp Acquisition Corp. resulted in Aspire Biopharma, Inc. becoming a wholly owned subsidiary, with stockholders receiving shares valued at $350 million[169]. - Aspire Biopharma Inc's existing stockholders will hold more than 64.4% of the voting interest in New Aspire under both no redemption and maximum redemption scenarios[181]. Product Development and Clinical Trials - The company is focused on developing and marketing a novel sublingual delivery mechanism for drugs, with an emphasis on high-dose aspirin products[129][141]. - Aspire has entered into a development and manufacturing agreement with Glatt to produce high-dose sublingual aspirin for clinical trials, with the first batch manufactured in March 2025[133][144]. - A clinical trial evaluating the pharmacokinetics of Aspire's sublingual aspirin was completed in July 2025, with results expected in August 2025[135][149]. - Aspire plans to submit a section 505(b)(2) NDA for its high-dose aspirin product, aiming for FDA approval to market the product for treating suspected acute myocardial infarction[149]. - Aspire is developing a sublingual testosterone formulation, with a Phase One clinical test planned for Q3 2026, involving approximately eight volunteers[152]. - A sublingual semaglutide product is in the final phases of development, with a timeline to market similar to that of testosterone[153]. - Aspire has developed a single dose sublingual pre-workout supplement and a "coffee or soda replacement" product, with initial sales planned for Q3 2025[154]. - The company is considering formulations for various drugs, including anti-nausea and anti-psychotic products, with plans to take several to market based on research and funding[155]. Financial Performance and Expenses - For the three months ended June 30, 2025, the net loss was $1,981,293, an increase of $1,884,370 compared to a net loss of $96,923 for the same period in 2024[215]. - General and administrative expenses for the three months ended June 30, 2025, were $395,692, up $309,269 from $86,423 in the same period in 2024[216]. - Research and development expenses for the three months ended June 30, 2025, were $352,887, an increase of $342,387 compared to $10,500 for the same period in 2024[217]. - Sales and marketing expenses for the three months ended June 30, 2025, were $51,311, reflecting an increase from $0 in the same period in 2024[218]. - For the six months ended June 30, 2025, the net loss was $17,922,621, an increase of $17,594,728 compared to a net loss of $327,893 for the same period in 2024[222]. - General and administrative expenses for the six months ended June 30, 2025, were $15,469,240, an increase of $15,250,013 from $219,227 in the same period in 2024[223]. - Research and development expenses for the six months ended June 30, 2025, were $615,980, an increase of $594,980 compared to $21,000 for the same period in 2024[224]. - Net cash used in operating activities was $2,891,838 for the six months ended June 30, 2025, compared to $249,215 for the same period in 2024[235]. - Net cash provided by financing activities was $3,094,438 for the six months ended June 30, 2025, compared to $257,645 for the same period in 2024[236]. - The company had an accumulated deficit of $20,699,854 as of June 30, 2025, with a working capital deficit of $9,567,500 and cash of $206,233[230]. Market Strategy and Competition - Aspire's new aspirin formulation aims to provide rapid absorption without gastrointestinal toxicity, targeting the opioid crisis by offering effective pain management[142]. - The company is exploring the possibility of obtaining an OTC FDA Monograph permit for its aspirin product to expedite market entry[143]. - Aspire's competitive landscape includes major pharmaceutical companies with greater resources and experience, posing challenges in product development and market entry[156][157]. - The company expects its products to compete based on efficacy, safety, convenience, and pricing, with a premium price over generic products anticipated[159][160]. - Aspire's aspirin products will compete with established brands, and there are currently no sublingual aspirin products on the market[162]. Corporate Governance and Management - The Company appointed Michael Howe as CEO on June 10, 2025, following the resignation of Kraig Higginson[196]. - The Company is currently undergoing a search for a permanent CEO after Michael Howe stepped down from the role[197]. - The Company maintains that it was not in default regarding the timely filing of its Form 10-K and related documents[192]. Financing and Capital Structure - Aspire issued $3.75 million in senior secured convertible debentures under a Securities Purchase Agreement, with a conversion price tied to the stock's trading price[175]. - The Company entered into an Equity Line of Credit Agreement allowing for the purchase of up to $100,000,000 in shares of common stock[179]. - The Company issued two 20% original issue discount senior secured convertible debentures totaling $3,750,000, with a conversion price set at 92.5% of the lowest daily VWAP[185][186]. - The Company received a Nasdaq compliance deficiency notice regarding a Market Value of Listed Securities below $50,000,000, with a 180-day period to rectify the issue[188]. - The Company entered into a settlement agreement to resolve default notices and extend the maturity dates of key promissory notes by 75 days[194].
Powerup Acquisition Corp.(PWUPU) - 2025 Q2 - Quarterly Report