Business Combination and Financial Structure - Aspire Biopharma Holdings, Inc. completed its Business Combination on February 17, 2025, transitioning from a privately held corporation to a publicly traded entity[142]. - Aspire's Business Combination with PowerUp Acquisition Corp. was completed on February 17, 2025, resulting in Aspire Biopharma, Inc. becoming a wholly owned subsidiary of New Aspire[179][185]. - The Business Combination involved Aspire Biopharma, Inc. stockholders receiving shares valued at $350 million, adjusted for cash and indebtedness at closing[179]. - Aspire issued $3.75 million in senior secured convertible debentures as part of a Securities Purchase Agreement, with a conversion price based on the lowest daily VWAP[186]. - The Business Combination was accounted for as a reverse recapitalization, treating Aspire Biopharma, Inc. as the accounting acquirer[188]. - The Company entered into an Equity Line of Credit Agreement allowing it to direct Arena to purchase up to $100,000,000 in shares of common stock[190]. - The Company issued two 20% original issue discount senior secured convertible debentures totaling $3,750,000, with a conversion price of 92.5% of the lowest daily VWAP[195]. - The Company received a Nasdaq notice for failing to maintain a minimum Market Value of Listed Securities of $50,000,000 for 30 consecutive business days[198]. - The Company is entitled to a 180-day period to rectify the MVLS deficiency, ending on October 13, 2025[198]. - The Company received a second Nasdaq notice for not maintaining a minimum bid price of $1.00 per share for continued listing[199]. - The Company entered into a settlement agreement to resolve default notices and extend maturity dates of key promissory notes by 75 days[203]. - The Company agreed to issue 625,000 shares of common stock to Blackstone Capital Advisors, Inc. as part of the settlement agreement[205]. 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 sublingual aspirin, branded as "Instaprin"[141][145]. - Aspire plans to conduct a clinical trial to evaluate the pharmacokinetics of its sublingual aspirin product, with the trial expected to enroll at least eight healthy adult volunteers and conclude by June 30, 2025[147]. - The company has entered into a development and manufacturing agreement with Glatt to produce its high-dose sublingual aspirin for clinical trials, with the first batch manufactured in March 2025[145][155]. - Aspire aims to submit a section 505(b)(2) NDA for its high-dose aspirin product following the completion of its clinical trials, targeting FDA approval for treatment of suspected acute myocardial infarction[159]. - The company is also developing sublingually administered melatonin and vitamins D, E, and K, with plans to validate manufacturing processes and conduct pharmacokinetic studies in 2025[160][161]. - Aspire is developing a sublingual testosterone formulation, with a Phase One clinical test expected in Q4 2025, involving approximately eight volunteers[162]. - A sublingual semaglutide product is in the final phases of development, with a timeline to market similar to testosterone, as it is not likely a candidate for fast-track approval[163]. - Aspire has developed a single dose sublingual pre-workout supplement and a "coffee or soda replacement" product, with plans to launch around July 1, 2025[164]. - The company is exploring formulations for various drugs, including anti-nausea and anti-psychotic products, with market entry dependent on research and funding[165]. Financial Performance and Expenses - As of March 31, 2025, the Company has not earned any revenue from the sale or licensing of products[207]. - Operating expenses include general and administrative, research and development, and sales and marketing costs[211]. - General and administrative expenses increased to $15,073,548 for the three months ended March 31, 2025, up from $132,804 in the same period of 2024, reflecting a rise of $14,940,744[224]. - Research and development expenses rose to $263,093 for the three months ended March 31, 2025, compared to $10,500 for the same period in 2024, an increase of $252,593[225]. - Sales and marketing expenses increased to $219,839 for the three months ended March 31, 2025, up from $87,666 in the same period of 2024, reflecting a rise of $132,173[226]. - The net loss for the three months ended March 31, 2025, was $15,941,328, compared to a net loss of $230,970 for the same period in 2024, an increase in loss of $15,710,358[223]. - Net cash used in operating activities was $1,751,528 for the three months ended March 31, 2025, compared to $192,971 for the same period in 2024, indicating a significant increase in cash outflow[235]. - Net cash provided by financing activities was $3,094,438 for the three months ended March 31, 2025, compared to $229,084 in the same period of 2024, reflecting a substantial increase in cash inflow[236]. - As of March 31, 2025, the company had an accumulated deficit of $18,718,561 and a working capital deficit of $6,903,439[230]. - The company received approximately $265,827 in proceeds from business combination and subscription agreements in February 2025, along with $100,000,000 from an ELOC Agreement[231]. - The company anticipates that its general and administrative, research and development, and sales and marketing expenses will continue to increase in future periods due to business growth[224][225][226]. - The company's liquidity condition raises substantial doubt about its ability to continue as a going concern for the next twelve months[233]. Market Competition and Strategy - Aspire faces competition from larger pharmaceutical companies with greater resources and experience in drug development and commercialization[166][167]. - The company expects its products to compete based on efficacy, safety, convenience, and price, with potential challenges from generic products[169][170]. - Aspire is exploring licensing agreements for its products, which may include development funding and milestone payments[143]. - The company has not yet established a sales or marketing infrastructure but plans to build a focused sales organization in the U.S. upon receiving marketing approvals[149][150]. Compliance and Manufacturing Practices - The company is committed to compliance with current good manufacturing practices (cGMP) and has engaged contract manufacturers to support its production needs[146]. - Aspire's new patent-pending formulation for its aspirin product is designed to provide rapid absorption and therapeutic effects without gastrointestinal toxicity, addressing limitations of traditional aspirin[152][153].
PowerUp Acquisition (PWUP) - 2025 Q1 - Quarterly Report