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[142]. - Aspire's recent recapitalization involved a merger with PowerUp Acquisition Corp, resulting in Aspire Biopharma, Inc becoming a wholly owned subsidiary of New Aspire, with stockholders receiving shares valued at $350 million[179]. - The Business Combination was accounted for as a reverse recapitalization, treating PowerUp as the legal acquirer and Aspire Biopharma as the accounting acquirer[188]. - Aspire Biopharma Inc's existing stockholders will retain over 64.4% voting interest in New Aspire post-business combination[192]. Product Development and Clinical Trials - The company is developing a high-dose sublingual aspirin product, with clinical trials expected to conclude by June 30, 2025, to support a 505(b)(2) New Drug Application (NDA) submission[147][159]. - Aspire's initial clinical trial (Trial 1) will evaluate pharmacokinetic endpoints, including Cmax, Tmax, and AUC, comparing its sublingual aspirin to standard oral aspirin[157]. - Aspire plans to seek FDA Fast Track designation for its high-dose aspirin product in 2025, leveraging over 100 years of safety data associated with aspirin[153]. - Aspire has developed a working formulation for sublingually administered melatonin in 3mg, 5mg, and 10mg doses, with plans for a limited pharmacokinetic study[160]. - The company is also working on sublingually administered vitamins D, E, and K, with a manufacturing process development planned for the first three quarters of 2025[161]. - Aspire is developing a sublingual testosterone formulation, with a Phase One clinical test expected in Q4 2025 and an NDA submission anticipated in Q1 or Q2 2026[162]. - A working formulation for sublingual semaglutide is in the final phases, with a timeline to market similar to testosterone, as it is also not 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, following consumer and safety testing[164]. - The company is exploring formulations for various drugs, including anti-nausea and anti-psychotic products, with market entry dependent on R&D and funding[165]. Manufacturing and Supply Chain - Aspire's manufacturing strategy relies on third-party contract manufacturers, with a current agreement with Glatt for the production of its aspirin product[144][145]. Sales and Marketing Strategy - 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]. - Aspire is exploring licensing opportunities for its melatonin formulation, which does not require FDA approval as it is classified as a supplement[160]. Financial Performance and Condition - For the three months ended March 31, 2025, the net loss was $15,941,328, an increase of $15,710,358 compared to a net loss of $230,970 for the same period in 2024[223]. - General and administrative expenses rose to $15,073,548 for the three months ended March 31, 2025, up $14,940,744 from $132,804 in the prior year, primarily due to increased stock-based compensation and professional services[224]. - Research and development expenses increased to $263,093 for the three months ended March 31, 2025, compared to $10,500 in 2024, reflecting higher personnel and supplies costs[225]. - Sales and marketing expenses were $219,839 for the three months ended March 31, 2025, an increase of $132,173 from $87,666 in the previous year, driven by higher marketing costs[226]. - Net cash used in operating activities was $1,751,528 for the three months ended March 31, 2025, compared to $192,971 in 2024, attributed to the net loss and changes in working capital[235]. - Net cash provided by financing activities was $3,094,438 for the three months ended March 31, 2025, a significant increase from $229,084 in the prior year, mainly due to higher proceeds from stock issuances[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, with cash reserves of $1,346,543[230]. - The company anticipates earning revenue from pharmaceutical and nutraceutical products, but as of March 31, 2025, no revenue has been earned[207]. - Operating expenses include general and administrative, research and development, and sales and marketing costs, which are monitored to ensure sufficient capital for operations[211][213]. - The company anticipates that general and administrative, research and development, and sales and marketing expenses will continue to increase in future periods in line with business growth[224][225][226]. - The company has no off-balance sheet financing arrangements as of March 31, 2025, and does not engage in transactions that create variable interest entities[237]. - The company faces substantial doubt about its ability to continue as a going concern due to its liquidity condition, as assessed in accordance with relevant accounting standards[233]. Competition and Market Position - Aspire faces competition from larger pharmaceutical companies with greater resources and experience, which may impact its ability to develop and commercialize products[166][167]. - The company expects its products to compete based on efficacy, safety, convenience, and price, with potential challenges from generic products and reimbursement issues[169][170]. Financing Activities - The Company entered into an Equity Line of Credit Agreement allowing it to direct Arena to purchase up to $100,000,000 in common stock[190]. - The purchase price for ELOC Shares will be 96% of the VWAP, with a floor price of $4.00 per share[193]. - 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 two compliance deficiency notices from Nasdaq regarding a minimum Market Value of Listed Securities of $50,000,000 and a minimum bid price of $1.00 per share[198][199]. - The Company entered into a settlement agreement to resolve default notices, extending the maturity dates of key promissory notes by 75 days[204]. - The Company will issue 625,000 shares of common stock as part of the settlement agreement, with registration to be filed by May 13, 2025[205].
Powerup Acquisition Corp.(PWUPU) - 2025 Q1 - Quarterly Report