Corporate Actions - Aspire Biopharma Holdings, Inc. completed a Reverse Acquisition on February 17, 2025, changing its name from PowerUp Acquisition Corp.[150] - The Reverse Acquisition on February 17, 2025, resulted in Aspire Biopharma, Inc becoming a wholly owned subsidiary of New Aspire, with stockholders receiving shares valued at $350 million[183]. - The Reverse Acquisition was treated as a reverse recapitalization, with Aspire recognized as the accounting acquirer for financial reporting purposes[191]. Product Development - The company plans to submit a 505(b)(2) New Drug Application (NDA) for its high-dose sublingual aspirin product in early 2026, following positive clinical trial results[154][165]. - A clinical trial in July 2025 demonstrated that Aspire's sublingual delivery technology provides faster aspirin bioavailability compared to standard oral tablets[154]. - Aspire has developed a sublingual melatonin sleep-aid product in 3mg, 5mg, and 10mg doses and is exploring licensing possibilities[167]. - The company is also developing sublingually administered vitamins D, E, and K, with plans to patent these formulations[168]. - Aspire is developing a sublingual semaglutide product, with a market timeline of 2-3 years for FDA approval[169]. - Aspire's caffeine products include a single dose sublingual pre-workout supplement and a coffee/soda replacement, with initial sales expected in Q3 2025[170]. - The company is exploring formulations for various drugs, including anti-nausea and anti-psychotic products, leveraging its sublingual administration technology[171]. Intellectual Property - The company has filed patent applications for its new sublingual delivery technologies, including a high-dose version of its aspirin product[159]. - Aspire's patent applications for its sublingual absorption technology have nominal expirations in 2044 and 2045, covering formulations and uses[177]. Market Strategy - Aspire's aspirin product aims to target the heart attack and stroke prevention market, leveraging its rapid absorption technology to mitigate gastrointestinal side effects[160]. - Aspire's strategy includes potential licensing or collaboration agreements to generate revenue through development funding and milestone payments[151]. - Aspire faces competition from larger biopharmaceutical companies with greater resources and experience in drug development and commercialization[173]. - The company anticipates that its products will compete based on efficacy, safety, convenience, and price, with a premium pricing strategy over generics[175]. - Aspire's aspirin products will compete with established brands like Bayer and Advil, with no current sublingual aspirin products on the market[176]. Financial Performance - For the three months ended September 30, 2025, the company reported net revenue of $1,941,000, with a cost of goods sold of $1,057,000, resulting in a gross profit of $884,000[234]. - General and administrative expenses for the three months ended September 30, 2025, were $512,993, an increase of $321,415 compared to $191,578 for the same period in 2024[236]. - Research and development expenses for the three months ended September 30, 2025, were $207,899, reflecting a significant increase of $200,899 from $7,000 in the prior year[237]. - Sales and marketing expenses for the three months ended September 30, 2025, totaled $425,489, up $408,811 from $16,678 in the same period of 2024[238]. - The company incurred an interest expense of $1,480,058 for the three months ended September 30, 2025, primarily due to the accrual of interest on convertible notes and related party debt[239]. - The company reported a net loss of $1,850,493 for the three months ended September 30, 2025, compared to a net loss of $216,269 for the same period in 2024, reflecting an increase in losses of $1,634,224[234]. - The loss from operations for the nine months ended September 30, 2025, was $17,501,867, compared to a loss of $543,149 for the same period in 2024, indicating an increase of $16,958,718[240]. - As of September 30, 2025, the company had an accumulated deficit of $22,550,347 and a working capital deficit of $11,457,377, with cash reserves of $1,948,271[248]. Financing Activities - 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[188]. - 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, with a purchase price set at 96% of the VWAP, subject to a floor price of $4.00 per share[192]. - The Company issued 1,893,473 ELOC Commitment Shares to Arena, with 786,946 being freely tradable under a leak out agreement limiting sales to 15% of daily trading volume[194]. - The Company incurred debt issuance costs of $907,500 related to the August 2025 Notes, which have a principal amount of $9,687,500 and a maturity date of February 19, 2026[199]. - The company raised approximately $265,827 in February 2025 and $7,750,000 in August 2025, with plans to raise up to $100,000,000 through an ELOC agreement[249]. - Net cash provided by financing activities was $5,940,286 for the nine months ended September 30, 2025, a significant increase from $750,122 in the prior year[253]. Compliance and Regulatory Issues - The Company received two compliance deficiency notices from Nasdaq regarding a Market Value of Listed Securities below $50,000,000 and a bid price below $1.00 per share[203][204]. - The Company did not regain compliance with Nasdaq listing rules, leading to a notification of potential delisting on October 15, 2025[205]. - Management has raised substantial doubt about the company's ability to continue as a going concern for the next twelve months due to liquidity concerns[250]. Operating Expenses - Operating expenses are classified into general and administrative, research and development, and sales and marketing expenses[214]. - For the nine months ended September 30, 2025, general and administrative expenses reached $15,982,233, a substantial increase of $15,571,428 from $410,805 in the same period of 2024[242]. - Research and development expenses for the nine months ended September 30, 2025, were $823,879, compared to $28,000 for the same period in 2024, indicating a rise of $795,879[243]. - Sales and marketing expenses for the nine months ended September 30, 2025, were $696,639, a significant increase of $592,295 compared to $104,344 for the same period in 2024[244]. - Interest expense for the nine months ended September 30, 2025, totaled $2,297,882, primarily due to the accrual of interest on convertible notes and related party debt[245]. - The change in fair value of derivative liabilities and convertible notes was $390,744 for the nine months ended September 30, 2025[246]. - The company recorded a loss of $364,109 on extinguishment of debt for the nine months ended September 30, 2025, related to the amendment of the Blackstone Note[247].
PowerUp Acquisition (PWUP) - 2025 Q3 - Quarterly Report