Company Overview Summary

General Description

• Company Name: Aspire Biopharma Holdings, Inc.
• Type: Early-stage biopharmaceutical company
• Incorporation: Delaware, formed in February 2025
• Business Focus: Developing and marketing disruptive technology for novel sublingual drug delivery mechanisms, initially targeting known drugs such as aspirin.

Main Business Activities

• Technology Development:
  • Proprietary sublingual absorption systems designed for rapid drug delivery that bypasses the gastrointestinal tract.
  • Patent-pending formulations (e.g., for aspirin and high-dose aspirin).
  • Development of soluble, pH-neutral, fast-acting powders or granules.
• Product Focus:
  • Initial focus on a high-dose sublingual aspirin product ("Instaprin") for rapid treatment of heart attacks and strokes.
  • Development of additional products like melatonin sleep aids, vitamins D/E/K, testosterone, semaglutide, caffeine pre-workout, and other classes (anti-nausea, anti-psychotic, ED, seizure meds).
  • Aims to target the opioid crisis and promote rapid, effective pain and inflammation relief.

Regulatory & Patent Status

• Filed multiple patent applications, including:
  • One in March 2023 (application no. 63/456,290) aimed at patent protection for its aspirin technology.
  • Filed a patent application in October 2024 (application no. 63/702,381) for high-dose aspirin.
  • Pending patents and patent applications related to sublingual formulations.
• Patents expiring: primary patent applications expected to have patent life until 2044-2045.
• Trademark: "Instaprin"Trademark Serial No. 98793226 (pending).

Manufacturing & Development

• Contract manufacturing agreements (not owning manufacturing facilities).
• Has developed a batch of cGMP high-dose aspirin for clinical trials (manufactured in New Jersey).
• Clinical trials planned for April 2025 to evaluate pharmacokinetics and pharmacodynamics.
• Product development includes stability testing, formulation validation, and clinical testing (Bioavailability and Pharmacodynamic studies).

Market & Commercial Strategy

• Plans to seek FDA Fast Track designation for prescription high-dose aspirin.
• Intended to retail in the prescription and OTC markets, with a focus on hospital, specialty care, and OTC distribution.
• No current sales, marketing, or distribution infrastructure.
• Expect to start commercialization by building a sales force in the U.S. and entering international distribution agreements if approved.

Financial and Business Status

• No products currently on the market or generating revenue.
• Incorporated in 2025; prior operations were preclinical and development activities.
• Operates with a small team of officers and directors, with plans to expand as products progress.
• Anticipates continued significant R&D expenses, clinical trial costs, and regulatory costs.
• Has secured sufficient capital for operations following its recent Business Combination completed on February 17, 2025.

Key Executives

• CEO: Kraig Higginson (appointed September 2021)
• CFO: Ernest Scheidemann (appointed July 2022)

Employees

• Exact number of employees not specified.
• Management team includes experienced executives with backgrounds in biotech, finance, and operations.

Revenue & Income

• As of December 31, 2024:
  • No revenue reported as the company is early-stage and still in development.
  • Net loss for 2024: $12,537,472 (due to R&D, clinical trials, and operational expenses).
  • 2023: Net income of $4,464,079 (likely due to prior operational activities and interest income).

Note: The company's operations are primarily focused on technology development, patent filings, clinical trials, and regulatory planning, with no current product sales or revenue.