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Aspire Biopharma Announces Positive Top-Line Results from Clinical Trial of Investigational New Sublingual Aspirin Product for Treatment of Suspected Acute Myocardial Infarction (Heart Attack)

• According to the , Acute myocardial infarction (AMI) is a major cause of death, affecting nearly 3 million Americans each year and resulting in over a million deaths

• Trial demonstrates dramatically higher and more rapid therapeutic impact compared to standard chewed aspirin tablets in clinical trial

• Aspire's sublingual aspirin was safe and well-tolerated

• Aspire plans to review clinical trial results with the FDA to enable a potential regulatory submission for accelerated approval

ESTERO, FL / / August 18, 2025 / Aspire Biopharma Holdings, Inc. (Nasdaq:ASBP) ("Aspire" or the "Company"), developer of a multi-faceted patent-pending drug delivery technology, today announced positive top-line data from its recent randomized, crossover bioavailability trial to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of Aspire's investigational new sublingual aspirin product compared to chewed uncoated aspirin tablets in healthy adults. Pharmacokinetics is the term that describes the four stages of absorption, distribution, metabolism, and excretion of drugs. Pharmacodynamics (sometimes described as what a drug does to the body) is the study of the biochemical, physiologic, and molecular effects of drugs on the body.

The Aspire sublingual aspirin product produced higher and more rapid mean plasma concentrations of acetylsalicylic acid (ASA, the active antiplatelet form of aspirin) compared to chewed aspirin tablets (p<0.05). Significant improvement in absorption was evident within five minutes and continued throughout the first half-hour after dosing. Higher and more rapid mean plasma concentrations imply that the drug is absorbed quickly and reaches a higher concentration in the bloodstream shortly after administration. The product was also safe and well-tolerated by patients, and no adverse events were reported.

Aspire Benefits of Sublingual Aspirin Drug Delivery and Bypassing the Gut vs Standard Oral Aspirin

• Rapid absorption through the blood vessels directly, bypassing first-pass metabolic processes

• Faster onset of action

• Sublingual route avoids exposing the drug to the harsh acidic environment of the stomach and digestive enzymes

• Reduced drug-food and drug-drug interactions

• Lower risk of GI irritation

• Ease of administration and use in emergency situations

Clinical trial AB-101 was a randomized crossover bioavailability study of Aspire's investigational new sublingual aspirin product compared to chewed uncoated aspirin tablets. Six otherwise healthy 40 to 65-year-old subjects were administered 162 mg aspirin as a single dose in each of three treatment periods separated by two 14-day washout periods. Two different investigational sublingual powder and granule formulations (Aspire Biopharma) and chewed uncoated oral aspirin tablets (Bayer) were studied. The primary objective of the clinical trial was to evaluate the bioavailability of ASA in plasma over eight hours after dosing.

"We are extremely pleased to report these highly positive results for our sublingual aspirin formulation, providing an important validation of our drug delivery technology," said Kraig Higginson, Chief Executive Officer of Aspire. "The effectiveness of aspirin in treating a heart attack is dependent on the time it takes to deliver ASA into the bloodstream. The ability to achieve higher and more rapid ASA concentrations for patients with suspected acute MI could save lives. We would like to thank the patients, investigators and their staff for participating in the trial, and we look forward to working with regulatory agencies to discuss next steps as we work to advance this innovative therapy and improve the treatment options for patients with suspected acute MI."

Aspire is developing its investigational sublingual aspirin product for treatment of suspected acute myocardial infarction (AMI, blockage of blood flow to heart muscle causing damage or death of heart tissue - commonly known as a "heart attack"). There are an estimated 18 million Americans living with coronary artery disease with approximately 800,000 per year experiencing an AMI leading to 300,000 deaths.

Oral aspirin is FDA-approved for treatment of suspected AMI with the initial dose of 160-162.5 mg is administered as soon as an AMI is suspected.^[i] In a large, multicenter study of aspirin, streptokinase, and the combination of aspirin and streptokinase in 17,187 patients with suspected AMI, aspirin treatment produced a 23 percent reduction in the risk of death from cardiovascular diseases within five weeks.^[ii] Clinical practice guidelines recommend that aspirin be initiated as soon as possible with the initial dose chewed, when possible, to achieve faster onset of antiplatelet action.^[iii]

Aspire's sublingual aspirin is an investigational new drug and has not been approved for marketing by FDA or any other government regulatory authority.

About Aspire Biopharma, Inc.

Aspire Biopharma has developed a patent-pending sublingual delivery technology that can deliver drugs, nutraceuticals and supplements to the body rapidly and precisely. This allows for greater effectiveness and reduced side effects by going directly to the bloodstream and avoiding the gastrointestinal tract. Aspire Biopharma's delivery technology can be applied to many different active pharmaceutical ingredients (APIs) and other bioactive substances, spanning both small and large molecule therapeutics, nutraceuticals and supplements.

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