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ESTERO, FL - Aspire Biopharma Holdings, Inc. (NASDAQ:ASBP), a small-cap pharmaceutical company with a current market capitalization of $28.5 million, announced Wednesday that its sublingual aspirin formulation significantly inhibited serum thromboxane B2, a biomarker for blood clot formation, within two minutes of administration in clinical trials.
The company’s final results from its randomized crossover bioavailability trial showed the sublingual formulation acted approximately twice as fast as the current recommended treatment of chewed aspirin tablets. This rapid inhibition could be critical during suspected heart attacks, when blood clots blocking heart arteries can cause permanent muscle damage. According to InvestingPro data, while ASBP has shown strong returns over the past month, the company is not yet profitable, with a negative earnings per share of -$0.38 in the last twelve months.
"The final results from our recent clinical trial confirm our belief that our high dose sublingual aspirin has the potential to be a life-changing, market-leading treatment for patients experiencing a suspected heart attack," said Kraig Higginson, Interim Chief Executive Officer of Aspire, in a press release statement.
The study involved six healthy subjects aged 40-65 who were administered 162 mg aspirin doses in three different treatment periods. The primary objective was to evaluate the bioavailability of acetylsalicylic acid in plasma over eight hours after dosing.
According to the American College of Cardiology/American Heart Association guidelines, aspirin should be initiated with a loading dose of 162-325 mg in patients with Acute Coronary Syndromes as soon as possible. Aspire’s sublingual product delivers 162.5 mg of aspirin, within the recommended range.
The company plans to review its clinical trial results with the U.S. Food and Drug Administration to enable a potential regulatory submission for accelerated approval in the third quarter of 2025. InvestingPro analysis reveals that ASBP’s current ratio of 0.09 indicates potential challenges in meeting short-term obligations, a crucial factor for investors monitoring the company’s path to FDA approval. Get access to 6 more exclusive InvestingPro Tips and comprehensive financial metrics to better evaluate ASBP’s investment potential.
Aspire noted that approximately 800,000 Americans experience acute myocardial infarction annually, resulting in about 300,000 deaths. The company’s sublingual aspirin remains an investigational new drug and has not been approved for marketing by the FDA. Despite the significant market potential, ASBP’s stock has experienced a 95% decline year-to-date, trading at $0.58, though recent weeks have shown positive momentum with an 8% return over the past week.
In other recent news, Aspire Biopharma Holdings, Inc. has entered into a Securities Purchase Agreement, selling notes with a principal amount of $9.7 million for a subscription price of $7.75 million. These notes, which mature in February 2026, are convertible into common stock and come with a 20% original issue discount. Aspire Biopharma also launched a direct-to-consumer website, buzzbomb.buzz, for its sublingual caffeine product, BUZZ BOMB, designed for quick energy delivery. Additionally, the company plans to introduce BUZZ BOMB at two major fitness conventions in early August, including FitCon in Salt Lake City and FitExpo in Anaheim. In a strategic move, Aspire Biopharma has relocated its headquarters to Estero, Florida, as approved by its Board of Directors. The company also announced the appointment of Michael C. Howe as its new CEO, who brings over four decades of experience in consumer and healthcare sectors. Howe takes over as the company gears up for significant milestones, including a clinical trial and product launch slated for 2025.
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