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ESTERO, FL - Aspire Biopharma Holdings, Inc. (NASDAQ:ASBP), a micro-cap pharmaceutical company currently valued at $10.2 million, announced key development milestones for its sublingual drug delivery technology pipeline through early 2026, according to a press release statement issued Wednesday. According to InvestingPro data, the stock has seen significant volatility, trading near its 52-week low of $0.20.
The company’s lead program, a sublingual high-dose aspirin formulation, is targeted for New Drug Application submission in the second half of 2025. Aspire reported that recent clinical results showed their sublingual aspirin produced higher and more rapid plasma concentrations compared to chewed aspirin tablets, with significant inhibition of serum thromboxane B2 within two minutes after dosing. The company’s development efforts come amid challenging financial metrics, with InvestingPro data showing a current ratio of 0.09 and negative earnings per share of $0.38.
Two additional pipeline candidates include a sublingual erectile dysfunction medication and a sublingual semaglutide formulation, both scheduled for formulation finalization and clinical testing in the first half of 2026.
The company’s technology aims to deliver medications directly to the bloodstream through sublingual administration, potentially bypassing gastrointestinal tract issues associated with oral medications.
"By utilizing our disruptive sublingual drug delivery to develop new formulations of known generic drugs, we believe Aspire can provide improved patient outcomes and treatment options for many existing drugs," said Kraig Higginson, Interim CEO of Aspire Biopharma, in the press release.
The company is pursuing a 505(b)(2) regulatory pathway for its high-dose aspirin product, which would allow it to rely partly on previously established safety and efficacy data for FDA-approved aspirin.
Aspire also indicated it is exploring formulations for anti-nausea products, anti-psychotic medications, and seizure treatments using its sublingual delivery platform.
In other recent news, Aspire Biopharma Holdings, Inc. reported the completion of a $1 million funding tranche, part of a larger Securities Purchase Agreement, bringing their total funding to approximately $5.7 million out of a planned $7.75 million. Additionally, the company has entered into a $9.7 million note purchase agreement with investors, offering notes with a 20% original issue discount, set to mature in February 2026. In clinical developments, Aspire announced that its sublingual aspirin formulation demonstrated rapid blood clot inhibition in trials, acting twice as fast as traditional chewed aspirin tablets. This could have significant implications for treating suspected heart attacks. Furthermore, Aspire has launched a direct-to-consumer website, buzzbomb.buzz, for its sublingual caffeine product, BUZZ BOMB, aimed at providing rapid energy to athletes. The company plans to showcase this supplement at major fitness expos, including FitCon and FitExpo, in early August. Lastly, Aspire announced a change in its independent registered public accounting firm, as detailed in a recent SEC filing.
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