Aspire Biopharma Provides Q3 2025 Business Update
Rhea-AI Summary
Aspire Biopharma (Nasdaq:ASBP) provided a Q3 2025 business update highlighting clinical, regulatory, IP, commercial, and manufacturing progress.
Key disclosed developments: the company reported positive final bioavailability data for its sublingual high-dose aspirin showing platelet inhibition in under 2 minutes (about 4–5x faster than chewed aspirin); filed an omnibus patent application covering its sublingual delivery platform; received a positive FDA response to its Pre-IND request with written feedback due by Jan 2, 2026; and raised commercial capacity with an initial production order of 2 million servings of BUZZ BOMB™ caffeine ahead of a consumer e-commerce launch. The company targets an NDA submission in H1 2026 for the sublingual aspirin program.
Positive
- Platelet inhibition in under 2 minutes versus chewed aspirin (~4–5x faster)
- Filed an omnibus patent application for its sublingual delivery technology
- FDA issued a positive Pre-IND response; written replies due Jan 2, 2026
- Placed initial production order of 2 million servings for BUZZ BOMB™
- Targeting NDA submission for sublingual high-dose aspirin in H1 2026
Negative
- None.
Insights
Aspire shows clinical progress, IP and commercial traction that together create near-term regulatory and licensing catalysts.
Aspire reports a clear sequence of technical and commercial milestones: positive final bioavailability data showing platelet inhibition under two minutes, submission and a positive FDA Pre-IND response with written feedback promised by
Key dependencies and risks are explicit and narrow: regulatory acceptance of the planned NDA submission targeted in
Monitor three concrete items closely over the next six to twelve months: the FDA written responses by
ESTERO, FL / ACCESS Newswire / December 4, 2025 / Aspire Biopharma Holdings, Inc. (Nasdaq:ASBP) ("Aspire" or the "Company"), a developer of a multi-faceted patent-pending drug delivery technology, today provides a business update for the quarter ended September 30, 2025.
Q3 2025 and Recent Highlights
Expanded its scientific team with the addition of Mark J. Jaroszeski, PhD, a tenured professor in the Department of Medical Engineering at the University of South Florida. Dr. Jaroszeski, who holds a PhD in Engineering Science with a dissertation focused on mechanically facilitated cell-cell electrofusion. His expertise is expected to assist in further developing Aspire's unique sublingual delivery technology.
Submitted its Pre-IND meeting request and briefing package to the U.S. Food and Drug Administration (FDA). The submission concerns the Company's lead product candidate, a fast-acting, high-dose sublingual aspirin formulation for the treatment of suspected acute myocardial infarction (AMI) and represents a significant milestone on the path to potential FDA approval. On November 13, 2025, the FDA responded positively to the request and stated it would provide written responses in lieu of a meeting no later than January 2, 2026.
Participated in the CPHI Frankfurt trade show, the world's largest pharmaceutical event. The Company engaged in numerous strategic discussions with global pharmaceutical companies regarding technical collaboration and licensing opportunities for its lead product candidate, a novel sublingual high-dose aspirin. The conference has led to several licensing opportunities that the Company is considering.
Filed an omnibus patent application with the U.S. Patent and Trademark Office for its sublingual delivery technology. This application - which seeks patent protection of Aspire's proprietary technology in a variety of classes of drugs and other substances--focuses exclusively on protecting the Company's advanced sublingual drug delivery system, which is designed to enhance the pharmacokinetic performance of Active Pharmaceutical Ingredients ("APIs") and other substances into the bloodstream, increasing bioavailability and improving speed of onset. The omnibus patent supplements the patent protections already provided by Aspire's previously filed patents.
Shared its pipeline progress and key milestones expected through the remainder of 2025 and early 2026. The company is focusing its pipeline on reformulating approved drugs for multi-billion-dollar markets by utilizing its disruptive, patent-pending sublingual delivery technology and anticipates filing as many as five to ten additional patents before the end of Q1 2026.
Began its influencer marketing campaign designed to drive conversion, brand awareness and loyalty for its innovative BUZZ BOMB™ caffeine product. Featuring 50mg of caffeine and offered in four flavors (Tropical Fruit, Mixed Berry, Peach Mango, and Coffee Mocha), BUZZ BOMB™ provides nearly instant energy, in easy-to-use small sublingual packets, which can be taken as needed for immediate effect.
Increased the production capacity of its BUZZ BOMB™ single dose caffeine supplement through a new manufacturing relationship with SupraNaturals, a well-established contract manufacturer of nutritional and dietary supplements. As part of this agreement, Aspire Biopharma announced an initial production order of two million servings (100,000 20-packs) of BUZZ BOMB™ caffeine supplement, marking a significant milestone in the Company's expansion efforts. The new product will be available for sale just before Christmas.
Published positive final data from its 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. The sublingual formulation begins to inhibit platelet aggregation in under two minutes, acting approximately four to five times as fast as chewed aspirin.
Announced the successful launch and distribution of over 30,000 BUZZ BOMB™ sample four-packs, its new sublingual caffeine supplement, at FitCon and FitExpo, held August 1-3, in Salt Lake City and Anaheim, with an estimated combined attendance in excess of 70,000 people.
Announced that the Company's Board of Directors (Board) has appointed Kraig Higginson as interim Chief Executive Officer (CEO), effective July 24, 2025. Mr. Higginson serves as Chairman of the Board and previously served as CEO of Aspire for nearly four years.
Buzz Bomb Caffeine Company LC, a wholly owned subsidiary of Aspire:
Unveiled its new e-commerce solution, buzzbombcaffeine.com with BUZZ BOMB™ as its featured launch product. This new seamless direct-to-consumer shopping experience allows consumers to order BUZZ BOMB™ on the Buzz Bomb platform and have them shipped directly to their door with access to exclusive promotions, and customer support. To celebrate the launch, customers who register for Buzz Bomb's e-commerce site will have first access to special pricing, free shipping offers, and other promotions. The site features an introductory sample pack of four flavors as well as 30-packs in various flavors.
Announced positive initial consumer feedback from the Company's sampling of its sublingual caffeine supplement, BUZZ BOMB™. featuring 50mg of caffeine and designed to support sustained energy and mental focus, BUZZ BOMB™ is bringing its unique delivery technology benefits to the multi-billion-dollar caffeine market to help athletes, fitness enthusiasts, and others wanting a lift to maximize their performance potential. Buzz Bomb™ provides nearly instant energy, in easy-to-use convenient packs, which can be taken easily and without the need for mixing with water or relying on unhealthy energy drinks or soda.
Anticipated Upcoming Milestones
Sublingual High-dose Aspirin (Lead Program)
H1 2026: Target submission of New Drug Application (NDA).
Sublingual ED medication
H1 2026: Finalize formulation and manufacture test product.
Mid-2026: Initiate Phase 1 pharmacokinetic (PK) clinical cross-over study.
Kraig Higginson, Interim CEO of Aspire Biopharma, commented:
"Our third-quarter results represent the blueprint for our future value creation. We have clinically proven the superiority of our technology with sublingual aspirin, de-risking the platform, and we have demonstrated our ability to execute commercially with Buzz Bomb Caffeine Company's successful launch of BUZZ BOMB™."
Higginson continued, "Looking ahead, investors can see a clear line of sight to a series of major, value-driving catalysts. The most significant is our targeted NDA submission for sublingual aspirin in the first half of 2026, which aims to disrupt a multi-billion-dollar market. This will be followed by the initiation of clinical studies for our sublingual ED and other programs, our entry points into some of the largest pharmaceutical markets in the world. Our ability to scale commercially is already being validated, as demonstrated by Buzz Bomb Caffeine Company's second production order of two million servings of BUZZ BOMB™ to meet growing demand. We believe the accomplishments of this quarter have set the stage for a transformative period of growth, and the market has yet to fully recognize the value of the catalysts that lie directly ahead."
About Aspire Biopharma Holdings, Inc.
Aspire Biopharma has developed a patent-pending sublingual delivery technology that can deliver drugs to the body rapidly and precisely. This technology offers the potential to improve effectiveness and reduce 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.
For more information, please visit www.aspirebiolabs.com
Safe Harbor Statement
This press release contains "forward-looking statements" within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended, which are intended to be covered by the "safe harbor" provisions created by those laws. Aspire's forward-looking statements include, but are not limited to, statements regarding our or our management team's expectations, hopes, beliefs, intentions or strategies regarding our future operations. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. The words "anticipate," "believe," "contemplate," "continue," "estimate," "expect," "intends," "may," "might," "plan," "possible," "potential," "predict," "project," "should," "will," "would," and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. These forward-looking statements represent our views as of the date of this press release and involve a number of judgments, risks and uncertainties. We anticipate that subsequent events and developments will cause our views to change. We undertake no obligation to update forward-looking statements to reflect events or circumstances after the date they were made, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws. Accordingly, forward-looking statements should not be relied upon as representing our views as of any subsequent date. As a result of a number of known and unknown risks and uncertainties, our actual results or performance may be materially different from those expressed or implied by these forward-looking statements. Some factors that could cause actual results to differ include general market conditions, whether clinical trials demonstrate the efficacy and safety of our drug candidates to the satisfaction of regulatory authorities, or do not otherwise produce positive results which may cause us to incur additional costs or experience delays in completing, or ultimately be unable to complete the development and commercialization of our drug candidates; the clinical results for our drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approval; our ability to achieve commercial success for our drug candidates, if approved; our limited operating history and our ability to obtain additional funding for operations and to complete the development and commercialization of our drug candidates; and other risks and uncertainties set forth in "Risk Factors" in our most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q. In addition, statements that "we believe" and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this press release, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain, and you are cautioned not to rely unduly upon these statements. All information in this press release is as of the date of this press release. The information contained in any website referenced herein is not, and shall not be deemed to be, part of or incorporated into this press release.
Aspire Biopharma Holdings, Inc.
Contact
Brett Maas
Hayden IR: (646) 536-7331
brett@haydenir.com
James Carbonara
Hayden IR: (646)-755-7412
james@haydenir.com
SOURCE: Aspire Biopharma Holdings, Inc.
View the original press release on ACCESS Newswire
FAQ
What did Aspire Biopharma announce about its sublingual aspirin clinical results (ASBP) on December 4, 2025?
What regulatory progress did Aspire (ASBP) report for its lead sublingual aspirin program?
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