Aspire Biopharma Announces Milestone Roadmap Targeting H2 2025 FDA Submission for Sublingual Aspirin and Key 2026 Milestones for Needle-Free Semaglutide (Diabetes, Weight Management) and more-rapid ED medication

Rhea-AI Summary

Aspire Biopharma (NASDAQ:ASBP) has outlined its milestone roadmap through 2026, focusing on its patent-pending sublingual drug delivery technology. The company's lead program targets an H2 2025 FDA submission for sublingual high-dose aspirin, following positive clinical results showing faster absorption and better bioavailability compared to traditional tablets.

The pipeline includes two additional key programs scheduled for H1 2026: a rapid-acting sublingual ED medication and a sublingual version of semaglutide for diabetes and weight management. Both programs will undergo Phase 1 pharmacokinetic studies in 2026. The company's strategy focuses on reformulating approved drugs for multi-billion-dollar markets, with plans to expand into CNS, men's health, and anti-nausea medications.

Positive

• Positive clinical results for sublingual aspirin showing higher and faster plasma concentrations
• Strategic focus on reformulating approved drugs reduces development risk
• Pipeline targets multiple billion-dollar markets (heart disease, ED, diabetes/weight management)
• Technology potentially offers improved patient outcomes and reduced side effects

Negative

• Early stage development for most pipeline products
• Multiple clinical trials and regulatory approvals still required
• Potential competition from established pharmaceutical companies
• No current revenue-generating products

Insights

Pharmaceutical R&D Expert

Aspire's sublingual delivery platform shows promising clinical progress with clear regulatory pathways for products targeting multi-billion dollar markets.

Aspire Biopharma is strategically positioning its sublingual drug delivery technology to address major pharmaceutical markets through the 505(b)(2) regulatory pathway. Their approach is scientifically sound - reformulating approved drugs using their proprietary delivery system to bypass the gastrointestinal tract, potentially improving bioavailability, reducing side effects, and enhancing patient compliance.

The company has established a well-defined clinical roadmap with three prioritized programs:

• Their high-dose sublingual aspirin leads the pipeline with positive clinical data showing faster and higher plasma concentrations versus traditional administration. The reported inhibition of thromboxane B2 within two minutes has significant clinical implications for acute myocardial infarction treatment, where minutes matter. Their planned FDA submission in H2 2025 using the 505(b)(2) pathway strategically leverages existing safety data to potentially accelerate approval.
• The sublingual ED medication targets a common limitation of oral ED drugs - delayed onset of action. A more rapid-acting formulation would address a key patient need in this market.
• Their sublingual semaglutide program aims to solve the adherence challenges of injectable GLP-1 agonists while potentially reducing the gastrointestinal side effects common with the oral version.

From a development perspective, the company is following a logical progression: lead candidate advancing toward regulatory submission while earlier-stage assets move toward clinical testing. The focused pipeline with defined milestones suggests disciplined resource allocation rather than pursuing too many programs simultaneously.

Their dual commercialization strategy - advancing proprietary programs while exploring pharmaceutical partnerships - creates multiple potential value inflection points. However, while the announced milestones are substantial, investors should note that no revenue projections or funding requirements were disclosed, which will be critical factors in executing this ambitious development timeline.

Biotech Investment Analyst

Aspire presents substantial near-term milestones across three clinical programs targeting blockbuster markets with a potentially derisked 505(b)(2) pathway.

Aspire Biopharma's milestone roadmap reveals a strategic pivot toward high-value, expedited commercialization opportunities using the 505(b)(2) regulatory pathway - a significantly derisked approach compared to traditional new drug development. This pathway allows Aspire to leverage existing safety and efficacy data for approved compounds while developing proprietary delivery methods.

The company has three clear value drivers in development:

First, their sublingual high-dose aspirin program shows the most immediate potential with an NDA submission targeted for H2 2025. The positive clinical results demonstrating faster onset (within two minutes) positions this product well for emergency heart attack treatment - a massive market with established reimbursement pathways. The rapid thromboxane B2 inhibition data represents a meaningful clinical differentiator that could support premium pricing.

Second, their sublingual ED medication targets the $3.9 billion erectile dysfunction market with a compelling value proposition of faster onset - a key patient need in this category where timing significantly impacts satisfaction. With Phase 1 studies planned for mid-2026, this represents a medium-term value driver.

Third, the sublingual semaglutide program targets perhaps the most lucrative opportunity - the booming GLP-1 market that's revolutionizing diabetes and weight management. Current injectable GLP-1s face adherence challenges while the oral version has bioavailability limitations. A sublingual formulation could potentially address both issues, representing significant commercial potential.

The company appears to be executing a capital-efficient development strategy by prioritizing programs with established clinical precedent and clear regulatory pathways. The mention of potential pharmaceutical partnerships suggests options beyond traditional dilutive financing. However, investors should note the timeline extends into 2026 before seeing Phase 1 data on two programs, suggesting potential financing needs in the interim.

Prioritizes High-Value Approved Drugs in Multi-Billion-Dollar Markets to Accelerate Commercialization

Future Platform Expansion into CNS, Men's Health, and Anti-Nausea

ESTERO, FL / ACCESS Newswire / October 1, 2025 / Aspire Biopharma Holdings, Inc. (NASDAQ:ASBP) ("Aspire" or the "Company"), developer of a multi-faceted patent-pending sublingual drug delivery technology, today announced 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.

Anticipated Upcoming Milestones

• Sublingual High-dose Aspirin (Lead Program)

  • H2 2025: Request meeting with FDA to discuss 505(b)(2) pathway.

  • H2 2025: 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.

• Sublingual Semaglutide

  • H1 2026: Finalize formulation and manufacture test product.

  • H1 2026 Initial Phase 1 pharmacokinetic clinical cross-over study.

"Our pipeline is focused on research in therapeutic areas where we can increase speed to bioavailability, reduce the incidence of side effects and improve patient compliance of approved drugs," said Kraig Higginson, Interim CEO of Aspire Biopharma. "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 that currently generate multi-billion-dollar sales for large pharmaceutical companies."

Higginson added, "In order to maximize the value of Aspire's novel delivery technology, we believe it is essential to strategically focus our efforts on a set of high value programs. Importantly, each prioritized program is intended to allow us to advance our sublingual delivery technological leadership across a number of targeted approved and marketed drugs more rapidly and efficiently. In parallel, we plan to continue to leverage strategic business development and licensing opportunities to accelerate our market entry and revenue potential for many of our targeted programs. As an additional segment of our business, we plan to work closely with the major pharmaceutical companies to test and implement our delivery mechanism with their high-value, large-market drugs." said Higginson.

Clinical Pipeline Focused on Sublingual Delivery of Approved Drugs
Aspire's pipeline is focused on applying its proprietary technology to existing drugs that could significantly advance treatment standards for patients worldwide. The Company's patent-pending delivery system includes components specifically formulated to allow rapid sublingual absorption of drugs into the blood stream, thus by-passing the gastrointestinal tract.

High-dose Sublingual Aspirin

• Recently concluded and reported positive final results of Aspire's investigational new sublingual aspirin product demonstrated that its 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.

• The product was also safe and well-tolerated by patients, and no adverse events were reported. Aspire's sublingual formulation also significantly inhibited serum thromboxane B₂ (TxB₂) within the first two minutes after dosing compared to the chewed oral aspirin tablets. TxB₂ is a biomarker for the effect of aspirin on platelet aggregation.

• This has significant and important positive implications for its role in the inhibition of blood clotting and its role in heart attacks.

These important results underscore the potential of Aspire's sublingual aspirin product to be the market-leading treatment for 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"). Heart disease is the #1 killer of people in America today.

Aspire plans to review its clinical trial results with the U.S. Food and Drug Administration (FDA) to enable a potential regulatory 505(b)(2) NDA submission in the second half of 2025 for accelerated approval of its high-dose aspirin product.

ED (erectile dysfunction) Medication

• Aspire's scientists have developed a formulation for sublingually administered rapid acting ED medication.

• In the first and second quarters of 2026, Aspire plans to develop and validate the manufacturing process based on this formulation, and produce a cGMP batch for use in clinical testing and stability study.

• Aspire plans to conduct a Phase One clinical test in approximately the second or third quarter of 2026 for pharmacokinetics validation of product properties, using approximately six to eight volunteers, and to establish criteria for an NDA with the FDA.

• Aspire believes the current popular route of administration for ED medication (oral) limits the speed with which the medication can reach clinical levels and causes part of the orally administered medication to be digested.

• The development of a sublingual formulation of ED medication may provide the patients with a far more rapid impact, which is extremely important in this space.

Semaglutide (GLP-1)

• Aspire's scientists are in the final phases of developing a working formulation for a sublingual semaglutide product.

• Aspire believes the route of administration for semaglutide, currently available in both injectable and oral forms, presents distinct challenges related to patient adherence, side effects, and absorption.

The development of a sublingual formulation of semaglutide may provide the physician and patient with an alternative route of administration that could reduce or eliminate some of these adverse side effects and patient concerns related to the injectable formulation.

Other Products
Aspire's scientists are currently considering formulations for anti-nausea products, anti-psychotic products, seizure medication, and several other classes of drugs, all using Aspire's sublingual mode of administration.

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. "We don't make the drugs…We make them work better for your body".

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
PCG Advisory
Kevin McGrath
+1-646-418-7002
kevin@pcgadvisory.com

SOURCE: Aspire Biopharma Holdings, Inc.

View the original press release on ACCESS Newswire

FAQ

What is the expected FDA submission timeline for Aspire Biopharma's (ASBP) sublingual aspirin?

Aspire Biopharma plans to submit a New Drug Application (NDA) for its sublingual aspirin through the 505(b)(2) pathway in H2 2025.

How does Aspire Biopharma's sublingual aspirin perform compared to traditional aspirin tablets?

Clinical trials showed the sublingual aspirin achieved higher and more rapid mean plasma concentrations of acetylsalicylic acid compared to chewed aspirin tablets, with significant inhibition of serum thromboxane B2 within two minutes.

What are the key milestones for Aspire Biopharma's sublingual semaglutide development in 2026?

In H1 2026, Aspire plans to finalize the formulation, manufacture test product, and conduct an initial Phase 1 pharmacokinetic clinical cross-over study for its sublingual semaglutide.

When will Aspire Biopharma begin clinical trials for its sublingual ED medication?

Aspire plans to initiate a Phase 1 pharmacokinetic clinical cross-over study for its sublingual ED medication in mid-2026, following formulation finalization and test product manufacturing in H1 2026.

What therapeutic areas is Aspire Biopharma targeting for future expansion?

Aspire is considering expanding into CNS, men's health, anti-nausea products, anti-psychotic products, and seizure medications using their sublingual delivery technology.