With an innovative drug delivery mechanism that aims to help save millions of lives by improving the onset of action or reducing or eliminating side effects of approved therapeutics, Aspire Biopharma (NASDAQ: ASBP) is shaping the future of medicine.
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Overview
Aspire Biopharma (NASDAQ: ASBP) engages in the business of developing and marketing novel disruptive technology for the sublingual delivery of drugs and other products.
- Patent-pending drug delivery technology for rapid sublingual absorption and entry into the bloodstream of drugs and supplements
- Enhances the pharmacokinetic performance of Active Pharmaceutical Ingredients (“APIs”), supplements and nutraceuticals into the bloodstream, increasing bioavailability and improving speed of onset
- Multiple ℞ applications in heart attack/stroke, anxiety, nausea, and others
- Can be applied in multiple oral/intraoral product formats such as tablets, capsules, oral suspensions, and others
- Contract Manufacturing Relationships
- Lead Rx Product: Sublingual High Dose Aspirin
- Lead Consumer Product: BUZZ BOMB™ caffeine
- Focused on commercialization through partnerships, licensing and internal development
Drug and Supplement Delivery Technology Innovator
1. Fast Acting
Powder-form medication developed using our patent-pending technology enters the bloodstream in a fraction of the time as compared to oral tablets and capsules
2. Easy to Use
Dissolves easily under the tongue
3. Dosage Management
Drugs do not first pass through the liver and are not metabolized like swallowed products
4. Bypasses the Digestive Tract
Reduces or eliminates adverse reactions in the gastrointestinal tract
5. Replaces pills and tablets
Easy for patient or caregiver to administer
Aspire Patent and Patent Pending Portfolio Sublingual Aspirin Product Candidate
- Filed provisional patent applications with the USPTO on March 31, 2023 and October 2, 2024, respectively, pertaining to Oral Mucosal Formulations of Aspirin that utilize Aspire’s fast acting formulation.
Omnibus Patent Filing
- Filed an omnibus patent application with the U.S. Patent and Trademark Office (“USPTO”) for its sublingual delivery technology October 2025.
- Application seeks patent protection of Aspire’s proprietary technology in a variety of classes of drugs and other substances focusing exclusively on protecting the Company’s advanced sublingual drug delivery system,
- An omnibus claim is a statement in a patent application that describes the unique features of an invention and defines the scope of protection for the patent. It is a formal way of summarizing the points of novelty of the invention and is usually followed by a fixed form. The omnibus patent can provide IP protection in new areas/classes in addition to the patents already filed by Aspire.
Non-Aspirin Drug Product Candidate Patents Filed January 2026
▪ Alprazolam (Generic Xanax®): Formulation for sublingual administration of drug for treatment of anxiety. Provisional patent filed January 2026.
▪ Clopidogrel (Generic Plavix®): Antiplatelet to prevent blood clots. Provisional patent filed January 2026.
▪ Odansetron (Generic Zofran®): Antiemetic medication that prevents nausea and vomiting from chemotherapy, radiation, and surgery. Provisional patent filed January 2026.
▪ Meclizine: Antihistamine used primarily to prevent and treat motion sickness (nausea, vomiting, dizziness) and vertigo. Provisional patent filed February 2026.
Aspire’s Sublingual Aspirin Product Candidate
ASBP’s sSublingual aAspirin pProduct addresses cardiology emergencies and is intended for the 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.
Sublingual Aspirin Product Study Design and Top-Line Results
▪ The primary objective of the clinical trial was to evaluate the bioavailability of acetylsalicylic acid (ASA, the active antiplatelet form of aspirin) in plasma over eight hours after dosing.
▪ Randomized, crossover bioavailability trial to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of Aspire’s investigational new powder formulation sublingual aspirin product compared to chewed uncoated aspirin tablets in healthy adults.
▪ Aspire’s sublingual aspirin product produced higher and more rapid mean plasma concentrations of ASA, compared to chewed aspirin tablet.
Significant improvement in absorption was evident within five minutes and continued throughout the first half-hour after dosing.
Achieved therapeutic doses 2-3 times faster than chewable aspirin tablets
▪ Aspire product was safe and well-tolerated by patients, and no adverse events were reported.
Benefits of “rapid absorption” aspirin
▪ Address and limit heart attack and stroke
▪ Allow high dose absorption for pain management including quick headache relief, post surgery, cancer pain management, and general pain relief
Additional Important Clinical Trial Findings
▪ Aspire's sublingual aspirin formulation significantly inhibited serum thromboxane B2 (TxB2) within the first two minutes after dosing
▪ TxB2 is a biomarker indicating aspirin's effect on platelet aggregation, the clumping of platelets that leads to dangerous blood clots; average person has concentration at 120 ng/mL.
▪ This rapid inhibition is critical during suspected heart attacks, when clots blocking heart arteries can cause permanent muscle damage
▪ Lab results showed Aspire's product acted more than five times as fast as the current recommendation for chewed aspirin tablet treatment
* TxB2 is a stable metabolite of thromboxane A2 (TxA2), a potent chemical that promotes platelet clumping and vasoconstriction. Measuring low levels of TxB2 confirms that aspirin is working as intended
In the planned initial launch of its sublingual products, Aspire has focused on the delivery of aspirin, which may be the most studied and accepted analgesic and anti-inflammatory.
Aspirin is over a century old and is traditionally available in several forms, including effervescence, powder, capsule, and tablet. Over 100 years of documented safety and efficacy data is readily available.
The Company plans to seek FDA 505(b)(2) Fast Track designation for the prescription strength sublingual aspirin. The 505(b)(2) pathway specifically benefits new drugs that are similar to already approved drugs but have slight variations in formulation or administration routes. Aspire can reference the safety and efficacy data of the original innovator drugs–which are already FDA-approved–accelerating the approval process and reducing associated costs.
Sublingual Aspirin Product Commercialization and Go-to-Market Strategy
1 Launch product initially in the Rx market, likely through licensing or partnering agreements
2 Partner with an experienced end-to-end marketing and distribution firms
3 Significant potential licensing opportunities with leading drug manufacturers
The Market Opportunity
Global Analgesics Market
Valued at $47.32B in 2023 and projected to reach $75.73B by 2032, growing at a compound annual growth rate (CAGR) of 5.39% over the forecast period 2024-2032. (Source: SNS Inside
BUZZ BOMB™ Caffeine Products
Unlike traditional energy drinks or pills, BUZZ BOMB™ is a new and exciting caffeine product delivered in a single-serving stick pack of dry powder sprinkled under the tongue. This method provides flavored caffeine quickly without the hassle of mixing with water or consuming typical caffeine sources like energy drinks, coffee, or soda.
BUZZ BOMB™ features 50mg of caffeine and is currently offered in four delicious flavors: Tropical Fruit, Mixed Berry, Peach Mango, and Coffee Mocha. Designed for athletes, professionals, and the everyday person needing a rapid boost, BUZZ BOMB™ provides a precise serving of caffeine in easy-to-use single serving stick packs.
- Nano technology delivers caffeine rapidly to the blood stream, bringing its unique disruptive benefits to the caffeine market
- Initial offering of four flavor options
- Marketing plan focused on cost-effective multi-channel digital strategy targeting primary influencers, direct response sales and traditional retail sales channels launched
- Global pre-workout supplements market size is expected to reach $27.97 billion by 2030, registering a CAGR of 5.9% from 2025 to 2030
BUZZ BOMB™ Disruptive Characteristics
- Speed - works nearly immediately (less than 2 minutes) vs. 20-30 minutes
- Convenience – small, easy to use single-use packets (no mixing and measuring for beverages)
- Energy management - use as needed to precisely manage caffeine intake (50mg increments)
- Single Safe Active Ingredient – well-known benefits and use of caffeine
- Low manufacturing & packaging costs - competitive pricing with high margin potential
Global Pre-Workout Market
Supplements market valued at $19.90B in 2023. Estimated to reach $29.77B by 2032, growing at a CAGR of 4.58% during the forecast period (2024–2032). (Source: Straits Research)
- Rising fitness culture and gym memberships
- Consumer focus on performance and recover
- Expanding demographics (women, Gen Z, casual exercisers)
- Growth of RTD ("Ready To Drink"- no mixing) formats & natural formulations
- Digital fitness and influencer-led marketing
Management
Kraig Higginson
Interim Chief Executive Officer
Mr. Higginson brings to Aspire BioPharma, Inc. extensive experience in early-stage growth company management as well as vast public market expertise. Mr. Higginson founded and served as Chief Executive Officer of VIA Motors, Inc., a hybrid electric vehicle company from November 2010 to January 2015, which achieved more than a $1 billion market cap. From October 2003 until November 2010, he founded and served as Chairman of the Board of Directors of Raser Technologies, a NYSE company which achieved a $1.7 billion market cap. Earlier Mr. Higginson also founded American Telemedia Network, Inc., a publicly traded NASDAQ company that developed a nationwide satellite network broadcasting data for large corporations, as well as video programming and advertising to shopping centers and malls. He served as President and Chief Executive Officer of American Telemedia Network from 1984 through 1988. Mr. Higginson has been a leading entrepreneur for several decades.
Ernest J. Scheidemann, Jr.
CPA, MBA - Chief Financial Officer
Mr. Scheidemann brings over 20 years of CFO experience leading financial and operational teams of both publicly traded and private companies, in Fortune 500, mid-cap, mega start-ups and fast-paced entrepreneurial organizations in a variety of industries, and has served on boards of health care services related non-profits. Mr. Scheidemann’s expertise includes building and leading highly skilled accounting and finance teams, debt and equity financing, GAAP accounting, strategic planning, M&A, profitability maximization, financial processes, and SEC reporting. Previously, Mr. Scheidemann was the Chief Financial Officer for Benchmark Builders, Inc., ASG Technologies, Inc., WCI Communities, Inc., and Walker Digital, LLC, and earlier in his career served as also the Controller for AT&T’s $23 billion Consumer Services division. Mr. Scheidemann is a licensed Certified Public Accountant (CPA) in the State of New Jersey and holds a Certified Global Management Accountant designation (CMGA) and a Certification in Financial Forensics (CFF), each from the American Institute of CPAs.
In Summary…
Aspire Bio Labs (NASDAQ: ASBP)
- Multiple ℞ applications in heart attack/stroke, anxiety, nausea, antiplatelet drug to prevent blood clots, and others
- Large Addressable ℞ Markets
- High Dose Aspirin Prescription Product: Trial demonstrated dramatically higher and more rapid therapeutic impact compared to standard chewed aspirin tablets, safe and well-tolerated. Aspire's sublingual aspirin formulation significantly inhibited serum thromboxane B2 (TxB2) within the first two minutes after dosing. This rapid inhibition is critical during suspected heart attacks, when clots blocking heart arteries can cause permanent muscle damage.
- Expect to file in 2026 for FDA 505 (b)(2) Fast Track drug approval process for high dose aspirin
- BUZZ BOMB™, New Pre-Workout Supplement Launched in Q3 2025: Commercial revenue in 2026
- Global pre-workout supplements market size: Expected to reach $27.97 billion by 2030
- Focused on drug product commercialization through partnerships and licensing
- Proprietary Patent-Pending Technology: Enables ability to pursue broadened applications, using our solubility process, which can be used with other drug and supplement compounds
Aspire Biopharma (NASDAQ: ASBP) has developed a disruptive technology for delivering drugs and other products sublingually with the goal of bringing multiple already approved therapeutics to the market with improved onset of action or a reduction in side effects. While pursuing drug candidates in large markets, Aspire expects to grow its revenue in 2026 from the commercial launch of BUZZ BOMB™ it’s a proprietary sublingual caffeine supplement.. Now may be the ideal time to have the company on your watch list!
Learn More about Aspire Bio Labs. by gaining access to the latest corporate presentation
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