With an innovative drug delivery mechanism that aims to help save millions of lives with its first to market product, Aspire Bio Labs (NASDAQ: ASBP) is shaping the future of medicine.
The Company has assembled a world class team and is led by a CEO who has achieved more than $1B market caps on not one, but two previous companies!
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Overview
Aspire Bio Labs (NASDAQ: ASBP) engages in the business of developing and marketing novel disruptive technology for the sublingual delivery of drugs and other products. Using Aspire’s patent-pending sublingual drug delivery mechanism, drugs:
Are Faster Acting– drugs and other products enter the bloodstream in a minute or two;
Bypass the Digestive Tract- far less of drugs and other products get digested and initial bypassing of the GI-tract can eliminate irritation and adverse reactions;
Are Used Efficiently by the Body: by avoiding a first-pass through the liver drugs avoid being metabolized; and
Are Easier to Take: a small amount of pleasant tasting powder or granules can be taken by those who have trouble with pills and capsules– even someone who is unconscious can be dosed with our products.
A Nasdaq-Listed Biopharma Company
In February of 2025, Aspire Biopharma, Inc. and PowerUp Acquisition Corp. (Nasdaq: PWUP) successfully merged in a business combination to drive breakthrough innovations in FDA-approved drugs, nutraceuticals, and supplements.The new merged company is called Aspire Biopharma Holdings, Inc. and trades on Nasdaq under the symbol ASBP.
Highlights of the Merger:
- Transaction Valuation: The transaction values Aspire Biopharma, Inc. at a pre-money equity value of approximately $316 million.
- Industry-Leading Platform: Aspire is focused on developing a pipeline of products utilizing its novel sublingual delivery mechanism to enhance the efficacy of FDA-approved drugs, nutraceuticals, and supplements.
- Innovative Drug Delivery Technology: Aspire’s patent-pending delivery system allows rapid sublingual absorption of drugs directly into the blood stream, thus on first pass, avoiding the gastrointestinal tract and liver, mitigating rapid metabolizing of drugs and easing tensions on body organs..
- Growth and Innovation: Anticipated proceeds from the transaction are expected to further fuel Aspire’s strategic growth plan to accelerate the development of its differentiated pipeline and finance several key therapeutic programs to data announcements.
“As we step into this next phase of our growth, I’m incredibly proud of what our team has accomplished over the past year in building a strong foundation on both the science and business sides. With an innovative product tailored to address many of the shortcomings of existing drug and nutraceutical formulations, Aspire is ready for the next big leap. Our partnership with the PowerUp team will help us share our product vision with the world and pave the way for the launch of our first sublingual aspirin product.”
Kraig Higginson, Chief Executive Officer of Aspire
A Sublingual Aspirin Product
ASBP’s Sublingual Aspirin Product addresses cardiology emergencies and pain management. It is a granular or powder formulation of a soluble, Ph-neutral, fast-acting aspirin, which has been developed by using the company’s patented formulation, and “trade secret” process.
Benefits of “rapid absorption” aspirin are: to stop heart attack and stroke; allow high dose absorption for pain management, including quick headache relief, post-surgery, cancer pain management, and general pain relief.
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.
Aspirin is also the only drug in history to receive a certified recommendation by the FDA for heart attack, stroke and colon cancer prevention. However, current aspirin applications are limited due to side effects and the gastric tract.
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.
The Competitive Edge
ASBP’s sublingual aspirin product, which addresses cardiology emergencies and pain management among other impacts, is a granular or powder formulation of a soluble, Ph-neutral, fast-acting aspirin. Benefits of “rapid absorption” aspirin are to stop heart attack and stroke; allow high-dose absorption for pain management, including quick headache relief, post-surgery, cancer pain management, and general pain relief.
Commercialization and
Go-to-Market Strategy
- Launch the sublingual aspirin product initially in the Rx market, followed eventually by an OTC version, with the strategy of creating and preserving greater long-term value.
- Partner with an experienced end-to-end marketing and distribution firm. The company is currently evaluating potential partners.
- Significant Licensing Opportunity.
- Aspire is also developing important non-FDA products with limited regulatory hurdles to come to market sooner, such as a preworkout product and a melatonin-based sleep aid.
Manufacturing
ASBP has entered into a development and manufacturing agreement with a well-known manufacturer–Glatt, based in Ramsey, New Jersey–in the fourth quarter of 2024 to produce sufficient quantities of its sublingual drug product for the clinical trials required to obtain FDA approval to market the product and complete clinical trials.
Although the company believes that Glatt is capable of producing the drug product to support the company’s sublingual aspirin development plan, including its planned clinical trials, ASBP also believes there are a number of alternative third-party manufacturers that have similar capabilities and would be capable of providing sufficient quantities of drug product if necessary.
ASBP has entered into a fill-and-finish agreement with a contract manufacturer to convert sublingual aspirin manufactured by Glatt into packaged drug products that can be utilized in clinical trials and stability testing. The fill-and-finish contract manufacturer will package the aspirin product that has been produced by Glatt into a drug product to be used in the company’s upcoming clinical trials. The company believes that both Glatt and the fill-and-finish contract manufacturer are compliant under current good manufacturing practice, or cGMP, requirements and have experience with cGMP inspections of their respective facilities.
- Plans to use the sublingual aspirin manufactured by Glatt to conduct clinical trials to support approval of a section 505(b)(2) New Drug Application (“NDA”). An initial trial will be designed to study the pharmacokinetics of aspirin and its metabolites in blood following sublingual administration of a single dose of each of two different formulations of the Instaprin drug product and a single dose of standard oral aspirin. This initial trial is expected to enroll at least six healthy adult volunteers with each dose separated by a washout period of seven days and will provide information required to (i) select the optimal drug product formulation and (ii) inform the design of a second clinical trial to support FDA approval. The first trial will also demonstrate the relative quickness of Aspire’s sublingual aspirin’s absorption compared to orally administered aspirin tablets. The company plans to design a second clinical trial to demonstrate that sublingual administration of the final selected formulation delivers therapeutic concentrations of drug into the bloodstream, comparable to those of standard oral aspirin, but faster and without gastro-intestinal toxicity associated with oral aspirin. The second trials will also focus on the anti-platelet properties of the sublingual aspirin.
Commercialization
Subject to receiving marketing approvals, ASBP expects to commence commercialization activities by building a focused sales and marketing organization in the United States to sell its products, as well as the creation of a dedicated Medical Affairs team to support commercialization efforts. The company believes that such an organization will be able to address the physicians who are the key specialists in treating the patient populations for which its product candidates are being developed. Outside the United States, it expects to enter into distribution and other marketing arrangements with third parties for any of its product candidates that obtain marketing approval.
ASBP also plans to build a marketing and sales management organization to create and implement marketing strategies for any products that it markets through its own sales organization and to oversee and support its sales force.
The Market
- Aspire’s disruptive technology can be applied to any number of FDA-approved drugs, such as testosterone and other hormones, as well as many supplements such as melatonin, preworkout, vitamins, etc.
- Analgesics: global analgesics market (including Opioids) valued approximately $77.0 billion in 2021 and is projected to grow at a 5% CAGR and reach to roughly $103.0 billion by 2028
- Erectile Dysfunction (ED): global ED market valued approximately $3.6 billion in 2021 and is projected to grow at a 6.9% CAGR and reach to roughly $5.9 billion by 2028
- Traumatic Brain Injury (TBI): global N-acetylcysteine (NAC) market was valued at $1.1 billion in 2021 and is projected to grow at a 21.5% CAGR and attain a market value of $4.2 billion by 2028
Opioid Crisis Opportunity
- Opioids, while still broadly prescribed, have become the driver of one of the most significant consequential health crises of our time, resulting in destructive social, cultural, economic, and ethical impacts.
- Our sublingual, high dose aspirin products–which can help with post-surgical pain by bringing a higher concentration of aspirin quicker, while reducing inflammation– have the potential to gain support and tailwinds from regulatory bodies, the medical industry, medical insurance markets, political constituents, as well as the patient population.
- We are currently preparing to pursue “Fast Track” approval for our sublingual aspirin medication through the FDA and regulatory agencies to leverage the issues of the current anti-opioid initiatives.
Development Pipeline
In addition to ASBP’s lead candidate sublingual aspirin product, the company has numerous pharmaceutical and nutraceutical applications under development in the following areas, including but not limited to a:
- Proprietary Viagra/Cialis combination product, which is faster acting, requiring decreased dosages with the benefit of a longer half-life
- Various bi-hormonal drugs such as testosterone, estrogen and weight loss drugs.
- Semaglutide: Aspire’s scientists are in the final phases of developing a working formulation for a sublingual semaglutide product– one that would avoid the use of injections.
- Traumatic brain injury drugs
- Thyroid drugs
- Preworkou-t- the rapid, sublingual absorption of caffeine can bring the benefits of this supplement to the immense personal fitness market
The Business Plan
ASBP expects to generate revenue through developing and marketing the technology for the novel delivery mechanisms for FDA-approved drugs and many other products”.
Further, from time to time, the company may enter into license or collaboration agreements with other companies that include development funding and significant upfront and milestone payments and/or royalties, which may become an important source of the company’s revenue.
Management
Kraig Higginson
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. In 2010, Mr. Higginson was called to testify, as an expert, before Congress regarding the viability of vehicle electrification, and was directly instrumental in pushing through the $7,500 per vehicle legislation which is credited for launching the EV industry in the United States.
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) has developed a novel formulation of sublingual aspirin that increases rapid absorption, eliminates the GI tract side effects, and by-passes first pass liver metabolism resulting in faster peak serum concentration and rapid inhibition of cyclooxygenase (Cox-1). This innovative technology could provide alternative choices in pain care and even help reduce the current opioid epidemic.
Key aspects include:
- Patented Delivery System specifically formulated to allow rapid sublingual absorption of aspirin into the blood stream and bypassing the gastrointestinal tract
- Fast absorption to help resolve heart attack and stroke
- Proprietary formula and manufacturing process
- Absorbed instantly in the mouth, which reduces adverse reactions in the stomach (GI tract), not requiring the taking of pills by those who struggle with swallowing.
- Large dosage escalation for back pain, arthritis pain, headache, post surgery and cancer pain.
Opportunity:
- Large Addressable Market: $80 billion combined analgesics and opioid market
- Prescription: Utilizing the FDA 505 (b)(2) Fast Track drug approval process.
- OTC: Once the Rx market has been thoroughly established, an opportunity will arise for an OTC product.
- First to market: Prescription strength version to be followed by OTC
- Proprietary Technology: Enables the ability to pursue broadened applications, using our solubility process, which can be used with other compounds such as supplements.
Aspire Bio Labs (NASDAQ: ASBP) is aiming for an FDA approval of its sublingual aspirin products and only recently debuted on Wall Street through a SPAC merger. Now may be the ideal time to have the company on your watch list!
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