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Investor releaseQuarter not tagged2025-09-03Aspire Biopharma Announces Breakthrough Final Results from Clinical Trial of Investigational New Sublingual Aspirin Product for Treatment of Suspected Acute Myocardial Infarction (Heart Attack)
ACCESS Newswire
Aspire Biopharma Announces Breakthrough Final Results from Clinical Trial of Investigational New Sublingual Aspirin Product for Treatment of Suspected Acute Myocardial Infarction (Heart Attack)
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 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 approximately twice as fast as the current recommendation for chewed aspirin tablet treatment These clinical trial results enable a potential regulatory submission for accelerated approval on track for Q3 2025 ESTERO, FLORIDA / ACCESS Newswire / September 3, 2025 / Aspire Biopharma Holdings, Inc. (NASDAQ:ASBP) ("Aspire" or the "Company"), developer of a multi-faceted patent-pending drug delivery technology, today announced positive final results 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 final results demonstrated that Aspire's 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 (p<0.05), as detailed in Aspire's previous press release. The product was also safe and well-tolerated by patients, and no adverse events were reported. However, even more clinically significant results were discovered since the press release announcing top-line results was issued on August 18, 2025. Important New Findings Aspire's OTASA BA2039 sublingual formulation also significantly inhibited serum thromboxane B2 (TxB2) within the first two minutes after dosing compared to the chewed oral aspirin tablets (p<0.02). 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…Read full documentShow less
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 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 approximately twice as fast as the current recommendation for chewed aspirin tablet treatment These clinical trial results enable a potential regulatory submission for accelerated approval on track for Q3 2025 ESTERO, FLORIDA / ACCESS Newswire / September 3, 2025 / Aspire Biopharma Holdings, Inc. (NASDAQ:ASBP) ("Aspire" or the "Company"), developer of a multi-faceted patent-pending drug delivery technology, today announced positive final results 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 final results demonstrated that Aspire's 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 (p<0.05), as detailed in Aspire's previous press release. The product was also safe and well-tolerated by patients, and no adverse events were reported. However, even more clinically significant results were discovered since the press release announcing top-line results was issued on August 18, 2025. Important New Findings Aspire's OTASA BA2039 sublingual formulation also significantly inhibited serum thromboxane B2 (TxB2) within the first two minutes after dosing compared to the chewed oral aspirin tablets (p<0.02). 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"). 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. According to a report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines dated April 1, 2025, "Aspirin has long been considered an integral part of anti-platelet therapy to prevent recurrent atherothrombotic events among patients with Acute Coronary Syndromes (ACS). Aspirin reduces the incidence of vascular death after AMI, and in secondary prevention trials (that include patients after MI), it re-duces the occurrence of vascular and coronary events, including MI and stroke. Aspirin should be initiated with a loading dose (162-325 mg) in patients with ACS without an absolute contraindication as soon as possible on presentation irrespective of final management strategy (invasive or noninvasive)." Aspire's sublingual product rapidly delivers 162.5 mg of aspirin, precisely in the range suggested by this study, and Aspire's product begins to show TxB2 inhibition in two minutes or less." Kraig Higginson, Interim Chief Executive Officer of Aspire, commented, "The final results from our recent clinical trial confirm our belief that our high dose sublingual aspirin has to the potential to be a life-changing, market-leading treatment for patients experiencing a suspected heart attack. Patients in our study experienced a significantly improved time of inhibition of TxB2, a biomarker for platelet aggregation, the process where activated platelets stick to each other to block the flow of blood to heart muscle. We believe our new sublingually delivered aspirin has the potential to save lives. We look forward to presenting these data to the FDA as we move down the development pathway towards potential commercialization of our safe, novel and effective sublingual form of high dose aspirin. We hope the day will soon come that every EMT, emergency service provider, and hospital will have our sublingual aspirin on hand for those suffering from heart attacks." * 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. The results of Aspire's clinical study suggest that sublingual administration of aspirin provides earlier drug exposure and platelet inhibition than the current standard-of-care, which is chewing and swallowing uncoated aspirin tablets. Numerous published studies indicate that an even more rapid pharmacodynamic effect would be desirable during the early phase of thrombus evolution in the setting of myocardial infarction or ischemic stroke (i.e., the sooner TxB2 concentration can be reduced, the better for the patient). Reducing mean serum TxB2 concentration after aspirin dosing-which the clinical study demonstrates that Aspire's sublingual aspirin product does rapidly, starting in 2 minutes or less--indicates successful inhibition of platelet aggregation, which may reduce the risk of vascular death and other major adverse cardiovascular events. Advancing Aspire's Sublingual Aspirin Aspire plans to review its clinical trial results with the U.S. Food and Drug Administration (FDA) to enable a potential regulatory submission for accelerated approval in the third quarter of 2025. About Aspire's Clinical trial AB-101 Clinical trial AB-101 was a randomized crossover bioavailability study of Aspire's investigational new sublingual aspirin product compared to chewed uncoated aspirin tablets. Six otherwise healthy 40 to 65-year-old subjects were administered 162 mg aspirin as a single dose in each of three treatment periods separated by two 14-day washout periods. Two different investigational sublingual powder and granule formulations (Aspire Biopharma) and chewed uncoated oral aspirin tablets (Bayer) were studied. The primary objective of the clinical trial was to evaluate the bioavailability of ASA in plasma over eight hours after dosing. An additional objective was to evaluate the potentially life-saving effect of each treatment on serum TxB2. Aspire's sublingual aspirin is an investigational new drug and has not been approved for marketing by FDA or any other government regulatory authority. About Oral Aspirin Oral aspirin is FDA-approved for treatment of suspected AMI with the initial dose of 160-162.5 mg is administered as soon as an AMI is suspected.i In a large, multicenter study of aspirin, streptokinase, and the combination of aspirin and streptokinase in 17,187 patients with suspected AMI, aspirin treatment produced a 23 percent reduction in the risk of death from cardiovascular diseases within five weeks.ii Clinical practice guidelines recommend that aspirin be initiated as soon as possible with the initial dose chewed, when possible, to achieve faster onset of antiplatelet action.iii 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. i U.S. Food and Drug Administration. (2022, October 14). Final Administrative Order (OTC000027): Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use. ii ISIS-2 (Second International Study of Infarct Survival) Collaborative Group. Randomized trial of intravenous streptokinase, oral aspirin, both, or neither among 17,187 cases of suspected acute myocardial infarction: ISIS-2. Lancet. 1988; 2:349-60. iii Rao SV, O'Donoghue ML, Ruel M, et al. 2025 ACC/AHA/ACEP/NAEMSP/SCAI Guideline for the Management of Patients with Acute Coronary Syndromes: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2025; 151:e771-e862. Aspire Biopharma Holdings, Inc. Contact PCG Advisory Kevin McGrath +1-646-418-7002 [email protected] SOURCE: Aspire Biopharma Holdings, Inc. View the original press release on ACCESS Newswire
Investor releaseQuarter not tagged2025-08-18Aspire Biopharma Announces Positive Top-Line Results from Clinical Trial of Investigational New Sublingual Aspirin Product for Treatment of Suspected Acute Myocardial Infarction (Heart Attack)
ACCESS Newswire
Aspire Biopharma Announces Positive Top-Line Results from Clinical Trial of Investigational New Sublingual Aspirin Product for Treatment of Suspected Acute Myocardial Infarction (Heart Attack)
According to the NIH, Acute myocardial infarction (AMI) is a major cause of death, affecting nearly 3 million Americans each year and resulting in over a million deaths Trial demonstrates dramatically higher and more rapid therapeutic impact compared to standard chewed aspirin tablets in clinical trial Aspire's sublingual aspirin was safe and well-tolerated Aspire plans to review clinical trial results with the FDA to enable a potential regulatory submission for accelerated approval ESTERO, FL / ACCESS Newswire / August 18, 2025 / Aspire Biopharma Holdings, Inc. (Nasdaq:ASBP) ("Aspire" or the "Company"), developer of a multi-faceted patent-pending drug delivery technology, today announced positive top-line data from its recent 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. Pharmacokinetics is the term that describes the four stages of absorption, distribution, metabolism, and excretion of drugs. Pharmacodynamics (sometimes described as what a drug does to the body) is the study of the biochemical, physiologic, and molecular effects of drugs on the body. The Aspire 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 (p<0.05). Significant improvement in absorption was evident within five minutes and continued throughout the first half-hour after dosing. Higher and more rapid mean plasma concentrations imply that the drug is absorbed quickly and reaches a higher concentration in the bloodstream shortly after administration. The product was also safe and well-tolerated by patients, and no adverse events were reported. Aspire Benefits of Sublingual Aspirin Drug Delivery and Bypassing the Gut vs Standard Oral Aspirin Rapid absorption through the blood vessels directly, bypassing first-pass metabolic processes Faster onset of action Sublingual route avoids exposing the drug to the harsh acidic environment of the stomach and digestive enzymes Reduced drug-food and drug-drug interactions Lower risk of GI irritation Ease of administration and use in emergency situations Clinical trial AB-101 was a randomized crossover bioavailabilit…Read full documentShow less
According to the NIH, Acute myocardial infarction (AMI) is a major cause of death, affecting nearly 3 million Americans each year and resulting in over a million deaths Trial demonstrates dramatically higher and more rapid therapeutic impact compared to standard chewed aspirin tablets in clinical trial Aspire's sublingual aspirin was safe and well-tolerated Aspire plans to review clinical trial results with the FDA to enable a potential regulatory submission for accelerated approval ESTERO, FL / ACCESS Newswire / August 18, 2025 / Aspire Biopharma Holdings, Inc. (Nasdaq:ASBP) ("Aspire" or the "Company"), developer of a multi-faceted patent-pending drug delivery technology, today announced positive top-line data from its recent 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. Pharmacokinetics is the term that describes the four stages of absorption, distribution, metabolism, and excretion of drugs. Pharmacodynamics (sometimes described as what a drug does to the body) is the study of the biochemical, physiologic, and molecular effects of drugs on the body. The Aspire 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 (p<0.05). Significant improvement in absorption was evident within five minutes and continued throughout the first half-hour after dosing. Higher and more rapid mean plasma concentrations imply that the drug is absorbed quickly and reaches a higher concentration in the bloodstream shortly after administration. The product was also safe and well-tolerated by patients, and no adverse events were reported. Aspire Benefits of Sublingual Aspirin Drug Delivery and Bypassing the Gut vs Standard Oral Aspirin Rapid absorption through the blood vessels directly, bypassing first-pass metabolic processes Faster onset of action Sublingual route avoids exposing the drug to the harsh acidic environment of the stomach and digestive enzymes Reduced drug-food and drug-drug interactions Lower risk of GI irritation Ease of administration and use in emergency situations Clinical trial AB-101 was a randomized crossover bioavailability study of Aspire's investigational new sublingual aspirin product compared to chewed uncoated aspirin tablets. Six otherwise healthy 40 to 65-year-old subjects were administered 162 mg aspirin as a single dose in each of three treatment periods separated by two 14-day washout periods. Two different investigational sublingual powder and granule formulations (Aspire Biopharma) and chewed uncoated oral aspirin tablets (Bayer) were studied. The primary objective of the clinical trial was to evaluate the bioavailability of ASA in plasma over eight hours after dosing. "We are extremely pleased to report these highly positive results for our sublingual aspirin formulation, providing an important validation of our drug delivery technology," said Kraig Higginson, Chief Executive Officer of Aspire. "The effectiveness of aspirin in treating a heart attack is dependent on the time it takes to deliver ASA into the bloodstream. The ability to achieve higher and more rapid ASA concentrations for patients with suspected acute MI could save lives. We would like to thank the patients, investigators and their staff for participating in the trial, and we look forward to working with regulatory agencies to discuss next steps as we work to advance this innovative therapy and improve the treatment options for patients with suspected acute MI." Aspire is developing its investigational sublingual aspirin product for 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. Oral aspirin is FDA-approved for treatment of suspected AMI with the initial dose of 160-162.5 mg is administered as soon as an AMI is suspected.[i] In a large, multicenter study of aspirin, streptokinase, and the combination of aspirin and streptokinase in 17,187 patients with suspected AMI, aspirin treatment produced a 23 percent reduction in the risk of death from cardiovascular diseases within five weeks.[ii] Clinical practice guidelines recommend that aspirin be initiated as soon as possible with the initial dose chewed, when possible, to achieve faster onset of antiplatelet action.[iii] Aspire's sublingual aspirin is an investigational new drug and has not been approved for marketing by FDA or any other government regulatory authority. About Aspire Biopharma, Inc. Aspire Biopharma has developed a patent-pending sublingual delivery technology that can deliver drugs, nutraceuticals and supplements to the body rapidly and precisely. This allows for greater effectiveness and reduced 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. [i] U.S. Food and Drug Administration. (2022, October 14). Final Administrative Order (OTC000027): Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use. [ii] ISIS-2 (Second International Study of Infarct Survival) Collaborative Group. Randomized trial of intravenous streptokinase, oral aspirin, both, or neither among 17,187 cases of suspected acute myocardial infarction: ISIS-2. Lancet. 1988; 2:349-60. [iii] Rao SV, O'Donoghue ML, Ruel M, et al. 2025 ACC/AHA/ACEP/NAEMSP/SCAI Guideline for the Management of Patients with Acute Coronary Syndromes: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2025; 151:e771-e862. Aspire Biopharma Holdings, Inc. Contact PCG Advisory Kevin McGrath +1-646-418-7002 [email protected] SOURCE: Aspire Biopharma Holdings, Inc. View the original press release on ACCESS Newswire
Investor releaseQuarter not tagged2025-05-28Aspire Biopharma Holdings, Inc., Provides Development Update on BUZZ BOMB(TM), its New Sublingual Pre-Workout Supplement, Expected to Launch in Third Quarter of 2025
ACCESS Newswire
Aspire Biopharma Holdings, Inc., Provides Development Update on BUZZ BOMB(TM), its New Sublingual Pre-Workout Supplement, Expected to Launch in Third Quarter of 2025
Sublingual nano technology delivers caffeine rapidly to the blood stream, bringing its unique disruptive benefits to the Pre-workout market Initial production has commenced with six flavor options Expanded pre-launch consumer testing planned for Q2 2025 Aspire to launch BUZZ BOMB™ at two major upcoming fitness conventions Marketing plan focused on cost-effective multi-channel digital strategy targeting primary influencers, direct response sales and traditional retail sales channels 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 HUMACO, PUERTO RICO and NEW YORK, NY / ACCESS Newswire / May 28, 2025 / Aspire Biopharma Holdings, Inc. (Nasdaq:ASBP) ("Aspire" or the "Company"), a developer of a multi-faceted patent-pending drug delivery technology, today announced the brand name BUZZ BOMB™ and anticipated market launch for its novel sublingual pre-workout supplement. BUZZ BOMB™ features 50mg of caffeine and is designed to support sustained energy and mental focus, helping athletes and fitness enthusiasts maximize their performance potential. Aspire has commenced initial production of BUZZ BOMB™, its single serving pre-workout caffeine supplement utilizing Aspire's patent-pending and proprietary sublingual delivery technology.The pre-workout formula is conveniently packaged in a single serving packet for easy on-the-go use. Consumers will have a choice of six BUZZ BOMB™ flavors, including Tropical Fruit, Mixed Berry, Watermelon, Lemon Lime, Peach Mango, and Mocha Coffee. Fitness Convention Booth and Sponsor Events for BUZZ BOMB™ Launch The Company expects to begin expanded pre-launch consumer testing of this supplement product during the second quarter of 2025. In August, the Company will have a booth and be an event sponsor at two of the largest fitness conferences in the nation where over 50,000 people interested in health, fitness, optimization, nutrition, and overall wellbeing will be able to taste, sample, and experience the BUZZ BOMB™ pre-workout supplement. FITCON Expohttps://fitcon.com/ August 1-2, 2025Mountain America Expo Center, Salt Lake City, Utah The Fit Expo™https://thefitexpo.com/cities/anaheim/August 2-3The Anaheim Convention Center, Anaheim, CA Management Commentary "The introduction of Aspire's caffeine-based "Buzz Bomb™" Sublingual Pre-Workout…Read full documentShow less
Sublingual nano technology delivers caffeine rapidly to the blood stream, bringing its unique disruptive benefits to the Pre-workout market Initial production has commenced with six flavor options Expanded pre-launch consumer testing planned for Q2 2025 Aspire to launch BUZZ BOMB™ at two major upcoming fitness conventions Marketing plan focused on cost-effective multi-channel digital strategy targeting primary influencers, direct response sales and traditional retail sales channels 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 HUMACO, PUERTO RICO and NEW YORK, NY / ACCESS Newswire / May 28, 2025 / Aspire Biopharma Holdings, Inc. (Nasdaq:ASBP) ("Aspire" or the "Company"), a developer of a multi-faceted patent-pending drug delivery technology, today announced the brand name BUZZ BOMB™ and anticipated market launch for its novel sublingual pre-workout supplement. BUZZ BOMB™ features 50mg of caffeine and is designed to support sustained energy and mental focus, helping athletes and fitness enthusiasts maximize their performance potential. Aspire has commenced initial production of BUZZ BOMB™, its single serving pre-workout caffeine supplement utilizing Aspire's patent-pending and proprietary sublingual delivery technology.The pre-workout formula is conveniently packaged in a single serving packet for easy on-the-go use. Consumers will have a choice of six BUZZ BOMB™ flavors, including Tropical Fruit, Mixed Berry, Watermelon, Lemon Lime, Peach Mango, and Mocha Coffee. Fitness Convention Booth and Sponsor Events for BUZZ BOMB™ Launch The Company expects to begin expanded pre-launch consumer testing of this supplement product during the second quarter of 2025. In August, the Company will have a booth and be an event sponsor at two of the largest fitness conferences in the nation where over 50,000 people interested in health, fitness, optimization, nutrition, and overall wellbeing will be able to taste, sample, and experience the BUZZ BOMB™ pre-workout supplement. FITCON Expohttps://fitcon.com/ August 1-2, 2025Mountain America Expo Center, Salt Lake City, Utah The Fit Expo™https://thefitexpo.com/cities/anaheim/August 2-3The Anaheim Convention Center, Anaheim, CA Management Commentary "The introduction of Aspire's caffeine-based "Buzz Bomb™" Sublingual Pre-Workout energy supplement has the ideal unique characteristics to disrupt the fast-growing, multi-billion-dollar Sports Nutrition and Fitness market," said Kraig Higginson, Chief Executive Officer of Aspire. "We are excited about the early feedback from fitness trainers and athletes-who love how clean and simple our product is--and we look forward to the implementation of our phased marketing plan as we prepare for our market launch in the early third quarter. Initial production, performed by Desert Stream, a leading private label manufacturer in the health and wellness industry, has proceeded as planned and we expect to have ample product available for consumer testing and launch. While we are initially focused on the fitness pre-workout market, we believe the product also has tremendous broad market appeal in the Cognitive Focus and Energy Boost markets for professionals seeking a safe, healthy way to meet energy demands at work. We believe it may also appeal to a growing Health and Nutrition market as a weight loss enhancement, and as a coffee alternative, providing the taste, energy, and cognitive boost of coffee, while on the go, without the adverse effects of disrupting the gut micro biome and the liver, that is associated with long term coffee consumption." Higginson added, "As part of our commercial and revenue strategy, BUZZ BOMB™, is expected to provide Aspire with the opportunity for rapid, cost-effective market entry, and early revenue and cash flow while we complete our FDA clinical trials and application process for our high-dose aspirin product." BUZZ BOMB™: Disruptive Characteristics The Pre-Workout supplement market segment is flooded with many options for energy boosting and hydration products. Many, if not most, of these products today are based on a powdered "mix + water" combination that take 20-30 minutes to digest and begin to provide performance benefits. This disadvantage complicates use, response management, caffeine control, and effectiveness. In contrast, Buzz Bomb™ provides nearly instant energy, in easy-to-use small sublingual packets, which can be taken right before and during work out as needed. Market research shows that immediacy, ease of use and time management (take as needed, when needed) ranks highest in consumer preferences. Buzz Bomb™ offers potentially disruptive benefits and product characteristics that is expected to drive market penetration with significant differentiation, leading to rapid customer conversion, acquisition, and brand identity in this market. Aspire's sublingual nano technology is designed to deliver caffeine directly to the blood stream, bringing its unique disruptive benefits to the Pre-Workout market. These unique benefits provide significant product differentiation from powder mix beverage products that currently dominate the market segment. BUZZ BOMB™ Disruptive Features: Speed - works nearly immediately vs. 20-30 minutes Convenience - easy to use small packets vs. mix beverages Energy management - use as needed, when needed to manage energy Single Safe Ingredients - well known benefits and use of caffeine Low manufacturing & packaging costs - competitive pricing with high margin potential Easy powerful product demonstration - enabling low-cost sample kits Pre-workout Supplements Market & Growth Drivers According to Research and Market Reports recent report, "The 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." Growth Drivers Rising fitness culture and gym memberships Consumer focus on performance and recovery Expanding demographics (women, Gen Z, casual exercisers) Growth of RTD ("Ready To Drink"- no mixing) formats & natural formulations Digital fitness and influencer-led marketing About the Aspire Targeted Oral Delivery Platform Aspire's technology delivers a soluble, fast acting granular or powder formulation which has been developed by using our patent-pending methodology, and "trade secret" process. The technology's new mechanism of action allows for rapid sublingual absorption and entry into the bloodstream of supplements and other substances. The benefits of "rapid absorption" are to provide rapid impact in more precise quantities. About Aspire Biopharma, Inc. Headquartered in Humacao, Puerto Rico, Aspire Biopharma has developed a disruptive technology through a Novel Soluble Formulation which can deliver supplements and drugs rapidly and precisely. For more information, please visit www.aspirebiolabs.com. Safe Harbor Statement Certain statements made in this communication are "forward-looking statements" within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements may generally be identified by the use of words such as "estimate," "projects," "expects," "anticipates," "forecasts," "plans," "intends," "believes," "seeks," "may," "will," "would," "should," "future," "propose," "potential," "target," "goal," "objective," "outlook" and variations of these words or similar expressions (or the negative versions of such words or expressions) are intended to identify forward-looking statements. These forward-looking statements include, but are not limited to, statements regarding the financial position, business strategy and the plans and objectives of management for future operations. These statements are based on various assumptions, whether or not identified in this communication, and on the current expectations of Aspire's management and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as and must not be relied on by any investor as a guarantee, an assurance, a prediction or a definitive statement of fact or probability. These forward-looking statements are not guarantees of future performance, conditions or results, and involve a number of known and unknown risks, uncertainties, assumptions and other important factors, many of which are outside the control of the parties, that could cause actual results or outcomes to differ materially from those discussed in the forward-looking statements. The Company undertakes no obligation to update these statements for revisions or changes after the date of this release, except as required by law. Aspire Biopharma Holdings, Inc. Contact TraDigital IRKevin [email protected] SOURCE: Aspire Biopharma Holdings, Inc. View the original press release on ACCESS Newswire

