Aspire Biopharma Holdings, Inc. · NASDAQ:ASBP
Aspire Biopharma — Investor Presentation (April 2025)
30 slides from Aspire Biopharma's investor presentation, April 2025
Slide 1: Investor Presentation April 2025
April 2025 Investor Presentation Nasdaq: ASBP
Slide 2: Safe Harbor Statement
Safe Harbor Statement Certain statements made in this presentation 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
Slide 3: Outline
Outline ▪ Company Overview ▪ Product Pipeline and Planned 2025 Milestones ▪ Market Opportunity ▪ Manufacturing ▪ Marketing, Distribution & Sales ▪ Sublingual Aspirin Lead Product Candidate ▪ Investment Considerations Investor Presentation | April 2025 3
Slide 4: Overview – The Technology
Overview – The Technology Aspire Biopharma has Technology delivers a soluble, New mechanism of action developed and acquired fast acting granular or powder (absorption pathway) allows disruptive technologies for form drug formulation which for rapid sublingual delivering drugs and other has been dev
Slide 5: Technology Overview
Technology Overview 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 Water Soluble Dissolves easily under the tongue Dosage Management Drugs do not first pass through the liver a
Slide 6: Delivery Method
Delivery Method Blood Supply First Pass Metabolism Alternative Routes ▪ Suppository ▪ Intravenous Dorsalis Lingual Artery ▪ Intramuscular ▪ Inhalational aerosol Lingual Vein Veins of Dorsum of Tongue ▪ Transdermal ▪ Sublingual or buccal routes Aspire’s sublingual dose form avoids the harms of variou
Slide 7: Aspire Product Pipeline and Planned 2025 Milestones
Aspire Product Pipeline and Planned 2025 Milestones Aspirin Products Non-aspirin Prescription Drug Products ▪ Testosterone formulation for sublingually administration. High Dose ▪ Phase 1 clinical test planned for 3Q 2025. ✓ Commence clinical trial to evaluate the pharmacodynamic ▪ Sublingual semagl
Slide 8: Market Opportunity
Market Opportunity Aspire believes its disruptive technology can be applied to a number of approved drugs and supplements. 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
Slide 9: Manufacturing Strategy
Manufacturing Strategy A contract manufacturing strategy is being pursued with the potential for multiple supplier relationships to reduce risk and capex investments Glatt Air Techniques ▪ Technical Manufacturing Development Partner ▪ Pharmaceutical Development Agreement signed June 2022 ▪ Produced
Slide 10: Commercialization, Marketing, Distribution, Sales Strategy
Commercialization, Marketing, Distribution, Sales Strategy Aspire plans to engage a proven commercialization partner Commercialization Roadmap Target Disease Target Product Brand Market Access Commercial Commercial Profiling Evaluation Differentiation Evaluation Opportunity Evaluation Investment Eva
Slide 11: Aspire's Launch Product
Sublingual Aspirin Product Aspire’s Launch
Slide 12: Sublingual Aspirin Product: Overview
Sublingual Aspirin Product: Overview ▪ Addresses cardiology emergencies and pain management Absorption Level Illustration* ▪ Granular or powder formulation of a soluble, fast-acting aspirin ▪ Developed using patent-pending formulation, and "trade secret” process Benefits of “rapid absorption” aspiri
Slide 13: Sublingual Aspirin Product: Background
Sublingual Aspirin Product: Background Oral acetylsalicylic acid (ASA) has been used for its antithrombotic, antipyretic and anti-inflammatory properties for over 100 years Aspirin is believed to be the most-studied drug, with an approval pathway that benefits from its status as known and fully unde
Slide 14: Sublingual Aspirin Product
Sublingual Aspirin Product Benefits: ▪ ASA acetylates protein targets e.g., COX-1 and COX-2 which inhibit prostaglandin synthesis and platelet aggregation which have anti-thrombotic and anti-inflammatory effects ▪ ASA acetylates a variety of other protein targets and biological processes: protein sy
Slide 15: Sublingual Low-Dose Aspirin Product
Sublingual Low-Dose Aspirin Product Glatt Formulation Testing – October 2022 Objectives: Dilution in Weight of Sample Batch # USP Water pH Sample (mg) (mL) ▪ Develop a sublingual formulation for a novel API ‘Aspirin’, for the treatment of analgesic, anti- Aspirin API 22297 1861.9 5.0 2.62 pyretic, a
Slide 16: Sublingual High-Dose Aspirin Product
Sublingual High-Dose Aspirin Product Glatt Formulation Testing: October 2024 – March 2025 ▪ Glatt produced a feasibility batch of Aspire’s high-dose aspirin product in the fall of 2024. Testing through March 2024 showed that all essential product performance attributes were confirmed: size, weight,
Slide 17: Sublingual Aspirin Product: Proof of Concept
Sublingual Aspirin Product: Proof of Concept The Proof-of-Concept study verifies and validates that our formula enters the bloodstream with a therapeutic cardiac dose of aspirin in less than one minute There is no oral form of aspirin on the market today that ▪ can be absorbed into the bloodstream i
Slide 18: Caliira – Aspire's CRO Partner
Sublingual Aspirin Product Caliira – Aspire’s CRO Partner As a global Clinical Research Organization, Caliira is well positioned to optimize our development program to save time and resources. Assign a dedicated Develop an integrated, Act as your Strategic Leverage adaptive, point of contact to cust
Slide 19: Sublingual Aspirin Product: Clinical Trials
Sublingual Aspirin Product: Clinical Trials Strategy Aspire uses existing, approved generic-drug dosages. Generic drugs do not need to repeat the clinical trials related to active ingredients but must demonstrate our sublingual route of administration (i) effectiveness (ii) amount of drug that gets
Slide 20: Sublingual Aspirin Product: Clinical Trial Summary
Sublingual Aspirin Product: Clinical Trial Summary Title Sublingual aspirin powder vs oral aspirin tablet: Pharmacokinetic and pharmacodynamic characterization Study Description Objective: To compare the pharmacokinetic and pharmacodynamic characteristics of normal healthy adult volunteers administe
Slide 21: Sublingual Aspirin Product: Clinical Trial Summary
Sublingual Aspirin Product: Clinical Trial Summary ▪ Intervention model: Single group assignment ▪ Intervention model description: single dose, cross-over design Arms and Interventions ▪ Healthy adult volunteers given sublingual aspirin (powder containing 162 mg aspirin) or oral aspirin tablet (2X81
Slide 22: Clinical Trial Summary
Clinical Trial Summary Primary Outcome Measure ▪ Plasma acetyl salicylic acid concentration versus time data. Time frame: pre-dose and up to 24 hours post dose. Secondary outcome measures ▪ C-max ▪ T-max ▪ Terminal phase elimination constant ▪ T1/2 ▪ Plasma thromboxane B2 concentration, pre-dose and
Slide 23: Sublingual Aspirin Product: FDA Approval Pathway
Sublingual Aspirin Product: FDA Approval Pathway Aspire is requesting to pursue fast track 505(b)(2) approval from the FDA (for serious conditions that demonstrate substantial improvement for treating the disease or fill an unmet medical need). The fast-track pathway includes eligibility for acceler
Slide 24: Product Commercialization and Go-to-Market Strategy
Sublingual Aspirin Product Commercialization and Go-to-Market Strategy Launch product initially in the Rx market, followed 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 Significant potent
Slide 25: Sublingual Aspirin Product: Analgesics Market Opportunity
Sublingual Aspirin Product: Analgesics Market Opportunity Non-opioid analgesic and opioid markets combined currently estimated at$80+B and projected to grow to nearly $100B in five years 2022 2023 2024 2025 2026 2027 Market Data ($-Bil) Opioids $32.5 $33.6 $34.6 $35.7 $36.8 $37.9 Analgesics $48.0 $5
Slide 26: Aspire's Investment Considerations
Aspire’s Investment Considerations ▪ Patent-pending Delivery System specifically formulated to allow rapid sublingual absorption of aspirin into the blood stream and by-passing the gastrointestinal tract ▪ Fast absorption to help resolve heart attack and stroke and provide quicker analgesic effects
Slide 27: Thank You.
Aspire BioPharma Holdings, Inc. 194 Candelero Drive, Suite 223 Thank You. Humacao, PR 00791 www.aspirebiolabs.com info@aspire-biopharma.com Investor Relations investors@aspire-biopharma.com 27
Slide 28: Appendix
Appendix ▪ Medical Advisory Board ▪ Strategic Advisors Investor Presentation | April 2025 28
Slide 29: Medical Advisory Board
Medical Advisory Board ▪ James Kofi Dzandu, Ph.D, Pharmaceutical Chemistry, Assistant Professor of Pathology and Associate Director of the DNA/Identity laboratory at University of Texas Health Science center, Fort Worth Texas ▪ Morhaf Ibrahim, MD, FHRS, FACC, Electrophysiologist and Cardiologist, Fo
Slide 30: Strategic Advisors
Strategic Advisors Nancy Taylor, FDA Advisor, Chair of the Health Care & FDA Practice at Greenberg Traurig, and focuses her practice on health and FDA related matters Michael Shuster, Partner, Goodwin’s Life Sciences group, providing strategic intellectual property advice to biotechnology, chemical,
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