Apimeds Pharmaceuticals Us, Inc. · AMEX:APUS
Apimeds Pharmaceuticals Us — IPO Roadshow (February 2025)
30 slides from Apimeds Pharmaceuticals Us's IPO roadshow presentation, Feb 10, 2025
Slide 1: Issuer Free Writing Prospectus
NYSE American (proposed) : APUS Issuer Free Writing Prospectus Filed Pursuant to Rule 433 Registration Statement No. 333 - 282324 February 10 , 2025
Slide 2: Forward-Looking Statements
Forward - Looking Statements 2 NYSE AMERICAN (proposed): APUS This presentation contains "forward - looking statements" that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this presentation are forward - looking statements.
Slide 3: Offering summary for APUS on NYSE American
Offering summary for APUS on NYSE American ISSUER APIMEDS PHARMACEUTICALS INC, US 3 NYSE AMERICAN (proposed): APUS 4.5 mm Shares Offering Size 15% Over Allotment Over - Allotment $4.00 – $5.00 Price Range NYSE American I APUS Exchange/Ticker Corporate and Clinical Development Use of Proceeds 180 Day
Slide 4: Ready to Maximize the Apitox Opportunity
Apimeds Pharmaceuticals US, Inc. Ready to Maximize the Apitox * Opportunity US company established in May 2020 • Based in Matawan, NJ • Subsidiary of Inscobee Inc • Form S - 1 filed with the SEC on September 25, 2024 Primary asset is Apitox, licensed from Apimeds Korea • Initially being developed as
Slide 5: Company Leadership and Operational Partners
Company Leadership and Operational Partners MANUFACTURING HR SOLUTIONS CRO REGULATORY CFO MARK CORREA CMO CHRIS KIM CEO ERIK EMERSON 5 NYSE AMERICAN (proposed): APUS
Slide 6: Drive Immediate Executional Imperatives
Drive Immediate Executional Imperatives 1 Initiate a Phase 3 confirmatory trial in Knee Osteoarthritis 2 Launch a corporate - sponsored study in Multiple Sclerosis 3 Identify and pursue a 3rd development indication, initiating a corporate - sponsored study 6 NYSE AMERICAN (proposed): APUS
Slide 7: Apitox Positioned for Success in the US Market
Apitox Positioned for Success in the US Market Differentiation from traditional therapies 1 3 7 NYSE AMERICAN (proposed): APUS • Apitox provides an alternative to NSAIDs, corticosteroids, and biologics, offering a new option for patients who have experienced limited efficacy or adverse effects • Pos
Slide 8: Differentiation from traditional therapies
Differentiation from traditional therapies 1
Slide 9: Apitox: Demonstrated efficacy with >20 years of safety
Apitox Demonstrated efficacy with >20 years of safety A purified formulation of honeybee venom that has potent anti - inflammatory and analgesic properties A Phase 3 trial has demonstrated that patients experienced clinically significant pain relief and improved physical functioning Standard - of -
Slide 10: Knee Osteoarthritis Pain: A Strategic First Indication for Apitox
Knee Osteoarthritis Pain A Strategic First Indication for Apitox Defining knee osteoarthritis • Osteoarthritis is a degenerative joint disease, which, when affecting the knee, is a leading cause of pain and disability in the US Commercial proof - of - concept and proven track record established by A
Slide 11: Guidelines Suggest Various Treatments for Knee OA, But All Fall Short
Guidelines Suggest Various T r e a t m e n ts for Knee OA, But All Fall Short — Creating a Clear Need for Better Solutions The limitations of existing pharmacologic treatments for knee osteoarthritis underscore the clinical need for new anti - inflammatory analgesic agents, such as Apitox Strongly r
Slide 12: Apitox Was Rigorously Evaluated in a Phase 3 Trial
Apitox Was Rigorously Evaluated in a Phase 3 T rial Key inclusion criteria • Kellgren - Lawrence radiograph grade 1 - 3 • Score ≥2 on question no. 1 of WOMAC • Use of chronic pain medication ≥4 days/week in the 28 days before screening Key exclusion criteria • Hypersensitivity to bee venom • Positiv
Slide 13: Apitox Was Significantly More Efficacious Than Control at Week 15
Change from baseline in WOMAC physical function score Patient global assessment of knee osteoarthritis condition (Week 15) Apitox Was Significantly More Efficacious Than Control T r e a t m e n t at Week 15 and Through Week 19 Efficacy outcomes achieved by Apitox at Week 15 were comparable to than t
Slide 14: Apitox Demonstrated Efficacy Across All Grades of Knee OA Severity
Apitox Demonstrated Efficacy Across All Grades of Knee Osteoarthritis Severity 78.0% 80.0% 72.5% 54.1% 63.8% 59.0% 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% Grade 1 Grade 2 Grade 3 Proportion of patients responding (%) Apitox Control 64.4% 69.0% 42.5% 23.7% 39.7% 43.6% 70% 60% 50% 40% 30% 20% 10%
Slide 15: FDA Feedback Confirmed Need for a Second Study
FDA Feedback Confirmed Need for a Second Study to Support Initial Trial FDA meeting held on January 18, 2018 Notable comments regarding the additional trial • "Replicated evidence from two adequate and well - controlled studies will be required for your BLA." • "After extensive discussion, the Spons
Slide 16: Countdown to Success: Phase 3b Knee OA Trial Timeline
Countdown to Success Phase 3b Knee OA Trial Timeline General Assumptions Protocol 01 - 13 Site distribution US: 10 sites Number of patients 120 completed 120 enrolled 230 screened Project Timeline Treatment: 4 months Feasibility: 1 month Follow - up: 1 month Startup: 3 months Closeout: 3 months Enro
Slide 17: Potential efficacy across multiple indications
Potential efficacy across multiple indications 2
Slide 18: Unmet Need in Multiple Sclerosis Pain Management
Unmet Need in Multiple Sclerosis (MS) Pain Management Presents a Key Opportunity for Apitox 18 MS is an autoimmune disease in which the immune system attacks the central nervous system (CNS) 1 • Primarily affects women between the ages of 20 and 50 2 • Causes immune - mediated damage to the myelin s
Slide 19: Benefits in Treating MS Patients with Pain Complications
Benefits in T r e a t i n g MS Patients with Pain Complications Anti - inflammatory effects • Apitox has potent anti - inflammatory properties 1,2 , which may help reduce the inflammation associated with MS, potentially slowing disease progression Immune modulation • MS is an autoimmune condition wh
Slide 20: Initial Proposed Single-Site MS Study
Initial Proposed Single - Site MS Study Trial design • The trial design will incorporate feedback from the FDA's CBER Neurology revision to the Phase 3 protocol submitted in 2022 • Will be conducted as a smaller, single - site study to validate the hypothesis in a controlled clinical environment Pro
Slide 21: Multiple Near-term, Value-creating Milestones
Multiple Near - term, Value - creating Milestones, Unlocking Significant Growth Opportunities for Investors Structured approach to "stacking" additional indications • De - risked by initial knee osteoarthritis approval • Targeting large underserved markets • Strong clinical rationale for Apitox usag
Slide 22: Untapped market potential
Untapped market potential 3
Slide 23: Harnessing Nature's Power: Venom-Derived Compounds
Harnessing Nature's Power Breakthrough Therapies from Venom - Derived Compounds Capoten Derived from the Jamaican pit viper Integrilin Derived from Southeastern pygmy rattlesnake venom Prialt Derived from the venom of Conus magus , also known as the "magician’s cone snail” Byetta/Bydureon Derived fr
Slide 24: Similarities Exist between Botox and Apitox
Apitox Similarities Exist between Botox and Apitox Naturally occurring toxin (botulinum toxin) Treats an array of symptoms (wrinkles, migraines, etc.) Multiple injection sites (example shown for migraine) Generic versions difficult to show equivalency; Botox sales remain strong despite multiple appr
Slide 25: Knee OA Affects Millions
Knee OA Affects Millions, Making Personalized, Effective T r e a t m e n ts More Crucial than Ever Number of persons with knee osteoarthritis (OA) in the United States, by age, sex, and race/ethnicity (2007 – 2008) Stratified by age and sex ~7% of the total US population ≥25 years of age has symptom
Slide 26: MS Affects Over a Million Patients in the US
MS Affects Over a Million Patients in the US, Underscoring the Market Potential of this Population Estimated number of persons with multiple sclerosis (MS) in the United States, stratified by age and sex (2010) 47.4 211.2 455.3 631.2 656.0 600.5 213.0 21.0 75.8 151.0 205.9 249.4 230.8 92.2 0 100 200
Slide 27: Apitox's Novel Biologic Status Ensures Years of Market Exclusivity
Apitox's Novel Biologic Status Ensures 12 years of Market Exclusivity, Driving Long - term Growth Under Section 351(k)(7)(c), biologic entities newly approved through the Centers for Biologics Evaluation and Research (CBER) receive 12 years of market exclusivity from the date of approval • No produc
Slide 28: Investing in the Company Behind Apitox
Investing in the Company Behind Apitox A Proven Path to Market Leadership and Growth Untapped market with significant growth potential • Global market for inflammatory and autoimmune treatments is growing rapidly • Apitox offers a differentiated solution with significant potential to capture market
Slide 29: Transformative Impact: FDA Approval Unlocks the Apitox Pain Franchise
T r ans f or m a t i v e Impact FDA Approval Unlocks the Potential of the Apitox Pain Franchise 29 NYSE AMERICAN (proposed): APUS Knee osteoarthritis Multiple sclerosis Other anti - inflammatory opportunities Apitox
Slide 30: NYSE American (proposed): APUS
NYSE American (proposed) : APUS
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