Apimeds Pharmaceuticals Us, Inc. · AMEX:APUS
Apimeds Pharmaceuticals Us — Investor Presentation (July 2025)
24 slides from Apimeds Pharmaceuticals Us's investor presentation, July 2025
Slide 1: Apimeds Pharmaceuticals US Corporate Presentation July 2025
NYSE American: APUS apimedsus.com July 2025
Slide 2: Forward-Looking Statements
Forward-Looking Statements 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. Forward-looking statements contained in
Slide 3: Apimeds Pharmaceuticals US, Inc.
Apimeds Pharmaceuticals US, Inc. Maximizing Apitox* for Inflammation and Pain Management US company established in May 2020 Confirmatory trial projected to be completed in ~24 months • Subsidiary of Inscobee Inc. • Phase 3b study in OA of the knee • May 2025 IPO raised $13.5 million • Current cash i
Slide 4: Company Leadership and Key Partners
Company Leadership and Key Partners Erik Emerson – CEO Prior executive positions at Gilead, XOMA, Symplmed, Adhera, Mezzion Pharma, and Odyssey NeuroPharma MANUFACTURING HR SOLUTIONS Christopher MH Kim, MD – CMO A leading investigator in the field of bee therapy and co-author of the book Biotherapy:
Slide 5: Near-term Executional Imperatives
Near-term Executional Imperatives 1 Initiate the Phase 3 confirmatory trial in knee osteoarthritis 2 Launch a corporate-sponsored study in multiple sclerosis 3 Identify and pursue a third development indication, initiating a corporate-sponsored study NYSE American: APUS 5
Slide 6: Apitox: Positioned for Success
Apitox Positioned for Success Differentiation from traditional therapies 1 • Apitox provides an alternative to NSAIDs, corticosteroids and biologics, offering a new option for patients who have experienced limited efficacy or adverse effects • Positioning Apitox as an essential option for managing c
Slide 7: Differentiation from traditional therapies
1 Differentiation from traditional therapies
Slide 8: 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 demonstrated that patients experienced clinically significant pain relief and improved physical functioning Standard-of-care treat
Slide 9: Knee Osteoarthritis Pain
Knee Osteoarthritis Pain First Indication for Apitox in the US Defining knee osteoarthritis Commercial proof-of-concept established by Apimeds Korea • Osteoarthritis is a degenerative joint disease • When afflicting the knee, it is a leading cause of pain and • Approved by the Korean Ministry of Foo
Slide 10: Guidelines Suggest Various Treatments of Knee OA
Guidelines Suggest Various Treatments of Knee OA But All Fall Short—Creating a Clear Need for Better Solutions Recommended pharmacologic therapies for the management of knee osteoarthritis, based on the 2019 guideline from the American College of Rheumatology (ACR) and the Arthritis Foundation (AF)
Slide 11: Apitox Was Rigorously Evaluated in a Phase 3 Trial
Apitox Was Rigorously Evaluated in a Phase 3 Trial A Phase 3, multicenter, randomized, double-blind, parallel-group clinical trial evaluating Apitox in subjects with knee osteoarthritis APITOX INTRADERMAL INJECTION 0.2 mL (200 µg) to 1.2 mL (1200 µg) 1.5 mL (1500 µg) Baseline Week 3 Week 6 Week 9 We
Slide 12: Apitox Was Significantly More Efficacious vs Control at Week 15
Apitox Was Significantly More Efficacious vs Control at Week 15 and Through Week 19 Change from baseline in WOMAC Change from baseline in WOMAC Patient global assessment of knee pain score physical function score osteoarthritis condition (Week 15) Apitox (N=234) Control (N=133) Apitox (N=234) Contro
Slide 13: Apitox Demonstrated Efficacy Across All Grades of Knee Osteoarthritis Severity
Apitox Demonstrated Efficacy Across All Grades of Knee Osteoarthritis Severity Rate of WOMAC physical function score response (Week 15) ≥40% improvement ≥60% improvement 100% Apitox Control Apitox Control 100% 90% Proportion of patients responding (%) 80.0% 90% Proportion of patients responding (%)
Slide 14: 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 Sponsor
Slide 15: Potential efficacy across multiple indications
2 Potential efficacy across multiple indications
Slide 16: Unmet Need in MS Pain Management
Unmet Need in MS Pain Management 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 502 • Causes immune-mediated damage to the myelin sheaths that protect neurons, leading to pain, fatigue and other ne
Slide 17: Benefits in Treating MS Patients with Pain Complications
Benefits in Treating MS Patients with Pain Complications Anti-inflammatory effects Pain relief • Apitox has potent anti-inflammatory • MS often causes chronic pain3 and Apitox’s properties1,2 that may help reduce the analgesic properties may provide relief, inflammation associated with MS, potential
Slide 18: Initial Proposed Single-Site MS Study
Initial Proposed Single-Site MS Study Protocol design accepted by FDA’s CBER Neurology, revised in 2022 PRIMARY ENDPOINTS SECONDARY ENDPOINTS Trial design • The trial design will incorporate Efficacy Quality of life Pain Intensity Numerical feedback from the FDA's CBER Changes in Expanded Disability
Slide 19: Multiple Near-term, Value-creating Milestones
Multiple Near-term, Value-creating Milestones Unlocking Significant Opportunities for Investors 12-24–month readout on initial programs 2025 2026 2027 2028+ Knee osteoarthritis Structured approach to Phase 3 data; <$10mm confirmatory trial "stacking" additional indications Multiple sclerosis pain •
Slide 20: Untapped market potential
Untapped market potential Zs ZA
Slide 21: Harnessing Nature's Power
Harnessing Nature's Power Illustrative Venom-Derived Therapies Capoten Integrilin Prialt Byetta/Bydureon Botox Derived from the Derived from Derived from the Derived from a Derived from Jamaican pit viper Southeastern pygmy venom of Conus hormone found Clostridium botulinum, rattlesnake venom magus,
Slide 22: Knee OA Affects Millions
Knee OA Affects Millions Making Personalized, Effective Treatments Crucial Knee OA in the US by age, sex and race (2007–2008) Stratified by age and sex Stratified by race/ethnicity and sex 4,000,0000 Advanced symptomatic knee OA 7,000,0000 Advanced symptomatic knee OA Non-advanced symptomatic knee O
Slide 23: Apitox's Novel Biologic Status Ensures 12 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 products
Slide 24: The Apimeds Opportunity
The Apimeds Opportunity The Path to Apitox 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 share Proven
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