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NYSE American: APUS apimedsus.com July 2025
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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 this presentation may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will" "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Apimeds Pharmaceuticals US, Inc. current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully in the sections titled "Risk Factors and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in the Company’s Registration Statement on Form S-1 (No. 333-282324) and the amendments thereto with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and Apimeds Pharmaceuticals US, Inc. undertakes no duty to update such information except as required under applicable law. Past performance is not indicative of future results. There is no guarantee that any specific outcome will be achieved. Investments may be speculative and there is a total loss of your investment. 2NYSE American: APUS
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Apimeds Pharmaceuticals US, Inc. Maximizing Apitox* for Inflammation and Pain Management 3 US company established in May 2020 • Subsidiary of Inscobee Inc. • May 2025 IPO raised $13.5 million Primary asset is Apitox, licensed from Apimeds Korea • Purified, pharmaceutical-grade honeybee venom-based toxin administered intradermally • Apitox has been sold and used in South Korea since 2003 Initial clinical focus is knee osteoarthritis (OA) • ~330 patients were treated in a US Phase 3 knee OA trial, which demonstrated clinical efficacy and safety • A follow-up meeting with FDA in 2018 confirmed the need for a second Phase 3 trial Confirmatory trial projected to be completed in ~24 months • Phase 3b study in OA of the knee • Current cash is sufficient to fund Apimeds through the completion of the trial Additional Apitox opportunity in multiple sclerosis (MS) pain • Unmet need with no approved therapies • Apimeds holds rights to FDA-cleared IND for a Phase 3 study • Clinical plan is a single-site study with 25-35 patients • Study designed to confirm the reduction of pain associated with MS exacerbations *Tradename pending FDA review and approval NYSE American: APUS
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Company Leadership and Key Partners 4 MANUFACTURING HR SOLUTIONS CRO REGULATORY NYSE American: APUS Erik Emerson – CEO Prior executive positions at Gilead, XOMA, Symplmed, Adhera, Mezzion Pharma, and Odyssey NeuroPharma Christopher MH Kim, MD – CMO A leading investigator in the field of bee therapy and co-author of the book Biotherapy: History, Principles and Practice, a practical guide to diagnosing and treating diseases using living organisms Erick J. Frim – CFO More than 40 years of experience as an accountant, financial executive and consultant including public company experience Brian Peters – S V P, a i2 Division Senior commercial executive with more than 30 years of experience in global branding, business development and product launches Susan Kramer – SVP , Clinical Development Senior clinical executive with more than 30 years of experience in biopharmaceutical research and development
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Near-term Executional Imperatives 5 1 Initiate the Phase 3 confirmatory trial in knee osteoarthritis Launch a corporate-sponsored study in multiple sclerosis Identify and pursue a third development indication, initiating a corporate-sponsored study 2 3 NYSE American: APUS
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Apitox Positioned for Success Differentiation from traditional therapies • 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 complex, chronic conditions 6 1 2 3 Potential efficacy across multiple indications • Honeybee venom has demonstrated therapeutic potential in multiple inflammatory-related conditions, such as knee osteoarthritis and multiple sclerosis Untapped market potential • Apitox novel mechanism of action may fill gaps in the treatment of inflammation and immune modulation • With limited competition in this space, and extensive history of success for toxin related therapies, Apitox is well positioned for success NYSE American: APUS
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Differentiation from traditional therapies 1
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Apitox Demonstrated efficacy with >20 years of safety 8 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 treatments such as NSAIDs and opioids come with risks of systemic toxicity, dependency and abuse; by contrast, Apitox offers a natural, non-addictive solution for managing joint pain Apitox may provide patients with a path to pain relief without the heavy burden of abuse potential, ushering in a new era of safer, non-addictive pain management Apitox is under consideration for its potential to modulate immune responses in other conditions, extending the lifecycle and value of Apitox NYSE American: APUS
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Knee Osteoarthritis Pain First Indication for Apitox in the US BLA=Biologics License Application 9 Defining knee osteoarthritis • Osteoarthritis is a degenerative joint disease • When afflicting the knee, it is a leading cause of pain and disability Commercial proof-of-concept established by Apimeds Korea • Approved by the Korean Ministry of Food and Drug Safety in 2003 for the treatment of pain and inflammation associated with osteoarthritis • >810,000 doses administered to patients at >1200 facilities, with no serious adverse events reported Osteoarthritis market size and growth • An estimated 32 million US adults suffer from osteoarthritis • The US market for osteoarthritis therapeutics was valued at $8.28 billion in 2022 • US market projected to grow to $20.24 billion by 2032 US knee osteoarthritis strategy • Initial clinical study on safety in the US completed in 2017 • Planned 8-week Phase 3 trial for patients with more severe, presurgical knee osteoarthritis • BLA for pain and inflammation associated with knee osteoarthritis will be filed upon successful completion of Phase 3 studies NYSE American: APUS
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Guidelines Suggest Various T reatments of Knee OA But All Fall Short—Creating a Clear Need for Better Solutions Kolasinski SL, et al. Arthritis Rheumatol. 2020;72(2):220-233. c 10 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) Limitations of existing pharmacologic treatments for knee osteoarthritis underscore the clinical need for new anti-inflammatory analgesic agents, such as Apitox Strongly recommended Conditionally recommended DRUG CLASS CONSIDERATION(S) Oral NSAIDs Risk of systemic side effects and drug interactions Topical NSAIDs Not consistently recommended across anatomical sites Intraarticular glucocorticoids Unclear long-term efficacy; may contribute to cartilage loss Topical capsaicin Inconsistent efficacy (small effect sizes and wide confidence intervals) Acetaminophen Poor efficacy; risk of hepatotoxicity Duloxetine Issues regarding tolerability and side effects Tramadol Modest efficacy; risk of addiction and side effects NYSE American: APUS
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Apitox Was Rigorously Evaluated in a Phase 3 T rial Conrad VJ, et al. J Altern Complement Med. 2019;25(8):845-855. Key inclusion criteria • Kellgren-Lawrence radiograph grade 1 -3 • Score ≥2 on WOMAC question No. 1 • Use of chronic pain medication ≥4 days/week in the 28 days before screening Key exclusion criteria • Hypersensitivity to bee venom • Positive skin test to bee venom • Intraarticular hyaluronic acid, corticosteroids, or Synvisc • Use of β-blockers, chronic oral antihistamines, or cytochrome P450 inhibitors • Concurrent inflammation or injury to target knee Primary endpoint • Absolute change in WOMAC pain subscale score from baseline to Week 15 Secondary endpoint • Absolute change in WOMAC physical function subscale score from baseline to Week 15 CONTROL (HISTAMINE) INTRADERMAL INJECTION Patients screened (n=932) Patients enrolled (n=538) APITOX INTRADERMAL INJECTION Week 3 Week 6 Week 9 Week 12 Week 15 Week 3 Week 6 Week 9 Week 12 Week 15 Dose escalation Maximum dosing Baseline 0.2 mL (200 µg) to 1.2 mL (1200 µg) 0.2 mL (5.5 µg) to 1.2 mL (33.0 µg) 1.5 mL (1500 µg) 1.5 mL (41.25 µg) R Baseline Week 19 Week 19 Follow-up A Phase 3, multicenter, randomized, double-blind, parallel-group clinical trial evaluating Apitox in subjects with knee osteoarthritis 11 WOMAC=Western Ontario and McMaster Universities Osteoarthritis Index NYSE American: APUS
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Change from baseline in WOMAC physical function score Patient global assessment of knee osteoarthritis condition (Week 15) Apitox Was Significantly More Efficacious vs Control at Week 15 and Through Week 19 Conrad VJ, et al. J Altern Complement Med. 2019;25(8):845-855. 12 Efficacy outcomes achieved by Apitox at Week 15 were comparable to those achieved with Synvisc-One, an FDA-approved hyaluronan viscosupplement intraarticular injection Change from baseline in WOMAC pain score -6.4 -6.3 -5.9 -5.3 -5.2 -5.1 -8 -7 -6 -5 -4 -3 -2 -1 0 Baseline Week 15 Week 17 Week 19 Mean change from baseline Apitox (N=234) Control (N=133) P=0.0057 P=0.0080 P=0.0850 PRIMARY ENDPOINT -20.7 -20.3 -19.5 -17.6 -17.2 -17.1 -25 -20 -15 -10 -5 0 Baseline Week 15 Week 17 Week 19 Mean change from baseline Apitox (N=234) Control (N=133) P=0.0292 P=0.0342 P=0.1006 SECONDARY ENDPOINT 20.9% 23.3% 61.1% 39.1% 15.0% 34.6% 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% Apitox (N=234) Control (N=133) Proportion of patients responding (%) Very good Good Fair Poor Very poor P=0.0001 WOMAC=Western Ontario and McMaster Universities Osteoarthritis Index NYSE American: APUS
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≥60% improvement≥40% improvement Apitox Demonstrated Efficacy Across All Grades of Knee Osteoarthritis Severity Apimeds Pharmaceuticals. Data on file. 78.0% 80.0% 72.5% 54.1% 63.8% 59.0% 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% Grade 1 Grade 2 Grade 3 Proportion of patients responding (%) Apitox Control 64.4% 69.0% 42.5% 23.7% 39.7% 43.6% 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% Grade 1 Grade 2 Grade 3 Proportion of patients responding (%) Apitox Control Rate of WOMAC physical function score response (Week 15) All grades of knee osteoarthritis showed greater rates of clinical response in the Apitox arm at Week 15, including higher- severity patients who are the most likely candidates for knee replacement surgery 13 WOMAC=Western Ontario and McMaster Universities Osteoarthritis Index NYSE American: APUS
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FDA Feedback Confirmed Need for a Second Study to Support Initial T rial 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 was told that they may submit the full results of Study 01-013 to the IND" • "The Division also recommended that the results from Study 01-013 be used to design future studies, and these studies should minimize dropouts and missing data" 14 FDA meeting held on January 18, 2018 BLA=Biologics License Application; IND=Investigational New Drug (IND) application No safety issues raised • Will utilize post-marketing surveillance from South Korea as a component of the safety database Review jurisdiction confirmed • Will be classified as a biologic with the Division of Anesthesia, Analgesia, and Addiction Products (DAAAP) NYSE American: APUS
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P otential efficacy across multiple indications 2
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Unmet Need in MS Pain Management 16 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 neurological symptoms1 Disease-modifying agents such as beta-interferons have improved the outlook for MS patients, particularly those with relapsing/remitting MS (RRMS)1 • However, most patients continue to experience symptoms1 No drugs are currently approved for MS-related pain • Acorda’s Ampyra and its generics are the only supportive care drugs approved for MS-related walking difficulties3,4 1. McGinley M, et al. JAMA. 2021;325(8):765-779. 2. Milo R, Kahana E. Autoimmun Rev. 2010;9(5):A387-A394. 3. Dunn J, Blight A. Curr Med Res Opin. 2011;27(7):1415-1423. 4. Ampyra prescribing information. NYSE American: APUS
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Benefits in T reating MS Patients with Pain Complications Anti-inflammatory effects • Apitox has potent anti-inflammatory properties1,2 that may help reduce the inflammation associated with MS, potentially slowing disease progression Immune modulation • MS is an autoimmune condition where the immune system attacks the nervous system3; Apitox may help modulate immune responses, reducing the severity of attacks1,2 Neuroprotection • Some studies suggest that Apitox has neuroprotective effects, helping to preserve nerve function and reduce tissue damage 2 Pain relief • MS often causes chronic pain3 and Apitox’s analgesic properties may provide relief, improving patient quality of life 2 Natural alternative • As a naturally derived compound, Apitox offers a unique mechanism of action compared with conventional synthetic treatments for MS 2 17 1. Wehbe R, et al. Molecules. 2019;24(16):2997. 2. Conrad VJ, et al. J Altern Complement Med. 2019;25(8):845-855. 3. McGinley M, et al. JAMA. 2021;325(8):765-779. NYSE American: APUS
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Initial Proposed Single-Site MS Study CBER=Center for Biologics Evaluation and Research 18 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 Protocol design accepted by FDA’s CBER Neurology, revised in 2022 Efficacy Changes in Expanded Disability Status Scale (EDSS) and Multiple Sclerosis Functional Composite (MSFC) through Week 16 Safety Serious adverse events, adverse events, and tolerability Quality of life (MSQoL-54) Pain Intensity Numerical Rating Scale (PI-NRS) Functional System Scores (FSS) Patient Global Assessment (PGA) Progression of disability, utilizing the change in EDSS and MSFC Physician Global Assessment (PhGA) PRIMARY ENDPOINTS SECONDARY ENDPOINTS NYSE American: APUS
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Multiple Near-term, Value-creating Milestones Unlocking Significant Opportunities for Investors BLA=Biologics License Application 19 Structured approach to "stacking" additional indications • De-risked by initial knee OA approval • Targeting large underserved markets • Strong clinical rationale for Apitox usage • Addressable markets without the need for large salesforces 2025 2026 2027 2028+ Knee osteoarthritis Phase 3 data; <$10mm confirmatory trial Multiple sclerosis pain early anecdotal data; <$2mm corporate- sponsored single-site study Future indications 12-24–month readout on initial programs BLA filing to occur post completion of confirmatory trial, assuming positive data NYSE American: APUS
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Untapped market potential 3
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Harnessing Nature's P ower Illustrative Venom-Derived Therapies 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 from a hormone found naturally in the saliva of the Gila monster Botox Derived from Clostridium botulinum, the bacterium that causes botulism 21 Bordon KCF, et al. Front Pharmacol. 2020;11:1132. NYSE American: APUS
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Knee OA Affects Millions Making Personalized, Effective Treatments Crucial Deshpande BR, et al. Arthritis Care Res (Hoboken). 2016;68(12):1743-1750. Knee OA in the US by age, sex and race (2007–2008) Stratified by race/ethnicity and sexStratified by age and sex ~7% of the US population age ≥25 has symptomatic knee OA, with significant variation across demographic groups 22 4,000,0000 3,500,000 3,000,000 2,500,000 2,000,000 1,500,000 1,000,000 500,000 0 Number with knee OA Advanced symptomatic knee OA Non-advanced symptomatic knee OA 7,000,0000 6,000,000 5,000,000 4,000,000 3,000,000 2,000,000 1,000,000 0 Number with knee OA Female Male Female Male Female Male Female Male Hispanic Non-Hispanic Black Non-Hispanic Other Race Non-Hispanic White Advanced symptomatic knee OA Non-advanced symptomatic knee OA 25-44 45-64 65+ 25-44 45-64 65+ Female Male NYSE American: APUS
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Apitox's Novel Biologic Status Ensures 12 years of Market Exclusivity, Driving Long-term Growth We anticipate Apitox will operate independently of bee venom competition for the treatment of associated diseases for ≥12 years post-approval, if appropriate exclusivity granted 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 may seek approval using Apitox as a reference for 12 years post-approval 23NYSE American: APUS
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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 efficacy with unique mechanism of action • Apitox’s unique mechanism of action differentiates it from conventional therapies • Natural composition appeals to both patients and HCPs, offering a competitive edge Innovative product with expanding indications • Apitox has shown to be a potential therapeutic option for the treatment of knee OA and MS • The broad therapeutic potential opens new revenue streams Experienced leadership and strategic vision • Company’s leadership team brings years of expertise in the biopharmaceutical industry, with a proven track record of bringing innovative therapies to market 24NYSE American: APUS