Apimeds Pharmaceuticals (APUS) investor relations material

Company overview and leadership

• Focused on developing Apitox, a purified honeybee venom-based biologic for inflammation and pain management, with initial clinical focus on knee osteoarthritis and expansion into multiple sclerosis pain.

• Raised $13.5 million in a May 2025 IPO, with current cash sufficient to fund ongoing confirmatory trials.

• Led by an experienced executive team with backgrounds in major pharmaceutical companies and biotherapy research.

• Strategic partnerships established for manufacturing, HR, CRO, and regulatory support.

Clinical development and trial results

• Apitox demonstrated significant efficacy and safety in a US Phase 3 trial for knee osteoarthritis, with over 330 patients treated and results comparable to FDA-approved Synvisc-One.

• FDA feedback confirmed the need for a second confirmatory Phase 3 trial, which is funded and projected to complete in ~24 months.

• Apitox showed efficacy across all grades of knee osteoarthritis, including severe cases likely to require knee replacement.

• Planned single-site Phase 3 study for MS pain, with protocol accepted by FDA and endpoints focused on efficacy, safety, and quality of life.

Market opportunity and differentiation

• Apitox offers a differentiated, non-addictive alternative to NSAIDs, corticosteroids, and opioids, addressing unmet needs in chronic pain and inflammation.

• Over 810,000 doses administered in South Korea since 2003 with no serious adverse events, supporting long-term safety.

• US osteoarthritis therapeutics market valued at $8.28 billion in 2022, projected to reach $20.24 billion by 2032.

• Apitox's novel biologic status ensures 12 years of market exclusivity upon approval, supporting long-term growth.