Egetis Therapeutics (EGTX) investor relations material

Strategic highlights and product development

• Emcitate (tiratricol) launched in Germany in May 2025 and rolling U.S. NDA completed in January 2026.

• Emcitate is the first and only approved treatment for MCT8 deficiency, with EU approval in February 2025 and anticipated FDA decision in September 2026.

• The product holds Breakthrough Therapy and Orphan Drug Designations, with market exclusivity of 10 years in the EU and 7 years in the US.

• Expansion opportunities include Resistance to Thyroid Hormone Type Beta (RTH-β), with orphan drug designation for this indication.

• Partnerships established for Japan (Fujimoto), Türkiye, Central/Eastern/Southeastern Europe (Er-Kim), and the Gulf region (taiba rare).

Clinical efficacy and safety

• Emcitate demonstrated significant and durable reduction of T3 levels, normalization of thyrotoxicosis, and improvements in cardiovascular health and bodyweight in MCT8 deficiency patients.

• Real-world evidence shows a threefold reduction in mortality risk for patients treated with tiratricol.

• Clinical trials (Triac Trial I, EMC cohort, ReTRIACt) confirm efficacy and a benign safety profile, with benefits maintained up to six years.

• European Thyroid Association recommends tiratricol as long-term therapy for all MCT8 deficiency patients.

• Patient-centered outcomes include improved interaction, alertness, motor skills, and reduced sweating.

Market access and commercialization

• Phased EU launch began in Germany, with pricing and reimbursement processes advancing in major markets.

• U.S. launch preparations include deep engagement with referral centers, expanded access programs, and payer strategy validation.

• Annual treatment costs for comparable orphan drugs range from $623K to $1.12M in the U.S.

• Lean, agile commercial team and targeted stakeholder engagement support efficient market entry.

• Priority Review Voucher upon U.S. approval could yield significant additional value.