MaaT Pharma (MAAT) Status Update summary

Strategic partnership and commercialization

• Signed exclusive licensing and distribution agreement with Clinigen for Xervyteg (formerly MaaT013) covering 27 EU countries, UK, Iceland, Norway, and Liechtenstein.

• Clinigen will manage early access programs, hospital distribution, market access, and commercialization, while manufacturing and market authorization remain in-house.

• Partnership leverages Clinigen’s expertise in rare diseases and hospital-based commercialization, ensuring broad and rapid patient access and maximizing revenue potential.

• Early access program demand increased 75% from 2023 to 2024, with further growth expected in 2025.

• Early access data show a 57% overall response rate and 51% overall survival, consistent with pivotal trial results.

Financial terms and business outlook

• Agreement includes €10.5M upfront payment, up to €18M in milestones, and royalties in the low to mid-thirties percentage on net sales.

• Estimated peak sales for Xervyteg in Europe are €75–100M, with market penetration of 1,200–1,600 patients.

• Upfront payment extends cash runway into early 2026, providing time for additional financial initiatives and commercial scale-up.

• Long-term supply agreement spans 14 years, aligned with IP duration and includes minimum annual purchase commitments.

• Partnership sets a benchmark for future deals in other regions or with other assets, enhancing funding options.

Regulatory and market status

• EMA accepted the marketing authorization submission for Xervyteg in June 2025; potential approval expected by mid-2026.

• If approved, Xervyteg could become the first EMA-approved microbiome therapy in Europe and the first in hemato-oncology globally.

• Xervyteg is a full-ecosystem, off-the-shelf, pooled-donor microbiome therapy for hospital use in aGvHD.

• Granted Orphan Drug Designation by both FDA and EMA.