MaaT Pharma (MAAT) Status Update summary

Strategic partnership and commercialization

• Signed an exclusive licensing and distribution agreement with Clinigen for Xervyteg (formerly MaaT013) covering 27 European countries, the UK, Iceland, Norway, and Liechtenstein, focusing on commercialization, supply, and early access programs.

• Clinigen will manage hospital distribution, market access, promotion, and the Early Access Program, while manufacturing and market authorization remain in-house.

• The partnership leverages Clinigen’s expertise in rare diseases and hospital-based commercialization, aligning with Xervyteg’s patient population and maximizing revenue potential.

• Early Access Program demand increased by 75% from 2023 to 2024, with further growth expected in 2025.

• The commercial launch will be sequenced country by country, depending on local pricing and reimbursement timelines.

Financial terms and business outlook

• The agreement includes a €10.5 million upfront payment, up to €18 million in regulatory and sales milestones, and royalties on net sales in the low to mid-thirties percentage range.

• Peak market penetration for Xervyteg is estimated at 1,200–1,600 patients, translating to €75–100 million in peak sales if approved mid-2025.

• The deal extends the cash runway into early 2026 and supports commercial scale-up, reducing reliance on capital markets.

• The 14-year supply agreement aligns with IP duration and includes minimum annual purchase requirements, ensuring a steady revenue stream.

• No additional CapEx is needed for manufacturing scale-up; current facilities are sufficient for commercial supply.

Clinical and regulatory progress

• EMA accepted the marketing authorization application for Xervyteg in June 2025, with potential approval by mid-2026, following positive pivotal phase III data in GVHD.

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

• Plans to continue and expand the early access program, with Clinigen managing operations until full commercialization.

• U.S. plans involve adjusting the clinical trial protocol based on European data, with a new trial expected to start in 2026.

• Exploring expansion into Asia, with organizational adjustments underway to assess market potential.