MaaT Pharma (MAAT) Study Result summary

Strategic Overview and Business Model

• Focus on innovative microbiome-based therapies for immune modulation in oncology and hematology, leveraging proprietary data science and AI platforms.

• Short-term revenue generation through licensing, deals, and early reimbursement, targeting a market opportunity exceeding EUR 750 million for the first two products.

• Unique pooled microbiome and co-culture approaches standardize product quality and ensure comprehensive bacterial diversity for therapeutic efficacy.

• Expansion plans include additional indications in immuno-oncology, collaborations with major cancer centers, and partnerships with pharmaceutical companies specializing in rare diseases or hematology.

• Cash position of EUR 27 million as of September 2024, with ongoing exploration of both dilutive and non-dilutive funding options to support milestones.

Lead Asset: MaaT013 in aGvHD and Clinical Impact

• ARES phase 3 trial of MaaT013 in third-line, steroid- and ruxolitinib-refractory acute GVHD showed a 62% overall GI response rate at day 28 and 64% response across all organs.

• One-year survival probability reached 54%, far exceeding the historical 15% for this population, with responders at day 28 achieving 67% survival.

• Early Access Program data with 154 patients treated closely mirrored ARES results, supporting robustness and real-world applicability.

• Safety profile confirmed as outstanding, with ongoing monitoring and consistent results from both the trial and early access program.

• Expert endorsement highlights the therapy as a transformative advance in transplant medicine, shifting care toward proactive, targeted microbiota modulation.

Regulatory and Commercialization Pathway

• Regulatory submission for marketing authorization in Europe is on track, with eligibility confirmed by EMA and submission planned before summer 2025, six months ahead of schedule.

• U.S. plans include discussions with FDA and preparation for a phase 3 trial (APOLLO), aiming for rapid and optimized development.

• Preferred commercialization strategy is partnering with pharmaceutical companies, but direct commercialization is feasible if needed.

• Manufacturing capacity and regulatory compliance are sufficient to support commercialization of the first two products, with Europe’s largest cGMP facility scalable to ~11,000 patients/year.

• U.S. Nasdaq listing is being considered within 18–24 months to maximize funding and valuation.