Medigene (MDG1) Status Update summary

Strategic refocus and organizational realignment

• Capital allocation prioritizes high-return R&D, focusing on off-the-shelf TCR-guided therapies, especially MDG3010 in partnership with WuXi Biologics.

• Autologous cell therapy programs, except MDG1015, are paused; MDG1015's phase one trial is delayed pending partnerships or financing, with a CTA submission to EMA planned for Q4 2024.

• Organizational realignment includes a 40% headcount reduction and cost-saving measures to align with the updated R&D focus.

• Financial guidance and cash runway extend to July 2025, with €9.5M in cash and equivalents as of September 30, 2024.

• All financing and strategic options, including a potential sale, are being evaluated to secure the long-term future.

Pipeline and partnership updates

• MDG3010, a bispecific TCR-TCE, is the primary focus, with proof-of-principle data expected in H2 2025.

• Partnership with WuXi Biologics involves joint development and a 50/50 economic split until lead candidate selection.

• Preclinical autologous programs (MDG2021, MDG2011, MDG2012) are paused, with partnering sought for further advancement.

• Multiple partnerships with BioNTech, Regeneron, and WuXi Biologics validate the platform and provide milestone and royalty opportunities.

• Milestone payments from Regeneron and BioNTech depend on their clinical progress; Regeneron has initiated a trial in China.

Technology and platform innovation

• Proprietary end-to-end platform generates best-in-class, specific, sensitive, and safe (3S) TCRs for multiple modalities.

• Platform advancements include rapid CD8+ cell manufacturing, off-the-shelf TCR-guided modalities, and broadening of the IP portfolio.

• 3S TCRs offer superior specificity, safety, and efficacy compared to antibody-based approaches, with resistance to antigen shedding and optimal affinity.

• Discovery modules leverage healthy donor pools and advanced screening to identify high-affinity, safe TCRs.

• Continued innovation in TCR generation and platform development supports future pipeline expansion.