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Medigene (MDG1) investor relations material
Medigene Status Update summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.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.
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