Medigene AG: Medigene AG Announces Refocus of Corporate Strategy and Organizational Realignment

Planegg/Martinsried (pta029/26.11.2024/11:55) - Medigene AG (Medigene, FSE: MDG1, Prime Standard), an oncology platform company focused on the research and development of T cell receptor (TCR)-guided therapies for the treatment of cancer, announced today an update of its corporate strategy to refocus its capital allocation on R&D programs with highest potential for return on invested capital resulting in an organizational realignment. This strategic refocus supports the Company's short-, mid-, and long-term vision of generating optimal 3S (sensitive, specific and safe) TCRs for the development of multiple off-the-shelf TCR-guided therapies while creating value for patients, investors and partners.

The organizational realignment will include a workforce reduction of approximately 40% effective in 2025 as well as other cost-reducing measures in line with the refocused R&D activities. Medigene intends to retain employees essential for supporting these activities and including the Company's ability to continue to deliver on its obligations for its existing partners, which will remain unaffected.

Medigene remains confident in the potential of its lead program MDG1015, a third-generation autologous T cell receptor-engineered T cell (TCR-T) therapy targeting NY-ESO-1/LAGE-1a, co-expressing the costimulatory switch protein PD1-41BB. As such, the Company will temporarily delay the start of its IND approved, clinic-ready MDG1015 Phase 1 clinical trial while actively seeking partnerships and additional financing options to advance this program into the clinic.

Strategic refocus

* Portfolio Prioritization in 2025
* Medigene will continue to focus on generating 3S TCRs for use in off-the-shelf TCR-guided modalities.
* Medigene will focus its R&D on generating new TCRs for TCR-guided therapies, and also in advancing its TCR-guided T cell engager (TCR-TCE) MDG3010 program in collaboration with WuXi Biologics. The Company expects to expand its TCR-TCE pipeline through additional partnerships in the near future.
* The Company will temporarily delay the start of its IND approved, clinic-ready MDG1015 Phase 1 clinical trial while actively seeking partnerships and additional financing options to advance this program into the clinic. In line with the Company's previous communication, the CTA submission is planned for Q4 2024 to enhance the opportunity for patient recruitment.
* Medigene will deprioritize further work on all other autologous cell therapy programs including MDG2021, MDG2011 and MDG2012. As such, the Company will pause all pre-clinical development work and will actively seek partnerships to advance those programs through pre-clinical stage to IND.

* Corporate Update
* The Company's ability to continue to deliver on its obligations for its existing partners will remain unaffected. Medigene will also continue to explore establishing new partnerships as it has successfully done in the past.
* The organizational realignment and optimization will include a workforce reduction of approximately 40%, effective in 2025 as well as other cost-reducing measures in line with the reduced R&D activities. Medigene intends to retain employees essential for supporting activities as part of its strategic refocus.
* The Company maintains its 2024 guidance including its cash runway guidance into July 2025 due to lower income expected in 2025 off-setting the aforementioned cost reductions.
* The Company continues to evaluate all appropriate financing and strategic options to advance its cash runway into 2026 and beyond.

(Ende)