GlobeNewswire

Planegg/Martinsried, November 26, 2024. 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 as well as the Company’s ability to continue to deliver on its obligations for its existing partners, which will remain unaffected.

“Medigene has continuously prioritized projects and optimized the allocation of our resources to the R&D work and programs that we believe create the most value for patients and shareholders. While we have successfully advanced our lead TCR-T therapy MDG1015 to IND approval, we have decided to delay the MDG1015 clinical trial and pause all further development of our other autologous cell therapy programs, whilst we continue to seek future financing and partnerships to re-initiate their further development. This enables us to keep our strategic options open while focusing near term on our ability to generate 3S TCRs for TCR-guided therapies, and in advancing our TCR-guided T cell engager (TCR-TCE) MDG3010 program in collaboration with WuXi Biologics,” said Selwyn Ho, CEO at Medigene.

“The decision to reduce personnel to match our new focus has been a difficult decision to make, but this is a necessary step to ensure the long-term success of Medigene. As we implement these changes, we are grateful to all our employees for their dedication, passion and commitment in advancing TCR-guided therapies to patients and we will support all our employees through this difficult process.”

Medigene remains confident in the potential of MDG1015, a first-in-class, third-generation T cell receptor-engineered T cell (TCR-T) therapy targeting NY-ESO-1/LAGE-1a. This innovative therapy, co-expressing the costimulatory switch protein PD1-41BB, is designed to address a significant unmet medical need in the treatment of solid tumors. 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 (targeting KRAS G12D with HLA-A*11), MDG2011 (targeting KRAS G12V with HLA-A*11) 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.

Medigene will host a conference call in English and German on Wednesday, 27 November 2024 at 2:30 pm CET/8:30 am EDT. Please register at least 10 minutes in advance using the following link:

https://us06web.zoom.us/webinar/register/WN_GAqv8kFeQGWuQG1QjVS9dQ

You will receive an e-mail with your registration confirmation, which contains the link to participate in the audio webcast as well as dial-in numbers for participation by phone. Please note that the Q&A function will only be available for webcast participants.

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About Medigene AG

Medigene AG (FSE: MDG1) is an immuno-oncology platform company dedicated to developing T cell receptor (TCR)-guided therapies to effectively eliminate cancer. Its End-to-End Platform generates optimal 3S (sensitive, specific and safe) T cell receptors with unique and distinctive attributes that are utilized in multiple therapeutic modalities, such as off-the-shelf TCR-guided T cell engager (TCR-TCE) therapies (MDG3010), TCR-natural killer cell (TCR-NK) therapies and T cell receptor engineered T cell (TCR-T) therapies (MDG1015). For more information, please visit https://medigene.com/

This press release contains forward-looking statements representing the opinion of Medigene as of the date of this release. The actual results achieved by Medigene may differ significantly from the forward-looking statements made herein. Medigene is not bound to update any of these forward-looking statements. Medigene^® is a registered trademark of Medigene AG. This trademark may be owned or licensed in select locations only.

Medigene AG

Pamela Keck
Phone: +49 89 2000 3333 01
E-mail: investor@medigene.com

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