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Medigene AG. (9/22/20). "Press Release: Strategic Measures including Restructuring with Extension of Cash Runway and Improved EBITDA". Planegg.

Organisation Organisation Medigene AG (FSE: MDG1, Prime Standard)
  Group Medigene (Group)
Products Product MDG1011 (TCR targeting PRAME)
  Product 2 TCR engineering technology (T-cell receptor engineering technology)
Person Person Schendel, Dolores J. (Medigene 201602– CEO before CMO before Trianta Immunotherapies + HelmholtzZentrum München)
     


Medigene AG (Medigene, FSE: MDG1, Prime Standard), a clinical stage immuno-oncology company focusing on the development of T cell immunotherapies, announces today measures to reduce the cash burn and secure the Company's financing into Q3 2022.

Medigene has been proactively progressing its product development activities to further position itself as a key player in the development of novel immunotherapies. To address this mission, the Company has decided to concentrate all future preclinical research and development activities on developing functionally enhanced TCR-T cells as treatments for solid tumors (MDG10XX), the most significant commercial opportunities for Medigene's clearly differentiated technologies.

Contingent on results from the Phase I part of its ongoing MDG1011 Phase I/II clinical trial in Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS) patients, Medigene has decided to look for a partner for the Phase II part of this clinical trial. Furthermore, Medigene had so far expected the completion of dosing of the third dose cohort in the Phase I dose-escalation part of the MDG1011 trial by end of 2020. This timeline is now likely to be extended into Q1 2021 due to feasibility challenges associated with treating hematological cancer patients with very advanced and highly aggressive disease. Other clinical trials and existing collaborations continue as planned.

This new strategic approach will be implemented with cost-saving measures and a reduction of the number of employees by approx. 25% compared to the headcount published with the half-year results 2020. These measures will be enacted beginning immediately. In this context, the Company expects one-time expenses in the amount of approximately Eur1 m, which will be incurred in the fiscal years 2020 and 2021. The guidance for 2020 regarding total revenues remains unchanged at Eur7-9 m. The guidance for research and development expenses is reduced to the range of Eur22-26 m (previously Eur24-29 m). Consequently, the guidance for the anticipated EBITDA loss improves to the range of Eur17-24 m (previously EBITDA loss of Eur19-27 m). Based on this planning, the Company is financed into Q3 2022 (previously end of 2021).

Prof. Dolores J. Schendel, CEO/CSO of Medigene AG, comments: "In a year which has presented many challenges on a global scale, we are taking strategic actions to extend our cash runway, primarily by focusing all new pre-clinical product development activities on our competitively differentiated, enhanced TCR-T therapies for solid tumor indications. Unfortunately, these cost savings necessitate headcount reductions. I would personally like to thank the entire Medigene team and our partners for the great work. We continuously strive to position ourselves as a key player in the development of novel immunotherapies. Focusing the pre-clinical product development activities is, we believe, the best path forward to meet our mission at Medigene of developing breakthrough cancer therapies that fundamentally improve patients' lives."


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About Medigene

Medigene AG (FSE: MDG1, Prime Standard, ISIN DE000A1X3W00) is a publicly listed biotechnology company headquartered in Martinsried near Munich, Germany. The company is developing highly innovative immunotherapies to target various forms and stages of cancer. Medigene concentrates on the development of personalized T cell-based therapies, with associated projects currently in pre-clinical and clinical development.
For more information, please visit www.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.

   
Record changed: 2020-10-01

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