Medigene provides Q2 update and 6M report 2020

Martinsried/ Munich – Medigene AG (Medigene, FSE: MDG1, Prime Standard), a clinical stage immuno-oncology company focusing on the development of T cell immunotherapies, today published its 6-Months Report 2020 with an overview on its business performance and financial results. The full version of the report can be downloaded here:

Prof. Dolores Schendel, CEO/CSO at Medigene: “We are in the fortunate position to report that our research and development projects have continued to progress uninterrupted over the past six months. With the start of our second clinical trial with T cell receptor (TCR) immunotherapy MDG1021 at the Leiden University Medical Center (LUMC), we have reached another milestone. Despite the special circumstances caused by the coronavirus pandemic, the trial site in the Netherlands is working intensely at screening and recruiting patients. Recruitment for our clinical Phase I/II trial with MDG1011 in acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) patients is on track. We have also made further progress in our strategic collaboration and discovery agreement with our Asian partner Cytovant Sciences HK Ltd. (Roivant/Cytovant). Within this collaboration, Medigene started research and development work for the first target antigen chosen by Roivant/Cytovant for a TCR immunotherapy. We look forward to an exciting second half of 2020 and thank our shareholders for their confidence in us.”

Business review Q2 2020:
* In June 2020, Medigene received the approval to start a Phase I study of MDG1021 at the LUMC, the Netherlands. The study enrolls patients suffering from relapsed or persistent blood cancers after allogeneic (non-self) hematopoietic stem cell transplantation, an area with high unmet medical need.
* Medigene presented a poster on preclinical data regarding the mode of action of its PD1-41BB switch receptor at the 2020 American Association for Cancer Research (AACR) Virtual Annual Meeting II in June 2020. The experiments showed that the addition of the PD1-41BB switch receptor strongly enhanced the antigen-specific functions of the T cell receptor-modified T cells (TCR-Ts) against solid tumors.
* Within the license and cooperation agreements with Roivant/Cytovant, the development of the first TCR, which will be directed against a target antigen defined by Roivant/Cytovant, was started at Medigene as planned in April 2020.

Company outlook:
* By the end of 2020, Medigene expects to complete dosing of the first three dose cohorts of the Phase I part of the Phase I/II trial of MDG1011 in AML and MDS.
* Medigene will continue to work on further developing its T cell enhancers, characterizing new TCR candidates, and collecting preclinical data for future TCR clinical trials, especially targeting solid tumor indications.
* Medigene retains development and commercialization rights to its DC vaccine outside of Greater China, South Korea and Japan. The Company intends to leverage its expertise with the DC platform along with the resources of partners to efficiently advance the clinical development of the DC vaccine program. Medigene will provide further updates from the completed Phase I/II trial and more detailed data and analyses will be presented at upcoming scientific conferences.
* Medigene continues its successful collaborations with bluebird bio and Roivant/Cytovant and is constantly evaluating new partnering opportunities related to its portfolio of product candidates to maximize the Company’s value.

Financial development and guidance:
* The revenue generated by the Company decreased by 35% to Eur3,673 k in the reporting period (6M 2019: Eur5,619 k) and consisted of the revenue from the existing partnership with bluebird bio and the cooperation with Roivant/Cytovant entered into in April 2019. The first half of 2019 was influenced by the agreement with Roivant/Cytovant, in which exclusive development, manufacturing and marketing rights were granted, resulting in revenues of Eur2,233 k. Prior to the sale of the Veregen® business, Medigene generated revenue from its non-core business of Eur693 k in the first half year of 2019.
* Research and development (R&D) expenses increased in the first half year 2020 by 7% to Eur11,673 k (6M 2019: Eur10,922 k) on account of the intensification of both preclinical activities and, more importantly, clinical development and production activities for Medigene’s immunotherapy programs.
* The negative EBITDA increased as expected due to lower revenues and slightly higher R&D costs by 33% in the period to Eur11,325 k (6M 2019 (adjusted): Eur8,532 k).
* The management confirms the financial guidance and continues to expect total revenue of Eur7-9 m, R&D expenses of Eur24-29 m and an EBITDA loss of Eur19-27 m.
* As of 30 June 2020, cash and cash equivalents and fixed-term deposits amounted to Eur39,882 k (31 December 2019: Eur54,682 k). Based on current planning, the Company is financed till the end of 2021.

Conference call:
The Management Board will hold a conference call in English today:

Date of telephone conference: Friday, 7 August 2020
Time: 2pm CET (Frankfurt) / 8am EDT (New York)

Register online/ Dial in number:

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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.
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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.

Dr. Gary Waanders, Claudia Burmester, Dr. Anna Niedl
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