Medigene provides Q1 2020 update

Martinsried/ Munich – Medigene AG (MDG1, Frankfurt, Prime Standard), a clinical stage immuno-oncology company focusing on the development of T cell immunotherapies for the treatment of cancer, today provides an update on the first quarter of 2020 and confirms the financial guidance. The full version of the Quarterly Statement Q1 2020 can be downloaded here:

Prof. Dolores Schendel, CEO/CSO at Medigene: “Medigene’s clinical and preclinical projects continued to progress well in the early part of 2020 and have not been disrupted by the COVID-19 pandemic. The health and safety of employees and patients is our first priority and the entire Medigene team has been working intensively and under exceptional conditions over the past weeks so that social distancing measures do not affect our progress.

Most importantly, patient recruitment in our first clinical trial with MDG1011 in blood cancer patients with no further treatment options is proceeding according to plan and we continue to expect to complete dosing of the first three dose cohorts this year. Preparations for the second clinical T cell receptor (TCR) trial with MDG1021 are on track as well and the study could begin in the first half of 2020. As there is generally increased uncertainty regarding clinical development programs in the biotechnology sector due to COVID-19, we continue to closely monitor any effects on our clinical activities.”

Business review since beginning of 2020 and outlook:

* Medigene continues to enroll patients according to plan in the Phase I/II clinical trial of MDG1011 against blood cancers. Complete dosing of the first three dose cohorts of the Phase I part is expected by the end of 2020 despite the ongoing COVID-19 pandemic.

* Preparations are on track for the Phase I clinical trial of MDG1021 in patients with relapsed or persistent hematologic malignancies after allogeneic hematological stem cell transplantation. The trial is expected to start in the first half of 2020 at the Leiden University Medical Center (LUMC), the Netherlands, however, in conjunction with LUMC management we continue to closely monitor the evolving COVID-19 situation and how it might influence clinical trial activity at LUMC.

* Medigene continues the research and development work on its different approaches (inducible Medigene TCR/ iM-TCR, the PD1-41BB switch receptor and tumor-specific antigens/TSAs from the Université de Montréal and IRICoR collaboration) as innovative tools to enhance the safety and activity of TCR-T therapies with the objective of advancing Medigene’s technology towards solid tumor indications. The progress of these preclinical projects is currently not affected by the COVID-19 pandemic.

* After the presentation of positive 2-year topline results of the completed Phase I/II DC vaccine clinical trial in patients with acute myeloid leukemia, Medigene’s partner Cytovant Sciences HK Limited (Roivant/Cytovant) will continue the development of the DC vaccine as “CVT-DC-01” in its licensed territories in Asia. Further partnerships for other regions are currently being evaluated.

* Medigene was granted two patents covering the novel CrossTAg-1 technology in Japan and New Zealand. Patent applications in various other jurisdictions are still pending. This technology is of particular relevance for the further development of both TCR-T and DC vaccine immunotherapies.

* To date, progress of Medigene’s development and marketing partnerships has not been affected by the COVID-19 pandemic

Financial development and financial forecast

* As of 31 March 2020, cash and cash equivalents and fixed-term deposits amounted to Eur48.53 m (31 December 2019: Eur54.68 m). The decrease is primarily due to research and development expenses to advance Medigene’s expanded clinical and preclinical activities.

* Total revenue in the first quarter 2020 decreased to Eur1.40 m from Eur2.10 m in the first quarter 2019 due to the sales of Veregen® included in the prior-year quarter, a product which was sold to Aresus Pharma GmbH in April 2019. Revenues in the first quarter 2020 include payments by the strategic partner company bluebird bio, Inc.

* Research and development expenses of Eur6.36 m were Eur0.83 m higher than in the prior-year quarter (Q1 2019: Eur5.54 m) which is mainly attributable to ongoing costs for the preparation and conduct of clinical trials and preclinical development activities of Medigene in line with the expansion of its development pipeline.

* As a result, earnings before interest, taxes, depreciation and amortization (EBITDA) decreased by Eur0.96 m on the prior-year quarter (Q1 2019: Eur-4.99 m), amounting to Eur-5.95 m in the first quarter 2020.

Medigene confirms its financial forecast for 2020 published in the Group Management’s Discussion and Analysis 2019. The Company continues to expect total revenue of Eur7.0 – 9.0 m in 2020 (excluding potential future milestone payments from existing or future partnerships or transactions), research and development expenses of Eur29 – 34 m and a loss at EBITDA level of Eur24 – 32 m.

Currently, Medigene expects no material influence of the COVID-19 pandemic on total revenue, research and development expenses and loss at EBITDA level. Based on current planning, the company is financed into the second half of 2021.

Conference Call
Medigene will not hold a telephone conference regarding the Quarterly Statement Q1 2020 but we remain available in the usual way for all enquiries.

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Medigene AG (FSE: MDG1, ISIN DE000A1X3W00, Prime Standard) 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 a focus on T cell receptor-modified T cells (TCR-Ts) and 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.

Contact Medigene AG
Dr Gary Waanders, Claudia Burmester, Dr Anna Niedl
Tel.: +49 89 2000 3333 01