Martinsried/Munich – –
Key Financial Figures
* Preliminary financial results confirmed as published on March 3, 2019
* Increase in revenues from immunotherapies by 22%
* Increase in R&D expenditure by 15%
* Increase in EBITDA loss as planned by 11%
* Increase in liquid assets and time deposits by 38%
* Start of Phase I/II clinical trial with T cell receptor-modified T cell therapy (TCR-T) MDG1011 for treatment of various blood cancers and first patient treated (Q1 2019)
* Encouraging interim results from Phase I/II study with DC (dendritic cell) vaccines for the treatment of leukemia type AML
* Expansion of TCR alliance with bluebird bio
* Licensing of potential future clinical TCR candidate (targeting HA-1 antigen)
* Expansion of TCR patent portfolio
* Licensing of co-stimulator to optimize future TCR therapies for solid tumors (Q1 2019)
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 released its financial results and Annual Report for 2018. The Company reaffirmed preliminary financial results published on March 3, 2019.
“Treating the first patient in our Phase I/II trial with our TCR therapy MDG1011 constitutes an important milestone for Medigene. We plan to build on this momentum and will open up to five additional treatment centers over the coming months so we can potentially accelerate dosing and conduct the first dose cohorts of the trial in the course of this year. We also made progress with our DC vaccine and published encouraging interim results from the ongoing Phase I/II study,” explained Dr. Kai Pinkernell, CMO and CDO at Medigene.
“Medigene continues evaluating new TCR candidates to expand our own clinical pipeline as well as for our partner bluebird bio and in cooperation with our academic partners. We look forward to generating clinical data in both of our cell therapy programs in 2019 and to further developing our technologies with the goal to ultimately make next-generation immunotherapies for hematological cancers and solid tumors a reality for patients and physicians,” added Prof. Dolores Schendel, CEO/CSO at Medigene AG.
2018 Financial Highlights:
|In EUR K||2018||2017 restated (1)||Change|
|Other operating income||178||1,206||-85%|
|thereof gain on sale of intangible assets, net||0||1,080||-100%|
|Selling and general administrative expenses||-7,613||-8,266||-8%|
|Research and development expenses||-17,117||-14,877||15%|
|Net profit/loss for the year||-17,049||-15,989||7%|
|Cash and cash equivalents and time deposits||71,408||51,724||38%|
(1) IAS 8 correction – see note 3 in the notes to the consolidated financial statements
2019 Outlook for Immunotherapies:
* T cell receptor-modified T cells (TCRs)
Medigene commenced patient treatment in the phase I/II clinical trial of its TCR-based T cell therapy MDG1011 for the treatment of acute myeloid leukemia (AML), myelodysplastic syndrome (MDS) and multiple myeloma (MM) in the first quarter of 2019. In addition to the three active study centers to date, up to five additional centers will begin recruiting patients in the next three to five months. The Phase I portion of this first-in-human clinical trial is a dose escalation trial with approximately 12 patients, which will evaluate the safety and feasibility as well as other secondary endpoints. The subsequent Phase II portion including 80 patients will include a control group (40 of 80 patients) and will investigate the safety and efficacy of the therapy as co-primary endpoints. In 2019, the focus of the trial will be continued recruitment of the first dose cohorts to assess safety and tolerability of the treatment with MDG1011.
In 2019, in addition to the MDG1011 clinical trial, Medigene will work on characterizing new TCR candidates for future clinical trials under the responsibility and funding of Medigene and collecting preclinical data to prepare an application for a further clinical TCR trial. Furthermore, Medigene continues its successful collaboration with bluebird bio and expects to make further progress on TCR candidate discovery.
Medigene also intends to drive forward the preparations for a clinical trial of the HA-1 T cell receptor in 2019 in order to expand Medigene’s clinical TCR development program.
The chimeric co-stimulator receptor (PD-1/4-1BB molecule) licensed from HMGU will be assessed in combination with Medigene’s tumor-specific T cells (TCR-Ts) in preclinical models in order to optimize future TCR therapies for solid tumors.
Medigene’s academic partner Max Delbrück Center and Charité, both Berlin, Germany, expect to start their investigator-initiated trial (IIT) of clinical phase I with their MAGE-A1 specific TCR candidate for the treatment of MM in 2019.
* Dendritic cell vaccines (DCs)
Medigene will continue conducting the ongoing Phase I/II DC vaccine clinical trial for the treatment of acute myeloid leukemia (AML) and the treatment period will end as planned toward the end of 2019. The detailed data from the interim analysis will be presented at a scientific conference in the first half of 2019. The final data will be available towards the end of 2019/beginning of 2020.
2019 Financial Guidance:
The financial guidance for 2019 reflects Medigene’s focus on ongoing clinical studies and the expansion of its core business of immunotherapies:
* Total revenue: The Company is expecting to generate total revenue of EUR 5.5 – 6.5 m in 2019. The decrease in comparison to 2018 (EUR 7.8 m) is related to an anticipated decrease in sales of the non-core product Veregen®. In addition, 2018 was impacted by a non-recurring effect related to the extended cooperation with bluebird bio.
* R&D expenses: Due to the progress of the preclinical and clinical development programs in the core area of immunotherapies including manufacturing costs for clinical trial material and deferred expenses from 2018, the company expects a significant increase of research and development costs to EUR 24 – 29 m (2018: EUR 17.1 m).
* Planned EBITDA loss of EUR 23 – 28 m (2018: loss of EUR 16.3 m).
* This assessment does not include potential future milestone payments or cash flows from existing or future partnerships or transactions.
* Based on its current planning, the Company has sufficient financial resources to fund business operations beyond the forecast period of two years.
The full version of the Annual Report for 2018 can be downloaded here: http://www.medigene.com/investors-media/reports-presentations/
Conference call and webcast: A telephone conference (webcast) in English will be held today at 3:00 pm CET (Munich/Frankfurt) / 10:00 am EST (New York) and transmitted live in the internet. Access and transmission of the synchronized presentation slides and a recording of the presentation is available on the homepage of Medigene at http://www.medigene.com/investors-media/reports-presentations/webcasts/
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.
For more information, please visit http://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.
Contact Medigene AG
Julia Hofmann, Dr. Robert Mayer
Tel.: +49 – 89 – 20 00 33 – 33 01