Martinsried/Munich – Medigene AG (FSE: MDG1, Frankfurt, Prime Standard), a clinical stage immuno-oncology company focusing on the development of T cell immunotherapies, today reported financial results for the first three months of 2019 and provided a review of recent accomplishments and anticipated upcoming milestones. The company further adjusted its financial guidance for the fiscal year 2019 following two business transactions announced in the second quarter of 2019.
Major events since the beginning of 2019:
* Medigene treated the first patient in the Phase I/II clinical trial of the T cell receptor-modified T cell immunotherapy (TCR-T) MDG1011
* Medigene and Roivant affiliate Cytovant entered into a strategic partnership for the research and development of cell therapies in Asia
* bluebird bio presented preclinical data of first TCR candidate from ongoing collaboration with Medigene and announced plans to start clinical development of this MAGE-A4 targeting TCR in 2020
* Medigene licensed a chimeric co-stimulatory receptor to enhance TCR therapies for solid tumors
* Medigene sold the remaining rights and stocks of the legacy product Veregen®
* Medigene presented positive results from in vitro tests to assess the potential TCR-mediated off-target toxicity for neuronal cells at the annual meeting of the American Society of Gene & Cell Therapy (ASGCT) and presented preclinical data on the selective killing of tumor cells by PRAME TCR-transduced T cells at the AACR conference
* Medigene obtained two European patents for its dendritic cell (DC) vaccine platform and for the TCR building block library to develop neoantigen-specific TCRs
* Medigene appointed Axel-Sven Malkomes as CFO/CBDO
Prof. Dolores Schendel, CEO of Medigene AG, comments: “We have had a very productive start to 2019 with progress in our own clinical projects and in the development of partner programs. Patient treatment in our TCR-T study MDG1011 has started, and we anticipate accelerating patient recruitment following the upcoming expansion of the number of clinical centers in this trial. Additionally, our licensing agreement with Roivant/Cytovant will enable us to generate and deliver our TCR constructs and Dendritic Cell vaccine to Cytovant, who will ultimately develop, manufacture and commercialize these promising immunotherapies for the East Asian patient populations.”
“Moreover, we were thrilled that the first TCR discovery project we developed for our partner bluebird bio yielded a TCR candidate displaying convincing preclinical data and has been selected for clinical development by bluebird bio.”
“Finally, with the sale of the remaining Veregen® rights, we have completed our transformation into a pure-play immuno-oncology company. With an improved financial forecast and sufficient liquid assets, we are well positioned to continue making further progress across our immunotherapy platform and development candidates.”
Three months’ financial results:
* Revenue from immunotherapies stable at EUR 1.4 m
* Research and development expenses (R&D) increased as planned by 28% to EUR 5.5 m due to expansion of clinical activities
* EBITDA loss increased as planned by 31% to EUR 5.0 m due to progress in immunotherapy programs
* Net loss for the period increased as planned by 36% to EUR 5.7 m
* Cash and cash equivalents and time deposits of EUR 65.5 m as at March 31, 2019
Financial guidance 2019:
Medigene revises the financial guidance for 2019 published in the 2018 Annual Report following the Roivant/Cytovant partnership in cellular immunotherapies and the sale of remaining rights to Veregen®, both closed in April 2019.
* The Company improves its revenue guidance and expects to generate total revenues of between EUR 10 – 11 m (previous guidance: EUR 5.5 – 6.5 m) in 2019, approximately EUR 5 m anticipated from the cell therapy deal with Roivant/Cytovant.
* Medigene continues to expect research and development expenses of EUR 24 -29 m in 2019 due to progress of the preclinical and clinical development programs including manufacturing costs for clinical trial material.
* The Company also confirms its EBITDA-guidance and continues to expect a loss at EBITDA level of EUR 23 – 28 m, as the additional revenue from the Roivant/Cytovant deal will be compensated by a non-cash effect of EUR -4 and -5 m resulting from the Veregen® deal, as announced in the press release from April 8, 2019.
Medigene confirms its outlook for immunotherapies published in the Annual Report 2018:
T cell receptor-modified T cells (TCR-Ts)
Current Phase I/II clinical trial with MDG1011: In addition to the three active study centers to date, it is anticipated that up to five new centers will begin recruiting patients in the second quarter and early third quarter of 2019. The University Clinic of Dresden was the first new study center to open. In 2019, the focus of the trial will be the recruitment of the first dose cohorts to assess the safety and tolerability of the treatment with MDG1011.
Development of additional TCR candidates: 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 further clinical TCR trials.
Evaluation of HA-1 TCR as a potential clinical candidate: Medigene is assessing the in-licensed HA-1-specific T cell receptor to determine if it is a suitable candidate for expansion of Medigene’s TCR-T clinical development program.
Optimization of future TCR therapies for solid tumors: In addition, the chimeric co-stimulatory receptor (the PD-1/4-1BB molecule) exclusively 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.
TCR partnerships: Within the framework of the collaboration entered into with Roivant/Cytovant, Medigene will now, together with the collaboration partner, undertake preparations to generate TCR constructs tailored specifically to Asian patients using its proprietary TCR discovery platform. In addition, Medigene continues the successful collaboration with bluebird bio.
IIT from academic partners: In addition to the Company’s own development activities, the start of the academic investigator initiated TCR-modified T cell therapy clinical trial (IIT) under the responsibility of Max-Delbrück-Center and Charité University Hospital in Berlin, Germany is expected.
Dendritic cell vaccines (DCs)
Conclusion of the Phase I/II clinical trial at the end of 2019: Medigene will continue the current Phase I/II clinical trial for DC vaccines for the treatment of acute myeloid leukemia (AML) as planned and bring it to a conclusion at the end of 2019. The data from the interim analysis will be presented beforehand at the Annual Congress of the European Hematology Association (EHA) taking place from June 13 – 16 in Amsterdam. The final data will be available towards the end of 2019/beginning of 2020.
The full version of the quarterly statement 3M-2019 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) / 9:00 am EST (New York) and transmitted live via webcast. 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 focuses on the development of personalized T cell-based therapies, with projects currently in preclinical and clinical development.
For more information, please visit http://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® and Veregen® are registered trademarks of Medigene AG. These trademarks 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