Planegg - Conference call and webcast (in English) today, May 9, 2017 at 3:00 pm CET (Munich/Frankfurt)/ 9:00 am EDST (New York)
Medigene AG (FSE: MDG1, Frankfurt, Prime Standard, TecDAX), 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 provided an update on its business operations for the first three months of 2018.
Prof. Dolores Schendel, CEO/CSO at Medigene AG, commented: "We made encouraging progress in the first quarter of 2018, most notably by starting the clinical trial with our cancer immunotherapy MDG1011. With a TCR-based cell product in clinical stage development, Medigene is now among the few leading companies worldwide exploring this promising therapy field. The appointment of Dr. Kai Pinkernell to the Board as Chief Medical Officer and Chief Development Officer underlines Medigene's commitment to ramping up our clinical focus and reflects the progress Medigene has made in the development of TCR-Ts and DC vaccines for the treatment of severe cancer indications. Along with our operational progress, our financial results are also in line with our guidance."
Major events since the beginning of 2018:
- Medigene started Phase I/II clinical trial with T cell receptor (TCR)-modified T cell therapy MDG1011 and initiated patient recruitment
- Medigene presented data on the successful production of acute myeloid leukemia (AML) dendritic cell (DC) vaccines in the current Phase I/II clinical trial at the AACR annual conference
- Oslo University presented clinical data for DC vaccines in prostate cancer investigator-initiated clinical trials (IITs) at the AACR annual conference
- Medigene further strengthened its patent portfolio with a US patent on a tagged TCR and a European patent covering a T cell identification method
- Medigene appointed Dr. Kai Pinkernell as Chief Medical Officer and Chief Development Officer of the Executive Management Board
- 'Deutsche Krebshilfe Preis' awarded to CEO Prof. Dolores Schendel
Key figures in the first quarter of 2018
- Total revenue increased by 6% to Eur2,766 k (3M 2016: Eur2,609 k)
- Revenue from bluebird bio partnership increased by 24% to Eur1,384 k
(3M 2017: Eur1,118 k)
- Research and development expenses increased as planned by 20% to Eur4,319 k
(3M 2017: Eur3,612 k) due to progress in proprietary immunotherapy programs
- Selling and general administrative expenses decreased by 12% to Eur1,633 k
(3M 2017: Eur1,854 k)
- EBITDA loss increased as planned by 6% to Eur3,188 k (3M 2017: Eur3,020 k)
- Net loss for the period decreased by 3% to Eur3,550 k (3M 2017: Eur3,678 k)
- Cash and cash equivalents and time deposits of Eur49,104 k as of March 31, 2018 (December 31, 2017: Eur51,724 k)
- Confirmation of financial guidance for FY 2018
- TCR-T MDG1011: Ongoing patient recruitment and patient treatment in all indications with the aim of conducting the first study cohorts of Phase I
- MAGE-A1 TCR-T (IIT): Start of the academic TCR-T clinical trial by the Max-Delbrück-Center and Charité University Hospital in Berlin, Germany
- DC Vaccine: Presentation of preliminary data on specific aspects of the current Phase I/II AML clinical trial for Medigene's proprietary WT-1/PRAME-specific DC vaccine
- Further operational progress in bluebird bio cooperation
- Ongoing identification, validation, and characterization of additional TCR candidates to feed Medigene's proprietary TCR pipeline
Financial guidance 2018
Medigene confirmed its financial guidance for 2018 published in the 2017 annual report, which reflects the Company's focus on and progress in the core immunotherapy business.
- The Company is expecting to generate total revenue of between Eur7.5 - 9.5 m in 2018. The expected decrease from 2017 (Eur11.4 m) results from the sale of US rights to a non-core product (Veregen®) in fiscal year 2017 resulting in declining revenues of Veregen® in 2018.
- Due to the progress of the clinical development programs in the core area of immunotherapies and the start of Medigene's first clinical TCR-T trial in 2018, the Company is forecasting significantly increasing research and development expenses of Eur22 - 24 m (2017: Eur14.9 m) and a loss at EBITDA level of Eur21 - 23 m (2017: Eur12.1 m). For 2018, Medigene anticipates total cash burn of Eur21 - 26 m (cash (on hand) as of December 31, 2017: Eur51.7 m consisting of cash and cash equivalents and time deposits).
- These estimates do not include potential future milestone payments from existing or future partnerships or transactions, as the occurrence of such events and their timing and amount to a large extent depend on external parties and therefore cannot be reliably predicted by Medigene.
- Based on its current planning, the Company has sufficient financial resources to fund business operations beyond the planning horizon of two years
Outlook for immunotherapies:
T cell receptor-modified T cells (TCR-Ts)
Medigene started patient recruitment for the Phase I/II clinical trial with its TCR-T cell immunotherapy MDG1011 in March 2018. Patients are first tested for suitable HLA status and whether their tumor cells are positive for the expression of the PRAME antigen. Patients must meet these basic requirements, among other inclusion criteria, in order to be enrolled into the clinical trial. As a first step, an apheresis is performed to isolate the patient's T cells. These T cells are then equipped with Medigene's specific PRAME TCR and subsequently expanded. After comprehensive quality testing of the T cell therapy product, the patient undergoes a preparative chemotherapy and a one-time infusion of MDG1011. In the early stages of this clinical development, Medigene expects a production time of about six weeks from the beginning of an apheresis process until completion of the cell product.
The Phase I part of the clinical trial is a dose escalation of the T cell product with 3-4 dose cohorts (depending on the results). Each dose cohort includes one patient for each of the three blood cancer indications acute myeloid leukemia (AML), myelodysplastic syndrome (MDS) or multiple myeloma (MM) respectively. Phase I focuses on the safety and tolerability of the treatment with MDG1011. In the early stages of the trial, the patients will be included in the clinical trial sequentially in compliance with requirements imposed by the authorities to ensure patient safety. Medigene expects to conduct the first trial cohorts of Phase I in the course of 2018.
In addition to the ongoing MDG1011 clinical trial, Medigene will also work to characterize new TCR candidates for future clinical trials under the responsibility and funding of Medigene and collect preclinical data to prepare an application for a further clinical TCR-T cell therapy trial. In addition, Medigene continues its successful collaboration with bluebird bio and expects to make further progress on TCR candidate discovery within this collaboration.
In addition to the Company's own development activities, Medigene anticipates that the academic investigator initiated TCR-modified T cell therapy clinical trial under the responsibility of Max-Delbrück-Center and Charité University Hospital in Berlin, Germany will commence in 2018 as planned.
Dendritic cell vaccines (DCs)
Medigene will continue the currently ongoing Phase I/II clinical trial for DC vaccines for the treatment of acute myeloid leukemia (AML) as planned, and intends to present preliminary data on certain aspects of the trial at scientific conferences. The final data will be available towards the end of 2019.
The full version of the quarterly statement 3M-2018 can be downloaded here: 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 CEST (Munich/Frankfurt) / 9:00 am EDT (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 www.medigene.com/investors-media/reports-presentations/webcasts/
Medigene AG (FSE: MDG1, ISIN DE000A1X3W00, Prime Standard, TecDAX) 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 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