Planegg – – Starting Phase I/II clinical trial with TCR immune cell therapy MDG1011
– Patient recruitment completed for Phase I/II study with DC vaccines
– Total revenues increased by 17%
– Consistently strong cash and cash equivalents
– Raised 2017 guidance met, EBITDA loss lower than forecasted; loss reduced by 2%
Martinsried/Munich, March 22, 2018. Medigene AG (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 annual report for 2017. Medigene significantly increased its total revenues and reduced its EBITDA loss in 2017. The Company has consistently invested in its immunotherapy programs and met and partially exceeded its financial guidance.
In addition, the Company today announces the start of the Phase I/II clinical trial with its TCR therapy MDG1011 for the treatment of various types of blood cancers. It is planned to include approximately 92 blood cancer patients with acute myeloid leukemia (AML), myelodysplastic syndrome (MDS) or multiple myeloma (MM). MDG1011 is Medigene’s first clinical TCR immunotherapy product candidate.
Prof. Dolores Schendel, CEO/CSO at Medigene AG: “I am very pleased to announce today the start of our first clinical TCR trial. This makes Medigene one of the few companies worldwide with a TCR-based immunotherapy in clinical development. We laid the groundwork for this important step forward in 2017; in 2018, we will collect initial data on safety and tolerability of this innovative cancer therapy. Additionally, we are generating new TCR candidates with our high-performance TCR discovery platform; these candidates are being developed for our partners as well as to further expand our own clinical pipeline.”
Dr. Thomas Taapken, CFO of Medigene AG: “The positive progress made over the past year is reflected in our financials. The successful private placement of new shares brought us approximately EUR 20 million in additional cash to help us finance the next steps in the development of our immunotherapy projects. We met our financial guidance raised in November 2017 and with the sale of the Veregen®-US rights we largely completed the focus on our core business immunotherapies. In the new fiscal year, we will consequently invest in our clinical TCR study and will continue developing new candidates in order to further enhance our strong position as T cell immuno-oncology company.”
2017 Clinical/Operative Highlights:
– Submission of clinical trial application for first study with proprietary T cell receptor (TCR)-modified T cells, MDG1011 – approval and start of clinical trial in Q1 2018
In July 2017, Medigene filed a clinical trial authorization application to begin the first clinical trial in this field with its proprietary T cell receptor-modified T cells. Final approval for the Phase I/II trial with Medigene’s first TCR-candidate MDG1011 was granted by the German regulatory authority Paul-Ehrlich-Institute (PEI) and the relevant ethics committee in the first quarter of 2018. In addition, the necessary manufacturing license was granted. Medigene announced the start of the trial today.
– Preclinical data on MDG1011 presented at AACR
Preclinical data on Medigene’s first TCR candidate MDG1011 was presented at the American Association for Cancer Research (AACR) Annual Meeting that took place from April 1-5, 2017, in Washington, D.C. Effector cells with the TCR selected by Medigene to target PRAME show a high natural avidity for the target epitope without the need of further manipulation, e.g. functional efficacy enhancement by affinity maturation. In addition, toxicity studies using various in vitro and in silico tools revealed a favorable preclinical safety profile for this TCR.
– Patient recruitment for phase I/II clinical trial DC vaccines for the treatment of AML completed
In November 2017, Medigene completed patient recruitment for the clinical trial with DC vaccines in acute myeloid leukemia (AML). All 20 planned patients have been enrolled in the Phase I/II study. The completion of the study is expected in 2019 after a treatment period of two years for all patients.
– Focus on core immunotherapies business: US rights to Veregen® sold
In December 2017, Medigene sold the US-rights for Veregen® to Fougera Pharmaceuticals, Inc., thereby largely completing the Company’s repositioning as a pure immunotherapy company.
2017 Financial Highlights:
|In EUR K||2017||2016||CHANGE|
|Other operating income||3,699||5,648||-35%|
|thereof gain on sale of intangible assets, net||1,08||2,365||-54%|
|Selling and general administrative expenses||-8,266||-10,025||-18%|
|Research and development expenses||-14,877||-11,538||29%|
|Income from the sale of financial assets||0||4,242||–|
|Net profit/loss for the year||-13,573||-9,492||43%|
|Cash and cash equivalents and time deposits||51,724||52,63||-2%|
– The total revenue of the Company increased by 17% to EUR 11.4 m in the reporting period (2016: EUR 9.8 m). This increase is mainly due to the strategic cooperation on research and development agreed with bluebird bio, Inc. In addition, Medigene generated revenue of EUR 2.8 m with its out-licensed drug Veregen®. Other operating income showed a decrease of 35% to EUR 3.7 m (2016: EUR 5.7 m). This is mainly due to a positive non-recurring effect in the previous year 2016 relating to the sale of the former drug candidate EndoTAG®. As a result, the Company met its total revenue guidance for 2017, which it had raised in November 2017 (forecast 2017: total revenue of EUR 10.5 – 11.5 m).
– Research and development expenses rose to EUR 14.9 m in the reporting period (2016: EUR 11.5 m) as a result of the expansion of research in immunotherapy projects, mainly due to services, personnel expenses, capital expenditure and the cost of laboratory materials. This was lower than originally planned (forecast 2017: R&D expenses EUR 16 – 18 m).
– EBITDA loss generated by the Company decreased slightly to EUR 12.1 m in 2017 (2016: EUR 12.4 m) and was less than expected (forecast 2017: EBITDA loss of EUR 14 – 15 m).
– The increase in net loss for the year to EUR -13.6 m, (2016: EUR -9.5 m) is primarily due to a positive non-recurring effect in the previous year from the sale of financial assets.
– Cash and cash equivalents and time deposits amounted to EUR 51.7 m on the reporting date (31.12.2016: EUR 52.6 m), partly due to a capital increase successfully completed in May 2017 with gross proceeds of EUR 20.7 m.
2018 Outlook for Immunotherapies
– T cell receptor-modified T cells (TCRs)
Medigene starts the first clinical trial with its TCR-based T cell therapy MDG1011. MDG1011 targets the tumor antigen PRAME. The multi-center, open-label Phase I/II clinical trial is planned to treat approximately 92 blood cancer patients with advanced stage acute myeloid leukemia (AML), myelodysplastic syndrome (MDS) or multiple myeloma (MM). The Phase I part of this first-in-human clinical trial is a dose escalation trial with approximately 12 patients, which will evaluate the safety and feasibility. The Phase II part includes 80 patients (40 therapy, 40 control) and will investigate, as co-primary endpoints, the safety and efficacy of the therapy. In 2018, the focus of the trial will be the recruitment of the first dose cohorts to assess safety and tolerability of the treatment with MDG1011.
In 2018, 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. In addition, Medigene continues its successful collaboration with bluebird bio and expects to make further progress on TCR candidate discovery.
– Dendritic cell vaccines (DCs)
Medigene will continue the current Phase I/II clinical trial for DC vaccines for the treatment of acute myeloid leukemia (AML) as planned, and will present preliminary data on certain aspects of the trial at scientific conferences in 2018. In April 2018, Medigene will present data on the manufacturing of the DC vaccines during the AACR conference in Chicago. The final data should be available at the end of 2019.
2018 Financial Guidance:
The financial guidance for 2018 reflects Medigene’s alignment and continued focus on its core business of immunotherapies:
– Total revenue: The Company expects to generate total revenue of between EUR 7.5 – 9.5 m in 2018. The decrease compared with 2017 will be due to the sale of rights of a non-core product (Veregen®) in 2017 and the related net gain as well as to declining revenues of Veregen®.
– R&D expenses: Due to the progress of the clinical development programs in the core area of immunotherapies and the start of Medigene’s first clinical TCR trial, the Company is budgeting for significantly increasing research and development expenses of EUR 22 – 24 m.
– Planned EBITDA loss of EUR 21 – 23 m.
– Anticipated total cash burn of EUR 21 – 26 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 planning horizon of two years.
The full version of the annual report for 2017 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, 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 concentrates on the development of personalized T cell-based therapies, with 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