On November 9, 2017 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, reported its financial results for the first nine months of 2017 (Press release, MediGene, NOV 9, 2017, View Source [SID1234521817]).
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Major events:
– Clinical trial application submitted for its first study with proprietary T cell receptor (TCR)-modified T cells, MDG1011 – Study start expected for end of 2017
– Automated high throughput screening platform for the identification and validation of T cell receptors (TCRs) and neoantigens presented at various international conferences
– Preclinical data on Medigene’s first immunotherapy MDG1011 presented at AACR (Free AACR Whitepaper)
– Academic partner Oslo University presented additional data on compassionate use for DC vaccines against acute myeloid leukemia (AML) at AACR (Free AACR Whitepaper)
– Medigene raised EUR 20.7 m gross proceeds through placement of new shares with institutional investors in May
Key figures:
– Growing revenue from core business immunotherapies (bluebird bio partnership) of EUR 3,435 k (9M 2016: EUR 0 k) – collaboration progressing according to plan
– Increased total revenue of EUR 7,176 k (9M 2016: EUR 7,052 k); non-recurring gain in previous year from the sale of EndoTAG rights was largely offset by revenue from the partnership with bluebird bio
– Research and development expenses increased as planned to EUR 11,073 k (9M 2016: EUR 7,985 k) due to progress in proprietary immunotherapy programs
– Thereby EBITDA loss increased as planned to EUR 10,143 k (9M 2016: EUR 9,095 k) and net loss to EUR 10,690 k (9M 2016: net loss of EUR 5,725 k positively influenced by special effect / sale of financial assets of EUR 4,242 k in 2016)
– Cash, cash equivalents and time deposits of EUR 55,374 k as at September 30, 2017 (12/31/2016: EUR 52,630 k)
– Confirmation of financial guidance 2017
Prof. Dolores Schendel, CEO/CSO at Medigene AG, commented: "Medigene has made important progress in the past three quarters. We look forward to start the clinical development of our core program MDG1011, a TCR-based immunotherapy, which is expected to commence by the end of the year. In parallel, we are continuing the phase II part of the clinical trial with our DC vaccines, in which all patients will soon be included. In addition, development cooperation with bluebird bio is progressing very well and we are confident that we will be able to report concrete results of this collaboration in the coming months."
Dr. Thomas Taapken, CFO of Medigene AG, adds: "We are fully on track with our financial result. This demonstrates Medigene’s consistent commitment to the speedy implementation and expansion of our immunotherapy programs. Progress in collaboration with bluebird bio is already evident in increasing revenue from our core business immunotherapies. This underlines the power of our TCR platform which also fuels our own development programs we are driving forward independently."
Financial guidance 2017
Medigene confirms its financial guidance for 2017 as published in the 2016 annual report. The forecast reflects Medigene’s continued focus on the core business of immunotherapies.
– Revenues: The Company is expecting to generate total revenue of EUR 8 – 10 m in 2017. This forecast does not include future milestone payments from the existing R&D partnership with bluebird or revenue from any potential new transactions.
– R&D expenses: Due to the progress of Medigene’s clinical development programs in the field of immunotherapies and a further increase in headcount, Medigene is forecasting rising research and development expenses in the amount of EUR 16 – 18 m.
– Planned EBITDA loss of EUR 16 – 18 m in fiscal year 2017.
– For 2017, Medigene anticipates cash utilization to be EUR 23 – 27 m, partly due to non-recurring effects such as investments in laboratory infrastructure. This forecast does not include any cash inflows from possible future milestone payments from the existing R&D partnership with bluebird bio or from potential new transactions.
– Based on its current planning, the Company has sufficient financial resources for well beyond the forecast horizon of two years and up to the time that data from the DC trial and TCR trials become available.
The full version of the quarterly statement 9M-2017 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 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 www.medigene.com/investors-media/reports-presentations/webcasts/