"We made substantial progress in the first half of 2018, having initiated our first T cell receptor (TCR) trial, which will include approximately 92 patients with various types of blood cancers. We also significantly expanded our collaboration with bluebird bio, increasing the number of TCR projects from four to six, providing us with an additional one-time payment and significantly increasing R&D funding and potential milestone payments to Medigene", said Prof. Dolores Schendel, CEO/CSO at Medigene AG. "The successful completion of a private placement to new and existing shareholders raising EUR 32.3 million in gross proceeds leaves us well-positioned to drive forward on our broader drug development plans as we transition from recruitment to treatment within our TCR-T trial."
Major events since the beginning of 2018:
* Medigene started a Phase I/II clinical trial with T cell receptor-modified T cell therapy (TCR-T) MDG1011. Patient enrollment in the first dose cohort of this trial and personalized cell product production began recently.
* TCR alliance significantly expanded with bluebird bio, with the number of target antigen/MHC restriction combinations for the discovery of specific TCR lead candidates by Medigene increased from four to six; under the revised terms of the agreement, Medigene received an additional one-time payment of USD 8 million and is eligible to receive increased R&D funding and up to USD 250 million in milestone payments per TCR program in addition to tiered royalty payments.
* Medigene generated EUR 32.3 million gross proceeds from an oversubscribed private placement of new shares and attracted existing and new healthcare-focused institutional investors.
* Medigene presented data at the AACR conference on the successful production of dendritic cell (DC) vaccines for the current Phase I/II clinical trial in acute myeloid leukemia (AML).
* Oslo University presented clinical data at the AACR conference for DC vaccines in prostate cancer investigator-initiated clinical trials (IITs).
* Medigene strengthened its patent portfolio with a US patent on a tagged TCR and a European patent covering a T cell identification method.
Key figures in the first half of 2018:
* Total revenue increased by 12% to EUR 5.5 million (6M 2017: EUR 4.9 million)
* Revenue from the core business of immunotherapies increased by 49% to EUR 3.4 million (6M 2017: EUR 2.3 million)
* Research and development expenses increased as planned by 17% to EUR 8.7 million (6M 2017: EUR 7.4 million) mainly due to progress in the clinical development of immunotherapy programs
* Selling and general administrative expenses decreased by 22% to EUR 3.4 million (6M 2017: EUR 4.3 million)
* EBITDA loss reduced by 10% to EUR 6.2 million (6M 2017: EUR 6.9 million)
* Net loss for the period reduced by 3% to EUR 7.2 million (6M 2017: EUR 7.5 million)
* Cash and cash equivalents and time deposits of EUR 80.8 million as at June 30, 2018 (December 31, 2017: EUR 51.7 million)
Financial guidance 2018
Medigene improves its current financial guidance for 2018.
* The Company is expecting to generate total revenue of between EUR 9.5 - 10.5 million (previous guidance EUR 7.5 - 9.5 million) in 2018, mainly due to increased revenues from the TCR collaboration with bluebird bio. The expected decrease compared to last year (2017: EUR 11.4 m) results from the one-time effect of the sale of US rights of Veregen® in 2017.
* Due to lower than estimated clinical trial costs in 2018, the company now expects to spend EUR 21 - 23 million (previous guidance EUR 22 - 24 million) for research and development in 2018. The increase of the R&D cost, compared to 2017 (2017: EUR 14.9 million) results from the progress of the clinical development programs in the core area of immunotherapies and the start the clinical TCR-T trial in 2018.
* As a result of the improved guidance on revenues and R&D costs, Medigene improves the EBITDA guidance and now expects a lower EBITDA loss of EUR 18 - 20 million (previous guidance: EUR 21 - 23 million). The increase compared to last year (2017: EUR 12.1 million) is due to the development progress of the immunotherapy programs.
* Without considering the proceeds from the capital increase conducted in May 2018, Medigene now plans a total cash burn of EUR 15 - 17 million for 2018 (previous guidance: EUR 16 - 19 million).
* This forecast 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.
T cell receptor-modified T cells (TCR-Ts)
In the Company's Phase I/II clinical trial for blood cancer types acute myeloid leukemia (AML), myelodysplastic syndrome (MDS) and multiple myeloma (MM), a personalized, single dose of TCR-T therapy MDG1011 should be administered to the first patient in the near future. Medigene expects to be able to conduct the first trial cohorts of Phase I by the end of 2018 and is in ongoing dialogue with the regulatory authorities about the clinical trial protocol to simplify patient enrolment. The Phase I part of the clinical trial is a dose escalation of MDG1011 with 3-4 dose cohorts (depending on the results). The patients will first be included in the clinical trial sequentially in compliance with requirements imposed by the authorities to ensure patient safety. Phase I focuses on the safety and tolerability of the treatment with MDG1011.
In addition to the ongoing MDG1011 clinical trial, Medigene will also work on characterizing new TCR candidates for future clinical trials under the responsibility of Medigene and collecting preclinical data to prepare an application for further clinical TCR-T trials. In addition, Medigene will continue its successful and expanded collaboration with bluebird bio and expects to make further progress on TCR candidate discovery.
In addition to the Company's own development activities, Medigene expects the start of 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.
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) and intends to present preliminary data on certain aspects of the trial at scientific conferences at appropriate times. The final clinical data will be available towards the end of 2019.
The full version of the quarterly statement 6M-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 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 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 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. (end)
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