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Medigene AG. (11/12/18). "Press Release: Medigene Reports Financial & Business Results for the First Nine Months of 2018". Planegg.

Organisations Organisation Medigene AG (FSE: MDG1, Prime Standard)
  Group Medigene (Group)
  Organisation 2 Structured Immunity (US)
Products Product TCR engineering technology (T-cell receptor engineering technology)
  Product 2 DC vaccine (dentritic cell vaccine)
Persons Person Schendel, Dolores J. (Medigene 201602– CEO before CMO before Trianta Immunotherapies + HelmholtzZentrum München)
  Person 2 Mayer, Robert (Medigene 201512– Senior Manager PR + IR before College Hill Life Sciences/Northbank Munich)
     


Conference call and webcast (in English) today, November 13, 2018 at 3:00 pm CET (Munich/Frankfurt)/ 9:00 am EST (New York)


Medigene AG (FSE: MDG1, Frankfurt, Prime Standard, SDAX), a clinical stage immuno-oncology company focusing on the development of T cell immunotherapies for the treatment of cancer, today reported financial results for the first 9 months of 2018 and provided a review of recent accomplishments and anticipated upcoming milestones. The company further improved its financial guidance for the fiscal year 2018.


Major events in the first three quarters of 2018:

- Start of a Phase I/II clinical trial with T cell receptor-modified T cell therapy (TCR-T) MDG1011 in blood cancers including Acute myeloid leukemia (AML), myelodysplastic syndrome (MDS) and multiple myeloma (MM)

- Expansion of TCR alliance with bluebird bio from four to six TCR projects

- Raise of EUR 32.3 million in oversubscribed private placement to new and existing investors

- Strengthened patent portfolio with new TCR patents in USA and Europe

- Presented data on the successful production of dendritic cell (DC) vaccines for the current Phase I/II clinical trial

- Collaboration with Structured Immunity on improved T cell receptor development


Update Immunotherapies

- Authority approves simplified criteria for patient recruitment in Phase I/II trial with TCR-therapy MDG1011: The German regulatory authority, the Paul-Ehrlich-Institut (PEI), has approved Medigene's amendment of the trial inclusion criteria. Initial trial protocol required inclusion of one patient per indication (AML, MDS, MM) in a dose cohort of three patients. The adjusted trial protocol requires at least one patient with MM and at least one patient with either AML or MDS. The adjusted trial protocol enables more flexibility and potentially more rapid enrollment of patients. Moreover, an analytical method for determining PRAME expression has been optimized, which results in an increase in the number of potential patients for the clinical trial.

- Successful manufacturing of the first personalized cell product MDG1011: The first personalized MDG1011 cell product was successfully manufactured with patient-specific T cells in compliance with the clinical trial protocol in the course of the trial. A sufficient number of therapeutic TCR-modified T cells with autologous T cells were generated despite the advanced disease stage of the patient. However, the patient could not be treated with the therapeutic product because he dropped out of the trial beforehand due to rapid progression of the underlying disease.

- Preparations to increase the number of trial centers started: Medigene is undertaking intensive preparations with a number of additional hospitals in order to increase the number of centers to allow for an accelerated patient recruitment.

Prof. Dolores Schendel, CEO of Medigene AG, comments: "We are delighted to show that the manufacturing of our highly innovative product MDG1011 worked well with a patient's own cells in our first-in-man and first-in-country trial with a TCR-modified T cell therapy. The modified study protocol and the expansion of the study centers will improve the general admission for the treatment of these critically ill patients. Our financials are on track and the guidance reflects our intensive research and development activities in the further development of our immunotherapies."


Nine months' financial results:

- Total revenue increased by 11% to EUR 8.0 million

- Revenue from the core business of immunotherapies increased by 38% to EUR 4.7 million

- Research and development (R&D) expenses increased as planned by 20% to EUR 13.3 million due to extension of the preclinical and clinical development activities for immunotherapy programs

- EBITDA loss increased as anticipated by 5% to EUR 10.7 million

- Net loss increased by 14 % to EUR 12.2 million due to higher R&D expenses and currency effects

- Cash & cash equivalents and time deposits of EUR 76.3 million as at September 30, 2018

- Further improvement of the financial guidance 2018


Financial guidance 2018:

Medigene further improves the financial guidance for 2018 which was raised in the 6M financial statement:

- The Company continues to expect total revenue of EUR 9.5 - 10.5 million in 2018.

- Due to lower than estimated clinical trial costs in 2018, the company now expects to spend EUR 19 - 21 million for the full year 2018 (previous guidance: EUR 21 - 23 million).

- As a result, Medigene is expecting to make a loss at EBITDA level of EUR 16 - 18 million (previous guidance: EUR 18 - 20 million).

- Excluding the proceeds from the capital increase conducted in May 2018, Medigene forecasts a total cash usage of EUR 12 - 14 million for 2018 (previous guidance: EUR 15 - 17 million)

- This forecast does not include potential future milestone payments or cash flows from existing or future partnerships or transactions, as the occurrence of such events and their timing and amount depend to a large extent 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 immunotherapies:


T cell receptor-modified T cells (TCR-Ts)

The Company is planning to commence treatment of the first dose cohort in the Phase I/II clinical trial of Medigene's TCR-T MDG1011 therapy for acute myeloid leukemia (AML), myelodysplastic syndrome (MDS) and multiple myeloma (MM). Phase I focuses on the safety and tolerability of the treatment with MDG1011.

In addition to the MDG1011 clinical trial, Medigene will also work on characterizing new TCR candidates for future Medigene-sponsored clinical trials and collecting preclinical data to prepare applications 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.


Dendritic cell vaccines (DCs)

Medigene continues its ongoing Phase I/II clinical trial with the DC vaccine to treat acute myeloid leukemia (AML). Data from all patients over a treatment duration of one year is expected in the fourth quarter of 2018. This corresponds to the half-way point of the full treatment period. This interim analysis is planned to be presented at scientific conferences in 2019. The final clinical data from the Phase I/II trial are expected at the conclusion of the two-year treatment for all patients towards the end of 2019.


The full version of the quarterly statement 9M-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 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 www.medigene.com/investors-media/reports-presentations/webcasts/


Medigene AG (FSE: MDG1, ISIN DE000A1X3W00, Prime Standard, SDAX) 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
email: investor@medigene.com

   
Record changed: 2018-11-16

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