Medigene Provides Results for Fiscal Year 2019 and Outlook

MARTINSRIED, Germany and MUNICH, Germany, March 26, 2020 (GLOBE NEWSWIRE) -- Medigene AG (MDG1, Frankfurt, Prime Standard), a clinical stage immuno-oncology company focusing on the development of T cell immunotherapies for the treatment of cancer, today published its financial results and Annual Report for the 2019 financial year and its outlook for the current 2020 financial year. The full version of the Annual Report 2019 can be downloaded here: http://www.medigene.com/investors-media/reports-presentations/

Company highlights in 2019 and since period end:

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

• Medigene commences treatment of patients in the Phase I/II trial of its first TCR-T immunotherapy MDG1011 against several blood cancers and opens additional clinical trial sites.
  
  
• MDG1021 from Leiden University Medical Center (LUMC) was selected as next clinical TCR-T development candidate for testing in patients with relapsed or persistent hematologic malignancies after allogeneic hematological stem cell transplantation (allo-HSCT).
  
  
• Medigene developed the inducible Medigene TCR (iM-TCR) and in-licensed the PD1-41BB switch receptor from Helmholtz Zentrum München (HMGU) for an improved safety and activity of Medigene's TCR-T candidates and future applications in solid tumors.

Dendritic cell (DC) vaccine

• Medigene completed the Phase I/II clinical trial of the DC vaccine in AML patients in December 2019 and reported positive final 2-year topline results in January 2020. These results were consistent with the 12-month interim analysis presented in 2019.

Partnerships

• Medigene and Roivant Asia Cell Therapy Holdings Ltd. (a subsidiary of Roivant Sciences Ltd.) on behalf of Cytovant Sciences Co. Ltd. entered into a strategic license and cooperation agreement for cell therapies in Asia. Medigene received an upfront payment of US $10 m and is eligible to receive potential development, regulatory, and commercial milestone payments.
  
  
• bluebird bio Inc. presented preclinical data on the first therapeutic TCR-T candidate arising from the Medigene collaboration targeting the tumor antigen MAGE-A4 which is expressed by a variety of solid tumor types. bluebird bio announced its intention to start clinical development of the MAGE-A4 TCR-T candidate in 2020.
  
  
• The remaining rights to the non-core product Veregen^® and the complete stock of the corresponding active pharmaceutical ingredient were sold to the German pharmaceutical company Aresus Pharma GmbH.
  
  
• The research collaboration with the Université de Montréal and IRICoR, a pan-Canadian drug discovery research commercialization center, will provide Medigene with tumor-specific antigens as novel targets for various cancer indications, particularly for solid tumors.

Prof. Dolores Schendel, CEO/CSO at Medigene AG: “In the past fiscal year we set the course for the expansion of our clinical programs. We are pleased that for our ongoing clinical trial with the TCR-T immunotherapy candidate MDG1011 we were able to treat the first patients and that the activities to improve patient recruitment have borne fruit. Our clear goal is to complete dosing of the first three dose cohorts this year.

“In the coming months, we plan to start our second clinical trial with development candidate MDG1021 and we continue intensive work for the innovation of our technologies. Safe and targeted immune therapies are needed, especially for solid tumors, and here we are focusing on potential combinations of approaches for next-generation TCR-T cell therapies with our iM-TCRs and the co-stimulatory receptor PD1-41BB.

“The cooperation with IRICoR offers us exclusive access to a still untapped world of potential target antigens for solid tumors. We look forward to progress in our partnerships with bluebird bio and Roivant/Cytovant which we believe should provide both financial and scientific benefits. We currently don’t see effects on our business caused by the circumstances due to the Coronavirus crisis but will continue to monitor developments closely. Furthermore, we believe Medigene is well-equipped to cope.”

Company outlook:

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

• By the end of 2020, Medigene expects to complete dosing of the first three dose cohorts in the dose-escalation part of the Phase I/II trial of MDG1011 in acute myeloid leukemia (AML), myelodysplastic syndrome (MDS) and multiple myeloma (MM).
  
  
• Subject to regulatory approval, Medigene plans to initiate the Phase I study of MDG1021 in patients with relapsed or persistent hematologic malignancies after allo-HSCT in the first half of 2020. This trial will be conducted at LUMC.
  
  
• Building an extensive pipeline of potential TCR development candidates is an important goal to secure future clinical programs. In 2020, Medigene will continue to work on further developing its T cell enhancers, characterizing new TCR candidates and collecting preclinical data for future clinical TCR-T trials, especially targeting solid tumor indications.

Dendritic cell vaccines (DCs)

• Medigene retains development and commercialization rights to its DC vaccine outside of Greater China, South Korea and Japan. The Company intends to leverage its expertise with the DC platform along with the resources of partners to efficiently advance the clinical development of the DC vaccine program.

Partnerships

• Medigene continues its successful collaborations with bluebird bio and Roivant/Cytovant and is constantly evaluating new partnering opportunities related to its portfolio of product candidates to maximize the Company’s value.

Key financials in full year 2019 and financial forecast:

The financial forecast for 2020 reflects the Company’s focus on and progress in the core business of immunotherapies and does not include potential future milestone payments from existing or future partnerships or transactions, as the timing and extent of such events depends to a large extent on external parties and therefore cannot be reliably predicted by Medigene.

Currently the Company expects no material influence of the recent outbreak of the coronavirus on total revenue, research and development expenses and loss at EBITDA level. Furthermore, in preparation of the financial forecast 2020 the Company has assumed that there will be no significant events which could have a material influence or lasting effect on the operations of the Group such as force majeure (e.g. fire, flood, earthquakes, strike or war) or extraordinary economic events.

Medigene is expecting to generate total revenue of between €7.0 - 9.0 m in 2020. The decrease in comparison to 2019 (€10.6 m) is based on the prepayments from Medigene’s development partnerships that were collected immediately in 2019 but are not expected in 2020. Due to the progress of the preclinical and clinical development programs in the core area of immunotherapies, including manufacturing costs for clinical trial material and deferred expenses from 2019, the company expects a significant increase of research and development costs to €29 - 34 m (2019: €22.6 m) and a loss at EBITDA level of €24 - 32 m (2019: €17.8 m).

Based on its current planning, Medigene has sufficient financial resources to fund business operations into the second half of 2021.

Conference call:

The Management Board will hold a conference call in English today:

Medigene AG (FSE: MDG1, ISIN DE000A1X3W00, Prime Standard) 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 a focus on T cell receptor-modified T cells (TCR-Ts) and 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
Dr Gary Waanders, Claudia Burmester, Dr Anna Niedl
Tel.: +49 89 2000 3333 01
email: [email protected]

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