Planegg/Martinsried (pta007/12.08.2021/07:30) - Medigene AG (Medigene, FSE: MDG1, Prime Standard), a clinical stage immuno-oncology company focusing on the development of T cell immunotherapies, today published its Half-Year Report 2021 with an overview on its business performance and financial results. The full version of the report can be downloaded here: http://www.medigene.com/investors-media/reports-presentations/
Prof. Dolores Schendel, CEO/CSO at Medigene:
"We have made great steps in advancing the development of our immunotherapies. Our focus is now fully on T cell-based therapies for the treatment of solid tumors - in our opinion the most promising business opportunity for our company, both scientifically and commercially.
For example, through years of intensive research, we have established a sound basis for our TCR-T cells to overcome the adverse conditions surrounding solid tumors and fight cancerous tissue with the combination of our impressive product candidate TCR-4 and the PD1-41BB switch receptor.
We will continue to characterize new target antigens, i.e. in our partnership with the University of Montréal, and TCR candidates for future studies to pursue own clinical programs as well as new development partnerships. Overall, we must never lose sight of the overarching goal - to provide patients, physicians and relatives with the best possible therapeutic options as soon as possible."
Business review Q2 2021 and outlook
In advancing its activities towards solid tumor indications, Medigene continues the research and development work on its suite of technologies and product candidates:
* TCR-4, Medigene's lead TCR candidate against solid tumors, is a non-mutated TCR isolated using Medigene's high-throughput screening platform that specifically recognizes a peptide stemming from the PRAME protein presented by human leukocyte antigen (HLA) A2. PRAME is expressed by a variety of solid cancer types. TCR-4 is highly sensitive to this PRAME epitope and its activity has been demonstrated both in vitro (against a variety of tumor cell types including lung cancer, uterine carcinoma, melanoma, and ovarian cancer, among others) and in in vivo models against melanoma alone as well as with significantly improved efficacy when combined with Medigene's PD1-41BB switch receptor. The switch receptor turns the tumor's off-signal sent by PD-L1 into an activation signal for the TCR-T cells.
* Under the collaboration with the University of Montréal, Medigene gained access to 47 potential new tumor-specific antigens (TSAs) which were found to be shared among specimens of several patients with solid tumors of different origin, such as ovarian, breast, and lung cancer. Medigene's high-throughput screening technology identified ten peptides as immunogenic and able to induce specific T cell responses. To date, Medigene has isolated more than 20 TCRs of T cell clones that recognize these novel TSAs and have the potential to become next-generation TCR-T therapy candidates. Their further functional and safety characterization is ongoing.
* In June 2021, the last patient was recruited into the third dose cohort of the Phase I part of the Phase I/II clinical trial of MDG1011 against blood cancers. In line with Medigene's focus shifting towards solid cancers, the Company has decided that, contingent on the results from the Phase I part, the Phase II part of the trial would only be conducted with or by a partner. Topline data of the Phase I portion are expected to be published in the second half of 2021.
* Also in line with the strategic focus on solid tumors, the MDG1021 development program was discontinued in January 2021. All rights to the HA-1-specific TCR, as well as sponsorship of the Phase I clinical trial, were transferred to Miltenyi Biotec B.V. & Co. KG (Miltenyi) in July 2021. From now on, Miltenyi will continue the development of this program.
* Medigene continues its successful collaborations with bluebird bio, Inc. and Cytovant Sciences HK Limited, a biopharmaceutical company founded by Roivant Sciences (Roivant/Cytovant). To maximize the Company's value, it continues to evaluate new partnering opportunities related to its suite of TCR technologies and portfolio of product candidates.
Financial development and financial forecast
The Company's revenues increased by 17% to Eur4.3 m in the first half of 2021 (6M 2020: Eur3.7 m), research and development (R&D) expenses decreased by 43% to Eur6.3 m (6M 2020: Eur11.1 m) and the EBITDA improved by 61% to Eur-4.5 m (6M 2020: Eur-11.3 m) due to the realignment and associated efficiency measures.
Management confirms the financial forecast and still expects total revenues of Eur7 - 9 m, R&D expenses of Eur14 - 20 m and negative EBITDA of Eur10 - 17 m in 2021, without the COVID-19 pandemic having a material impact on these expectations. These estimates do not include potential future milestone payments from existing or future partnerships or transactions, as the occurrence of such events or their timing and scope depends to a large extent on external parties and therefore cannot be reliably forecast by Medigene.
As of 30 June 2021, cash and cash equivalents and time deposits amounted to Eur22.2 m (31 December 2020: Eur30.0 m). Based on its current planning, the Company has sufficient financial resources to fund business operations into the third quarter of 2022.
Investor and analyst conference call
Date: Thursday, 12 August 2021, 3:00 pm CET (9:00 am ET)
Please register beforehand and latest 2 hours prior to the event through the registration link provided above to receive your personal access information (phone number, passcode, personal PIN). Please don't distribute your dial-in details which will be personalized. Please dial in at least 10 minutes before start time.
The Management presentation can be downloaded here: http://www.medigene.com/investors-media/reports-presentations/
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Medigene AG (FSE: MDG1, ISIN DE000A1X3W00, Prime Standard) is a publicly listed biotechnology company headquartered in Planegg/Martinsried near Munich, Germany. With its scientific expertise, Medigene is working on the development of innovative immunotherapies to enhance T cell activity against solid cancers in fields of high unmet medical need. Medigene's pipeline includes preclinical as well as clinical programs in development.
Medigene's strategy is to develop its own therapies towards clinical proof-of-concept. In addition, the Company offers selected partners the opportunity to discover and develop therapies on the basis of its proprietary technology platforms. In return for such partnerships, Medigene expects to receive upfront and milestone payments as well as research and development funding and royalties on future product sales.
For more information, please visit https://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.
Dr. Anna Niedl
Phone: +49 89 2000 3333 01
Sandya von der Weid
Phone: +41 78 680 05 38
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