Planegg/Martinsried - Medigene AG (Medigene, FSE: MDG1, Prime Standard), an immuno-oncology company focusing on the development of T-cell-based cancer therapies, today provides an update on the first quarter of 2022 and confirms its financial guidance for the full year. The full version of the Quarterly Statement Q1 2022 can be downloaded here: http://www.medigene.com/investors-media/reports-presentations/
Prof. Dolores Schendel, Chief Executive Officer (CEO) and Chief Scientific Officer (CSO) at Medigene: "Medigene continues to develop technology to power the activity and safety of T cell receptor-modified T cell (TCR-T) immunotherapies in solid cancers. Our extensive partnership signed with BioNTech SE (BioNTech) in February not only validated our leading position in the field but also provided a sound financial basis at an important phase in the Company's evolution. Also in February, we reported that our blood cancer program MDG1011 was successfully produced, safe, well tolerated, with signals of both biological and/or clinical activity.
The Company is strategically positioned to increase value through partnerships and internal discovery, seeking novel T cell receptors (TCRs) and developing the necessary vital tools that will make TCR-T therapies safer, more efficacious and cost effective."
Business review since beginning of 2022 and outlook
Validating, comprehensive TCR-T and technology partnership with BioNTech SE (BioNTech)
BioNTech recently acquired Medigene's PRAME-specific TCR-4 from the MDG10XX program and has an exclusive option to acquire additional existing TCRs in Medigene's discovery pipeline. Medigene will develop a number of new TCRs under a development partnership agreement with BioNTech lasting initially for three years and has granted BioNTech licenses to its PD1-41BB switch receptor and precision pairing library. These are technologies that could make TCR-T therapies safer and more effictive.
Under the agreement, Medigene received an upfront payment of EUR 26 million and will be reimbursed for research and development costs incurred during the period of the collaboration. Medigene will be eligible for development, regulatory and commercial milestone payments up to a triple-digit million Euro amount per program. In addition, the Company will be eligible for tiered deferred option payments on global net sales for products based on TCRs arising from the collaboration and royalties on products utilizing at least one of the licensed technologies.
MDG1011 – clinically validated TCR-T therapy in blood cancers
In June 2021, the last patient was enrolled in the third dose cohort of the Phase-I part of the Phase I/II trial of MDG1011 in blood cancer. Medigene reported on safety, tolerability and feasibility in December 2021. In February 2022, first efficacy and immune monitoring data were published. MDG1011 was successfully produced for 12 of the 13 heavily pretreated patients (92.3%) and proved to be safe and well tolerated. MDG1011 showed signs of both biological and clinical activity. One patient is currently still under observation, over nine months after treatment. In line with Medigene's focus on solid cancers, the Company has decided that, contingent on the final results from the Phase I part, the Phase II part of the trial would only be conducted with or by a partner.
Tools to empower TCR-T therapies
Medigene develops several tools to make TCR-T therapies even safer, more specific and more effective, especially for use in solid cancers. In March 2022, preclinical data on Medigene's PD1-41BB switch receptor were published in the peer-reviewed scientific publication "T-Cells Expressing a Highly Potent PRAME-Specific T-Cell Receptor in Combination with a Chimeric PD1-41BB Co-Stimulatory Receptor Show a Favorable Preclinical Safety Profile and Strong Anti-Tumor Reactivity" in the scientific journal Cancers.
Medigene continues its successful collaboration with 2seventy bio, Inc. (formerly: bluebird bio, Inc.) and has initiated operations under the new partnership with BioNTech. Cytovant Sciences HK Limited, a biopharmaceutical company founded by Roivant Sciences, has reported that its development activities would be delayed due to the COVID-19 pandemic, and separately has temporarily suspended Medigene's activities within the second TCR-T development project since April 2022.
To maximize the Company's value, Medigene continues to evaluate new partnering opportunities related to its suite of technologies and portfolio of product candidates.
Financial development and financial forecast
As of 31 March 2022, cash and cash equivalents amounted to EUR47.8 m (31 December 2021: EUR22.4 m). In Q1 2022, Medigene generated revenues of EUR23.0 m (Q1 2021: EUR2.1 m) and had research and development expenses of EUR2.0 (Q1 2021: EUR4.0 m). As a result, the earnings before interest, taxes, depreciation, and amortization (EBITDA) amounted to EUR16.8 m (Q1 2021: EUR‑3.1 m).
Currently, Medigene does not expect any material impact on revenues, research and development expenses and EBITDA due to COVID-19 or the Ukraine crisis. Thus, Medigene confirms its financial forecast for 2022 published in the Group Management's Discussion and Analysis 2021 and continues to expect revenues of EUR23 – 28 m, research and development expenses of EUR11 – 15 m and a positive EBITDA in the amount of EUR3 – 5 m in 2022. Based on its current planning, the Company has sufficient financial resources to fund business operations into Q4 2024.
Medigene will not hold a telephone conference regarding the Quarterly Statement Q1 2022, but we remain available in the usual way for all enquiries.
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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 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