Medigene provides Q3 2022 business update

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 its business in Q3 2022. The full version of the report can be downloaded here: https://www.medigene.com/investors-media/reports-presentations

Dr. Selwyn Ho, CEO at Medigene: "I am delighted to have joined Medigene at an exciting time in the company's history and look forward to working with the team to shape strategy going forward. I have been consistently impressed with the work I have seen in my first few months at Medigene and believe that our unique in-house R+D capabilities have the potential to deliver truly groundbreaking therapies to treat a multitude of underserved oncological indications.

The company has made good progress in the third quarter as we continue to pioneer development of potentially highly differentiated T-cell receptor (TCR) based therapies for solid tumors. Our pipeline of wholly owned TCR immunotherapies and proprietary and exclusive optimization tools are moving towards clinical development and we have a strong collaboration with our new partner BioNTech. We continue to explore possibilities for out-licensing and partnerships with other companies and with a cash position of €36.0 million, Medigene is in a strong financial position to fund development of our products with a runway into the fourth quarter of 2024.

I look forward to providing further updates on our strategy and pipeline shortly and by end of 2022."

Business review Q3 2022 and outlook

MDG1011 – Clinically validated T cell receptor-modified T cell (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 patients and Medigene successfully reported on safety, tolerability and feasibility in December 2021. In February 2022, the first positive efficacy and immune monitoring data were published. The last trial visit of a patient whose myelodysplastic syndrome did not progress to secondary acute myeloid leukemia took place in June 2022 and the patient remains under observation in a long-term follow-up study linked to the now concluded Phase I study. With the focus on solid cancers, Medigene 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.

Development partnerships

At the end of June 2022, the research term for the partnership with 2seventy bio, Inc. was successfully concluded in accordance with the contract and Medigene remains eligible for potential milestone payments and royalties on future products already licensed by 2seventy bio, Inc, based on Medigene's technology.

Due to financing constraints, Hongsheng Sciences has temporarily suspended its development activities within the Medigene partnership.

Medigene has meanwhile already started the extensive work under the new partnership with BioNTech SE (BioNTech) signed in February 2022.

Medigene continues to evaluate out-licensing and partnerships with other innovative immuno-oncology companies to maximize the value of its assets and technologies.

Target antigen screening – Improving safety and efficacy

Medigene continuously evaluates new potential cancer target antigens for future TCR development, both using its in-house technologies and through external collaborations with leading academic institutions. Through its research collaboration with the University of Montréal and IRICoR, a pan-Canadian drug discovery research commercialization center, Medigene gained access and investigated 47 novel tumor-specific antigens (TSAs) through its proprietary, bioinformatics-driven high-throughput screening tools. Fifteen TSAs displayed immunogenic potential and thus able to induce specific T cell responses. All of the TSAs we have studied, were found to be expressed distinctively in ovarian cancer only.With none of the TSAs passing Medigene's high-set criteria for the selection of target antigens suitable for the clinical development of TCR T cell therapy in a wider range of cancers, Medigene will not proceed with further characterization of these potential targets but focus its resources on target antigens which are deemed more promising for the development of T cell-based adoptive cell therapies for a wider number of indications.

Financial development and financial forecast

The Company generated revenue of €1,424 k compared to €2,187 k in Q3 2021. The decline in revenues was mainly due to suspension of activities within the partnership with Hongsheng Sciences.

R&D expenses increased to €3,258 k in Q3 2022, €766 k higher than in Q3 2021: €2,492 k of the expenses are due to additional charge of costs for the MDG1011 clinical trial. EBITDA decreased by €2,009 k versus the prior-year quarter (Q3 2021: €-1,754 k), amounting to €-3,763 k in Q3 2022.

Management adjusted the financial forecast for 2022 due to the successful closing of the MDG1011 clinical trial as well as further savings and now expects revenues of €23-28 m, R&D expenses of €9 – 11 m and a positive EBITDA in the amount of €8 – 9 m in 2022. 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.

Medigene does not expect any material impact due to COVID-19 or the Ukraine crisis on revenues, research and development expenses and EBITDA.

As of 30 September 2022, cash and cash equivalents and time deposits amounted to €35,978 k (31 December 2021: €22,417 k). Based on its current planning, the Company has sufficient financial resources to fund business operations into the fourth quarter of 2024.

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About Medigene

Medigene (FSE: MDG1) is a late pre-clinical stage immuno-oncology company, focusing on discovering and developing differentiated, breakthrough cellular therapies to improve the lives of cancer patients. With an end-to-end technology platform built on multiple proprietary and exclusive product enhancement and product development technologies, Medigene aims to create best-in-class T cell receptor-modified T cell (TCR-T) therapies that are optimized for both safety and efficacy. Medigene's strategy is to develop product candidates both for its in-house therapeutics pipeline and for partnering. 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.

Medigene

Phone: +49 89 2000 3333 01
E-mail: investor@medigene.com

LifeSci Advisors

Sandya von der Weid
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E-mail: svonderweid@lifesciadvisors.com