Medigene provides Q3 2021 update

Planegg/Martinsried – Medigene AG (Medigene, FSE: MDG1, Prime Standard), a clinical stage immuno-oncology company focusing on the development of T cell immunotherapies, today provides an update on Q3 2021. The full version of the Quarterly Statement Q3 2021 can be downloaded here:

Prof. Dolores Schendel, Chief Executive Officer and Chief Scientific Officer at Medigene: “We continue to add to value and potential of our advanced immunotherapies by understanding the precise way in which they work. Using T cell receptors (TCRs) to direct T cells to tumor-specific antigens on cancer cells lies at the heart of Medigene’s work and we anticipate topline data of the Phase I part of our Phase I/II clinical trial of MDG1011 in blood cancer before the end of this year.

In the development of treatments for solid cancer, our intensive preclinical program has shown that T cells bearing both a cancer-specific TCR and our PD1-41BB switch receptor enhance the molecular and cellular response to the tumor and promote tumor clearance in preclinical models. Our scientific and preclinical programs ensure that the company is built on strong and essential foundations, connecting us to clinicians and investors. But their principal goal is to propel us towards making the best treatment options available to cancer patients as soon as possible.”

Business review Q3 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. 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. Cytokine analysis of dual-equipped TCR-T cells showed that the expression of effector and stimulatory cytokines as well as chemo-attractive cytokines, which help the T cells to migrate to their target tissue in the body, was particularly enhanced.

* 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 2021.

* Medigene continues its successful collaborations with 2seventy bio, Inc. (formerly: 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 guidance

As of 30 September 2021, total revenues have increased by EUR622 k to EUR6,478 k (30 September 2020: EUR5,856 k), research and development costs of EUR8,806 k are EUR7,791 k lower than in the previous year (30 September 2020: EUR16,597 k), while earnings before interest, taxes, depreciation and amortization (EBITDA) of EUR-6,208 k are EUR10,318 k higher than in the previous year (30 September 2020: EUR-16,526 k).

In the third quarter of 2021, Medigene sold all its remaining shares in Immunocore Holdings Ltd., consisting of 162,035 ordinary shares, net of transaction costs for approx. USD4.7 m. However, research and development expenses to advance Medigene’s clinical and preclinical activities are still the main reason for the decrease in cash and cash equivalents and time deposits as of 30 September 2021. As of 30 September 2021, cash and cash equivalents amounted to EUR23,200 k (31 December 2020: EUR30,033 k).

In October 2021, a milestone from the agreement with Roivant/Cytovant in the amount of USD2 m was realized. The received milestone payment as well as reduced research and development expenses, which are now better estimated towards the year end, reflect cost-saving measures achieved as part of the strategic focus on solid tumors in 2020, and enabled Medigene to improve its financial guidance for the fiscal year 2021, as first published with the Annual Report 2020.

The forecast for total revenues has been increased from previously EUR7-9 m to a range of EUR10-11 m and the forecast for research and development costs has been reduced from previously EUR14-20 m to a range of EUR11-12 m. As a result, the forecast for the expected EBITDA loss has improved to EUR7-9 m (previously EUR10-17 m).

Based on its current planning, the Company remains financed into the first quarter of 2023.

Conference call

Medigene will not hold a telephone conference regarding the Quarterly Statement Q3 2021 but we remain available in the usual way for all enquiries.

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About Medigene

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.

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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.

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