• Pipeline expansion into neoantigens with multiple KRAS mutations as the first targets
• Acquired exclusive, worldwide rights to a CD40L-CD28 costimulatory switch protein
• Data from MDG1015 and multiple TCRs combined with PD1-41BB costimulatory switch receptor, presented at American Academy of Cancer Research and the Immuno-Oncology Summit Europe, respectively
• Announced IP expansion for its PD1-41BB costimulatory switch receptor in Japan, and TCR targeting PRAME in Europe and China

Planegg/Martinsried, August 17, 2023. Medigene AG (Medigene or the “Company”, FSE: MDG1, Prime Standard), an immuno-oncology platform company focusing on the discovery and development of T cell immunotherapies for solid tumors, today reported financial and operational results for the six months ended June 30, 2023. The half-year 2023 earnings report can be found here.

“In the first half of 2023, we have accomplished many significant milestones, and made substantial progress towards our strategic objectives”, said Selwyn Ho, Chief Executive Officer at Medigene. “We advanced our IND / CTA enabling work on MDG1015 and expanded our pipeline into neoantigens targeting multiple KRAS mutations and HLAs in solid tumors. We also acquired a worldwide, exclusive license of a CD40L-CD28 costimulatory switch protein to further optimize the efficacy and safety profile of T cell receptor engineered T cell (TCR-T) therapies. With our expanding TCR-T therapy pipeline enhanced with two costimulatory switch proteins, bolstered by a robust IP portfolio, we are confident that we remain well on track to achieve our aim to develop best-in-class TCR-T therapies for patients suffering from difficult-to-treat solid tumors.”

Financial and Corporate Highlights

• The financial performance in the first half of 2023 was in line with the Executive Management Board’s expectations. Revenues amounted to EUR 3.1 million, primarily from the partnership with BioNTech. Reflecting the strong commitment towards advancing and expanding the pipeline, R&D expenses amounted to EUR 5.2 million.
• The Executive Management Board, therefore, maintains its guidance for the fiscal year 2023 published in the annual report 2022 on March 29, 2023, in its entirety. Accordingly, the Executive Management Board expects revenue in 2023 to be between EUR 5 and 7 million. The Company expects R&D costs ranging from EUR 13 to 16 million. As of June 30, 2023, cash and cash equivalents and time deposits amounted to EUR 24.6 million (December 31, 2022: EUR 33.2 million). Based on current planning, the Company is financed until the fourth quarter of 2024.
• In June, Medigene hosted an R&D Event to discuss the pipeline expansion and the evolution of its end-to-end platform. The replay as well as the accompanying slide deck can be found here.
• In May, the Company has been issued a patent by the Japan Patent Office protecting its PD1-41BB switch receptor. In addition, the Company reported that it had been granted the patent protection of its T cell receptor targeting PRAME (PReferentially expressed Antigen of MElanoma) in Europe and China.
• In April, the Company entered into a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute to evaluate the use of Medigene’s proprietary T cell receptors in novel cell constructs.
• In January, the Company announced the receipt of a USD 3 million milestone payment from its partner 2seventy bio, Inc.
• During the reporting period, the Company has strengthened and complemented its executive leadership team with the addition of Pamela Keck as Head of Investor Relations & Corporate Communications and Kirsty Crame, MD as Head of Clinical Research & Development.

Research & Development Highlights:

• In June, the Company announced its pipeline expansion into neoantigens with KRAS (Kirsten rat sarcoma viral oncogene homolog) as the first target in its MDG10xx program, a TCR-T therapy being developed in combination with the company’s PD1-41BB switch receptor technology. The first KRAS antigens and HLAs (human leukocyte antigens) of the library target are KRAS G12V-A11 (MDG2011), KRAS G12V-A03 (MDG2012), and KRAS G12D-A11 (MDG2021).
• In June, the Company presented an overview on elevated activity of TCR-T therapies when combining Medigene´s PD1-41BB costimulatory switch receptor with T cell receptors (TCRs) targeting different antigens at the Immuno-Oncology-Summit Europe.
• In May, the Company expanded its portfolio of product enhancement technologies by acquiring the worldwide, exclusive license of the CD40L-CD28 costimulatory switch protein.
• In April, the first MDG1015 pre-clinical data was presented at the American Academy of Cancer Research 2023 Annual Meeting showing the potential for significant benefits of MDG1015 in improving long-term anti-tumor effects by mitigating the immunosuppressive tumor microenvironment. The MDG1015 program will be the first clinical trial in which the ‑PD1-‑41BB costimulatory switch receptor is applied in the clinic. The program is progressing as planned and IND/CTA filing is expected in H2 2024 in line with the Company’s clinical development guidance.
  
  

Conference Call and Webcast

The Company will host a conference call and webcast today at 3 pm CET / 9 am ET. A Q&A session will follow management’s formal presentation.

Full details for the conference call and webcast are as follows:

Participants may pre-register and will receive dedicated dial-in details to easily and quickly access the call with the above registration link for the conference call.

Please dial in 10 minutes ahead of time to ensure a timely start of the conference call.

Following the call, an archived webcast will be accessible on the Investors & Media section of the Medigene website: https://www.medigene.com/investors-media/reports-presentations

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About Medigene

Medigene AG (FSE: MDG1) is an immuno-oncology platform company dedicated to developing T cell therapies to effectively eliminate cancer. Its end-to-end technology platform, built on multiple proprietary and exclusive product development and product enhancement technologies, allows Medigene to create best-in-class differentiated, T cell receptor engineered T cell (TCR-T) therapies for multiple solid tumor indications that are optimized for both safety and efficacy. This platform provides product candidates for both its in-house therapeutics pipeline and partnering. For more information, please visit 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

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

LifeSci Advisors

Sandya von der Weid
Phone: +41 78 680 05 38
E-mail: svonderweid@lifesciadvisors.com

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