• Focus on executing the strategic plan and delivering shareholder value
• First MDG2011 pre-clinical data support potential in solid tumor therapy
• Expansion of patent portfolio and license agreement for technologies in our End-to-End Platform
• Guidance confirmed; cash runway maintained through Q4 2024

Planegg/Martinsried, October 26, 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 results and provided a corporate update for the third quarter of 2023. The Company’s Quarterly Statement Q3 2023 is available on Medigene’s website: https://medigene.com/investors-media/reports-presentations/

“In the past quarter, we continued to successfully execute our corporate strategy and deliver on our commitments. We have further progressed our lead candidate, MDG1015 with our IND / CTA enabling work and also expanded our pipeline into neoantigens with the annoucement of the lead for MDG2011, which targets KRAS G12V A*11, and the first pre-clinical data presentation at the European Society for Medical Oncology (ESMO) Congress in October. Here, MDG2011 showed significantly enhanced anti-tumor activity and tumor killing of our optimal affinity T cell receptor (TCR) when combined with the PD1-41BB costimulatory switch protein,” said Selwyn Ho, Chief Executive Officer at Medigene.

“On our End-to-End Platform, we expanded the license for our PD1-41BB and CD40L-CD28 costimulatory switch proteins to include uses in additional cell types and in Chimeric Antigen Receptor T cell (CAR-T) therapies. Backed by a growing T cell receptor engineered T cell (TCR-T) therapy pipeline, additional armoring, enhancement and optimization technologies, as well as a solid IP-portfolio, we are advancing towards our ambition of developing first-in-class / best-in-class TCR-T therapies for patients suffering from solid tumors. We are confident that by fully leveraging the capabilities of our End-to-End Platform, we will deliver significant value to patients and shareholders.”

Financial and Corporate Highlights:

• The financial performance in the third quarter of 2023 was in line with the Executive Management Board’s expectations. Revenues in the third quarter 2023 amounted to EUR 1.6 million compared to EUR 1.4 million in the previous year period (9-month period 2023: EUR 4.6 million), primarily from the partnership with BioNTech. Reflecting our commitment towards advancing and expanding the pipeline, R&D expenses for the quarter were EUR 3.2 million compared to EUR 3.3 million in the prior year period (9-month period 2023: EUR 8.4 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 September 30, 2023, cash and cash equivalents and time deposits amounted to EUR 21.2 million (December 31, 2022: EUR 33.2 million). Based on current planning, the Company is financed until the fourth quarter of 2024.
• In September, the Company’s partner 2seventy bio, together with JW Therapeutics, has announced the acceleration of their T cell-based immunotherapy projects in Greater China. Specifically, the program containing Medigene’s MAGE-A4-targeted TCR is on track to initiate an investigator-initiated study in China by the end of 2023.
• Due to the prolonged funding and development pause by Hongsheng Sciences of the partnered program that included Medigene’s NY-ESO-1-targeted TCR, the parties have mutually agreed to terminate the partnership agreement as it relates to the NY-ESO-1 asset in Q3 2023. The return of this asset to Medigene allows Medigene to find a new strategic development partner in Asia, but now for our first-in-class MDG1015 program containing the Company’s optimal affinity NY-ESO-1-targeted TCR.

Research & Development Highlights:

• In August, Medigene announced the expansion of the intellectual property (IP) license for its PD1-41BB and CD40L-CD28 costimulatory switch proteins, enabling their application to additional cell types and for use in Chimeric Antigen Receptor T cell (CAR-T) therapies.
• In September, the Company was granted a patent by the European Patent Office protecting its PD1-41BB costimulatory switch protein technology. The patent complements the PD1-41BB IP-portfolio with similar patents already granted in the United States, China and Japan.
• In September, Medigene delivered on its commitment to select a lead candidate for the second TCR-T therapy program in solid tumors, MDG2011, targeting KRAS (Kirsten rat sarcoma viral oncogene homologue) G12V with HLA-A*11 (HLA, human leukocyte antigen) and being developed in combination with Medigene’s PD1-41BB costimulatory switch protein  technology. Medigene’s End-to-End Platform has successfully generated not one but three KRAS G12V-HLA-A*11-directed TCRs, of which the Company has prioritized one as the lead to move forward to the pre-clinical stage for the MDG2011 program.
• Subsequent to the quarter, first pre-clinical data on MDG2011 was presented at the European Society for Medical Oncology (ESMO) Congress 2023 held in Madrid in October 2023. The pre-clinical data presented showed significantly enhanced T cell activity and tumor killing when combining the PD1-41BB costimulatory switch protein with recombinant TCRs not only when directed at the cancer-testis antigen NY-ESO-1/LAGE-1a (MDG1015), but also, presented for the first time, against the neoantigen mutant KRAS G12V.
• Describing in detail our End-to-end Platform approach, the paper Evolution by Innovation as a Driving Force to Improve TCR-T Therapies, by Dolores J. Schendel, was published in Frontiers in Oncology, section Molecular and Cellular Oncology in September 2023.

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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 Platform, built on multiple proprietary and exclusive TCR generation and optimization, as well as 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 safety, efficacy and durability. 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

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