Medigene AG. (5/3/23). "Press Release: Medigene AG Reports Financial Results and Business Update for Q1 2023". Martinsried.

	Organisation	Medigene AG (FSE: MDG1, Prime Standard)
	Group	Medigene (Group)
	Organisation 2	2seventy bio Inc. (Nasdaq: TSVT)
	Product	CD40L-CD28 costimulatory switch receptor
	Product 2	MDG1015 (Medigene, TCR-T therapy)
	Person	Ho, Selwyn (Medigene 202207– CEO before Connect Biopharma)
	Person 2	Gabriel, Raimund (MC Services 1999–201101– Founder + CEO)

> Focus on executing the strategic plan and delivering shareholder value

> MDG1015 pre-clinical data underline potential in solid tumor therapy

> Subsequent to Q1, expansion of tools and technologies in our end-to-end technology platform

> Guidance confirmed; cash runway maintained through Q4 2024

Medigene AG (Medigene, 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 for the first quarter of 2023. The full Quarterly Statement Q1 2023 can be downloaded here: https://medigene.com/investors-media/reports-presentations/

“Since the beginning of 2023, we have been making significant progress on our strategy in addressing the unmet needs in treating solid tumors. We have expanded the technologies in our end-to-end technology platform through our research collaboration with the National Cancer Institute as well as with the addition of a second exclusive costimulatory switch receptor CD40L-CD28, designed to optimize both the efficacy and safety profiles of TCR-T therapies. I remain convinced that our unique end-to-end platform and our approach to its continued innovation will be the key differentiators for Medigene allowing us to develop new, best-in-class therapies,” said Selwyn Ho, Chief Executive Officer of Medigene. “Further, our internal programs MDG1015 and MDG10xx as well as our partnerships with BioNTech and 2seventy bio have continued to advance well, further validating our end-to-end platform. Finally, we continue to explore options to extend our cash reach beyond 4Q 2024 in order to meet these planned future milestones and create further shareholder value.”

Financial and Corporate Development

The financial performance in Q1 2023 was in line with the Executive Management Board’s expectations. Revenues amounted to EUR 1.5 million, primarily from the partnership with BioNTech. Reflecting the strong commitment towards advancing the pipeline, R&D expenses amounted to EUR 2.3 million. The Company maintains strong liquidity of EUR 32.1 million, with cash & cash equivalents in the amount of EUR 21.1 million and time deposits of EUR 11.0 million as of March 31, 2023.

The Management Board therefore maintains its guidance for fiscal year 2023 published in the annual report 2022 on March 29, 2023, in its entirety. Management is confident to achieve further progress with partnerships, potentially generating additional milestone payments and revenues.

As previously announced, Medigene moves forward with a strengthened leadership team. During the first quarter, Pamela Keck joined as Head of Investor Relations and Corporate Communications with more than 15 years of experience in the field, as well as Kirsty Crame, MD, who brings more than 10 years of experience in drug development and clinical operations, focused primarily in immuno-oncology and in cell therapy development, into her role as Head of Clinical Research & Development.

Scientific progress

Presented at the American Academy of Cancer Research (AACR) in April 2023, pre-clinical data for the Company’s lead program MDG1015 highlighted the potential for significant benefits of MDG1015 in improving long-term anti-tumor effects by mitigating the immunosuppressive tumor microenvironment (TME) that currently limits solid tumor therapies. Specifically, the findings demonstrate that the combination of a NY-ESO-1-specific T cell receptor (TCR) combined with co-expression of Medigene’s chimeric PD1-41BB switch receptor on the TCR-T cell surface significantly increases anti-tumor activity, compared to T cells expressing the TCR alone.

Just after the end of Q1, Medigene entered into a cooperative R&D agreement with the U.S. National Cancer Institute to evaluate the use of Medigene’s proprietary TCRs in novel cell constructs. Also subsequent to the end of the quarter, as announced on May 2, Medigene has partnered with Helmholtz Munich to acquire the exclusive, worldwide rights to the CD40L-CD28 costimulatory switch receptor.

— end of press release —

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

MC Services AG

Raimund Gabriel, Julia von Hummel
Phone: +49 89 210 228-0
E-mail: medigene@mc-services.eu

Record changed: 2024-01-20