Planeg/Martinsried, April 26, 2024. Medigene AG Medigene (or the “Company”, FSE: MDG1, Prime Standard), an immuno-oncology platform company focused on the discovery and development of T-cell immunotherapies for solid tumors, today announced its first quarter 2024 financial results. I reported it. The Q1 2024 statement can be downloaded here. https://medigene.com/investors-media/reports-presentations/.
“In the first quarter of 2024, we will continue to execute on our strategic plan and advance the development of our unique TCR-T therapies for solid tumors, including our lead program MDG1015,” said Selwyn Ho, CEO of Medigene. “I focused on it,” he said. “While our core expertise lies in generating optimal TCRs, we are also exploring ways to expand its applications beyond TCR-T cell therapy.”
“The recently announced capital increase will strengthen our financial position,” Selwyn Ho continued. “This not only allows us to continue to advance TCR-T therapies, but also to pursue new partnerships and expand our portfolio of TCR-based therapies such as T-cell engager (TCE) and TCR-natural killer (TCR-NK).” By expanding our therapeutic offerings, we aim to create added value for both solid tumor patients and our shareholders. ”
Financial and corporate development
Financial performance for the first quarter of 2024 was in line with the Executive Board's expectations.revenue Revenues from the partnership amounted to EUR 3 million in the first quarter of 2024. Research and development expenses for the quarter amounted to €3.2 million, demonstrating the company's continued commitment to pipeline advances. As of March 31, 2024, the Company had cash and cash equivalents of €4.4 million and term deposits of €8.0 million.
Accordingly, the Management Committee maintains the fiscal year 2024 guidance published in Annual Report 2023 on March 28, 2024, and confirms the funding runway through April 2025.
From a partnership perspective, our ongoing global strategic alliance with BioNTech is progressing well and Medigene is working on a number of undisclosed goals. In January 2024, Regeneron Pharmaceuticals Inc. (Regeneron, formerly known as 2seventy bio, Inc.) announced that it would be enrolling patients into investigator-initiated trials (IITs) in Greater China for Medigene's TCR-based program targeting MAGE-A4. Registration has started. Medigene expects to receive additional milestone payments upon reaching IIT's contractually agreed upon milestones. As previously announced, Medigene and Honsheng Sciences have mutually agreed to terminate the remaining framework agreements of their partnership. These assets previously under this agreement have been returned to Medigene for potential pipeline expansion.
After the same quarter, on April 23, 2024, the Company announced the start of a capital increase through stock acquisition rights as part of its near- to medium-term funding strategy. Medigene intends to use gross proceeds of up to approximately EUR 5.9 million to fund operating activities and advance clinical development work on its flagship program, his MDG1015.
Medigene AG's management and members of the Supervisory Board will subscribe to the new shares as part of the stock acquisition rights and private placement. Within the framework of the backstop agreement, an investor declared a commitment to Medigene to acquire new unsubscribed shares for up to 3 million euros.
The conditions for the capital increase are as follows. The Company intends to increase its share capital from EUR 24,562,658.00 to EUR 4,912,531.00, up to a maximum of EUR 29,475,189.00, by issuing 4,912,531 new registered shares with no par value at a par value proportional to the face value. His capital is 1.00 euros, with full dividend rights from January 1, 2023.
The new shares will be offered to all shareholders for subscription. Oversubscription is allowed. The unsubscribed new shares will be offered for purchase in a private placement to new investors within the European Union. The underwriting ratio is set at 5:1. That is, 5 old shares are entitled to his 1 new share. Systematic trading of stock acquisition rights takes place. The subscription price for both the exercise of the subscription rights and the private placement is EUR 1.20. The subscription period for new shares will begin on April 24, 2024 and end at 24:00 (Central European Time) on May 7, 2024. Once issued, the new shares will be allowed to trade on the Frankfurt Stock Exchange (Prime Standard). A prospectus is not required for capital increases. Details of the rights offer are published in the Federal Register and are also available on our website. https://medigene.com/investors-media/stock-information/capital-measures/
Scientific and clinical development
In February 2024, Medigene announced initial clinical indications for the first-in-human Phase 1 clinical trial of its lead program MDG1015, targeting cancers such as gastric cancer, ovarian cancer, myxoid/round cell liposarcoma, and synovial sarcoma. selected. Following recent positive preliminary regulatory responses from the EU and US, the program is on track for his IND/CTA approval in the second half of 2024. Subject to the funding, the company plans to begin Phase 1 clinical trials of his MDG1015 by the end of 2024.
In April 2024, the company presented data on MDG1015 at the American Association for Cancer Research (AACR) annual meeting, showing that in addition to superior T-cell functionality and tumor cell killing, it is enhanced and enhanced with Medigene's anti-cancer agents. showed a favorable safety profile of TCR-T cells. PD1-41BB Co-stimulatory switch protein. The poster data further demonstrate that this costimulatory switch protein-mediated costimulatory signal is TCR dependent, indicating that costimulation occurs only when the TCR binds to tumor antigens present on tumor cells. Therefore, regardless of PD-L1 expression, healthy cells that do not express the tumor antigen (NY-ESO-1) were not targeted, and no signs of toxicity were observed in various healthy tissues in vitro.
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About Medigene AG
Medigene AG (FSE: MDG1) is an immuno-oncology platform company focused on developing differentiated T-cell therapies for the treatment of solid tumors. The company's end-to-end platform is built on multiple proprietary proprietary technologies, allowing the company to generate optimal T-cell receptors for both testicular cancer antigens and neoantigens, and to develop these T-cell receptors. Body Modified (TCR) T cells can be protected and strengthened to create optimal T cells. We offer in-class differentiated TCR-T therapies and optimize drug compositions to ensure safety, efficacy, and durability. The end-to-end platform provides product candidates for both proprietary treatment pipelines and partnerships. Medigene's flagship TCR-T program MDG1015 is expected to receive his IND/CTA approval in the second half of 2024. For more information, please visit: https://Medigene.com/
This press release contains forward-looking statements that represent Medigene's opinion as of the date of this release. The actual results achieved by Medigene may differ materially from the forward-looking statements made herein. Medigene undertakes no obligation to update these forward-looking statements.medigene® is a registered trademark of Medigene AG. This trademark may be owned or licensed only in select locations.
Medigene AG
pamela keck
Phone: +49 89 2000 3333 01
Email: investor@medigene.com
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