Planegg/Martinsried, April 26, 2024. 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 for the first quarter of 2024. The full Quarterly Statement Q1 2024 can be downloaded here: https://medigene.com/investors-media/reports-presentations/.
"During the first quarter of 2024, our focus remained on executing our strategic plan and advancing the development of our unique TCR-T therapies for solid tumors, such as our lead program MDG1015," said Selwyn Ho, CEO at Medigene. "While our core expertise lies in generating optimal TCRs, we are also exploring ways to broaden their application beyond TCR-T cell therapies."
"The recently announced capital increase will bolster our financial position," Selwyn Ho continued. "This will enable us to continue to advance our TCR-T therapies as well as pursue new partnerships and expand our End-to-End Platform into TCR-based therapies like T cell engagers (TCE) and TCR-Natural Killer (TCR-NK) therapies. By expanding our platform, we aim to create added value for both patients with solid tumors and our shareholders."
Financial and corporate development
The financial performance in Q1 2024 was in line with the Executive Management Board’s expectations. Revenues amounted to EUR 3.0 million during the first quarter of 2024, derived from partnerships. R&D expenses for the quarter amounted to EUR 3.2 million, demonstrating the Company’s continued dedication to advancing its pipeline. As of March 31, 2024, the Company holds cash and cash equivalents in the amount of EUR 4.4 million and time deposits of EUR 8.0 million.
The Management Board therefore maintains its guidance for fiscal year 2024 published in the annual report 2023 on March 28, 2024, in its entirety, and confirms its cash runway into April 2025.
From a partnering perspective, the Company’s ongoing global strategic collaboration with BioNTech continues to make good progress and Medigene is working on a number of undisclosed targets. In January 2024, Regeneron Pharmaceuticals Inc. (Regeneron; formerly: 2seventy bio, Inc.) commenced patient enrollment in an investigator-initiated trial (IIT) in Greater China for the program utilizing Medigene's TCR targeting MAGE-A4. Upon reaching the contractually agreed milestone for the IIT, Medigene anticipates receiving an additional milestone payment. As previously announced, Medigene and Hongsheng Sciences have mutually agreed to terminate the remaining framework agreement of the partnership. Those assets previously under this agreement have been returned to Medigene for potential expansion of its pipeline.
Subsequent to the quarter, on April 23, 2024, the Company announced the launch of a capital raise with subscription rights as part of the Company’s near and medium-term financing strategy. Medigene intends to use the gross proceeds of up to approximately EUR 5.9 million to fund its operating activities and to progress work for the clinical development of the Company’s lead program, MDG1015.
Members of Medigene AG’s management and Supervisory Board will subscribe for new shares as part of the rights offering and the private placement. Within the framework of a backstop agreement, an investor has declared his commitment to Medigene to acquire unsubscribed new shares in an amount of up to EUR 3 million.
The parameters of the capital increase are as follows: The Company plans to increase its share capital from EUR 24,562,658.00 by up to EUR 4,912,531.00 to up to EUR 29,475,189.00 by issuing up to 4,912,531 new no-par value registered shares with a pro rata amount of the share capital of EUR 1.00 and with full dividend rights from January 1, 2023.
The new shares will be offered to all shareholders for subscription. Over-subscription is permitted. Any unsubscribed new shares will be offered for purchase in a private placement to new investors within the European Union. The subscription ratio is set at 5:1, i.e. five (5) old shares entitle the subscription to one (1) new share. Organized trading of subscription rights is arranged. The subscription price for both the exercise of subscription rights and the private placement is EUR 1.20. The subscription period for the new shares commenced on April 24, 2024 and ends on May 7, 2024 at 24:00 hours (CEST). The new shares are to be admitted to trading on the Frankfurt Stock Exchange (Prime Standard) after they are issued. The capital increase will not require a prospectus. Details of the rights offering are published in the Federal Gazette also are available on the Company’s website https://medigene.com/investors-media/stock-information/capital-measures/
Scientific and clinical development
In February 2024, Medigene announced the initial clinical indications for the first-in-human Phase 1 clinical trial for its lead program MDG1015, selecting gastric cancer, ovarian cancer, myxoid/round cell liposarcoma and synovial sarcoma as the target cancers to be treated. Following recent positive EU and US preliminary regulatory interactions, the program remains on track for an IND/CTA approval in the second half of 2024. Subject to financing, the Company expects to initiate a Phase 1 trial for MDG1015 by the end of 2024.
In April 2024, the Company presented data for MDG1015 at the American Association for Cancer Research (AACR) Annual Meeting, which showed superior T cell functionality and tumor cell killing as well as a favorable safety profile of TCR-T cells armored and enhanced with Medigene’s PD1-41BB costimulatory switch protein. The poster data further illustrated that this costimulatory switch protein-mediated costimulatory signal is TCR-gated, indicating that costimulation only occurs when the TCR binds to the tumor antigen present on a tumor cell. As such, healthy cells that did not express the tumor antigen (NY-ESO-1) were not targeted, irrespective of their PD-L1 expression and no signs of toxicity were seen in diverse healthy tissues in vitro.
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About Medigene AG
Medigene AG (FSE: MDG1) is an immuno-oncology platform company dedicated to developing differentiated T cell therapies for treatment of solid tumors. Its End-to-End Platform is built on multiple proprietary and exclusive technologies that enable the Company to generate optimal T cell receptors against both cancer testis antigens and neoantigens, armor and enhance these T cell receptor engineered (TCR) -T cells to create best-in-class, differentiated TCR-T therapies, and optimize the drug product composition for safety, efficacy and durability. The End-to-End Platform provides product candidates for both its own therapeutics pipeline and partnering. Medigene’s lead TCR-T program MDG1015 is expected to receive IND/CTA approval in the second half of 2024. For more information, please visit https://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 AG
Pamela Keck
Phone: +49 89 2000 3333 01
E-mail: investor@medigene.com
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