Medigene AG Announces Prioritization of Pipeline and Resource Allocation as well as Extension of Cash Runway

Lead program MDG1015 on track for CTA/IND approval in 2H 2024
Prioritization of pipeline to accelerate the advancement of Medigene’s maturing KRAS-library
Projected cash runway extended to Q1 2025. Exploring financing options to extend cash runway into 2026 and beyond

Planegg/Martinsried, November 21, 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 announced an update and prioritization of its pipeline and resource allocation to support the execution of its long-term corporate strategy.

“Over the past 18 months, Medigene has been focused on prioritizing our projects and optimizing the allocation of our resources to the R&D work and programs that create the most value for patients and shareholders. This update confirms we remain on track for IND/CTA filing of our lead program MDG1015 and allows us to accelerate Medigene’s emerging KRAS (Kirsten rat sarcoma viral oncogene homologue)-library while extending the cash runway into Q1 2025,” said Selwyn Ho, CEO at Medigene.

“We will continue to optimize our resource allocation based on business demands. As a small biotech company in a challenging capital markets environment, we have a focus on careful cost management and resource allocation that allows us to remain committed to our mission of delivering best-in-class, differentiated T cell receptor engineered T cell (TCR-T) therapies for solid tumor patients.”

Corporate update

Portfolio Prioritization
- Medigene’s lead program MDG1015 remains on track for IND/CTA approval in 2H 2024. In line with the Company’s previous communication, the clinical Phase I trial will commence as soon as possible thereafter and remains subject to financing.
- In 2024, Medigene will focus on the development of two of its previously announced KRAS-targeted programs. By optimizing the technology and processes for the development of MDG2011 (targeting KRAS G12V with HLA-A*11; lead selected in Q3 2023) and MDG2021 (targeting KRAS G12D-HLA-A*11; lead selection in 1H 2024), the Company expects an accelerated development for future KRAS progams as well as other cancer targets.
- As such, the lead selection for the Company’s third announced KRAS-targeted program MDG2012 has been moved to 2025 (previously 2H 2024).
- The Company’s ability to deliver on its contractual obligations within its partnerships remains unaffected.
Costs & Cash Runway
- Cost reductions made to date and planned in 2024 mainly relate to external expenses that lower professional and consulting fees, as well as moving of programs into 2025. The Company continues to operate a lean staff structure.
- Medigene remains focused on partnering opportunities, including for some of its currently announced product candidates, to expedite their continued development.
- The Company has extended its projected cash runway into Q1 2025 (without including potential milestones from partners) and continues to evaluate all appropriate financing options to advance its cash runway into 2026 and beyond.

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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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