ExpreS2ion Biotech

The decision follows initial considerations taking into account limited funding options in challenging capital markets, an expected delay in the clinical trial application (CTA) due to the need for further GMP manufacturing preparations, and anticipated clinical development costs that cannot be committed without the company having secured sufficient funding to complete patient treatments in the ES2B-C001 first-in-human study. ExpreS²ion will now investigate its strategic options for the ES2B-C001 project and initiate a cost reduction program. Certain activities to advance the breast cancer program towards CTA readiness will continue, including the ongoing GLP preclinical safety toxicology study.

CEO Bent Frandsen comments:

"Our near-term cash position enables us to maintain the current activity level into 2024. However, the Company believes that the current financial outlook makes it unlikely to raise the cash required to commit to the costs associated with a Phase I clinical study. As a result, and despite the remarkable preclinical proof-of-concept data for the breast cancer vaccine candidate ES2B-C001, the decision has been made to pause the program and focus on identifying new ways to bring the asset forward. We will initiate a review of ExpreS²ion's strategy, pipeline and organization to materially extend the runway in a tight funding market and identify how to best create value with our unique technology platform, expertise and exploratory pipeline projects."

"The clinical trials data from Bavarian Nordic's COVID-19 vaccine, ABNCoV2, and exceptional preclinical safety and efficacy findings in the breast cancer project have validated our technology platform. We are now actively exploring opportunities to leverage our expertise, including the ExpreS2 platform, to develop innovative vaccines with a faster and less costly path to value creation."

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Svensk Kapitalmarknadsgranskning AB