ExpreS2ion Biotech (EXPRS2) Stora Aktiedagarna Stockholm summary

Key developments and pipeline progress

• Lead breast cancer vaccine asset (ES2B-C001) is approaching phase I, with clinical trial authorization filed in Q3 2024 and approval expected soon; first-in-human trial planned by Q1 2026.

• The vaccine targets HER2-expressing cancers, initially focusing on breast cancer, with potential to expand into HER2-low, gastric, and other HER2-expressing cancers.

• Preclinical data show strong efficacy, including 100% survival in animal models and no observed cardiac, gastrointestinal, or liver toxicity.

• The company aims to partner for phase III and commercialization after achieving clinical proof of concept, with phase I results expected in 2026 and phase II proof-of-concept by 2026-2029.

• Additional pipeline includes a CMV project in collaboration with Evaxion and several infectious disease vaccines, including malaria and influenza, largely grant-funded.

Strategic partnerships and business development

• Holds a 34% stake in AdaptVac, whose VLP technology is integral to the breast cancer vaccine.

• Announced a term sheet with Serum Institute of India for malaria vaccine projects, granting manufacturing and commercialization rights, with milestone and royalty payments.

• The agreement with Serum Institute is seen as a significant validation and potential door opener for further collaborations.

• Actively engages with potential partners at industry events, aiming to secure deals post-clinical proof of concept.

• High licensing potential, with top oncology deals averaging $3B and early-stage assets in high demand.

Financial position and funding

• Recent rights issue and ongoing warrant programs (TO10 and TO11) are designed to fund clinical activities, with current funding sufficient to advance through phase I.

• Growth funding through warrant subscriptions in late 2024 and 2025 to support clinical milestones.

• Additional funding opportunities are anticipated as clinical milestones are reached.