Lyme Phase III Efficacy and Regulatory Path
Strong efficacy observed in Phase III: overall vaccine efficacy >70%; first prespecified statistical criterion not met but second prespecified analysis met with 95% CI lower bound above 20. The vaccine was well tolerated with no safety concerns; Pfizer is planning submissions to regulatory authorities.
Unique Market Opportunity for Lyme Vaccine
VLA15 (LB6V) is the only Lyme vaccine candidate at this stage in ~30 years, with broad serotype coverage for North America and Europe (addressing ~90M and >200M people in high‑risk areas) and significant unmet medical need (reported ~500,000 US cases and >100,000 Europe annually).
Cash Position and Financing
Total cash and cash equivalents at end of March 2026: EUR 105 million (down slightly from EUR 110 million at fiscal year end); cash figure excludes proceeds from a successful reserved offering completed in April 2026, which will further improve liquidity.
Operational Cost Reduction Program
Comprehensive restructuring initiated in April 2026 targeting a global workforce reduction of ~10%–15% and an overall operating expense reduction of ~25%–35% versus 2025 to contain cash burn and improve operating leverage.
IXCHIQ Progress and Brazil Campaign
Active IXCHIQ (Chikungunya) activities: over 30,000 people vaccinated in Brazil pilot campaign (targeting 20%–40% coverage in 18–59 adults across municipalities) and aim >100,000; locally produced Butantan‑chik achieved licensure in Brazil — major access/manufacturing milestone.
Shigella Program Advancement
Tetravalent Shigella candidate progressing with two ongoing studies (children in Africa and a controlled human infection model); readouts expected over the summer and program targets a global market expected north of USD 0.5 billion annually.
Disciplined R&D and SG&A Trends
R&D spend stable at EUR 15.2 million (Q1 2026); marketing & distribution decreased to EUR 7.0 million from EUR 10.4 million (Q1 2025); G&A decreased to EUR 8.2 million from EUR 9.0 million, indicating early expense discipline aligned with restructuring.
Manufacturing Network Progress Outside U.S.
Manufacturing transfer to the Almeida facility completed with regulatory approvals from non‑U.S. authorities; local manufacturing partnerships and network expansion in endemic countries are advancing to support access.