SynAct Pharma (SYNACT) CMD 2025 summary

Strategic and operational update

• Focused on advancing lead compound resomelagon in rheumatoid arthritis (RA) with a 240-patient Phase 2B study on track for data by year-end, aiming for first-line treatment positioning and steroid-sparing benefits.

• Launched a new investigator-driven study in polymyalgia rheumatica (PMR), complementing the RA program and enhancing deal attractiveness for potential partners.

• Expanded into viral infectious diseases with a dengue project, leveraging prior COVID-19 proof-of-concept and ongoing collaborations in Brazil, with plans for further clinical development.

• Acquired TXP Pharma assets, advancing TXP-11 peptide for intensive care indications, with preclinical work progressing toward Phase I readiness.

• Strengthened management and board, completed two capital raises at a premium, and secured a credit facility, ensuring funding through 2026 and supporting ongoing and new clinical programs.

Financial guidance and business development

• Raised approximately SEK 110 million through two premium capital raises and established a SEK 65 million credit line, providing financial runway into 2027.

• Financing structure designed to strengthen negotiation position in upcoming business development discussions, with a focus on licensing, acquisition, or regional deals post-positive RA data.

• Ongoing engagement with potential partners for RA and PMR, with additional interest generated by the expanded pipeline and new indications.

• Targeting a deal upon positive RA data, with flexibility for various transaction types, including licensing, acquisition, or option-to-acquire models.

• Additional soft funding opportunities being pursued for infectious disease programs, particularly dengue.

Pipeline and clinical development highlights

• RA Phase 2B ADVANCE study recruiting to plan, with primary endpoint DAS28 and results expected soon after last patient dosed.

• PMR study to launch in 2024, aiming for first-line or early second-line positioning, leveraging similarities with RA and addressing unmet need for steroid-sparing therapies.

• Dengue and chikungunya programs supported by strong preclinical and early clinical data, with host-directed therapy approach showing benefits beyond immunosuppression.

• TXP-11 peptide program targeting acute organ dysfunction in intensive care, with robust patent protection and preclinical data supporting clinical entry.

• Patent portfolio significantly strengthened, extending exclusivity for resomelagon to 2042 and adding multiple layers of protection for both small molecules and peptides.