SynAct Pharma (SYNACT) CMD 2025 summary

Strategic and operational update

• Focus remains on advancing the rheumatoid arthritis (RA) Phase 2B ADVANCE study, with data expected by year-end and recruitment on track for 240 patients across the US and Europe.

• Parallel development in autoimmune (RA, PMR) and viral infectious diseases (dengue) aims to diversify opportunities and attract potential partners.

• Recent addition of PMR as an investigator-driven study complements RA and aligns with partner interests, enhancing deal attractiveness.

• Business development efforts are ongoing, maintaining and expanding contacts with potential partners, with readiness for licensing, acquisition, or regional deals depending on data outcomes.

• Two successful capital raises and a new credit facility provide financial runway through 2026, supporting clinical and business development milestones.

Pipeline and clinical development

• Lead compound resomelagon targets early-stage RA as a first-line treatment, aiming to reduce glucocorticoid use and improve safety versus current therapies.

• PMR study will use strict diagnostic criteria and aims to demonstrate steroid-sparing effects, with recruitment planned for this year.

• Dengue program leverages host-directed therapy, with preclinical and early clinical data supporting efficacy in viral infections without immunosuppression.

• TXP peptide program targets intensive care indications (e.g., post-surgical organ failure), with lead candidate TXP-11 nearing Phase I readiness.

• Investigator-driven studies are cost-effective, enabling rapid data generation and supporting broader business development objectives.

Financial and patent position

• SEK 110 million raised in two premium capital rounds, plus a SEK 65 million credit line, ensures funding for planned activities into 2027.

• Patent portfolio strengthened with new composition, formulation, and crystal form patents, extending exclusivity for resomelagon to 2042.

• Patent strategy validated by external legal review and designed to create multiple barriers to generic competition.

• Investor base expanded to over 15,000 shareholders, with strong support from key investors and board members.

• Financial stability enhances negotiating position for future partnering or licensing deals.