SynAct Pharma (SYNACT) Investor Update summary

Overview and clinical results

• Focused on first-in-class treatments for inflammatory diseases; AP1189 showed positive proof of concept in COVID-19 respiratory insufficiency and newly diagnosed severe RA.

• 2021 milestones included positive Phase 2a results in COVID-19 and RA, a new tablet formulation, completed toxicology for 12-week dosing, and patent protection extended to 2042.

• In the BEGIN Phase 2a RA study, AP1189 100 mg once daily reduced CDAI by 15.5 points vs 9.3 with placebo; ACR20 response was 60.6% vs 13.3% with placebo (both statistically significant).

• Proposed RA profile includes once-daily oral dosing, onset within days, efficacy approaching JAK inhibitors within 4 weeks, and no emerging adverse events or immunosuppression.

Pipeline and business development

• EXPAND Phase 2 in treatment-naïve RA was planned for Europe, with CTA filing in Q2 2022, 120 patients, 12 weeks of dosing, and high-level data targeted for Q3 2023.

• Adaptive Phase 2 in DMARD-inadequate responders was planned to start Part A in H2 2022 under an IND; Part A data targeted for Q3 2022 and final analysis for 2024.

• Pipeline milestones included a nephrotic syndrome program redesign in Q2 2022, pre-IND meeting in Q2, IND filing in Q3, and non-COVID disease-model data in H2 2022.

• Multiple large pharma and biotech firms had reviewed the program and expressed genuine interest; discussions were ongoing, with positive 12-week RA data expected to increase AP1189’s value.

Financing and strategy

• Rights issue terms: 1 new share per 11 held, subscription price SEK 63, proceeds of ~SEK 150m, and 100% secured; subscription period scheduled for Apr 6–22, 2022.

• Net proceeds of ~SEK 126m, together with cash on hand and tax credits, were expected to fund planned activities through end-2023; proceeds allocated across RA EXPAND, RA DMARD-IR, nephrotic syndrome, other R&D, and general and administration.

• Strategy for 2022–23: advance development with a strong RA focus and continue business development to optimize deal potential; plans included a Nasdaq Stockholm Main Market up-listing.

• Key planned readouts included EXPAND and DMARD-IR in Q3 2023 and nephrotic syndrome in Q4 2023; DMARD-IR Part I was scheduled to start in Q4 2022.