ACELYRIN (SLRN) H.C. Wainwright 26th Annual Global Investment Conference summary

Pipeline and strategic updates

• Positive trial results in PsA and early proof-of-concept data in thyroid eye disease (TED) were reported earlier this year.

• Internal development of HS and PsA was discontinued to focus resources on TED, seeking larger partners for those indications.

• Company restructuring and program prioritization extended cash runway by 18 months into mid-2027, fully funding the phase III TED program.

• Uveitis trial with izokibep is nearly complete, with data expected by year-end to inform future plans.

Thyroid eye disease (TED) program and market landscape

• Lonigutamab targets IGF-1R, similar to Tepezza, but is developed as a subcutaneous (subQ) solution, aligning with market trends for convenience.

• SubQ administration could expand treatment to inactive TED populations and improve patient accessibility.

• Lonigutamab is 70 times more potent than Tepezza, with potential for early and durable efficacy and chronic dosing.

• Safety differentiation is a focus, aiming to minimize ototoxicity and hyperglycemia through dose optimization.

• Phase II data will inform phase III design, with plans to meet the FDA and run concurrent pivotal trials.

Clinical development and regulatory plans

• Approximately 30 patients' data from four phase II cohorts will support FDA discussions for phase III trial design.

• Precedent phase III studies in TED have enrolled 100–150 patients per trial, mainly sized for safety databases.

• Focus on both active and chronic TED populations, addressing unmet needs such as relapse and hearing loss.

• Investor day planned for late 2024 or early 2025 to present additional phase II data and finalized phase III plans.