ACELYRIN (SLRN) Morgan Stanley 22nd Annual Global Healthcare Conference summary

Strategic portfolio updates

• Positive trial results in PSA and POC data in TED led to a portfolio review and prioritization earlier this year.

• HS and PSA programs, though positive, are being deprioritized due to capital intensity and better fit for larger organizations.

• Lonigutamab in TED is now the top priority, with company restructuring to align with this focus.

• Cash runway extended to mid-2027, fully funding both phase 3 TED trials.

• Uveitis remains in the pipeline for now, with data expected by year-end and future decisions pending results.

Clinical and commercial insights

• Uveitis market has high unmet need; only steroids and Humira are approved, with a significant patient population.

• Orphan pricing may be possible for uveitis, making it a distinct commercial opportunity.

• Lonigutamab shows high potency, rapid onset, and potential for subcutaneous administration, differentiating it from competitors.

• Early clinical data for lonigutamab indicate robust efficacy and favorable safety, with no hearing loss observed to date.

• SubQ delivery and lower exposure may reduce adverse events and improve patient convenience.

Development and regulatory plans

• Added a 70mg dose cohort to phase II TED study to complete dose-ranging within the trial.

• Plan to meet with FDA later this year to finalize phase III design, aiming to start the first phase III in Q1 next year.

• Two concurrent phase III trials for TED are planned, enabled by integrated dose-ranging in phase II.

• Future data updates will include more details on phase III design and FDA feedback.

• Next major milestone is the uveitis data readout, followed by TED phase II and III updates.