ACELYRIN (SLRN) Q2 2024 earnings summary

Executive summary

• Positive phase III results for izokibep in hidradenitis suppurativa, meeting primary and key secondary endpoints with deep clinical responses at 12–16 weeks; company to prioritize lonigutamab for thyroid eye disease and reduce investment in izokibep and SLRN-517.

• Strategic shift includes a 33% workforce reduction and discontinuation of SLRN-517 development, aligning resources to advance lonigutamab to phase III with plans to start in Q1 2025.

• Net loss for the six months ended June 30, 2024 was $120.6 million, a significant improvement from $202.5 million in the same period last year, driven by non-recurring income and lower R&D expenses.

• The company remains a late-stage clinical biopharma with no approved products or product revenue, and expects continued significant losses as it advances its pipeline.

Financial highlights

• Cash, cash equivalents, and short-term marketable securities totaled $635.8 million as of June 30, 2024, expected to fund operations to mid-2027.

• Q2 2024 R&D expense was $76.4 million (up from $30 million YoY), with 75% related to izokibep programs and including a $14.3 million contract termination cost.

• General and administrative expenses were $16.6 million in Q2 2024, up from $12.7 million YoY, with stock-based compensation for Q2 at $10.2 million.

• Net loss for Q2 2024 was $85.7 million, compared to $26.0 million in Q2 2023; net loss per share was $0.86 vs. $0.40.

• Projected 2024 year-end cash position between $420 million and $450 million.

Outlook and guidance

• Cash runway projected to mid-2027, fully funding lonigutamab through BLA filing and allowing for selective pipeline expansion.

• No proceeds from additional financing or partnerships included in guidance.

• Top-line results from izokibep phase IIb/III in uveitis expected before year-end 2024.

• Phase III lonigutamab program to begin in Q1 2025, with first top-line readout in 2026 and an EOP2 FDA meeting planned for 2024.

• A $31.0 million payment to Pierre Fabre is anticipated in Q4 2024 to buy out an option related to lonigutamab development rights.