Acelyrin (SLRN) Q2 Earnings call transcript Aug 13, 2024
In the latest earnings call, Acelyrin, Inc. provided an update on its second quarter 2024 financial results and discussed the positive Phase III results for its drug, izokibep, in Hidradenitis Suppurativa (HS). The company also announced a refocused pipeline strategy designed to extend its cash runway through mid-2027.
Key Highlights
Positive Phase III Results for Izokibep in Hidradenitis Suppurativa:Acelyrin reported positive Phase III results for izokibep in Hidradenitis Suppurativa, marking a significant milestone for the company. The trial met the primary endpoint of HiSCR75, with 33% of patients achieving a 75% reduction in abscesses and inflamed nodules compared to 21% in the placebo group. These results demonstrate izokibep's potential to be an effective therapy for multiple indications.
Refocused Pipeline Strategy:In light of these positive results, Acelyrin has decided to focus on its lonigutamab program in thyroid eye disease (TED), which has the potential to improve upon clinical response and convenience versus the standard of care. The company will continue ongoing trials for izokibep in HS and PsA but will not start new trials in these indications. It plans to complete the ongoing Phase IIb/III trial in uveitis and anticipates one additional Phase III trial if the data is positive.
Financial Update:Acelyrin reported a strong financial position, with a cash position of approximately $635 million at June 30, 2024. The company expects to have a cash runway to mid-2027, covering multiple anticipated milestones. This financial stability will enable Acelyrin to fund its ongoing and planned TED trials through BLA submission.
Looking Ahead:Acelyrin's strategy going forward is to focus on high-quality execution and capital consciousness. The company plans to meet with the FDA later this year to discuss its lonigutamab program and hold an investor presentation to provide additional details. Top line results from the izokibep Phase IIb/III trial in uveitis are expected before year-end, with the start of the Phase III program for lonigutamab anticipated in the first quarter of 2025.
Investor Questions:During the call, investors asked about the rationale for adding a 70-milligram dose in the ongoing Phase II trial for lonigutamab, potential partnerships for izokibep, the market size for uveitis, and the company's plans for pipeline expansion. Acelyrin's management provided detailed responses to these questions, shedding light on its strategic focus and plans for the future.
Conclusion:Acelyrin's positive Phase III results for izokibep in Hidradenitis Suppurativa, coupled with its refocused pipeline strategy and financial stability, position the company well for future success. The strategic decisions made during this call demonstrate Acelyrin's commitment to developing innovative therapies for unmet medical needs while maintaining a disciplined and capital-conscious approach. Investors and stakeholders will be closely watching Acelyrin's progress in the coming quarters, particularly the upcoming FDA meeting and investor presentation.