Laekna Inc (2105) H2 2024 earnings summary

Executive summary

• 2024 net loss narrowed to RMB254.3m from RMB368.8m; operating loss was RMB251.3m, while cash and cash equivalents rose to RMB636.4m.

• Clinical progress included LAE102’s completed China SAD study, the launch of Phase III AFFIRM-205, and FDA approval of the LAE201 Phase III protocol.

• A Lilly collaboration will fund and execute a U.S. Phase I trial of LAE102; global rights remain retained, with trial commencement expected in Q2 2025.

Financial highlights

• Other income rose to RMB38.2m from RMB16.7m, primarily on higher bank interest; other losses fell to RMB0.3m from RMB6.3m, mainly on lower FX losses.

• R&D expenses decreased 6.7% YoY to RMB215.1m; lower clinical development spending was partly offset by RMB17.8m in AFFIRM-205 milestone payments.

• Administrative expenses decreased 2.4% YoY to RMB74.1m, with no listing expenses in 2024 versus RMB13.0m in 2023.

• Total comprehensive loss narrowed to RMB242.9m from RMB458.7m; basic and diluted loss per share improved to RMB0.71 from RMB1.68.

Outlook and guidance

• Targeting China Phase I MAD initiation for LAE102 in March 2025 in 60 overweight or obese subjects; the U.S. Phase I trial is expected to start in Q2 2025.

• Targeting IND submissions for LAE103 in Q2 2025 and LAE123 in Q4 2025; LAE102 SAD results are slated for presentation at a 2025 scientific conference.

• AFFIRM-205 enrollment is targeted for completion in Q4 2025, with an NDA submission to CDE targeted for H1 2026.

• Long-term pipeline ambition is to have one drug candidate enter clinical development each year; further global pharmaceutical partnerships are planned.