Laekna Inc (2105) H1 2023 earnings summary

Executive summary

• Six clinical trials were underway as of June 30, 2023, including one registrational trial; three were multi-regional.

• Listed on the Hong Kong Stock Exchange on June 29, 2023; H1 net loss narrowed to RMB217.0 million from RMB301.9 million YoY.

Financial highlights

• H1 operating loss was RMB145.0 million versus RMB168.7 million YoY; net loss was RMB217.0 million versus RMB301.9 million.

• R&D expenses fell to RMB102.3 million from RMB123.7 million, while administrative expenses declined to RMB36.0 million from RMB43.5 million, mainly on lower discovery, clinical development and listing costs.

• Fair value losses on investor financial instruments fell to RMB71.2 million from RMB132.6 million; preferred shares converted at listing and the warrant had been exercised in March 2022.

• Other income rose to RMB3.2 million from RMB0.3 million; other losses increased to RMB9.9 million from RMB1.7 million, mainly due to unrealized FX losses.

• Total comprehensive loss was RMB285.8 million versus RMB366.4 million; basic and diluted loss per share was RMB2.63 versus RMB4.08.

Outlook and guidance

• PROFECTOR-II enrollment was complete in the U.S. and China; topline data was expected in late Q4 2023. NDA discussions with FDA and NMPA were conditional on meeting criteria; otherwise, another pivotal trial may be required.

• Afuresertib plus fulvestrant Phase Ib results were planned for Q4 2023, with pivotal Phase III initiation under regulatory discussion.

• Afuresertib plus LAE001 mCRPC readouts were scheduled for ESMO 2023; registration-trial design discussions with FDA and NMPA were planned, with initiation targeted for H2 2023.

• Plans included advancing existing assets and combination therapies, and aiming to move one internally discovered candidate into clinical development each year.