Mar 10, 2026 — Laekna, Inc. (‘‘Laekna’’) today announced that the Group, in collaboration with Eli Lilly and Company (“Lilly”), has successfully completed the Phase I single ascending dose study (the “U.S. SAD Study”) of LAE102 in the U.S. The U.S. SAD Study was a randomized, double-blind, placebo-controlled study designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of LAE102 administered via both subcutaneous and intravenous routes in healthy postmenopausal women with an average BMI of 26.99 kg/m2.

Consistent with the prior safety profile of LAE102, the U.S. SAD Study demonstrated a well-tolerated safety profile, with no serious adverse events reported.

The U.S. SAD Study demonstrated encouraging trends in body composition improvements following administration of a single dose. Dose-dependent effects on lean body mass increase and fat mass reduction were observed. On Day 29 following a single dose of LAE102, the group with the highest exposure exhibited a 5.06% increase in mean lean body mass from baseline (placebo group has 1.34% reduction from baseline) and a 0.12% decrease in mean fat mass from baseline (placebo group has 2.11% increase from baseline). Single doses of LAE102 resulted in significant and sustained increases in activin A levels, indicating robust target engagement. The duration of target engagement correlated with the dose level. The Group plans to present the detailed study results at an upcoming scientific conference.

These positive results add to a growing body of data supporting LAE102 as a therapeutic approach to cardiometabolic diseases. The Group is actively planning Phase 2 trials to evaluate LAE102 as an addon therapy to incretins in patients with higher BMI and related comorbidities.

Currently, the Group is in active discussions with potential partners to accelerate the global development and commercialization of LAE102. The Group aims to bring this precision therapy to overweight and obese patients in need of novel treatment options to achieve quality weight control.

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Contact Us

IR  ir@laekna.com

Corporate and Business Development  BD@laekna.com

About Laekna

Stock Code: 2105.HK

Laekna is a science-driven, clinical-stage biotechnology company committed to bringing novel therapeutics to patients with metabolic diseases, cancer and liver fibrosis around the world.

As of June 30, 2025, Laekna has initiated seven clinical trials for LAE102, LAE002 (afuresertib) and other drug candidates to address unmet medical needs in obesity and cancers.

LAE102 is our internally discovered antibody against ActRIIA. Blocking Activin-ActRII pathway could promote muscle regeneration and decrease fat mass, this positions LAE102 as a promising drug candidate for achieving quality weight control. We are advancing the Phase I clinical trials for obesity indication in both China and the U.S. In November 2024, Laekna entered into a clinical collaboration agreement with Eli Lilly and Company to support and accelerate global clinical development of LAE102 for the treatment of obesity.

In addition to LAE102, LAE103 is our internally discovered ActRIIB-selective antibody, LAE123 is an ActRIIA/IIB dual antagonistic monoclonal antibody. Laekna has established a comprehensive ActRII portfolio and is actively advancing these drug candidates to clinical studies as novel therapies for muscle and other disease indications.

In the cancer area, Laekna has built a comprehensive portfolio of drug candidates including LAE002(afuresertib), LAE001 and other clinical and pre-clinical drug candidates. LAE002 (afuresertib) is a potent AKT inhibitor that inhibits all three AKT isoforms (AKT1, AKT2 and AKT3) as well as one of the only two AKT inhibitors in late-stage development for breast and prostate cancer globally. Laekna has commenced the Phase III clinical trial (AFFIRM-205) for LAE002 in patients with HR+/HER2- breast cancer and the study recruitment is on track.

Laekna, Inc. (2105.HK) was listed on the Main Board of The Stock Exchange of Hong Kong Limited (the “Hong Kong Stock Exchange”) on June 29, 2023.

For more information, please visit: https://www.laekna.com/  or https://www.linkedin.com/company/74110713/

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