Oscotek announced on the 4th that it has received the Clinical Study Report (CSR) for the Phase 1a/1b clinical trial of ADEL-Y01, a treatment candidate for Alzheimer's disease.

■ U.S. Trial Approved by FDA... Combined Phase 1a and 1b Design

This clinical trial was conducted at five hospitals in the United States with approval from the U.S. Food and Drug Administration (FDA). It was designed as a randomized, double-blind trial to evaluate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of intravenous ADEL-Y01, with Alzheimer's disease as the target condition, comprising a Phase 1a single ascending dose (SAD) and a Phase 1b multiple ascending dose (MAD) study.

■ No Adverse Events up to Maximum 100mg/kg... Safety and Tolerability Confirmed

The trial results showed no treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), or trial discontinuations due to adverse events related to the investigational drug in healthy participants who received a single intravenous dose of ADEL-Y01 at up to 100mg/kg. No anti-drug antibodies (ADA) were observed in participants administered ADEL-Y01. Based on these results, the company stated that safety and tolerability were confirmed in healthy participants who received a single intravenous dose of up to 100mg/kg. The originally targeted number of participants was 73, but 42 were actually enrolled.

■ Technology Transferred to Sanofi in December Last Year... Sanofi to Lead Subsequent Development

ADEL-Y01 was transferred to Sanofi on December 16, 2025. Due to this change in the development sponsor, the existing clinical trial that Oscotek had been participating in was terminated for business reasons. Sanofi is expected to conduct the subsequent clinical development of ADEL-Y01.

■ Disclosure Date of Occurrence: September 4... To Be Used in Future Press Releases and IR Materials

The date of occurrence of this clinical trial result is September 4, 2026, the date on which Oscotek received the CSR from the contract research organization (CRO). The company stated that the disclosure will be used for future press releases and IR materials.

Meanwhile, Oscotek noted in its disclosure that the probability of a clinical trial drug ultimately receiving approval as a medicine is statistically known to be around 10%, and that results during the clinical trial and product approval process may not meet expectations, meaning there is a possibility of changing or abandoning commercialization plans, citing this as an investment caution.