ANKARA, Turkey – December 2, 2025 – GEN Pharmaceuticals (GENIL.IS), Türkiye's leading specialty pharmaceutical company, presented new positive Phase 1 clinical trial results for SUL-238, a first-in-class, orally administered mitochondria-targeted drug candidate for neurodegenerative diseases. The data were shared at the 18th Clinical Trials on Alzheimer's Disease (CTAD) conference in San Diego, USA.

Trial Design and Key Findings:
The randomized, double-blind, placebo-controlled study evaluated multiple-ascending doses of SUL-238 in healthy elderly volunteers over a 14-day treatment period.

• Excellent Safety Profile: SUL-238 demonstrated a favorable safety and tolerability profile, with no clinically significant changes in exams, vital signs, ECGs, or lab parameters. Adverse event rates were comparable to placebo, and all events were mild or unrelated to the drug.
• Favorable Pharmacokinetics: The drug was rapidly absorbed and showed a high cerebrospinal fluid (CSF) penetration, indicating its potential to effectively reach the brain—a critical factor for treating conditions like Alzheimer's and Parkinson's disease.

Executive Commentary:

• Abidin Gulmus, Chairman of GEN: "We're greatly motivated by these new positive results… which mark a key advance toward addressing Alzheimer's disease at its biological foundation."
• Nadir Ulu, MD, PhD, VP of R&D at GEN: "SUL-238 continues to represent a very strong drug candidate for further clinical development aimed at meeting the critical unmet needs in neurodegenerative diseases."

About SUL-238:
Developed in collaboration with Dutch biotech firm Sulfateq, SUL-238 is a hibernation-derived small molecule designed to target mitochondria (the cell's powerhouse). It aims to support mitochondrial bioenergetics and has shown promise in preclinical models for neurodegenerative, cardiovascular, and renal diseases.

Next Steps:
The positive Phase 1 results support the advancement of SUL-238 into further clinical development for neurodegenerative disorders.

For more information, visit www.genilac.com.tr or www.sulfateqbv.com.