TWi Biotechnology Announces Completion of Patient Enrollment for the Global Phase 2/3 Trial of AC-203 in Treating Epidermolysis Bullosa Simplex (EBS)

TAIPEI, Taiwan – [April 14, 2026] – TWi Biotechnology, Inc. (TWiB) announced today the completion of subject enrollment for its global Phase 2/3 clinical trial of AC-203 (EBShield Study) in the treatment of epidermolysis bullosa simplex (EBS), a pediatric rare disease caused by genetic mutations. The EBShield Study is a randomized, double-blind, and vehicle-controlled trial with a total trial period of 40 weeks (including a 16-week efficacy endpoint analysis and a 24-week safety follow-up).

With a total of 81 randomized subjects , the unblinded data for the primary efficacy endpoint for this study is expected to be announced in the fourth quarter of 2026. Upon successful unblinding, the company will immediately initiate preparations for a pre-NDA meeting with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

Region	Countries	Number of Clinical Sites	Number of Randomized Patients
America	USA	9	20
Asia	Malaysia, Australia, Philippines, China, UAE, Israel, Taiwan, Korea, India	14	28
Europe	UK, Spain, Italy, Poland, Ireland, Greece, Austria, Belgium, France	14	33
Total		37	81

We would like to extend our most sincere appreciation for all the patient investigators, clinical site teams, patients and their families that are participating in this trial."

Epidermolysis bullosa (EB) is a group of rare congenital skin diseases where genetic mutations lead to structural defects in skin, causing blisters and wounds to form, even from minor frictions. EBS is the most prevalent subtype of EB. AC-203 is a topical ointment containing 1% diacerein. Its mechanism of action involves reducing the abnormal accumulation of mutant keratins and inhibiting IL-1β production. The goal of the treatment is to reinforce the skin cell structure to reduce blister formation and promote wound healing. As there are currently no approved therapies worldwide, AC-203 is expected to become the first-in-class treatment for EBS.

AC-203 has received Orphan Drug, Fast Track, and Rare Pediatric Disease designations from the FDA as well as the Orphan Drug status from EMA and Taiwan's TFDA. It is eligible to apply for a Rare Pediatric Disease Priority Review Voucher (RPD-PRV) from the FDA.

About TWi Biotechnology, Inc.

TWi Biotechnology is a clinical-stage drug development company based in Taiwan. Focused on the development of therapeutic drugs following the 505(b)(2) regulatory pathway, the company's drug repositioning strategy leverages clinically proven compounds to address unmet medical needs across rare diseases, inflammatory skin conditions, and central nervous system disorders.

Media Contact:

Email: pr-ir@twibiotech.com

Statements: This press release contains forward-looking statements based on current expectations and assumptions involving risks and uncertainties. The Company undertakes no obligation to update them except as required by law.