4169 Taiso

Release Date: July 24, 115 Statement Date: July 23, 115 Statement Time: 17:08:28 Company Code: 4169 Company Name: Taiso Subject: Announcement of Interim Analysis Results from the Phase III Clinical Trial of U101, a Novel Drug for Preventing Recurrent Urinary Tract Infections (rUTI) Applicable Clause: Clause 10 Factual Date: July 23, 115 Explanation: 1. Factual Date: 07/23/115 2. Name or Code of the Investigational Drug: U101 3. Indication: Prevention of recurrent urinary tract infections (rUTI) 4. Planned Development Stages: Phase III clinical trial, New Drug Application (NDA) 5. Current Development Stage (Please specify whether the current stage is under application/approved/not approved. If not approved, describe risks and mitigation measures; also include future business direction and cumulative R&D expenditure): (a) Interim Analysis of U101 Phase III Clinical Trial: (1) Clinical Trial Design Overview Trial Protocol Name: A randomized, double-blind, placebo-controlled Phase III clinical trial to evaluate the efficacy and safety of U101 in preventing non-complicated recurrent urinary tract infections in women Trial Objective: To evaluate the efficacy of U101 in preventing recurrent urinary tract infections (rUTI) in women Indication: Prevention of non-complicated recurrent urinary tract infections in women Primary Endpoint: Proportion of subjects without urinary tract infection during the 24-week treatment period Number of Enrolled Subjects: 348 (2) Statistical Results of Primary and Secondary Endpoints (including p-values) and Statistical Significance: Per the interim analysis protocol, statistical results will not be disclosed. Data will be analyzed by an independent unit, and the Independent Data Monitoring Committee (IDMC) will review and discuss the results before issuing recommendations. The company will proceed with the trial based on these recommendations. (3) Market Entry Plan upon Knowledge of Phase III Clinical Trial (including interim analysis) Statistical Data: Not applicable. (b) Risks and Mitigation Measures if Not Approved by Regulatory Authorities, if Clinical Trial Results (including interim analysis) Do Not Achieve Statistical Significance, or if Other Major Events Affecting Drug Development Occur: Not applicable. (c) Future Business Direction if Approved by Regulatory Authorities, if Clinical Trial Results Achieve Statistical Significance, or if Other Major Events Occur: The Phase III clinical trial interim analysis has been completed. After rigorous review by the external Independent Data Monitoring Committee (IDMC), overall trial safety was confirmed, and the committee recommended “continuing the trial as originally planned.” (d) Cumulative R&D Expenditure: Not disclosed due to confidentiality agreements and commercial sensitivity. (e) “A single clinical trial result alone is insufficient to fully predict the success or failure of future drug development and commercialization. Investors should carefully assess and exercise caution.” 6. Next Development Stage (including expected completion date and anticipated obligations): (a) Expected Completion Date: Trial enrollment is currently ongoing; actual timeline subject to review progress. (b) Anticipated Obligations: None 7. Market Overview: The clinically recommended approaches for preventing recurrent urinary tract infections (rUTI) are, in order: (1) Behavioral modification, (2) Non-antibiotic prophylaxis, and (3) Antibiotic prophylaxis. Continuous low-dose antibiotic use often leads to antimicrobial resistance and is therefore not the preferred preventive method. While various non-antibiotic prevention methods are recommended before antibiotics, most lack robust evidence from large-scale studies—examples include cranberry, probiotics, hormone therapy, and bladder instillation. For instance, hyaluronic acid (HA), a medical device used in bladder instillation, is frequently employed off-label for rUTI prevention. However, its use requires administration in a clinical setting, involves catheter insertion (which may increase infection risk), and necessitates strict adherence to medical instructions—such as emptying the bladder before and retaining HA in the bladder afterward—making the procedure inconvenient. Based on public databases from official institutions in Taiwan and globally, the estimated number of female rUTI patients is approximately 360,000 in Taiwan and 99 million worldwide, with women aged 65 and above being the most affected group. Taiso’s U101 is a non-antibiotic, non-invasive oral drug under development, aiming to effectively prevent rUTI with greater convenience and without the risk of antimicrobial resistance, overcoming the limitations of current therapies. 8. Other Disclosures (if the event or resolution involves a publicly listed company and qualifies as a material matter affecting shareholder rights or securities prices under Article 7, Clause 8 of the Enforcement Rules of the Securities and Exchange Act): None 9. Drug development is a long-term, high-cost process with no guarantee of success. Investors should carefully evaluate and proceed with caution.