Tai Tsung Announces Interim Analysis Results of Phase III Clinical Trial for U101, a Novel Drug for Preventing Recurrent Urinary Tract Infections (rUTI)

1. Date of Event: 115/07/23

2. Name or Code of the Investigational Drug: U101

3. Indication: Prevention of recurrent urinary tract infections (rUTI)

4. All Planned Development Stages: Phase III clinical trial, New Drug Application (NDA)

5. Current Development Stage (Please specify whether the current stage involves application submission, approval, or rejection. If rejected, describe risks and mitigation measures. Also state future business direction and cumulative R&D expenses incurred):

(a) Interim Analysis of U101 Phase III Clinical Trial:

(1) Introduction to Clinical Trial Design

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 their statistical significance (if statistical data cannot be disclosed due to important reasons, please state the reason): According to the interim analysis protocol, statistical results will not be publicly disclosed. Data will be statistically analyzed by an independent unit, and the results will be reviewed and discussed by the Independent Data Monitoring Committee (IDMC), which will provide recommendations. The company will proceed with the subsequent trial plan based on these recommendations.

(3) Future Market Entry Plan upon Knowledge of Phase III Clinical Trial (including interim analysis) Statistical Data (content should avoid triggering full financial forecast disclosure obligations under the 'Criteria for Determining Complete Financial Forecasts for Public Companies'): 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 interim analysis of the Phase III clinical trial has been completed. After rigorous review by the external Independent Data Monitoring Committee (IDMC), overall trial safety has been confirmed, and the committee has recommended 'continuing the trial as originally planned.' Enrollment will therefore continue as scheduled.

(d) Cumulative R&D Expenses Incurred: Not disclosed due to confidentiality agreements and commercial sensitivity.

(e) A single clinical trial result alone is insufficient to fully reflect the success or failure of future drug development and market launch. Investors are advised to make careful judgments and exercise caution in investing.

6. Next Development Stage (Please specify expected completion time and expected obligations):

(a) Expected Completion Time: Trial enrollment is currently ongoing; however, the actual timeline may be adjusted according to review progress.

(b) Expected Obligations: None

7. Market Overview: For the prevention of recurrent urinary tract infections (rUTI), clinical guidelines recommend the following sequence of interventions: (1) Behavioral modification, (2) Non-antibiotic prophylaxis, and (3) Antibiotic prophylaxis.

Among these, long-term use of low-dose antibiotics is associated with the risk of developing antimicrobial resistance and is therefore not the preferred preventive approach. While various non-antibiotic prophylactic methods are recommended before antibiotic use, most lack robust evidence from large-scale studies. Examples include cranberry products, probiotics, hormone therapy, and bladder instillation.

Bladder instillation of hyaluronic acid (HA) medical devices is commonly used off-label for rUTI prevention. However, this method requires catheter insertion at medical facilities, which may increase infection risk. Additionally, patients must follow medical instructions to empty the bladder before and after instillation and retain HA in the bladder for a certain period, 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. Women aged 65 and above are at higher risk for rUTI.

Tai Tsung is currently developing U101, a non-antibiotic, non-invasive oral medication, aiming to effectively prevent recurrent urinary tract infections with improved convenience and without the risk of antimicrobial resistance, thereby overcoming the limitations of current prevention strategies.

8. Other Matters to be Disclosed (If the event or resolution involves a publicly listed company or above, this announcement also qualifies as a material event under Article 7, Paragraph 8 of the Enforcement Rules of the Securities and Exchange Act, significantly affecting shareholders' rights or securities prices): None

9. Drug development is a long-term process involving high costs and no guarantee of success, which may pose investment risks. Investors are advised to make careful judgments and exercise caution.