Microbio (Shanghai) Co.,Ltd. has been agreed by US FDA to proceed with Phase 2 clinical trial. Phase II clinical trial/Phase III clinical trial/NDA Current development stage: File application/approved/disapproved/Each of clinical trials (include interim analysis): SNS812, a broad-spectrum siRNA for treatment of SARS- COV-2 infection, has been agreed by the US FDA to proceed with the phase 2 clinical trial. Once disapproved by competent authority or each of clinical trials (include interim analyses) results less than statistically significant sense, the risks and the associated measures the Company may occur: Not applicable.

After obtaining official approval or the results (include interim analysis) which are statistically significant, the future strategy: Not applicable. Accumulated investment expenditure incurred: No disclosure of investment expenditure at the moment in consideration of future marketing strategies and to protect the interests of the company and investors. Upcoming development plan: Phase II/III clinical trial A. Scheduled completion date: The actual timeline will depend on the progress of the trial and the review of the regulatory agency.

Estimate responsibilities: SNS812, a wide-spectrum antiviral siRNA for COVID-19, is developed jointly by Microbio (Shanghai") Co.,Ltd. and Oneness. Market: Based on the data published on July 26, 2023, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has infected more than 768 million people worldwide and caused more than 6.95 million deaths. Pfizer announced in 2023 that its COVID-19 treatment drug (Paxlovid) has witnessed a significant surge in First Quarter sales, soaring from USD 1.4 billion in 2022 to USD 4.1 billion this year.

This far exceeds Wall Street's expectation of USD 2.7 billion, highlighting the immense market demand for COVID-19 treatment drugs. According to the Good Review Practice specified in the FDA's Policy and Procedures, the review period for the phase 2 clinical trial protocol is 60 calendar days after submission, which is due by July 30. After confirming with the FDA via email, they informed that the review of this trial cannot be completed at the moment due to an increased review load for other cases.

However, the FDA has agreed to proceed with this phase 2 trial. On June 28, 2023, SNS812 has been greenlighted by the Taiwan TFDA to proceed with the phase II clinical trial. This phase II clinical trial will enroll participants simultaneously in both the US and Taiwan to expedite the trial's progress.

In Taiwan, participant enrollment will begin in September at the main hospital and Yunlin branch of National Taiwan University Hospital. According to Guidelines by Taipei Exchange on the Material Information Announced by Listed and OTC Companies, new drug development companies shall make public announcement when filing application for clinical trials to domestic or overseas regulatory authorities, receiving approval or approval, obtaining the statistical date of endpoints in each of endpoints in each of clinical trials.