The board of directors of Sirnaomics Ltd. announced that the Group has received specific guidance from the U.S. Food and Drug Administration for further development of the Company's novel siRNA therapeutic, STP705, for the treatment of Squamous Cell Carcinoma in situ (isSCC). The company has received the U.S. Food and Drug Administration (FDA)'s written responses to a requested Type C meeting for further development of its novel siRNA therapeutic, STP705, for treatment of Squamous Cell Carcinoma in situ (isSCC). The purpose of the requested Type C meeting is to obtain FDA's advice and comments on the proposed non-clinical and clinical development plans in preparation for Phase II/III and Phase III clinical studies for the treatment of isSCC.

In response to the Company's proposal and questions regarding the relevant non-clinical studies and clinical study design, the FDA has provided a clear path forward with specific guidance for both non-clinical and clinical studies, modifications to the proposed Phase II/III and Phase III clinical studies and further justification required for using two active components in the drug candidate STP705. Currently, the Company is already initiating the requested preclinical studies according to the FDA's guidance. STP705, is an siRNA (small interfering RNA) therapeutic that takes advantage of a dual-targeted inhibitory property and polypeptide nanoparticle (PNP)-enhanced delivery to directly knock down both TGF-1 and COX- 2 gene expression.

The product candidate has received multiple IND approvals from both the FDA and the Chinese National Medical Products Administration (NMPA), including treatments of cholangiocarcinoma (CCA), non-melanoma skin cancer and hypertrophic scar. There are currently three product pipeline programs prioritized for STP705: the most advanced in isSCC, a completed Phase II for Basal Cell Carcinoma (BCC) and a Phase I for focal fat remodeling. For other indications, STP705 has received Orphan Drug Designation for the treatment of CCA and primary sclerosing cholangitis (PSC) from the FDA.