Hangzhou & Shaoxing, China, November 18，2020 -- Ascletis Pharma Inc. (HKEX code：1672) announces today that the board of directors of the Company (the “Board”) resolved to change the use of the remaining Net Proceeds from the Global Offering.
The main reasons for the changes in the proposed applications of the Net Proceeds and reallocation of the unutilized amount of the Net Proceeds are as follows:
(a) The proportion of the Net Proceeds to be used in continued research and development of the Company’s pipeline products has been raised from approximately 65% to 75% in total, primarily for the purpose of expansion of R&D portfolio into two new disease areas: hepatitis B clinical cure and NASH.
(b) The Prospectus stipulates that approximately 10.0% of the Net Proceeds is originally intended to be used for the Group’s research and development of ASC21, which is an IND-approved NS5B polymerase nocleot(s)ide inhibitor licensed from Medivir AB under the exclusive licensing agreement executed in June 2017. The Company and Medivir agreed to cease the cooperation on November 17, 2020. As a result, utilization the Company’s resources for the research and development of ASC21 was also ceased, and ASC21 is no longer a pipeline product of the Company. The Company currently has another IND-approved HCV dual-targeted fixed-dose combination (FDC) candidate in its pipeline, ASC18, which is in-house developed, one-pill once-a-day FDC as the complete treatment of hepatitis C. ASC18 FDC consists of two DAAs: Ravidasvir, an NS5A inhibitor and Sofosbuvir, an NS5B polymerase nocleot(s)ide inhibitor. Since ASC21 is also an NS5B polymerase nocleot(s)ide inhibitor, which intended to be combined with Ravidavir as FDC, ceasing cooperation with Medivir AB does not have material impact on the Company’s HCV pipeline.
(c) The Prospectus stipulates that approximately 25.0% of the Net Proceeds is originally intended to be used for the Group’s commercialization of Ganovo® and Ravidasvir. However, since all oral regimens have become standard for HCV treatment in 2020, Ganovo® (Danoprevir) in combination with injectable peginterferon is no longer an option for many HCV patients, the Company intends to reduce from approximately 25% to 18% of this portion of the Net Proceeds and re-allocate mainly to continued research and development of the Core Product pipeline in viral hepatitis, NASH, HIV/AIDS.
“Since Hong Kong IPO in 2018, Ascletis has developed from a single disease – HCV platform into multi-disease platform including viral hepatitis, NASH and HIV/AIDS,” said Dr. Jinzi J. Wu, Founder, Chairman and CEO of Ascletis, “The change in use of Proceeds from the Global Offering makes more resources available to support our global leading pipelines for hepatitis B clinical cure and NASH.”
Ascletis is an innovative R&D driven biotech and listed on Hong Kong Stock Exchange (Ascletis, 1672.HK). Ascletis is committed to developing and commercializing innovative drugs of viral hepatitis, NASH and HIV/AIDS, for unmet medical needs in China and globally. Led by a management team with deep expertise and a proven track record, Ascletis has developed into a fully integrated platform covering the entire value chain from discovery and development to manufacturing and commercialization. Ascletis has three marketed products and eleven R&D pipeline drug candidates (seven of them developed in house). 1. Viral hepatitis: (i) marketed all oral HCV regimen of Asclevir® and Ganovo® combination (RDV/DNV regimen) and ASC18 fixed dose combination (FDC), with bridging study finished, is an upgraded version of RDV/DNV regimen. ASC18FDC will further enhance the competitiveness of Ascletis ' hepatitis C products. (ii) marketed Pegasys® for HBV clinical cure; (iii) breakthrough therapies for HBV clinical cure. 2. NASH: global development of novel drug candidates against three different targets – FASN, THR-beta and FXR, which are expected to be used alone or in combination. NASH is a global disease, Ascletis conducts global clinical research in Europe, America and China. 3. HIV/AIDS: ASC09F is a FDC treatment of HIV targeting protease. The clinical trial application of ASC09F has been approved. For more information, please visit www.ascletis.com.
For Ascletis Pharma Inc.
Chenlin Li, +86-159-6815-8530