Sirnaomics Announces 2023 Annual Results
Sirnaomics Announces 2023 Annual Results |
[28-March-2024] |
Focuses on the Consolidation for Leading Projects Accelerates Clinical Trials for Core Products STP705, STP707 and STP122G HONG KONG, Germantown, Md. and SUZHOU, China, March 28, 2024 /PRNewswire/ -- Sirnaomics Ltd. (the "Company"; together with its subsidiaries, "Sirnaomics" or the "Group"; stock code: 2257), a leading biopharmaceutical company engaged in the discovery and development of advanced RNAi therapeutics, has announced its audited annual results for the year ended 31 December 2023 (the "Year"). In order to ensure sufficient cash runway in the face of global macroeconomic uncertainty, the Group has undergone three rounds of restructuring. It has also prioritized the allocation of resources to programs that have the significant potential to advance the development of its core products. The Group's loss for the Year narrowed by 12.7% to US$84.99 million, demonstrating the effectiveness of these initiatives. Clinical trials progress smoothly with orderly development of multiple product pipelines STP705 The Phase II clinical study of STP705 for the treatment of basal cell carcinoma (BCC) was fully completed in 2023. The final data readout showed very favorable efficacy with no systemic drug-related adverse events (AEs) and serious adverse events (SAEs), further validating the broad potential of this drug candidate for the treatment of non-melanoma skin cancers and beyond. The Group will hold the End-of-Phase II meeting with the U.S. FDA to obtain guidance on the future path forward for the late-stage development of STP705 for the treatment of BCC. Based on the previous experience with isSCC, the Group expects communication with the FDA to be smooth and efficient. The Group completed the Phase I study of STP705 for focal fat reduction in the fourth quarter 2023. The positive results and the histological observations provide preliminary evidence that STP705 may become a best-in-class drug candidate for focal fat reduction and is worthy of further investigation. This will better inform later stage development of this asset in the medical aesthetics category. STP707 STP122G Other product pipelines Two products of RNAimmune, Sirnaomics's non-wholly owned subsidiary specializing in the discovery and development of mRNA-based therapeutics and vaccines, received regulatory clearance on its IND from the U.S. FDA in December 2023 and April 2023, respectively. RNAimmune has initiated two Phase I clinical trials for RV-1770, an mRNA vaccine targeting the human respiratory syncytial virus, and RV-1730, a SARS-CoV-2 vaccine booster candidate. The Group expects to file a U.S. IND for STP125G and STP144G from the GalAhead™ delivery platform in 2025. Commencement of production at Guangzhou facility to meet clinical needs Following the second full year of successful operation of the Guangzhou Fill and Finish (F&F) Facility, which was established in December 2021, the facility continues to support the optimization of the Group's clinical supply strategy in Asia by adapting production to its current needs. The expected annual capacity of around 50,000 vials of lyophilized solid dose and 150,000 to 200,000 vials of liquid dose for human injectables dose capacity is sufficient to support all of the Group's currently planned clinical trials and future clinical developments. Dr. Patrick Lu, Founder, Chairman of the Board, Executive Director, President and Chief Executive Officer of Sirnaomics, said, "During the Year, we undertook a restructuring of our Group's operations and expanded cash flow through various measures, enabling us to proactively respond to the challenges of the macroeconomic environment while further enhancing operational efficiency, better aligning resources with our strategic objectives and further developing our core products. With the top priority of commercializing STP705 for the treatment of isSCC, we are moving full speed ahead with late-stage clinical studies and have begun to explore potential partnerships. We have also started to explore the application of STP705 in the medical aesthetic industry. As with the first GalAhead™ mxRNA candidate, STP122G, which was successfully advanced to the clinical stage, based on the Company's unique and innovative delivery platform technology, we will advance more promising first-in-class preclinical assets into clinical stage, such as STP125G for the treatment of familial hypertriglyceridemia. Our other core product, STP707, and our exclusive targeted PNP delivery have demonstrated their potential to treat a variety of solid tumors, especially for pancreatic cancer, and will set us apart from other RNA players globally. Going forward, we will continue to focus on creating healthier and better lives for patients while also creating value for our shareholders, customers and stakeholders." About Sirnaomics Ltd. (Stock Code: 2257) View original content:https://www.prnewswire.com/news-releases/sirnaomics-announces-2023-annual-results-302102380.html SOURCE Sirnaomics | ||
Company Codes: HongKong:2257 |