Clinical Development and Pipeline - The company has expanded its clinical pipeline to include treatments for anticoagulation, cardiovascular metabolic diseases, complement-mediated diseases, viral infections, and medical aesthetics, leveraging its proprietary dual-delivery technology platform, PNP and GalAheadTM [4] - As of December 2022, 78% of patients treated with STP705 for isSCC showed a high histological clearance rate, with the lowest dose treatment group achieving an 89% observation of treatment-related adverse events [4] - The company plans to submit a Phase III clinical study protocol for STP705 in treating isSCC to the FDA based on positive clinical data from Phase IIa and IIb studies [5] - In February 2022, the company announced a 100% complete response rate for STP705 in treating BCC at a dosage of 180 µg, with no serious adverse events reported [5] - The final data for the Phase II trial of STP705 in treating BCC is expected to be released in Q2 2023 [5] - The company initiated a Phase I proof-of-concept clinical trial for STP705 in adult abdominal fat reduction in May 2022, with mid-term data anticipated in Q2 2023 [5] - STP707, initiated in February 2022 for treating various solid tumors, has shown excellent safety and positive efficacy signals in early dose groups, with many patients maintaining stable disease for over 100 days [6] - The company plans to expand its oncology clinical research in the Asia-Pacific region, which has a high demand for innovative therapies [6] - STP122G, targeting the XI factor, is under development as a potential anticoagulant, with an IND submission planned for Q2 2023 [6] - The company expects to submit IND applications for STP125G in Q4 2023 and STP144G in 2024 in the United States [6] - The company is advancing a robust pipeline with nine clinical trials for key candidates STP705 and STP707, focusing on various therapeutic areas including oncology and infectious diseases [12] - The proprietary dual delivery technology platforms, PNP and GalAheadTM, are being utilized to enhance the delivery of RNA therapeutics, with STP705 entering late-stage clinical development for NMSC [11] - The company is evaluating multiple innovative siRNA molecules for various cancer types, HBV, and cardiovascular diseases, aiming to support IND submissions for clinical trials [17] - STP355 targets TGF-ß1 and VEGFR2, showing therapeutic potential in multiple cancer models including breast cancer and melanoma [18] - STP122G, targeting factor XI, has shown sustained target silencing activity for up to 28 weeks in non-human primate models, with IND submitted to the FDA [19] - STP125G targets ApoC3 for treating rare lipid metabolism disorders, with plans to submit IND to the FDA in 2023 [20] - STP144G targets complement factor B for potential treatment of complement-mediated immune diseases, with IND submission planned [21] Financial Performance - For the year ended December 31, 2022, the company reported a loss of $97.4 million, a decrease of $118.6 million or 55% compared to a loss of $215.9 million for the year ended December 31, 2021 [8] - Administrative expenses increased to $24.2 million, up $8.1 million or 50% from $16.1 million in 2021, primarily due to professional fees, marketing, and depreciation [9] - R&D expenses rose to $67.6 million, an increase of $26.9 million or 66% from $40.7 million in 2021, driven by costs related to clinical trials and materials [9] - The financial loss for the year was primarily offset by a significant reduction in fair value losses on financial liabilities, which decreased by 96% to $6.1 million from $146.0 million in the previous year [8] - The company reported a total net loss of $97.378 million for the year ended December 31, 2022, compared to a net loss of $215.934 million in 2021, indicating a significant improvement [82] - The net cash used in operating activities increased by $31.7 million or 56% to $(88.7) million for the year ended December 31, 2022, compared to $(56.9) million for the year ended December 31, 2021 [62] - The net cash used in investing activities increased by $26.6 million or 440% to $(32.6) million for the year ended December 31, 2022, compared to $(6.0) million for the year ended December 31, 2021 [63] - The net cash generated from financing activities decreased by $155.1 million or 91% to $15.9 million for the year ended December 31, 2022, compared to $171.0 million for the year ended December 31, 2021 [64] - The total assets decreased to $149.704 million as of December 31, 2022, from $224.419 million in 2021, indicating a decline in overall asset value [84] - The company reported a basic and diluted loss per share of $1.16 for the year ended December 31, 2022, compared to $14.30 in 2021 [83] - The company has not declared a final dividend for the year ended December 31, 2022, reflecting a focus on reinvestment [79] Operational Developments - The Guangzhou facility has successfully commenced operations, producing STP707, STP908, STP355, and STP369, with an expected annual capacity of approximately 50,000 vials of freeze-dried solid agents and 150,000 to 200,000 vials of liquid formulations to support ongoing clinical trials [7] - The Guangzhou facility produced 11 batches of drugs in 2022 to support clinical studies for STP707, STP908, STP355, and STP369, with plans to expand capacity for the GalAhead™ product line [27] - The company is expanding its R&D capabilities and production facilities in the U.S. and Asia to support market needs and regulatory approvals [11] - The company is exploring next-generation PNP formulation technologies for future commercialization applications [27] - The company is committed to expanding its market presence in mainland China, Hong Kong, Macau, and Taiwan through licensing agreements [125] - The company is focused on developing new drug delivery platforms and technologies, including GalNAc RNAi delivery platforms [123] - The company is utilizing microfluidics technology for drug development, allowing precise control of fluid dynamics at the microscale [125] Market and Strategic Positioning - RNAimmune announced a $27 million Series A financing in March 2022 to accelerate the development of mRNA vaccines targeting infectious diseases, cancer, and rare diseases [7] - The company was included in the Hang Seng Composite Index in September 2022, enhancing stock liquidity and reputation in the capital markets [7] - The company is exploring potential partnerships for STP705 and STP707 to enhance clinical development and market reach [46] - The company is actively involved in clinical trials and has submitted Investigational New Drug (IND) applications for its new drug candidates [125] - The company is leveraging its proprietary PNP delivery system for STP707, which shows potential for treating various solid tumors [45] Governance and Compliance - The audit committee reviewed the consolidated financial statements for the year ended December 31, 2022, ensuring compliance with accounting principles and policies [76] - The financial statements were prepared in accordance with International Financial Reporting Standards, with no significant impact from the new standards applied in the current year [91] - The group has not recognized any taxable profits in the two reported years, resulting in no provisions for income tax in jurisdictions such as Hong Kong and the United States [101] - The board of directors includes experienced professionals with backgrounds in biotechnology and pharmaceuticals [133]
圣诺医药-B(02257) - 2022 - 年度业绩