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]

Company Overview - Sirnaomics is focused on RNA therapies and innovative delivery platform technologies, aiming to become a fully integrated international biopharmaceutical company[9]. - The company is engaged in the development and commercialization of RNA interference (RNAi) technology and various therapies[97]. - The company was incorporated on October 15, 2020, and its shares have been listed on the Hong Kong Stock Exchange since December 30, 2021[97]. Clinical Trials and Product Development - The company is conducting seven clinical trials in the U.S. for two main clinical candidates, STP705 and STP707[10]. - Sirnaomics has expanded its focus from oncology and fibrosis to include anticoagulation therapies, cardiovascular metabolic diseases, complement-mediated diseases, and viral infections[9]. - The company is particularly targeting the U.S. and China markets, leveraging its R&D capabilities and production facilities in these regions[9]. - STP705 is a sterile drug targeting TGF-β1 and COX-2, developed for various cancers and fibrosis diseases, utilizing a proprietary peptide nanoparticle delivery platform[14]. - STP707, also a sterile drug, is designed for intravenous administration and is currently in studies for solid tumors and primary sclerosing cholangitis (PSC)[15]. - The company is evaluating multiple innovative siRNA molecules as candidates for different targets, leveraging established proprietary PNP delivery platforms[15]. - STP355 targets both TGF-β1 and VEGFR2, showing potential in treating various cancers including breast cancer, melanoma, and colorectal cancer[16]. - The company is developing STP707 in combination with immune checkpoint inhibitors and other existing cancer therapies[15]. - The company is focused on advancing candidates into clinical research to support drug application submissions across multiple countries[15]. - The company acknowledges the potential challenges in successfully developing and commercializing its core products STP705 and STP707[15]. Financial Performance - The company reported a loss of $46.1 million for the six months ended June 30, 2022, compared to a loss of $33.5 million for the same period in 2021, indicating a year-over-year increase in losses of approximately 37%[48]. - Research and development expenses amounted to $32.1 million for the six months ended June 30, 2022, compared to $12.3 million for the same period in 2021, reflecting a significant increase in investment in R&D[47]. - The company has no product sales revenue for the six months ended June 30, 2022, and has not recognized any income from the co-development licensing agreement with Watson[48]. - The total loss for the period increased from $33.5 million for the six months ended June 30, 2021, to $46.1 million for the six months ended June 30, 2022[58]. - The company's cash and cash equivalents decreased to $169.699 million as of June 30, 2022, down from $211.994 million at the end of 2021, reflecting a decline of 20%[92]. - The company reported a basic and diluted loss per share of $0.55 for the first half of 2022, compared to a loss per share of $2.26 in the same period of 2021[91]. Research and Development - The company is advancing its RNA-based therapies for various diseases, including cancer and fibrosis, leveraging its proprietary technology platform and clinical projects[42]. - The company plans to conduct new clinical trials for STP705 in the U.S. in the second half of 2022, with interim data expected for isSCC and solid tumors[43]. - The company is exploring potential partnerships to enhance the development of its clinical candidates, particularly STP705 and STP707[44]. - The company has established a clinical team in China to support the IND approval for STP705, aiming to expand its market presence in the region[43]. Production and Technology - The proprietary PLNP platform offers lower production complexity and stability at room temperature, eliminating cold chain storage costs associated with LNP platforms[30]. - The Guangzhou facility produced eight batches of drugs in the first half of 2022 to support preclinical toxicology studies and early clinical trials[31]. - The GalAhead™ delivery platform is being expanded with mature CDMO partners to enhance production capabilities for RNAi therapeutics[31]. - PDoV-GalNAc technology improves siRNA delivery efficiency by 3 to 5 times compared to single siRNA, demonstrating faster target gene knockdown[29]. - The company holds global rights for its proprietary PNP delivery technology, which has been successfully tested in multiple clinical studies[29]. Shareholder Information - As of June 30, 2022, the total number of issued shares was 89,040,230[78]. - Dr. Lu Yang holds a beneficial interest in 12,649,625 shares, representing 14.21% of the company's equity[71]. - Major shareholder Zeng Yu has a controlled corporation interest in 4,564,495 shares, equivalent to 5.13% of the equity[77]. - The company has implemented a pre-IPO equity incentive plan to attract and retain talent, issuing a total of 12,770,000 shares under this plan[66]. Corporate Governance - The audit committee consists of one non-executive director and two independent non-executive directors, ensuring compliance with corporate governance standards[85]. - The company has adopted its own code of conduct regarding securities trading, which meets or exceeds standard requirements[84]. - The company has complied with all applicable corporate governance code provisions during the reporting period, except for the separation of the roles of chairman and CEO[83]. Market and Economic Impact - The impact of the COVID-19 pandemic continues to affect the company's operations and financial performance, with ongoing adjustments to strategies based on the evolving situation[46]. - The company has not recognized any taxable profits, thus no income tax provisions were made for the period[114].

Financial Performance - The company reported a net loss of $215.934 million for 2021, compared to a loss of $46.428 million in 2020, indicating a significant increase in losses[19]. - Research and development expenses rose to $40.673 million in 2021 from $14.894 million in 2020, reflecting increased investment in clinical projects[19]. - The company recorded a net loss for the year ending December 31, 2021, and anticipates continuing to incur net losses in the foreseeable future[116]. - The majority of the net loss was attributed to fair value changes of financial liabilities, R&D expenses, administrative expenses, and listing expenses[60]. - The company has recorded cash outflows from operating activities since inception, indicating a need for additional financing to support business operations[116]. - The company has not generated any product sales revenue for the year ended December 31, 2021, nor did it confirm any income from the co-development licensing agreement with Watson[61]. - The company has a distributable reserve of $516,841,000 as of December 31, 2021[130]. - The company did not declare a final dividend for the year ended December 31, 2021[130]. Funding and Capital Structure - Sirnaomics successfully raised over HKD 460 million through its IPO, indicating strong investor confidence in its RNA therapeutic capabilities and strategic business model[13]. - The company has raised approximately HKD 1.4 billion in total funding during 2021, including E-round financing and seed funding for RNAimmune[13]. - As of December 31, 2021, the company had no revenue generated from product sales[162]. - The company allocated 57.9% of the raised funds for the development and commercialization of STP705, amounting to $26.9 million[160]. - The company plans to utilize $8.6 million for the development of STP707 by the end of 2022, which represents 15.6% of the total funds raised[160]. - The company had unutilized bank financing of $3.9 million as of December 31, 2021[78]. - The company issued a total of 12,770,000 shares under the pre-IPO share incentive plan to attract and retain talent[126]. Research and Development - The company is advancing its PNP technology for siRNA drug delivery, with promising efficacy and safety results from clinical trials for STP705 and STP707[13]. - Sirnaomics is advancing a broad pipeline of candidate products, including two major clinical candidates STP705 and STP707, with seven clinical trials currently ongoing in the U.S.[22]. - The company is conducting preclinical research on at least 16 other products, with seven expected to enter clinical stages soon[22]. - The company is evaluating over seven innovative candidates in preclinical studies, targeting various diseases including influenza, HBV, HPV, and COVID-19[26]. - The company aims to expand its proprietary delivery platform capabilities to overcome current delivery barriers for RNAi triggers and mRNA[21]. - The company plans to submit IND applications for STP355, STP908, and STP369 in the first half of 2023[42]. - The company is preparing to submit IND applications for HCC as part of a global multicenter clinical trial in China[22]. Clinical Trials and Product Development - STP705 is expected to expand its clinical development for facial isSCC based on excellent trial results announced in February 2022[14]. - STP707 has initiated a Phase I clinical trial in the U.S. to evaluate its safety, tolerability, and anti-tumor activity, with FDA approval received for its IND application[14]. - The company plans to launch a new clinical trial for adipose plastic treatment in Q2 2022, leveraging results from its ongoing isSCC trials[14]. - In the IIa clinical trial for STP705, 76% of participants achieved complete histological clearance, with 90% in the 30-60 microgram dosing group[40]. - The company initiated a Phase I clinical trial for STP707 in March 2022, focusing on safety, tolerability, and pharmacokinetics in healthy volunteers[41]. - STP705 is a dual TGF-B1/COX-2 inhibitor being developed for non-melanoma skin cancer and solid liver tumors[24]. - STP707, another dual TGF-B1/COX-2 inhibitor, is being developed for systemic treatment of liver or lung solid tumors[25]. Technology and Innovation - Sirnaomics is preparing to develop new RNAi therapies for a wide range of diseases, supported by validated proprietary PNP and GalNAc technology platforms[13]. - The proprietary RNA delivery platform STP122G targets coagulation factor XI, showing sustained (>33 weeks) targeted inhibition and therapeutic benefits in non-human primate studies[15]. - The proprietary delivery platforms include PNP, GalNAc RNAi, and LNP technologies, with global rights secured for these platforms[35]. - The company has developed a combination of gemcitabine with siRNA to enhance the efficacy of cancer treatment, demonstrating strong effects in preclinical studies[35]. - STP122G is set to be the first candidate from the GalAheadTM delivery platform to enter clinical stages, targeting subcutaneous delivery of factor XI[52]. - Sirnaomics has filed multiple patent applications for the GalAheadTM platform, covering specific molecular targeting factors such as factor XI and complement factor B[46]. Corporate Governance and Management - The company has established a legal advisory framework to support its operations and compliance, ensuring adherence to regulatory standards in the biotech industry[95]. - The board consists of 12 directors, including three executive directors, five non-executive directors, and four independent non-executive directors[105]. - The company has adopted a board diversity policy to enhance board efficiency and maintain high standards of corporate governance[178]. - The company emphasizes the importance of independent directors in decision-making processes, ensuring a balanced governance structure[92]. - The leadership team collectively brings a wealth of experience from various sectors, which is crucial for the company's growth and market expansion strategies[91]. - The company has arranged appropriate liability insurance for directors, which will be reviewed annually[184]. - The company encourages directors to participate in continuous professional development activities to update their knowledge and skills[179]. Market and Strategic Focus - The focus markets for the company are the United States and China, leveraging R&D capabilities and production facilities in these regions[21]. - The company aims to expand its indications in oncology and fibrosis through its proprietary delivery systems[14]. - Sirnaomics is actively seeking global and local collaboration opportunities to maximize the potential of its clinical candidates, particularly STP705 and STP707[53]. - The company is evaluating partnership options to maximize market potential, focusing on partners with extensive biopharmaceutical industry backgrounds[55]. - The company aims to expand market coverage through the knowledge and networks of current and future business partners[55]. - The company plans to establish a commercial-scale production facility in China to meet future commercialization demands[53]. Risks and Challenges - The regulatory approval process for biopharmaceutical products is lengthy, costly, and unpredictable, which poses risks to the company's business and financial outlook[114]. - The company faces risks related to the successful completion of clinical development and obtaining regulatory approvals for its candidates[114]. - The company is subject to various risks associated with reliance on third parties for drug development, which could affect its ability to obtain regulatory approvals[119]. - The company has faced risks related to the high regulation of the biopharmaceutical industry in China, which may impact drug approval and commercialization[121]. - Changes in Chinese government policies could significantly affect the company's business, financial condition, and growth strategy[121]. - The impact of the COVID-19 pandemic on the business remains uncertain, and the company is closely monitoring the situation and adjusting strategies accordingly[56].