Core Viewpoint - 圣诺医药-B reported a significant reduction in losses for the six months ending June 30, 2025, compared to the same period in the previous year, despite no product sales revenue generated [1] Financial Performance - The company recorded a loss of $3.4 million for the six months ending June 30, 2025, compared to a loss of $43.5 million for the same period in 2024 [1] - The reduction in losses is attributed to decreased fair value losses on financial assets, reduced R&D expenses, lower administrative expenses, and decreased fair value losses on financial liabilities [1] Strategic Initiatives - The company is actively seeking global and regional partnerships for STP705 and STP707, evaluating collaboration opportunities for the GalAhead™ platform assets, and establishing strategic alliances to enhance development capabilities [1] - Efforts are focused on maximizing the potential of the pipeline while minimizing development risks through shared expertise and resources [1] - The company is in discussions with several venture capital funds to establish a new entity aimed at advancing its product pipeline while optimizing R&D expenditures [1] Future Outlook - The company aims to submit a New Drug Application (NDA) for STP705 as early as 2027, with commercial success dependent on positive clinical data, regulatory approval, and robust intellectual property protection [1] - The commercialization strategy includes detailed market access planning, development of necessary infrastructure, and building partnerships [1]

期内亏损减少主要归因于：截至2025年6月30日止六个月，按公平值计入损益的金融资产公平值变动亏 损减少;研发开支减少;行政开支减少;及按公平值计入损益的金融负债公平值变动亏损减少。 圣诺医药-B(02257)发布2025年中期业绩，其他收入12.4万美元，同比下降87.4%;公司拥有人应占亏损 369.8万美元，同比收窄91%;每股基本亏损0.04美元。 ...

Clinical Development - Sirnaomics reported a positive clinical trial outcome for its lead candidate STP705, targeting two tumor indications: squamous cell carcinoma in situ (isSCC) and basal cell carcinoma (BCC) [17]. - The company is strategically prioritizing the advancement of isSCC into pivotal Phase IIb/III trials while retaining future development pathways for all indications [17]. - STP707 is currently undergoing Phase I clinical trials in the US for treating multiple solid tumors, with completion expected by the end of 2025 [18]. - STP705 has shown positive clinical results in the isSCC trial, leading to its evaluation in the medical aesthetics field, with an ongoing Phase I study in the US demonstrating excellent safety and early efficacy signals [18]. - STP705 has shown good efficacy in Phase IIa and IIb studies for isSCC and BCC, with plans to advance to later-stage clinical development [25]. - STP122G, based on the GalAhead™ mxRNA platform, is in Phase I trials, with initial safety data supporting continued clinical progress, expected to complete by 2026 [20]. - STP707 shows good tolerance and therapeutic effects, especially in pancreatic cancer patients, with a Phase I trial involving 50 patients expected to complete by the end of 2025 [26]. - The company is advancing STP125G and STP144G into clinical development, with STP125G targeting ApoC3 for hypertriglyceridemia and cardiovascular diseases, and IND submission planned for 2025 [29]. Technology and Innovation - Sirnaomics utilizes a dual delivery system (PNP and GalAhead) to advance a diverse pipeline addressing unmet medical needs across oncology, fibrosis, aesthetic medicine, anticoagulation, and cardiovascular metabolic diseases [17]. - The GalAhead™ delivery platform is being researched for various liver cell-related diseases, utilizing mxRNA and muRNA therapies for subcutaneous administration [19]. - The PNP delivery platform is clinically validated and supports therapy development across oncology, fibrotic diseases, and medical aesthetics [31]. - The GalAhead™ platform has shown strong clinical validation, with STP122G demonstrating excellent safety in initial clinical cohorts [39]. - The company is positioned as a pioneer in the RNA interference field, focusing on dual-gene targeting projects to address significant scientific and commercial interest [20]. Financial Performance - For the six months ended June 30, 2025, the company reported a loss of $3.4 million, a significant improvement from a loss of $43.5 million for the same period in 2024, representing a reduction of approximately 92% [48]. - The group’s loss decreased from $43.5 million for the six months ended June 30, 2024, to $3.4 million for the six months ended June 30, 2025, primarily due to reduced fair value losses on financial assets and lower R&D and administrative expenses [62]. - The company reported a net loss of $3,388,000 for the six months ended June 30, 2025, compared to a net loss of $41,065,000 for the same period in 2024, indicating a significant improvement [161]. - The total comprehensive loss for the period was $3.410 million, compared to $43.887 million in the previous year [154]. - The company had no product sales revenue for the six months ended June 30, 2025 [50]. - The company recognized share-based payments totaling $1,599,000 during the reporting period [159]. Cost Management - Research and development expenses decreased by $11.3 million or 79% to $3.0 million for the six months ended June 30, 2025, attributed to a strategic focus on developing STP705 and STP122G while pausing other projects [59]. - Administrative expenses were reduced by $7.6 million or 75% to $2.6 million for the six months ended June 30, 2025, due to restructuring strategies and cost-saving measures [57]. - Employee costs totaled $2,710,000, a decrease of 68% from $8,459,000 in the prior year, with salaries and other allowances dropping from $6,402,000 to $2,248,000 [176]. Strategic Partnerships and Licensing - The company is actively engaging potential partners to accelerate innovative medical aesthetics projects based on STP705 [25]. - The company aims to leverage proprietary technology through strategic licensing to empower biopharmaceutical partners while advancing its internal pipeline [21]. - The company is actively seeking global and regional partnerships for STP705 and STP707 to enhance development capabilities and reduce risks [40]. Restructuring and Financial Strategy - A comprehensive restructuring plan has been implemented to enhance operational efficiency and extend financial runway [38]. - The company is exploring additional financing opportunities and evaluating strategic options, including selective divestiture of non-core assets [38]. - The company is actively seeking external financing through equity and debt to supplement its cash reserves [162]. - The company is exploring business development opportunities for its pipeline assets to enhance revenue generation [162]. Employee Incentives and Share Options - The group has adopted a pre-IPO equity incentive plan, restricted share unit plan, and stock option plan to incentivize eligible employees [81]. - The pre-IPO equity incentive plan aims to attract and retain outstanding talents for the group [82]. - The plan allows for the reallocation of shares if rewards expire, lapse, or are canceled, enabling those shares to be used for new rewards [90]. - The stock option plan aims to attract and retain talent, align interests with shareholders, and provide additional incentives for performance [117]. - The company granted a total of 8,904,023 share options under the share option scheme adopted on June 28, 2022 [6]. Shareholder Information - The company did not declare any interim dividend for the reporting period [149]. - The company has not purchased, sold, or redeemed any of its listed securities during the six months ending June 30, 2025 [140]. - The company plans to grant a total of 8,137,550 further share options, representing approximately 7.74% of the issued shares [9]. Legal and Compliance - The company has made no significant litigation or arbitration claims as of June 30, 2025 [143]. - The company is currently undergoing arbitration proceedings related to a claim against the investment manager, with the arbitration tribunal established on November 8, 2024 [184]. - The group has significant uncertainty regarding its ability to continue as a going concern due to the potential failure to implement restructuring plans [164].

Group 1 - The Hong Kong biotechnology stocks experienced a collective decline, with notable drops in several companies [1] - WuXi AppTec (02126) saw a decrease of 12.95%, closing at 4.840 [2] - BioNTech (06952) fell by 12.53%, with a latest price of 13.750 [2] Group 2 - Other companies such as Valiant (09887) and Beihai Kangcheng (01228) also reported significant declines of 9.93% and 9.75% respectively [2] - The decline extended to companies like Saint Noble (02257) and MIRXES (02629), which dropped by 9.64% and 8.43% [2] - Overall, the biotechnology sector is facing downward pressure, impacting multiple firms [1]

圣诺医药宣布，该公司将于2025年8月28日(星期四)举行董事会会议，藉以(其中包括)考虑并批准公司及 其附属公司截至2025年6月30日止六个月的中期业绩及其发布。 智通财经APP获悉，香港联交所最新资料显示，8月26日，圣诺医药-B(02257)股东将股票存入招银国际 证券，存仓市值1.81亿港元，占比16.67%。 ...

圣诺医药宣布，该公司将于2025年8月28日(星期四)举行董事会会议，藉以(其中包括)考虑并批准公司及 其附属公司截至2025年6月30日止六个月的中期业绩及其发布。 香港联交所最新资料显示，8月26日，圣诺医药-B(02257)股东将股票存入招银国际证券，存仓市值1.81 亿港元，占比16.67%。 ...

香 港 交易 及 結 算 所 有限 公 司 及 香港 聯 合 交 易 所有 限 公 司 對 本公 告 的 內 容概 不 負 責， 對 其 準 確 性或 完 整 性 亦不 發 表 任 何 聲明 ， 並 明 確 表示 ， 概 不 對因 本 公 告全 部 或 任 何 部份 內 容 而 產生 或 因 倚 賴 該等 內 容 而 引 致的 任 何 損 失承 擔任何責任。 Sirnaomics Ltd. 聖 諾 醫 藥 * （ 於開曼群島註冊成立的有限公司） （股份代號：2257） 承董事會命 Sirnaomics Ltd. 主席兼獨立非執行董事 黃夢瑩 香港，2025年8月18日 於 本 公告 日 期 ， 董 事會 包 括 執 行董 事 潘 洪 輝 博士 、 非 執 行 董事 歐 陽 雲 龍先 生 ， 以及 獨 立 非 執 行董 事 黃 夢 瑩女 士 、 于 常 海博 士 、 王 宇 山先 生 及 張 鵬博 士。 * 僅供識別 董事會會議通告 Sirnaomics Ltd.（「本公司」）董事會（「董事會」）謹此宣佈，本公司將於2025年 8 月 28 日（ 星 期 四 ）舉 行 董 事 會 會 議 ， 藉 以（ 其 中 ...

Core Viewpoint - The Hong Kong pharmaceutical stocks are experiencing a strong performance, with notable gains in several companies [1] Company Performance - Sanofi Pharmaceutical-B (02257.HK) increased by 5.50% - Kangfang Biotech (09926.HK) rose by 5.23% - Genscript Biotech (01952.HK) saw a rise of 4.38% - Fudan Zhangjiang (01349.HK) grew by 4.21% [1]

Group 1 - The Hong Kong pharmaceutical stocks showed a strong performance, with several companies experiencing significant gains [1] - Baset Pharmaceutical (02616.HK) increased by 9.86%, indicating a robust market response [1] - Other notable gainers included Charoen Pokphand International (03839.HK) with a rise of 7.06%, Sanofi Pharmaceutical (02257.HK) up by 6.93%, and Weiya Biotechnology (01873.HK) which saw a 5.80% increase [1]

Clinical Development Progress - Sirnaomics achieved significant progress in clinical projects, particularly with the STP705 candidate drug, which is advancing to Phase III trials for treating isSCC[16]. - The company completed a Phase I clinical study for STP705 in localized fat reduction, showing promising results that validate its RNAi-based aesthetic solutions[16]. - The STP707 project, involving advanced solid tumor patients, has concluded its Phase I clinical study, demonstrating strong safety results[16]. - Sirnaomics is advancing its GalAhead™ product pipeline, completing the second cohort of the STP122G Phase I trial and initiating IND preparations for the STP125G project[16]. - The company is advancing STP705 for non-melanoma skin cancer, with promising results from Phase II trials and guidance from the FDA[24]. - STP707 is being tested in clinical studies across 11 leading cancer centers in the U.S., showing good tolerability and significant therapeutic effects[25]. - The GalAhead™ platform is under investigation for various liver-related diseases, with the first product STP122G having commenced Phase I clinical trials[29]. - The company is preparing to advance a new medical aesthetic product based on STP705, following positive Phase I clinical results[27]. - STP705 has demonstrated efficacy in Phase II trials for non-melanoma skin cancer (NMSC) and excellent safety in Phase I trials for localized fat reduction, with plans to advance to Phase II clinical studies[36]. - STP707, targeting multiple solid tumors, has shown good tolerability and treatment effects in a Phase I study involving 50 advanced cancer patients, particularly benefiting pancreatic cancer patients[37]. - STP122G, aimed at anticoagulation therapy, has completed Phase I trials with excellent safety and dose-dependent target silencing activity, applicable for conditions like atrial fibrillation and deep vein thrombosis[38]. - Sirnaomics is preparing to submit IND for STP125G, targeting ApoC3 for hypertriglyceridemia and cardiovascular diseases, with IND studies completed[40]. - Positive data from STP705's clinical studies for isSCC and BCC treatments have been reported, with ongoing communication with the FDA for late-stage clinical development guidance[48]. - STP707's Phase I basket trial completed in August 2023 showed good tolerability and treatment effects, particularly in pancreatic cancer patients, indicating potential for further research[49]. - The Phase I trial of STP122G for coagulation disorders continues, with no dose-limiting toxicities reported, highlighting its sustained pharmacological effects[50]. Financial Performance and Challenges - Total revenue for 2024 reached $1.778 million, with a gross profit of $1.199 million[22]. - Research and development expenses for 2024 were $20.802 million, a decrease from $54.382 million in 2023[22]. - The company reported a net loss of $50.245 million for 2024, an improvement from a loss of $84.990 million in 2023[22]. - The non-current assets totalled $8.870 million in 2024, down from $17.069 million in 2023[22]. - The total liabilities net worth was reported at $(16.004) million in 2024, compared to $24.457 million in 2023[22]. - Other income decreased by 29% to $1.029 million in 2024 from $1.414 million in 2023, primarily due to a drop in interest income[71]. - The fair value change of financial assets recorded a loss of $18.178 million in 2024, compared to a gain of $0.241 million in 2023, indicating significant market volatility[74]. - The company has implemented targeted cost-saving measures to improve financial management and increase cash reserves[60]. - Cash used in operating activities decreased by $50.6 million or 72% from $70.3 million in 2023 to $19.7 million in 2024, primarily due to a slowdown in R&D activities[89]. - Cash and cash equivalents decreased by $11.8 million from $23.9 million at the beginning of the year to $11.8 million at the end of the year[88]. - The current ratio dropped significantly from 134.5% in 2023 to 52.3% in 2024, indicating a decline in liquidity[93]. - The net asset value changed from $24.5 million as of December 31, 2023, to a net liability of $16.0 million as of December 31, 2024, mainly due to a fair value loss of $18.2 million on financial assets[91]. - The company is actively seeking strategic partnerships and licensing deals to generate revenue in 2025, leveraging its leading clinical assets[18]. - The budget proposal for 2025 aims to substantially reduce operating expenses and monthly burn rate[18]. - The company is focusing business development efforts on advanced and late-stage clinical assets to attract potential collaborators[18]. - In 2024, Sirnaomics faces financial constraints impacting its ability to expand manufacturing capabilities, yet it maintains GMP-compliant production processes and focuses on existing partnerships to support its global supply chain[46]. - The company has generated a net cash outflow from operating activities since its inception and may require additional financing to support its operations[150]. Strategic Initiatives and Restructuring - The company is implementing a comprehensive restructuring plan aimed at improving operational efficiency and driving sustainable growth[17]. - The company prioritizes resource allocation to high-potential projects, specifically developing STP705 and STP122G, while slowing down other project developments due to global economic uncertainties[47]. - Sirnaomics emphasizes the importance of strategic partnerships to accelerate RNA therapy breakthroughs and create mutually beneficial opportunities[31]. - The company is collaborating with innovative biopharmaceutical companies to expand the therapeutic range of RNA-based drugs, leveraging its advanced GMP facilities[31]. - Leadership changes in 2024 aim to strengthen the executive team, with Dr. Pan Honghui appointed as CEO, expected to drive strategic initiatives and operational excellence[58]. - The company has a strong management team with extensive experience in biopharmaceuticals and drug development[126][128]. Compensation and Equity Incentive Plans - The company has made adjustments to the compensation of its executives, with annual cash remuneration set at $200,000 and $360,000 for specific roles[140]. - The pre-IPO equity incentive plan was adopted on January 21, 2021, with a total of 12,770,000 shares issued under the plan[158]. - The plan aims to attract and retain outstanding talents, including directors, senior executives, employees, consultants, and advisors[159]. - The total number of shares reserved for issuance under the pre-IPO equity incentive plan is 12,770,000[165]. - The vesting schedule for stock options includes 25% vesting after one year and the remaining 75% vesting monthly over the next 36 months[168]. - The company has a total of 10,824,345 unexercised stock options as of December 31, 2024[170]. - The average exercise price of the stock options granted ranges from $1.356 to $3.55[170]. - The company approved a Restricted Share Unit Plan on April 22, 2022, to incentivize skilled personnel[172]. - The restricted share unit plan has a validity period of 10 years, with 7 years remaining[175]. - The maximum number of shares available for rewards under the restricted share unit plan is capped at 10% of the issued shares as of the adoption date[180]. - The plan allows for rewards to be linked to performance milestones or targets achieved by the group or its members[179]. Risks and Regulatory Environment - The company faces significant risks related to the development, regulatory approval, and commercialization of its candidate drugs, which could adversely affect its business and competitive position[145]. - The company relies on stable and sufficient supply of raw materials and services, facing supply chain risks that could impact its operations[145]. - The company is subject to stringent regulations in the biopharmaceutical industry, and changes in laws or regulations could negatively impact its drug approval and commercialization[157]. - The company has received government grants and tax incentives for its R&D activities, which may be adversely affected by changes in policies or failure to meet conditions[157]. - The company emphasizes the importance of maintaining good relationships with stakeholders, which is key to its success[155].