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].

Financial Performance - For the fiscal year ending December 31, 2024, the group reported total revenue of $1.778 million, a decrease from the previous year's revenue of $1.414 million[11]. - The group incurred a net loss of $50.245 million for the year, compared to a net loss of $84.990 million in the prior year, indicating an improvement in financial performance[11]. - The group's annual loss decreased from $85.0 million for the year ended December 31, 2023, to $50.2 million for the year ended December 31, 2024, primarily due to reductions in R&D expenses, administrative expenses, and fair value losses on financial liabilities[12]. - The company reported a net loss attributable to shareholders of $51,383,000 for 2024, compared to a loss of $78,691,000 in 2023, representing a 34.6% improvement year-over-year[148]. - The company reported a total comprehensive loss of $50,647,000 for the year, compared to $85,221,000 in the previous year[124]. - The company achieved significant progress with STP707, showing promising safety and efficacy in Phase I trials for multiple solid tumors, with plans to explore Phase II combination trials[55]. Clinical Development - The company completed Phase I clinical trials for STP705 in localized fat reduction, demonstrating excellent safety and efficacy[5]. - The Phase I clinical study for STP707 involved 50 patients with advanced solid tumors, showing good safety, particularly for pancreatic cancer patients[5]. - STP705, used for the treatment of non-melanoma skin cancer, has shown promising results and is advancing towards a pivotal II/III trial with guidance from the FDA[14]. - STP707, an innovative treatment for various solid tumors, has demonstrated good tolerability and significant therapeutic effects in clinical studies across leading cancer centers in the U.S.[15]. - The first GalAhead™ mxRNA product, STP122G, has received FDA regulatory approval and is currently undergoing Phase I clinical trials to assess its safety and efficacy[17]. - The I phase clinical trial for STP122G, targeting coagulation disorders, has shown no dose-limiting toxicity or severe adverse events, indicating its potential as a necessary anticoagulant[42]. Research and Development - The company is focusing on cost reduction measures and reallocating resources to high-potential programs while prioritizing the development of STP705 and STP122G[5]. - Research and development expenses decreased by $33.6 million or 62% to $20.8 million for the year ended December 31, 2024, from $54.4 million for the year ended December 31, 2023, as the group focused financial resources on developing STP705 and STP122G[12]. - The company is exploring the potential of siRNA candidates in the medical aesthetics field, with promising results from Phase I clinical studies indicating excellent safety and efficacy[16]. - The company is advancing the GalAhead™ platform's first candidate drug, STP122G, which has shown excellent safety in initial sequences, with plans to submit an IND application for STP125G by 2025[53]. - The company is developing innovative conjugated drugs, particularly antibody oligonucleotide conjugates (AODC), with at least three patents pending[47]. Cost Management and Restructuring - The group's administrative expenses decreased by $6.0 million or 26% to $17.2 million for the year ended December 31, 2024, down from $23.2 million for the year ended December 31, 2023, due to cost-saving measures and restructuring strategies[12]. - The company implemented restructuring strategies and cost-saving measures, leading to significant reductions in various expense categories[68]. - The company is focusing on maintaining existing production capacity and supporting its core product pipeline despite financial constraints affecting manufacturing capabilities in 2024[37]. - The company is relying on existing CDMO partnerships for commercialization of later-stage products while continuing to develop new strategic partnerships to expand manufacturing capabilities[35]. Strategic Initiatives - The company is committed to creating value for shareholders through strategic focus, maintaining financial discipline, and advancing its innovative RNAi therapeutic product line[10]. - The company is actively exploring global and local partnership opportunities for its key products STP705 and STP707 to accelerate the development of clinical assets[56]. - The company is exploring market expansion opportunities in international markets, aiming for a DD% increase in market share[163]. - The company is actively collaborating with innovative biopharmaceutical companies to expand the therapeutic range of RNA-based drugs, creating mutually beneficial opportunities[20][21]. Governance and Compliance - The company has adopted corporate governance practices in compliance with the listing rules, with a change in the roles of the chairman and CEO effective November 5, 2024[102]. - The Audit Committee consists of three independent non-executive directors, with Mr. Wang Yushan serving as the Chairman, overseeing financial reporting, risk management, and internal control systems[107]. - The independent auditor issued a qualified opinion on the consolidated financial statements for the year ending December 31, 2024, highlighting significant uncertainties related to going concern[113]. Financial Position - The company's current liabilities net amount to $17,767,000, with total liabilities at $16,004,000 and cash and cash equivalents of $11,769,000 as of December 31, 2024[119]. - The group recorded a fair value loss of $18.178 million on financial assets measured at fair value through profit or loss as of December 31, 2024[88]. - The company reported impairment losses of $2.19 million on property, plant, and equipment, reflecting a significant decrease from $8.345 million in the previous year[65]. - The company recognized a fair value loss of approximately $18,178,000 on financial assets measured at fair value through profit or loss, compared to a fair value gain of $241,000 in 2023[123]. Future Outlook - The company provided guidance for the next fiscal year, projecting revenue growth of B% and an expected EBITDA margin of C%[168]. - The company is focused on expanding its competitive advantage and establishing itself as a global leader in RNA-based innovative drugs[51]. - The company is exploring potential acquisitions to enhance its product portfolio, targeting companies with complementary technologies[170].

Clinical Development and Pipeline - Sirnaomics has established a robust clinical pipeline focusing on RNA therapeutics, with key candidates STP705 and STP707 showing positive clinical data in non-melanoma skin cancer and solid tumors[7]. - The company is advancing its GalAhead™ delivery platform, with the first product STP122G currently in Phase I clinical trials, targeting diseases that may benefit from liver cell targeting[7]. - Sirnaomics is conducting four clinical trials in North America for its lead candidates STP705, STP707, and STP122G, alongside mRNA vaccine projects RV-1730 and RV-1770 also in Phase I trials[8]. - The company aims to leverage its proprietary PNP delivery platform to maintain its leading position in RNAi therapeutics for cancer treatment globally[7]. - Sirnaomics is focusing on expanding its research and development capabilities in the US and Asia to support market entry and regulatory approvals[7]. - The RNA therapeutics market, including RNAi, mRNA, and RNA editing technologies, is expected to experience rapid growth for treating and preventing serious diseases[7]. - The company is collaborating with RNAimmune to advance mRNA vaccine development and support early discovery and clinical project selection for EDIRNA[7]. - Sirnaomics has a strategic focus on clinical development, starting trials in the US before expanding to Asian countries and then seeking global regulatory approvals[7]. - The company has built an international professional team dedicated to exploring and developing RNAi therapies[7]. - Sirnaomics' dual delivery technology platforms, PNP and GalAhead™, are central to its strategy for expanding its therapeutic applications across various disease areas[7]. - The company has prioritized resources towards the development of STP705 and STP122G, while pausing or slowing down other projects due to global macroeconomic uncertainties[11]. - STP705 has shown promising results in clinical studies, with good data from 69 patients with isSCC and significant dose-dependent effects observed in 30 patients with BCC[12]. - The FDA has provided clear development pathways for STP705, including specific guidance on non-clinical and clinical studies, as well as modifications for proposed II/III and III phase clinical trials[12]. - STP705 demonstrated excellent safety and tolerability in early studies, with low incidence of local skin reactions (LSR) compared to deoxycholic acid (DCA) injections[13]. - STP707 is currently undergoing a Phase I clinical study designed to treat various types of solid tumors using a different proprietary nanoparticle carrier[14]. - The company is focusing on advancing its pipeline projects, particularly in oncology and metabolic diseases, while optimizing its management team to reflect strategic priorities[11]. - STP705 is being developed for both oncology and aesthetic applications, targeting TGF-ß1 and COX-2 pathways[12][13]. - The company has received written feedback from the FDA regarding the further development of STP705 for isSCC treatment, indicating a supportive regulatory environment[12]. - The company aims to leverage its proprietary PNP delivery platform for effective drug administration in various therapeutic areas[12]. - The ongoing clinical trials and research are expected to provide strong evidence for the efficacy and safety of STP705, potentially positioning it as a superior alternative to existing treatments[13]. - STP707 demonstrated good tolerability and significant therapeutic effects across all six dosing regimens in a clinical trial involving 50 patients with advanced solid tumors[15]. - In the completed Phase I clinical study for STP707, 11 pancreatic cancer patients showed a disease stabilization average of 92 days, with the 48 mg group achieving stabilization for up to 112 days[15]. - STP122G's Phase I clinical trial showed no dose-limiting toxicities or serious adverse events, with a follow-up period of 140 days indicating sustained pharmacological effects[17]. - RV-1770, an mRNA vaccine for RSV, has shown strong immune responses in preclinical studies and is currently preparing for IND application with the FDA[18]. - RV-1730, a booster candidate vaccine for SARS-CoV-2, has also received FDA IND approval and is undergoing clinical trials[19]. - STP355, targeting TGF-ß1 and VEGFR2, has shown significant tumor growth inhibition in preclinical models and is being prepared for IND studies[21]. - STP369, targeting BCL-xL and MCL-1, is under development for head and neck cancer and bladder cancer, with potential for combination therapy with cisplatin[22]. - The company is expanding its clinical trial scope for STP707 to address unmet medical needs in pancreatic cancer and other difficult-to-treat solid tumors[16]. - The ongoing research includes a range of innovative siRNA candidates utilizing proprietary delivery platforms, aiming for initial human clinical trials in multiple countries[20]. - The company is focused on advancing its pipeline of candidates to meet various therapeutic needs, particularly in oncology and infectious diseases[20]. - STP125G, targeting ApoC3, has shown dose-dependent silencing activity with a maximum effect at 10mg/kg lasting for 9 weeks in NHP studies[23]. - STP144G, targeting complement factor B, has completed GMP standard clinical testing drug development and single-dose non-clinical toxicology studies[24]. - STP136G, targeting angiotensinogen, has successfully completed efficacy studies in cell cultures and animal models[25]. - STP237G, targeting both AGT and ApoC3, is under development for hypertension and hypercholesterolemia, having completed efficacy studies[26]. - STP247G, targeting complement factor B and C5, has also completed efficacy studies in cell cultures and animal models[27]. - The new ODC formulation has demonstrated effective anti-tumor activity in various cancer cell lines and mouse models, significantly enhancing the efficacy of gemcitabine[28]. - The proprietary GalAhead™ delivery platform is designed for targeted subcutaneous delivery of siRNA drugs to liver cells, utilizing unique RNA structures[30]. - A joint venture with Gore Range, Sagesse Bio, will focus on innovative local fat reduction therapies, with potential milestone cash payments of up to $33 million[31]. - Sirnaomics has signed a material transfer agreement with a multinational company to evaluate PNP delivery technology for protein administration[32]. - The company has developed a clinical-scale GMP-compliant manufacturing process, utilizing microfluidic technology, to support its product pipeline[33]. - Sirnaomics aims to expand its cash flow through various measures, including seeking external funding via equity and debt financing[36]. - The company is advancing the clinical trials of its lead candidates STP705, STP707, and STP122G, with STP705 showing promising human clinical data for treating isSCC[36]. - STP707 has demonstrated safety and efficacy in intravenous administration, with plans to explore combination trials with approved cancer therapies[37]. - The Guangzhou factory, completed in 2021, has enhanced internal production capacity and supports clinical research for GalAhead™ products[33]. - Sirnaomics is focusing on RNA-based therapies for tumors, viral infections, liver metabolic diseases, and medical aesthetics, leveraging its proprietary technology platform[34]. - The company is undergoing significant restructuring to improve operational efficiency and increase cash reserves amid challenging macroeconomic conditions[35]. - Sirnaomics plans to complete the Phase I trial of STP122G by the end of 2025, having already completed 2 out of 5 sequences[37]. - The company is actively engaging in business development discussions with other multinational and domestic biopharmaceutical companies[32]. Financial Performance - The company recorded a loss of $43.5 million for the six months ended June 30, 2024, compared to a loss of $41.1 million for the same period in 2023, indicating a year-over-year increase in losses of approximately 5.8%[41]. - Other income decreased by 11% from $1.1 million for the six months ended June 30, 2023, to $1.0 million for the same period in 2024, primarily due to a significant drop in interest income from bank balances[43]. - The fair value loss on financial assets amounted to $18.1 million for the six months ended June 30, 2024, compared to a gain of $0.2 million for the same period in 2023, reflecting a substantial negative shift in investment performance[45]. - The fair value loss on financial liabilities increased by 215% to $1.4 million for the six months ended June 30, 2024, from $0.4 million in the prior year, primarily due to an increase in the valuation of RNAimmune preferred shares[46]. - Administrative expenses decreased by 6% from $10.8 million for the six months ended June 30, 2023, to $10.2 million for the same period in 2024, with notable reductions in director remuneration and employee costs[47]. - The company aims to commercialize its core product STP705 for the treatment of isSCC, with a new drug application anticipated as early as 2027, subject to FDA review and funding availability[39]. - The company is actively seeking collaborative opportunities to enhance the development of its clinical and preclinical assets, including STP705 and STP707, with significant interest from multiple pharmaceutical companies[38]. - The company has successfully established a licensing agreement for RV-1770 through its subsidiary RNAimmune, and a transaction with Gore Range has been approved by the board[38]. - The company has received numerous proposals for future collaborations, including interest from a major domestic pharmaceutical company in mainland China[38]. - The company has not generated any product sales revenue for the six months ended June 30, 2024[41]. - For the six months ended June 30, 2024, the group's administrative expenses decreased by $0.6 million or 6% to $10.2 million compared to $10.8 million for the same period in 2023[48]. - Research and development expenses for the six months ended June 30, 2024, decreased by $16.4 million or 54% to $14.3 million from $30.7 million for the same period in 2023, primarily due to reductions in chemical, production, and control expenses, clinical trial expenses, and toxicology research expenses[50]. - The group recorded other expenses of $7,000 for the six months ended June 30, 2024, compared to $150,000 for the same period in 2023[51]. - Financial costs, specifically lease liability interest, increased by $0.1 million or 18% to $0.5 million for the six months ended June 30, 2024, from $0.4 million for the same period in 2023[52]. - The group's loss for the six months ended June 30, 2024, increased to $43.5 million from $41.1 million for the same period in 2023, mainly due to fair value losses on financial assets[53]. - Net cash used in operating activities decreased by $22.9 million or 60% to $15.4 million for the six months ended June 30, 2024, compared to $38.3 million for the same period in 2023[55]. - Cash and cash equivalents decreased from $23.9 million as of December 31, 2023, to $7.7 million as of June 30, 2024, primarily due to research and development activities and general corporate expenses[56]. - The current ratio as of June 30, 2024, was 48.5%, down from 134.5% as of December 31, 2023[57]. - The group had bank borrowings of $0.4 million as of June 30, 2024, with no undrawn bank financing[56]. - The group's total current assets were $21.6 million, while current liabilities amounted to $44.6 million as of June 30, 2024[56]. - The group made independent investments totaling $15 million and $5 million in 2022 and 2023, respectively, aimed at enhancing returns through idle cash utilization[58]. - As of June 30, 2024, the capital account balance of the independent investment portfolio was reported at $1,935,000, representing 5.6% of the group's total assets[59]. - The group recorded a fair value loss of $18,108,000 on financial assets measured at fair value through profit or loss for the six months ended June 30, 2024[59]. - The group has not engaged in any significant acquisitions or disposals of subsidiaries, associates, or joint ventures during the six months ended June 30, 2024[60]. - The total employee compensation cost for the six months ended June 30, 2024, was $8.5 million, down from $11.9 million for the same period in 2023[62]. - The group had a total of 90 employees as of June 30, 2024, with 34 in research and 9 in management[62]. - The group currently has no significant plans for future investments or capital assets beyond what is disclosed in the interim report[60]. - The group faces low foreign exchange risk as most expenses are denominated in USD, matching the majority of its deposits[61]. - The investigation into the potential default of a private debt issuer is ongoing, with the first report expected by September 2024[59]. - The group has adopted various incentive plans to attract and retain talent, including a pre-IPO share option plan[63]. - The board's compensation committee has full authority to manage the pre-IPO equity incentive plan, including interpreting its provisions and making necessary decisions[65]. - A total of 12,770,000 shares are reserved for issuance under the pre-IPO equity incentive plan[68]. - The compensation committee can determine the type and number of rewards granted to participants under the pre-IPO equity incentive plan[67]. - If rewards expire or are canceled without issuing shares or paying cash, the related shares can be reused for new rewards[69]. - The exercise price for incentive stock options must be at least 110% of the fair market value of the shares on the grant date for 10% owners[70]. - The vesting schedule for stock options typically includes a 25% vesting after one year, followed by monthly vesting over the next 36 months[70]. - The terms for stock appreciation rights include a requirement that the grant price must not be less than the fair market value of the shares on the grant date[71]. - The compensation committee must determine the terms for restricted stock awards, including the number of shares and any conditions for forfeiture[72]. - The company can grant stock options, stock appreciation rights, or restricted shares as part of the pre-IPO equity incentive plan[66]. - The compensation committee has the discretion to grant rewards to participants without requiring them to receive rewards in subsequent years[67]. - The company reported a total of 10,824,345 shares outstanding as of the latest financial period[74]. - The company has a stock option plan with a vesting schedule of 12/48, meaning options vest monthly over four years[75]. - The restricted stock unit plan was adopted on April 22, 2022, and is effective for a period of 10 years[76]. - The purpose of the restricted stock unit plan is to recognize contributions from eligible participants and align their interests with shareholders[77]. - The company aims to attract suitable talent for further development through the restricted stock unit plan[77]. - The stock options granted prior to the IPO will vest upon the achievement of specific research and development milestones[75]. - David Mark Evans, Ph.D., will resign as an executive director after the annual general meeting on June 20, 2024[75]. - The company has granted stock options totaling 1,134,700 and 111,045 shares in the latest batch[74]. - The company aims to maximize its value through the alignment of interests between eligible participants and shareholders[77]. - The stock options are set to vest monthly, with the first anniversary of the grant date marking the initial vesting date[75]. - The board has the exclusive authority to interpret and determine the terms of the restricted share unit plan, including the allocation of rewards to senior and junior participants[79]. - Eligible participants for the restricted share unit plan include employees, management, and consultants who contribute to the group's growth[80]. - The board and senior management have discretion to grant rewards under the restricted share unit plan, which may vary based on selected eligible participants[81]. - 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 plan's adoption date, with an annual limit of 3% unless otherwise approved by shareholders[82]. - Any shares forfeited or expired under the plan will not be returned for future issuance unless permitted by the plan[83]. - The maximum number of shares that can be awarded to any single eligible participant is limited to 1% of the issued shares as of the plan's adoption date[84]. - Rewards granted under the plan are subject to performance milestones or conditions, and unachieved conditions will result in automatic forfeiture[85]. - The company will facilitate the transfer of shares to participants or provide cash equivalent to the market value of the shares upon vesting[86]. - The company reported a total of 422,484 restricted share units granted, with an average closing price of HKD 57.8 per share prior to the grant date[88]. - The fair value of the restricted share units granted in the first batch was approximately USD 6.82 to USD 7.50 each[88]. - A total of 8,904,023 restricted share units can be granted under the plan, with 9.22% of the issued shares available for further grants[88]. - The company plans to issue a 2023 annual report on April 29, 2024, covering the year ending December 31, 2023[89]. - The company has a total of 8,081,273 restricted share units available for issuance under the plan as of the report date[88]. - The first batch of restricted share units will vest 50% on the first and second anniversaries of the grant date[88]. - The second batch of restricted share units will vest 25% on the first, second, third, and fourth anniversaries of the grant date[88]. - The company anticipates the expiration of the annual authorization for the issuance of new shares on June 30, 2024[88]. - The total compensation for the five highest-paid individuals (excluding directors) was reported at HKD 22,000 for the first batch and HKD 9,075 for the second batch[88]. - David Mark Evans, an executive director, will resign after the annual general meeting on June 20, 2024[89]. - The total number of restricted share units granted under the plan is 8,081,273, accounting for approximately 9.22% of the issued shares[93]. - A total of 339,000 restricted share units were conditionally granted to related participants on November 24, 2022, which was approved by independent shareholders on February 3, 2023[91]. - The fair value of each restricted share unit granted in the first and second batches is approximately between $6.82 and

Clinical Development and Pipeline - Sirnaomics reported significant progress in its clinical pipeline, focusing on STP705 and STP122G, while suspending or slowing down other projects due to global economic uncertainties[8]. - The company is advancing four clinical trials in North America for its key candidates STP705, STP707, and STP122G, alongside mRNA vaccine projects RV-1730 and RV-1770, which are currently in Phase I trials[5]. - The proprietary PNP delivery platform has shown potential in clinical trials for non-melanoma skin cancer (NMSC) and solid tumors, reinforcing Sirnaomics' leadership in RNAi therapies for cancer treatment[3]. - The GalAhead™ delivery platform is being explored for subcutaneous administration, with the first product STP122G currently in Phase I clinical research targeting anticoagulant and thrombotic diseases[4]. - The clinical pipeline includes candidates targeting various diseases, such as STP705 for basal cell carcinoma and STP122G for high cholesterol, with a global commercialization strategy[6]. - STP705 demonstrated good safety and efficacy in treating 69 patients with isSCC and 30 patients with BCC, showing a clear dose-dependent therapeutic effect[9]. - In a Phase I clinical study of STP707, 50 patients with advanced solid tumors were treated, with doses ranging from 3 mg to 48 mg, showing good tolerability and stable disease activity[12]. - The average duration of stable disease for 11 pancreatic cancer patients treated with STP707 was 92 days, with one patient achieving stability for 281 days[12]. - STP122G's Phase I clinical trial showed no dose-limiting toxicities or serious adverse events, indicating its potential as an ideal anticoagulant[14]. - The clinical data for STP122G demonstrated dose-dependent target silencing activity, supporting its development as a therapeutic anticoagulant[14]. - STP705 showed excellent safety and tolerability in local fat reduction studies, with low incidence of local skin reactions compared to DCA[10]. - STP707's unique ability to recruit active T cells into the tumor microenvironment suggests potential for further studies in combination with immune checkpoint inhibitors[13]. - The company is exploring the potential of STP707 to address unmet medical needs in difficult-to-treat solid tumors like pancreatic cancer[13]. - STP705's local administration demonstrated significant efficacy in reducing subcutaneous fat tissue thickness in preliminary studies[10]. Financial Performance and Position - The company recorded a loss of $43.5 million for the six months ended June 30, 2024, compared to a loss of $41.1 million for the same period in 2023, indicating an increase in losses of approximately 5.8%[39]. - There were no product sales revenue generated during the six months ended June 30, 2024[40]. - The company reported other income of $984,000 for the six months ended June 30, 2024, down from $1.1 million in the same period in 2023[38]. - Research and development expenses decreased to $14.3 million for the six months ended June 30, 2024, from $30.7 million in the same period in 2023, reflecting a reduction of approximately 53.4%[38]. - The company reported a net loss of $43.493 million and a net cash outflow from operating activities of $15.365 million for the six months ended June 30, 2024[77]. - As of June 30, 2024, the company's cash and cash equivalents decreased from $23.9 million on December 31, 2023, to $7.7 million, primarily due to R&D activities and general corporate expenses[53]. - The current ratio dropped significantly from 134.5% on December 31, 2023, to 48.5% on June 30, 2024, indicating a decline in liquidity[54]. - The company reported a fair value loss of $18.1 million on financial assets measured at fair value through profit or loss for the six months ended June 30, 2024[56]. - As of June 30, 2024, the company's total current assets were $21.6 million, while total current liabilities amounted to $44.6 million, resulting in a negative net asset value of $17.8 million[53]. - The company has a net current liability of $22.972 million and a net liability of $17.829 million as of June 30, 2024[77]. - The company is actively seeking external financing through equity and debt to supplement its cash reserves[78]. - The company is exploring business development opportunities for pipeline assets to enhance its financial position[78]. Strategic Focus and Restructuring - Sirnaomics is focusing its resources on high-potential projects, particularly STP705 and STP122G, while optimizing its workforce and management team to align with its strategic development goals[8]. - A comprehensive restructuring plan has been implemented to enhance operational efficiency and align resources with strategic goals, including targeted cost-saving measures[32]. - The restructuring includes salary reductions for selected senior and mid-level management and streamlining various office functions to improve flexibility in uncertain market conditions[32]. - The company is actively managing costs and optimizing operations to navigate current economic challenges and position itself for long-term success[32]. - The company aims to expand its competitive advantage by focusing on innovative RNAi therapies for tumors, viral infections, liver metabolic diseases, and medical aesthetics[31]. Partnerships and Collaborations - The company is actively exploring global and local partnerships to enhance the development of its key products STP705 and STP707[35]. - The company has received significant interest from multiple pharmaceutical companies regarding its product pipeline, including potential collaborations with a major domestic pharmaceutical company from mainland China[36]. - The company is seeking to maximize its potential through selective collaborations and partnerships, particularly for its proprietary PNP delivery platform[35]. - A joint venture with Gore Range, Sagesse Bio, is proposed to accelerate clinical development of RNAi-based local fat reduction therapies, with potential milestone cash payments of up to $33 million[28]. - The company has signed a material transfer agreement with a multinational company to evaluate PNP delivery technology for protein delivery[29]. Research and Development Initiatives - The company is evaluating multiple innovative siRNA candidates using proprietary delivery platforms, with potential candidates expected to enter clinical trials[17]. - STP355 targets TGF-ß1 and VEGFR2, showing significant tumor growth inhibition in preclinical models, with a p-value of <0.05 compared to control[18]. - STP369 targets BCL-xL and MCL-1 for head and neck cancer and bladder cancer treatment, exploring combination therapy with cisplatin[19]. - STP125G, targeting ApoC3, has shown dose-dependent silencing activity in non-human primate studies, with a maximum silencing effect at 10 mg/kg lasting for 9 weeks[20]. - STP144G and STP136G are in further development for complement-mediated immune diseases and hypertension, respectively, after successful preclinical efficacy studies[21][22]. - STP247G targets CFB and C5 for immune diseases, having completed successful preclinical efficacy studies[24]. - The company announced significant progress on its new oligonucleotide-drug conjugate (ODC) formulation, demonstrating effective anti-tumor activity in various cancer models[25]. - The proprietary RNA-based delivery platform is foundational for the company's clinical pipeline, focusing on PNP delivery for RNAi therapies targeting various liver cell types[26]. - The GalAhead™ delivery platform, developed by Sirnaomics, utilizes unique RNA structures to silence multiple mRNA targets, demonstrating specific liver cell targeting through ASGPR[27]. Market and Growth Outlook - The company anticipates rapid growth in RNA therapies, including RNAi, mRNA, and RNA editing technologies, to treat and prevent various serious diseases[4]. - RV-1770 is an advanced mRNA therapy vaccine developed by RNAimmune, aimed at preventing RSV infections in adults, showing strong immune response in preclinical studies[15]. - RV-1730, another mRNA-based vaccine for SARS-CoV-2, has received FDA IND approval and is currently in clinical trials, enhancing RNAimmune's technical platform[16]. - The company plans to allocate the remaining net proceeds from the global offering for the development and commercialization of its products, including STP705 and STP707, as well as other clinical candidates[64]. - The company is investing $100 million in new technology development aimed at improving product delivery systems[116]. - The company is expanding its market presence in Asia, targeting a 15% market share by the end of the next fiscal year[118].

Clinical Development - In 2023, Sirnaomics submitted clinical data for STP705 to the FDA for Phase IIa and IIb trials, preparing for late-stage clinical research[9]. - The Phase I clinical study of STP707 involved 50 patients with advanced cancers, demonstrating strong safety and significant clinical efficacy[9]. - The company has made significant progress in advancing STP122G to Phase I clinical trials and expanding its pipeline to include treatments for complement diseases, hypertension, and elevated triglyceride levels[9]. - The clinical advancements of STP705 and STP707 validate the proprietary PNP delivery platform's effectiveness in both intradermal and intravenous applications[9]. - The company is advancing its lead clinical candidates STP705 and STP707, with STP705 moving towards a pivotal II/III trial design after FDA guidance[14]. - STP707 has shown promising results in a Phase I basket trial, with a median stable disease duration of 4.5 months in the high-dose group for pancreatic cancer patients[14]. - STP705 is a sterile lyophilized drug targeting TGF-β1 and COX-2, currently under development for non-melanoma skin cancer (NMSC) and localized fat reduction[22]. - Early data indicates that STP705 shows good tolerability and efficacy in reducing subcutaneous fat thickness in preliminary pig models, comparable to deoxycholic acid (DCA) injections[23]. - STP707, a sterile lyophilized drug, is in a Phase I clinical study for various solid tumors, showing significant treatment effects, particularly in pancreatic cancer patients with an average stable disease (SD) duration of 4.5 months in the high-dose group[24]. - The clinical study for STP707 includes 50 patients across 11 leading cancer centers in the U.S., focusing on advanced cancers such as colorectal and pancreatic cancer[24]. - The company emphasizes the importance of further research for STP707, either as a standalone treatment or in combination with immune checkpoint inhibitors[24]. - The Phase II clinical trial for STP705 in treating BCC has been completed, demonstrating ideal efficacy without serious adverse events, indicating significant potential for non-melanoma skin cancer treatment[44]. - STP705 has shown positive results in a Phase I trial for local fat reduction, with significant efficacy and excellent safety profile observed across all dosage groups[45]. - STP707 clinical trial completed dose escalation with 50 patients, showing 74% of evaluable patients had stable disease[47]. - STP122G Phase I trial completed with no dose-limiting toxicities or serious adverse events reported, leading to progression to the second dosing sequence[49]. Financial Performance - Total revenue for 2023 was $1,414,000, compared to $2,114,000 in 2022, reflecting a decrease of 33%[13]. - Research and development expenses decreased to $54,382,000 in 2023 from $67,641,000 in 2022, a reduction of approximately 19%[13]. - The company reported a net loss of $84,990,000 in 2023, an improvement from a net loss of $97,378,000 in 2022, indicating a decrease in losses of about 8%[13]. - Non-current assets totaled $17,069,000 in 2023, down from $46,682,000 in 2022, representing a decline of approximately 63%[13]. - Current assets decreased significantly to $58,718,000 in 2023 from $117,249,000 in 2022, a drop of about 50%[13]. - The company reported a net loss of $85.0 million for the year ended December 31, 2023, down from a net loss of $97.4 million for the year ended December 31, 2022[86]. - Other income decreased to $1.41 million in 2023, down 33% from $2.11 million in 2022, primarily due to a reduction in interest income and government grants[73]. - The company achieved a significant turnaround in other gains and losses, reporting a gain of $1.91 million in 2023 compared to a loss of $0.29 million in 2022, mainly due to lease termination gains[74]. - The fair value change of financial liabilities recorded a loss of $1.51 million in 2023, a reduction of 75% from $6.12 million in 2022, attributed to a decrease in the valuation of RNAimmune preferred shares[75]. - The company reported a net cash outflow from operating activities, highlighting ongoing financial challenges[126]. - The company has recorded a net cash outflow from operating activities, indicating a continued need for additional financing to support business operations[126]. Strategic Initiatives - A comprehensive restructuring plan has been initiated to enhance operational efficiency, strengthen competitive position, and drive long-term growth[9]. - The restructuring includes organizational adjustments, portfolio optimization, and cost rationalization to streamline operations and focus resources on core strategic priorities[9]. - Sirnaomics aims to accelerate the development and commercialization of novel therapies in key therapeutic areas through strategic partnerships and rigorous execution[10]. - The company is committed to prudent capital allocation, strategic investments, and strict financial management to enhance shareholder value[10]. - The company is exploring potential partnerships and commercialization plans for STP705 as it prepares for upcoming clinical studies[61]. - Sirnaomics anticipates funding for STP705 trials through existing financial resources, new capital from markets, and collaborations[61]. - The company is expanding its clinical trial capabilities to support future clinical needs through its GalAhead™ platform[54]. - The company is actively seeking collaboration opportunities to maximize the potential of its clinical candidates, particularly STP705 and STP707[67]. - The company is expanding its market presence through strategic partnerships and collaborations in the biotechnology sector[103]. Research and Development - The company is focusing on expanding its clinical development strategy in the US and Asia, aiming for regulatory approvals in multiple global markets[17]. - RNA therapies, including RNAi and mRNA, are expected to grow rapidly, with the company supporting mRNA vaccine development through its subsidiary RNAimmune[18]. - The company is evaluating multiple innovative siRNA candidates using proprietary PNP and GalAhead™ delivery platforms, with plans to enter clinical trials for several candidates[29]. - The company is advancing its RNA innovation pipeline to develop new RNAi therapies for tumors, viral infections, liver metabolic diseases, and medical aesthetics[59]. - The company is committed to exploring and developing innovative drugs for treatment[117]. Governance and Management - The company has established a comprehensive intellectual property portfolio covering PNP-based RNA drug products for cancer and fibrotic diseases[38]. - The company has a strong board with members possessing over 40 years of experience in biotechnology and public health, enhancing strategic decision-making[100]. - The board includes independent directors with significant scientific and operational expertise, contributing to governance and oversight[103]. - The company has received annual confirmations of independence from its independent non-executive directors, affirming their status[121]. - The management team has a diverse background in investment management and biotechnology, which supports the company's strategic initiatives[100]. - The company appointed Dr. Francois Lebel as Chief Medical Officer in December 2023, enhancing its drug development capabilities with his extensive experience in immuno-oncology and nucleic acid therapies[57]. Market Presence and Future Outlook - The company is expanding its market presence in the Asia-Pacific region, targeting a market share increase of EE% by the end of the next fiscal year[109]. - The company plans to file IND applications for STP125G and STP144G in the U.S. by 2025[53]. - The company aims to commercialize its core product STP705 for treating isSCC, with a new drug application anticipated by 2027, subject to FDA review and funding availability[68]. - The company provided guidance for the next fiscal year, projecting revenue growth of BB% and aiming for a total revenue of $CC million[107]. - New product launches are expected to contribute an additional $DD million in revenue, with a focus on innovative technologies in the upcoming quarters[108]. Risks and Challenges - The company faces significant risks related to the successful development and commercialization of its clinical and preclinical candidates, which could adversely affect its business and competitive position[123]. - Regulatory approval processes for biopharmaceutical products are lengthy and costly, with potential negative impacts on the company's reputation and financial performance if not adhered to[125]. - The company relies on third-party collaborations for drug development, which may pose risks if those parties fail to meet contractual obligations[129]. - The company has faced significant supply chain risks, including reliance on stable and quality raw materials and potential disruptions from international trade policies[126]. - Changes in government policies or regulations in China could adversely affect the company's operations and growth strategies[132].

Clinical Trials and Drug Development - Sirnaomics Ltd. reported that the STP705 clinical trial for treating isSCC is progressing, with plans for a II/III phase trial in 2024 following discussions with the FDA[4]. - The II phase clinical study for treating BCC with STP705 was fully completed in 2023, showing ideal efficacy without any severe adverse events[5]. - STP705 demonstrated good safety and efficacy in a phase I trial for local fat reduction, with a significant effect observed at a dosage of 240 μg/1.0ml[6]. - The STP707 clinical trial for advanced solid tumors showed a disease stabilization duration of 4.5 months in pancreatic cancer patients, indicating a dose-response relationship[6]. - The STP122G phase I clinical trial for anticoagulation treatment was completed with no dose-limiting toxicities or serious adverse events, leading to further dosing sequences[7]. - The clinical data from STP705 and STP707 supports the potential for these drugs to become leading candidates in their respective therapeutic areas[6]. - The company plans to submit IND applications for STP125G and STP144G in the U.S. by 2025, based on progress in efficacy and toxicity evaluations[8]. - The RV-1770 mRNA vaccine clinical trial has received FDA approval, with plans to recruit 162 participants for safety and immunogenicity assessments[8]. - STP707 has shown good tolerability and significant therapeutic effects in a Phase I trial involving 50 patients with advanced cancers, particularly pancreatic cancer[14]. - The company is preparing to advance the STP705 clinical project to Phase II trials, following guidance from the FDA after a Phase II meeting[13]. - STP705 is being developed for non-melanoma skin cancer (NMSC) and local fat reduction, utilizing a proprietary PNP delivery platform, showing good tolerability and safety in early studies[19][20]. - STP707 is currently in a Phase I clinical study for various solid tumors, demonstrating significant treatment effects, particularly in pancreatic cancer patients, with an average stable disease (SD) duration of 3.5 months[21]. - The 48mg high-dose treatment group of STP707 showed an average SD duration of 4.5 months, indicating a dose-response relationship[21]. - The Phase I trial of STP122G for anticoagulation therapy showed no dose-limiting toxicities or serious adverse events, indicating its potential as an ideal anticoagulant[42]. - The Phase I trial of STP705 was completed in Q4 2023, showing excellent tolerability and minimal local skin reactions across all doses[39]. - The mid-term data from the STP705 clinical trial for abdominal liposuction patients indicated no systemic adverse events and positive histological evidence of fat remodeling[54]. - The company plans to begin Phase II studies for STP705 in 2024, contingent on available financial resources[54]. - The clinical team plans to initiate global multi-center trials for NMSC and various solid tumors, leveraging diverse patient populations in the US and Asia[52]. Financial Performance - The company reported a net loss of $84.99 million for the year ended December 31, 2023, a decrease of 12.3% from a net loss of $97.38 million for the year ended December 31, 2022[9]. - Research and development expenses decreased to $54.38 million in 2023, down 19.5% from $67.64 million in 2022[9]. - Administrative expenses were reduced to $23.16 million, a decrease of 4% compared to $24.19 million in the previous year, primarily due to cost-saving strategies in marketing and business development[11]. - The company recognized impairment losses of $8.34 million on property, plant, and equipment, with $6.9 million and $1.4 million attributed to specific assets[9][11]. - The company reported a net loss of $84,990,000 for the year ended December 31, 2023, compared to a net loss of $97,378,000 in 2022, representing a 12.4% improvement[93]. - Operating cash outflow for the year was $70,292,000, indicating ongoing liquidity challenges[91]. - Cash and cash equivalents decreased to $23,884,000 from $105,229,000 in the previous year, a decline of approximately 77.3%[96]. - Total assets less current liabilities amounted to $62,774,000, down from $149,704,000 in 2022, reflecting a significant reduction in financial stability[96]. - The company’s total comprehensive loss for the year was $85,221,000, compared to $99,228,000 in 2022, indicating a 14.1% reduction in overall losses[94]. - The company’s equity attributable to owners decreased to $40,196,000 from $122,006,000 in 2022, a drop of 67.0%[99]. - The independent auditor issued an unqualified opinion on the financial statements, with a note on significant uncertainties regarding the company's ability to continue as a going concern[88]. - The company is actively implementing plans to improve cash flow and liquidity, including restructuring measures and seeking external financing[91]. - The company recorded a loss of $84.99 million for the year ended December 31, 2023, compared to a loss of $88.71 million in 2022, indicating an improvement in financial performance[101]. - Operating cash outflow for the year was $70.29 million, a decrease from $88.71 million in the previous year, reflecting efforts to improve cash flow management[101]. - Cash and cash equivalents at the end of the year were $23.88 million, down from $105.23 million at the beginning of the year, showing a significant reduction in liquidity[101]. - The company is implementing a restructuring plan aimed at simplifying its organizational structure and improving operational efficiency to reduce cash outflows[102]. - The company is preparing cash flow forecasts covering a 21-month period ending September 30, 2025, to assess future funding needs[102]. Research and Development Focus - Sirnaomics is expanding its drug development pipeline to include treatments for a range of diseases using its proprietary GalAhead™ technology[4]. - The company aims to address unmet needs in anticoagulation therapy, targeting conditions such as atrial fibrillation and deep vein thrombosis[7]. - Sirnaomics is focusing on enhancing its RNAi platform to improve treatment outcomes in various medical fields, including oncology and metabolic diseases[4]. - The GalAhead™ delivery platform is being explored for applications in various therapeutic areas, including hypercholesterolemia and complement-mediated diseases[15]. - The company aims to leverage its RNA delivery technology to support the development of mRNA vaccines and early discovery projects in collaboration with RNAimmune[15]. - The company is focusing on expanding its clinical pipeline with a total of 12 candidates across various therapeutic areas, including oncology and metabolic diseases[17]. - The product pipeline includes candidates targeting various conditions, such as STP355 for multiple myeloma and STP146G for metabolic diseases, indicating a broad therapeutic focus[17]. - The company is advancing its RNA innovation pipeline to develop new RNAi therapies for tumors, viral infections, liver metabolic diseases, and medical aesthetics, supported by a strong management team and established R&D facilities[50]. - The company is committed to adhering to GLP and GMP standards to ensure product quality and regulatory compliance[129]. - The company is exploring new therapeutic combinations, including the use of PD-L1 and PCSK9 inhibitors[131]. - The company is focused on preclinical research to gather efficacy, toxicity, pharmacokinetics, and safety data before moving to clinical trials[133]. - The company is committed to advancing its pipeline through strategic clinical trials and research initiatives[134]. Corporate Governance and Management - The company appointed Dr. Francois Lebel as Chief Medical Officer in July 2023, enhancing its capability to advance late-stage drug development[49]. - The board of directors includes key executives and independent directors, ensuring a diverse leadership team[134]. - The audit committee consists of one non-executive director and two independent non-executive directors, overseeing financial reporting and risk management[82]. - The company has adopted a code of conduct for securities trading, ensuring compliance among all directors and relevant employees[79]. - The company has not identified any violations of the standard code by directors or relevant employees as of December 31, 2023[79]. Manufacturing and Production Capabilities - The company has developed a GMP-compliant manufacturing process for PNP, which is scalable for commercial production, utilizing microfluidic technology[34]. - The Guangzhou facility, completed in 2021, has enhanced internal production capabilities and supported early clinical studies for the PNP product line[34]. - The Guangzhou factory has been operational for over two years, with an expected annual production capacity of approximately 50,000 vials of freeze-dried solid dosage forms and 150,000 to 200,000 vials of liquid formulations to support clinical trials and future developments[46]. - The Guangzhou factory has expanded its filling line capacity to support the GalAhead™ platform, enhancing clinical trial capabilities[46]. Strategic Partnerships and Collaborations - The company is actively seeking collaboration opportunities to maximize the potential of its clinical candidates, particularly STP705 and STP707[55]. - RNAimmune, a non-wholly owned subsidiary, is seeking equity and alternative financing to support its operations without relying on additional funding from the group[101]. - The company is exploring potential partnerships and commercialization plans for STP705 to prepare for market approval[52].

智通财经APP讯，圣诺医药-B(02257)发布公告，该公司董事会得悉最近公司股份的股价不寻常波动。经 作出有关公司于合理情况下的查询后，董事会确认，其并不知悉导致股价波动的任何原因，或任何必须 公布以避免公司证券出现虚假市场的资料，又或根据香港法例第571章证券及期货条例第XIVA部须予披 露的任何内幕消息。 董事会确认集团业务营运及公司核心产品研发并无重大不利变动。管理团队对集团的长期发展前景仍充 满信心。 ...

智通财经APP获悉，圣诺医药-B(02257)跌超26%，低见12.4港元创上市以来新低。截至发稿，跌 24.53%，报12.74港元，成交额2028.51万港元。 消息面上，圣诺医药去年12月宣布，子公司RNAimmune针对人类呼吸道合胞病毒（RSV）的创新型 mRNA疫苗RV-1770临床试验申请（IND）已获得美国食品药品管理局（FDA）批准，拟开展一期临床 研究试验。 公司2023年中期业绩显示，截至2023年上半年，公司账上现金及现金等价物仅有5729.9万美元，同比减 少66.23%。也就是说，以上半年公司净亏损4110.6万美元计算，账上现金仅够圣诺医药烧半年。此外， 从圣诺医药披露的2023年中期业绩可以看到，由于目前公司仍无一款已商业化产品，2019年至2023年上 半年的销售收入均为零。 ...

Clinical Development - Sirnaomics is advancing its RNAi therapeutic pipeline, focusing on STP705 and STP707, with positive clinical data for non-melanoma skin cancer (NMSC) and solid tumors[14]. - The company has initiated a Phase I clinical study for STP705 in aesthetic medicine, showing excellent safety and efficacy in preliminary results[14]. - Sirnaomics' GalAhead™ platform has received FDA regulatory approval for its first product, STP122G, which is currently in Phase I clinical trials[14]. - The company is expanding its clinical development strategy, starting trials in the US before moving to Asian markets and seeking global regulatory approvals[15]. - Sirnaomics is conducting four clinical trials for its priority product pipeline, including STP705, STP707, and STP122G, alongside RNAimmune's mRNA vaccine project RV-1730[17]. - Sirnaomics has completed a Phase II meeting with the FDA for STP705, advancing its clinical development for isSCC[14]. - The company is exploring the potential of siRNA candidates in aesthetic medicine, with ongoing discussions for potential collaborations[14]. - STP705 and STP707 are in clinical trials targeting TGF-ß1 and COX-2 for various cancers, with STP707 currently in a Phase I study for multiple solid tumors[19][20]. - STP122G, targeting factor XI, is in Phase I clinical trials and aims to provide anticoagulant therapy for conditions like atrial fibrillation and deep vein thrombosis[21]. - STP125G, targeting ApoC3, is set to submit an IND application to the FDA in Q4 2023 for treating rare lipid metabolism disorders[25]. - STP144G, targeting complement factor B, is planned for IND submission in H1 2024, focusing on complement-mediated immune diseases[26]. - RV-1730, a candidate vaccine for SARS-CoV-2, has received FDA approval for IND and is currently undergoing clinical research[27]. - The company has achieved optimal dosing for BCC and is preparing for late-stage trials following FDA guidance[18]. - The company is developing STP707 in combination with immune checkpoint inhibitors for enhanced treatment efficacy[20]. - The company is preparing to commercialize STP705 for isSCC treatment, with plans to advance to pivotal clinical trials following positive Phase II results discussed with the FDA[47]. - The company plans to leverage data from the STP705 study to expand into other areas of non-invasive fat remodeling treatments, with completion expected in the second half of 2023[35]. - STP707 clinical trial involved 50 patients with advanced solid tumors, showing 74% of evaluable patients had stable disease (SD) as the best response[36]. - The company aims to commercialize its core product STP705 for treating isSCC, with a potential new drug application by 2025, subject to FDA review and funding availability[51]. - The company anticipates that the STP705 Phase III clinical trial will begin by the end of 2023, with a well-designed optimal dose study[51]. Financial Performance - The company recorded a loss of $41.1 million for the six months ended June 30, 2023, compared to a loss of $46.1 million for the same period in 2022, reflecting an improvement of 6.5%[53]. - Other income increased by $0.2 million or 28% to $1.1 million for the six months ended June 30, 2023, primarily due to interest income from restricted bank balances[55]. - The company had no product sales revenue for the six months ended June 30, 2023[53]. - R&D expenses decreased by $1.4 million or 4% to $30.7 million for the six months ended June 30, 2023, compared to $32.1 million in the same period in 2022[60]. - Administrative expenses decreased by $0.3 million or 3% to $10.8 million for the six months ended June 30, 2023, compared to $11.1 million in the same period in 2022[59]. - The fair value change of financial liabilities recorded a loss of $0.4 million for the six months ended June 30, 2023, a significant decrease of 85% from a loss of $2.9 million in the same period in 2022[57]. - Clinical trial expenses increased by 19% to $4.2 million for the six months ended June 30, 2023, compared to $3.5 million in the same period in 2022[60]. - The net loss for the six months ended June 30, 2023, decreased to $41.1 million from $46.1 million for the same period in 2022, attributed to reduced R&D expenses and lower fair value losses on financial liabilities[64]. - Net cash used in operating activities decreased by $7.1 million or 16% to $38.3 million for the six months ended June 30, 2023, compared to $45.4 million for the same period in 2022[65]. - Net cash used in investing activities decreased by $3.5 million or 38% to $5.6 million for the six months ended June 30, 2023, from $9.1 million for the same period in 2022[66]. - The company reported a total of 11,553,762 shares granted with an average exercise price of $2.35[110]. - The company reported a total of 200,000 shares granted at an exercise price of $1.75, with no cancellations[110]. - The company has a total of 600,000 shares granted at an exercise price of $1.75, with 573,000 shares remaining after cancellations[110]. - The company has a total of USD 15.8 million remaining from the net proceeds, which will be utilized based on actual business needs[153]. - Total revenue for the six months ended June 30, 2023, was $1,102,000, compared to $858,000 for the same period in 2022, representing a 28.5% increase[167]. - The basic and diluted loss per share for the six months ended June 30, 2023, was $0.50, compared to $0.55 for the same period in 2022, showing a decrease of 9.1%[167]. - The company reported other comprehensive expenses totaling $468,000 for the six months ended June 30, 2023, compared to $1,061,000 for the same period in 2022, a reduction of 56.0%[167]. - The company’s equity attributable to owners was $82,448,000 as of June 30, 2023, down from $122,006,000 as of December 31, 2022, reflecting a decline of 32.4%[168]. Research and Development - The company is focusing on the late-stage development of RNAi innovative candidate drugs, which will be led by Dr. Lebel[91]. - The company is actively expanding its clinical projects and enhancing its research capabilities in RNAi-based therapies[76]. - The company is focused on the development and commercialization of RNA interference (RNAi) technologies and various therapies, indicating ongoing investment in research and development[175]. - Research and development expenses included outsourced service fees of $17,272 thousand for the first half of 2023, slightly down from $18,164 thousand in the same period of 2022[195]. - Employee costs totaled $11,904 thousand for the six months ended June 30, 2023, compared to $10,150 thousand for the same period in 2022, reflecting an increase of approximately 17.3%[195]. Governance and Management - The company has established a robust governance structure with various committees, including the Remuneration Committee chaired by Ms. Huang Mengying[87]. - The company is focused on maintaining high standards of corporate governance and compliance, as evidenced by the qualifications and roles of its board members[89]. - The management team includes Dr. Wang Yongxiang as Chief Manufacturing Officer, who has a background in biopharmaceutical development and has held senior positions in various organizations[90]. - The company has a strong board of independent directors, including Ms. Sheng Mu-Hsien, who serves as the Chair of the Audit Committee and has extensive experience in finance and governance[89]. - The company is actively involved in strategic decision-making through its board, which includes independent directors with diverse backgrounds in law, finance, and healthcare[88]. - The company has adopted pre-IPO equity incentive plans to motivate eligible employees[75]. - The company emphasizes attracting and retaining outstanding talent through its incentive plans, which include directors, senior executives, and consultants[98]. - The management team has extensive experience in finance and corporate governance, contributing to the company's strategic direction[95]. Market Strategy and Expansion - The company aims to establish Hong Kong as a leading RNA medicine hub in Asia, securing HKD 8 million in funding from the Hong Kong Science Park[45]. - The company is exploring strategic partnerships with academic institutions in Hong Kong for RNA therapy research and clinical collaboration[45]. - The company is focused on expanding its market presence and enhancing its operational capabilities through strategic hires and incentive programs[93]. - The company is actively pursuing strategic acquisitions to enhance its market position and product offerings[110]. - The company plans to expand its market presence with new product launches and technology developments in the upcoming quarters[110]. Shareholder and Equity Information - The company has confidence in its development prospects, as indicated by the decision to repurchase shares[149]. - The repurchase of shares reflects the board's belief that the trading price does not reflect the intrinsic value of the shares[149]. - The ownership structure includes various trusts and controlled entities, indicating a complex shareholder arrangement[146]. - The company has a total of 88,544,830 issued shares as of June 30, 2023, for calculations of ownership percentages[148]. - Major shareholder Mr. Zeng holds 4,564,495 shares, representing 5.16% of the total issued shares[147]. - The company did not declare any interim dividend for the reporting period[159]. - The company has a total of 1,768,006 restricted share units available for grant under the annual authorization as of January 1, 2023[125]. - The company has a stock option plan that was approved by shareholders on June 28, 2022, aimed at recognizing contributions and retaining qualified participants[126]. Facilities and Manufacturing - The company has established a GMP-compliant manufacturing process capable of scaling to commercial production, utilizing microfluidic technology and expanding partnerships to support a global supply chain[31]. - The Guangzhou facility, completed in 2021, has supported preclinical toxicity studies and early clinical trials, with plans to expand capacity for the GalAhead™ product line as it enters clinical stages[31]. - The Guangzhou facility has an expected annual production capacity of approximately 50,000 vials of freeze-dried solid formulations and 150,000 to 200,000 vials of liquid formulations[42]. - The Guangzhou facility has successfully operated for one year, supporting the clinical supply strategy for STP707 and expanding production capacity[42].

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。 Advancing RNAi Therapeutics 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） 截至2023年6月30日止六個月的 中期業績公告 Sirnaomics Ltd（.「本公司」，連同其附屬公司，統稱「本集團」）董事（「董事」）會 （「董事會」）欣然宣佈本集團截至2023年6月30日止六個月的未經審核簡明綜合 中期業績，連同截至2022年6月30日止六個月的比較數字。本公告載列本公司 截至2023年6月30日止六個月的中期報告（「2023中期報告」）全文，符合香港聯 合交易所有限公司（「香港聯交所」）證券上市規則（「上市規則」）有關中期業績 初步公告附載資料之相關規定。 該等中期業績已由董事會審核委員會及本公司核數師德勤‧關黃陳方會計師行 審閱。 刊發中期業績及中期報告 本 中 期 業 績 公 告 登 載 於 香 港 聯 交 ...