圣诺医药(02257) - 2025 - 中期财报

Company Information This section provides essential corporate details, including board composition, principal offices, and professional advisers Board of Directors and Committees This section details the composition and changes of the company's Board of Directors and its committees, including executive, non-executive, and independent non-executive directors, during the reporting period - Dr. Pan Honghui serves as CEO and Executive Director[6] - Mr. Ouyang Yunlong was appointed Non-executive Director effective July 3, 2025, while Mr. Zhang Jiankang, Dr. Lu Yang, and Mr. Huang Mincong resigned as Non-executive Directors[6] - Ms. Huang Mengying serves as Board Chairman and Remuneration Committee Chairman, and Mr. Wang Yushan was appointed Independent Non-executive Director and Audit Committee Chairman effective February 17, 2025[6] Principal Places of Business and Registered Information This section provides the company's principal business locations and headquarters in the U.S., China, and Hong Kong, along with details of its registered office and share registrars - U.S. principal place of business and headquarters: Sirnaomics, Inc., located in Germantown, MD 20876, U.S[7] - China principal place of business and headquarters: Sirnaomics Biopharmaceutical Technology (Suzhou) Co., Ltd., located in Suzhou Industrial Park, Suzhou, China[8] - Hong Kong principal place of business: 46th Floor, Hopewell Centre, 183 Queen's Road East, Wan Chai, Hong Kong[8] Professional Advisers This section lists the company's auditor, principal bankers, and legal advisers for Hong Kong, China, and Cayman Islands law - The auditor is ZH CPA Limited[9] - Principal bankers include DBS Bank (Hong Kong) Limited, The Hongkong and Shanghai Banking Corporation Limited, and Wells Fargo Bank, N.A[9] - Legal advisers include Linklaters (Hong Kong law), Commerce & Finance Law Offices (PRC law), and Maples and Calder (Hong Kong) LLP (Cayman Islands law)[10] Management Discussion and Analysis This section provides an overview of the company's business, R&D pipeline, core technology platforms, manufacturing, strategic outlook, and financial performance Business Overview Sirnaomics is a clinical-stage biopharmaceutical company developing siRNA therapeutics using PNP and GalAhead dual delivery systems across oncology, fibrosis, medical aesthetics, anticoagulation, cardiometabolic, and complement-mediated diseases - Founded in 2007, the company is a pioneer in siRNA therapeutics, aiming to become a global biopharmaceutical leader[12] - Core candidate STP705 showed positive results in clinical trials for isSCC and BCC tumor indications, with isSCC prioritized for Phase IIb/III pivotal trials[12] - STP707, an intravenously administered siRNA therapeutic, is being evaluated in a U.S. FDA-regulated Phase I clinical trial for various solid tumors, with the final report expected by the end of 2025[13] - STP122G, a leading therapeutic candidate based on the GalAhead™ mxRNA platform for anticoagulation and thrombotic diseases, is progressing well in Phase I clinical trials, expected to conclude in 2026[15] R&D Pipeline Progress The company's R&D pipeline, comprising 14 products and 15 programs, made continuous progress in H1 2025, with strategic financial resource allocation prioritizing STP705 and STP122G clinical advancement - In H1 2025, the company maintained strong momentum in pipeline advancement and business development, strategically prioritizing the clinical progress of STP705 and STP122G[19] Clinical Programs STP705 showed positive results in Phase II clinical studies for isSCC and BCC, with isSCC advancing to Phase IIb/III pivotal trials, while STP705 for local fat reduction demonstrated excellent safety in Phase I. STP707's Phase I clinical study showed good tolerability and efficacy, expected to conclude by end of 2025. STP122G's Phase I clinical trial showed good preliminary safety data, expected to conclude in 2026 - STP705 is used for isSCC and BCC treatment, with isSCC advancing to Phase IIb/III pivotal trials and BCC Phase IIa completed[20] - STP705's Phase I clinical study for local fat reduction showed excellent safety, supporting advancement to Phase II development[20] - STP707's Phase I clinical study for various solid tumors demonstrated good tolerability and therapeutic effects, with the final report expected by the end of 2025[21] - STP122G's Phase I clinical study for anticoagulation treatment showed good preliminary safety data, expected to conclude in 2026[22] Pre-clinical Programs The company is advancing STP125G and STP144G towards clinical development and exploring business development opportunities for other pipeline assets. STP125G has completed IND-enabling studies, and STP144G has completed GMP drug manufacturing, with IND submission planned for next year - STP125G (targeting ApoC3 for hypertriglyceridemia) has completed IND-enabling studies and is preparing for IND submission[24] - STP144G (targeting complement factor B for complement-mediated immunological diseases) has completed GMP drug manufacturing, with IND submission planned for next year[24] - IND-enabling activities for STP355 and STP369 will commence after the completion of Phase III data readout for STP705 and STP707[24] Core Technology Platforms The company possesses two proprietary delivery platforms: PNP and GalAhead™. The PNP platform utilizes biodegradable polymers for safe and effective siRNA delivery, clinically validated in oncology, fibrosis, and medical aesthetics. The GalAhead™ platform specifically targets hepatocytes via ASGPR-mediated uptake, incorporating mxRNA™ and muRNA™ technologies to enhance safety, delivery efficacy, and enable multi-mRNA targeting - The PNP delivery platform utilizes biodegradable histidine-lysine polymers, holding exclusive global rights and a strong intellectual property portfolio[26] - The GalAhead™ delivery platform specifically targets hepatocytes via ASGPR-mediated uptake, incorporating mxRNA™ (miniaturized RNAi triggers) and muRNA™ (multi-unit RNAi triggers)[27][29] Manufacturing Despite financial constraints, Sirnaomics successfully maintained operations of its clinical-scale GMP manufacturing facility and optimized production capacity. The company strengthened relationships with industry partners to secure API, excipient, and fill-finish supply chains, and utilized CDMO partners for pre-commercialization activities for later-stage programs - The company successfully maintained clinical-scale GMP manufacturing facility operations, optimized production capacity, and strengthened industry partnerships[28] - The Guangzhou fill-finish facility has been operational since 2021, supporting PNP pipeline development and retaining all key manufacturing functions to advance core therapeutic programs[28] Company Strategy and Outlook Sirnaomics is pioneering transformative RNA therapeutics to address global unmet medical needs, implementing a comprehensive restructuring plan to enhance operational efficiency and extend financial runway, while actively exploring additional financing and strategic partnerships to accelerate pipeline development and commercialization - The company implemented a comprehensive restructuring plan, streamlining organization, optimizing costs, and reallocating resources to enhance operational efficiency and extend its financial runway[33] - Actively exploring additional financing opportunities, including selective divestment of non-core assets, evaluating alternative financing options, and seeking business development collaborations[33] Leadership Changes The company anticipates adding more leadership team members in 2025 to strengthen the executive team and align its leadership with the strategic focus on advancing RNAi therapeutic pipelines and exploring new therapeutic areas - More leadership team members are expected to be added in 2025 to strengthen the executive team and align with the company's strategic focus[31] Future and Prospects Sirnaomics is committed to developing transformative RNA therapeutics, focusing on oncology, hepatometabolic diseases, and medical aesthetics, aiming to establish a leading position and drive sustainable growth through proprietary technology platforms, clinical-stage programs, and global R&D and manufacturing infrastructure - The company focuses on RNAi therapeutics in oncology, hepatometabolic diseases, and medical aesthetics, aiming to enhance competitive advantage and drive sustainable growth[32] Business Development Strategy and Commercialization The company is actively seeking global and regional partners for STP705 and STP707, evaluating collaboration opportunities for GalAhead™ platform assets, and discussing the formation of new companies with venture capital funds to optimize R&D expenditures. The goal is to submit the NDA for STP705 as early as 2027 - The business development team is actively seeking global and regional partnerships for STP705 and STP707, and evaluating collaboration opportunities for GalAhead™ platform assets[35] - Discussions are underway with several venture capital funds to establish new companies, leveraging existing capital to advance product pipelines and optimize R&D expenditures[35] - The goal is to submit the NDA for STP705 as early as 2027, with commercial success dependent on clinical data, regulatory approvals, and intellectual property protection[36] Commitment to Stakeholders and Key Strengths Sirnaomics is committed to creating sustainable value for shareholders, maintaining strict financial discipline, and achieving long-term growth by advancing its RNAi therapeutic pipeline, expanding its pipeline, and upholding financial discipline. The company's key strengths include clinically validated delivery platforms, a balanced pipeline, global presence, rigorous financial management, and an experienced leadership team - The company is steadfastly committed to creating sustainable value for shareholders while maintaining strict financial discipline[37] - Key strengths include: clinically validated proprietary RNAi delivery platforms, a balanced pipeline targeting high-value therapeutic areas, a strategic global presence with R&D and manufacturing capabilities, rigorous financial management and operational optimization, and an experienced leadership team with proven drug development expertise[40] Financial Review For the six months ended June 30, 2025, the Group recorded a loss of $3.4 million, a significant reduction from $43.5 million in the prior year, primarily due to substantial decreases in R&D and administrative expenses, and improved fair value changes in financial assets and liabilities. The company faces liquidity challenges and is actively pursuing external financing and implementing restructuring plans Loss for the Period Comparison (Six Months Ended June 30) | Indicator | 2025 (thousand USD) | 2024 (thousand USD) | | :--- | :--- | :--- | | Loss for the period | (3,388) | (43,493) | - The significant reduction in loss is primarily attributable to: decreased fair value loss on financial assets at fair value through profit or loss, reduced R&D expenses, lower administrative expenses, and decreased fair value loss on financial liabilities at fair value through profit or loss[57] Income Statement Analysis The Group generated no product sales revenue during the period. Other income significantly decreased by 87% to $0.1 million, mainly due to reduced consulting income and government grants. Other gains and losses shifted from a loss to a gain of $0.8 million, primarily from lease modification gains. Administrative and R&D expenses decreased by 75% and 79% respectively, driven by restructuring strategies and cost-saving measures - For the six months ended June 30, 2025, the Group generated no product sales revenue[45] Other Income Comparison (Six Months Ended June 30) | Indicator | 2025 (thousand USD) | 2024 (thousand USD) | Change (thousand USD) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Other income | 124 | 984 | (860) | -87.4% | | - Consulting income | 3 | 683 | (680) | -99.6% | | - Government grants | 64 | 227 | (163) | -71.8% | Administrative Expenses Comparison (Six Months Ended June 30) | Indicator | 2025 (thousand USD) | 2024 (thousand USD) | Change (thousand USD) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Total administrative expenses | 2,553 | 10,160 | (7,607) | -74.9% | | - Directors' emoluments and staff costs | 1,252 | 3,083 | (1,831) | -59.4% | | - Professional and consulting fees | 562 | 5,440 | (4,878) | -89.7% | R&D Expenses Comparison (Six Months Ended June 30) | Indicator | 2025 (thousand USD) | 2024 (thousand USD) | Change (thousand USD) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Total R&D expenses | 3,045 | 14,251 | (11,206) | -78.6% | | - Clinical trial expenses | 68 | 1,449 | (1,381) | -95.3% | | - Toxicology study expenses | 0 | 1,191 | (1,191) | -100.0% | Cash Flow Analysis For the six months ended June 30, 2025, net cash used in operating activities significantly decreased by 68% to $4.9 million, primarily due to slowing R&D activities for certain non-critical projects. Net cash generated from investing activities decreased by 98% to $4 thousand. Financing activities shifted from a net cash outflow to a net inflow of $20 thousand Cash Flow Comparison (Six Months Ended June 30) | Indicator | 2025 (thousand USD) | 2024 (thousand USD) | Change (thousand USD) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Net cash used in operating activities | (4,893) | (15,365) | 10,472 | -68.1% | | Net cash generated from investing activities | 4 | 201 | (197) | -98.0% | | Net cash generated from/(used in) financing activities | 20 | (696) | 716 | -102.9% | | Net decrease in cash and cash equivalents | (4,869) | (15,860) | 10,991 | -69.3% | - The decrease in net cash used in operating activities is primarily due to the Group slowing down R&D activities for certain non-critical projects[60] Liquidity, Funding Sources and Financial Ratios As at June 30, 2025, the Group's cash and cash equivalents were $6.9 million, current assets $13.9 million, and current liabilities $33.9 million, resulting in net current liabilities of $20.1 million. The current ratio decreased from 52.3% to 40.9%, and the debt-to-asset ratio increased from -2.5% to -3.4%, indicating increased liquidity pressure Liquidity and Financial Ratios Comparison | Indicator | June 30, 2025 (thousand USD) | December 31, 2024 (thousand USD) | Change (thousand USD) | | :--- | :--- | :--- | | Cash and cash equivalents | 6,872 | 11,769 | (4,897) | | Current assets | 13,891 | 19,459 | (5,568) | | Current liabilities | 33,944 | 37,226 | (3,282) | | Net current liabilities | (20,053) | (17,767) | (2,286) | | Net liabilities | (19,099) | (16,004) | (3,095) | Key Financial Ratios Comparison | Indicator | June 30, 2025 (%) | December 31, 2024 (%) | | :--- | :--- | :--- | | Current ratio | 40.9 | 52.3 | | Debt-to-asset ratio | (3.4) | (2.5) | - The Group relies on equity and debt financing as its primary sources of liquidity, with bank borrowings of $0.7 million as at June 30, 2025, and no unutilized bank facilities[61] Significant Investments and Asset Status The Group previously subscribed to a segregated portfolio, but due to the potential default of a private bond issuer invested by the fund, it recorded a significant fair value loss of $18.2 million in 2024. As at June 30, 2025, the Group held no financial assets at fair value through profit or loss. There were no significant acquisitions or disposals during the period, and some property, plant, and equipment were pledged as security for lease liabilities - Due to the potential default of a private bond issuer invested by the fund, the Group recorded a fair value loss of $18,178,000 on financial assets at fair value through profit or loss for the year ended December 31, 2024[66] - As at June 30, 2025, and December 31, 2024, the Group had no financial assets at fair value through profit or loss[67][180] - As at June 30, 2025, property, plant and equipment with a carrying value of $756,000 were pledged as security for lease liabilities[69][175] Employees and Remuneration As at June 30, 2025, the Group had 52 employees, with total remuneration costs of $2.7 million, a significant decrease from $8.5 million in the prior year, primarily due to restructuring and salary adjustments. The company provides social security schemes for employees and has adopted equity incentive plans to attract and retain talent Number of Employees by Function (As at June 30, 2025) | Function | Number of Employees | | :--- | :--- | | Management | 6 | | Research | 13 | | Manufacturing | 10 | | Clinical and Regulatory | 2 | | General and Administrative | 21 | | Total | 52 | Total Remuneration Costs Comparison (Six Months Ended June 30) | Indicator | 2025 (thousand USD) | 2024 (thousand USD) | Change (thousand USD) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Total remuneration costs | 2,700 | 8,500 | (5,800) | -68.2% | | - Share-based payment expenses | 300 | 1,600 | (1,300) | -81.3% | Corporate Governance and Other Information This section covers the company's equity incentive schemes, director and management information, corporate governance compliance, and financial and operational disclosures Equity Incentive Schemes The company has a Pre-IPO Equity Incentive Scheme, a Restricted Share Unit Scheme, and a Share Option Scheme, designed to attract, retain, and incentivize talent. During the reporting period, the Pre-IPO scheme ceased new grants, and details of share movements under the Restricted Share Unit and Share Option Schemes are disclosed - The company has adopted a Pre-IPO Equity Incentive Scheme, a Restricted Share Unit Scheme, and a Share Option Scheme to incentivize eligible employees[75] Pre-IPO Equity Incentive Scheme Adopted on January 21, 2021, this scheme aimed to attract and retain talent. The company terminated the scheme on April 22, 2022, but awards granted before termination remain subject to its terms. As at June 30, 2025, no shares were available for issuance under this scheme - The scheme was adopted on January 21, 2021, and terminated on April 22, 2022, but awards granted before termination remain effective[76] - As at June 30, 2025, no shares were available for issuance under the Pre-IPO Equity Incentive Scheme[76] Movement in Outstanding Share Options under Pre-IPO Equity Incentive Scheme (Six Months Ended June 30, 2025) | Category | As at January 1, 2025 (Number of Share Options) | Granted during the period | Exercised during the period | Cancelled during the period | Lapsed during the period | As at June 30, 2025 (Number of Share Options) | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Directors | 1,925,000 | – | – | – | – | 1,925,000 | | Top five highest paid individuals (excluding directors) | 2,135,000 | – | – | – | – | 2,135,000 | | Other grantees | 6,763,345 | – | – | – | – | 6,763,345 | | Total | 10,823,345 | – | – | – | – | 10,823,345 | Restricted Share Unit Scheme Adopted on April 22, 2022, with a 10-year validity, this scheme aims to incentivize skilled and experienced personnel. Under transitional arrangements, no new awards can be granted after January 1, 2023, unless the scheme is amended to comply with Listing Rule Chapter 17. As at June 30, 2025, a total of 38,866 restricted share units were granted but unvested - The scheme was adopted on April 22, 2022, with a 10-year validity period, aiming to recognize contributions, provide proprietary interests, encourage retention, offer additional incentives, attract talent, and maximize company value[91][93][98] - Under the transitional arrangements of the Hong Kong Stock Exchange, after January 1, 2023, the company can no longer grant any awards under the Restricted Share Unit Scheme unless it is amended to comply with Chapter 17 of the Listing Rules[104][108] Movement in Outstanding Restricted Share Units under Restricted Share Unit Scheme (Six Months Ended June 30, 2025) | Category | As at January 1, 2025 (Number of Restricted Share Units) | Granted during the period | Vested during the period | Cancelled during the period | Lapsed during the period | As at June 30, 2025 (Number of Restricted Share Units) | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Directors (Dr. Lu Yang) | 8,700 | – | – | – | (8,700) | – | | Top five highest paid individuals (excluding directors) | 16,526 | – | – | – | – | 16,526 | | Other senior grantees | 3,850 | – | – | – | (3,850) | – | | Other junior grantees | 26,994 | – | – | – | (4,654) | 22,340 | | Total | 56,070 | – | – | – | (17,204) | 38,866 | Share Option Scheme Adopted on June 28, 2022, with a 10-year validity, this scheme aims to recognize contributions, encourage talent retention, provide additional incentives, attract talent, and maximize company value. Under transitional arrangements, the company can continue to grant share options under existing shareholder authorization from June 28, 2022. As at June 30, 2025, a total of 788,999 share options were granted but unexercised - The scheme was adopted on June 28, 2022, with a 10-year validity period, aiming to recognize contributions, encourage talent retention, provide additional incentives, attract talent, and maximize company value[109][111][112] - Under the transitional arrangements of the Stock Exchange, the company may continue to grant share options under the Share Option Scheme in accordance with the existing plan authorization granted by shareholders on June 28, 2022[109] Movement in Outstanding Share Options under Share Option Scheme (Six Months Ended June 30, 2025) | Category | As at January 1, 2025 (Number of Share Options) | Granted during the period | Exercised during the period | Cancelled during the period | Lapsed during the period | As at June 30, 2025 (Number of Share Options) | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Directors (Dr. Lu Yang) | 218,600 | – | – | – | (58,800) | 159,800 | | Top five highest paid individuals (excluding directors) | 223,800 | – | – | – | – | 223,800 | | Other senior grantees | 220,311 | – | – | – | (19,476) | 200,835 | | Junior grantees — related parties (Dr. Yang Xianbin) | 4,750 | – | – | – | – | 4,750 | | Other junior grantees | 212,092 | – | – | – | (12,278) | 199,814 | | Total | 879,553 | – | – | – | (90,554) | 788,999 | Directors and Management Information This section discloses changes in director and chief executive information from December 31, 2024, to the end of the reporting period, including resignations, new appointments, remuneration adjustments, and committee role changes, as well as interests and short positions of directors, chief executive, and major shareholders in the company's shares - Mr. Huang Mincong, Ms. Sheng Muxian, and Dr. Lu Yang resigned from their directorships[129] - Mr. Wang Yushan, Dr. Zhang Peng, and Mr. Ouyang Yunlong were appointed to directorships[129] - Dr. Pan Honghui beneficially owns 17,527,696 shares, representing approximately 16.67% of the issued shares[132] - Dr. Lu Yang, as beneficial owner and settlor of a discretionary trust, collectively owns 10,586,582 shares, representing approximately 10.07% of the issued shares[134] Changes in Information of Directors or Chief Executive Since December 31, 2024, the company's Board of Directors has undergone several changes, including the resignations of Mr. Huang Mincong, Ms. Sheng Muxian, and Dr. Lu Yang, and the appointments of Mr. Wang Yushan, Mr. Ouyang Yunlong, and Dr. Zhang Peng. The remuneration of Dr. Pan Honghui and Mr. Zhang Jiankang was also adjusted - Mr. Huang Mincong resigned as Non-executive Director, and Ms. Sheng Muxian resigned as Independent Non-executive Director, both effective January 1, 2025[129] - Dr. Lu Yang resigned as Non-executive Director and Chief Scientific Officer, effective February 5, 2025[129] - Mr. Wang Yushan was appointed Independent Non-executive Director and Chairman of the Audit Committee, effective February 17, 2025[129] - Mr. Ouyang Yunlong was appointed Non-executive Director, and Dr. Zhang Peng was appointed Independent Non-executive Director, both effective July 3, 2025[129] Interests of Directors and Chief Executive As at June 30, 2025, Dr. Pan Honghui beneficially owned 17,527,696 shares, representing 16.67% of the company's equity Interests of Directors and Chief Executive in Shares and Underlying Shares (As at June 30, 2025) | Name of Director or Chief Executive | Nature of Interest | Number of Shares/Underlying Shares | Approximate Percentage of Interest in the Company | | :--- | :--- | :--- | :--- | | Dr. Pan Honghui | Beneficial interest | 17,527,696 (L) | 16.67% | Interests of Major Shareholders As at June 30, 2025, Dr. Lu Yang, as beneficial owner and settlor of a discretionary trust, collectively owned 10,586,582 shares, representing 10.07% of the company's equity Interests of Major Shareholders in Shares and Underlying Shares (As at June 30, 2025) | Name of Major Shareholder | Nature of Interest | Number of Shares/Underlying Shares | Approximate Percentage of Interest in Equity | | :--- | :--- | :--- | :--- | | Dr. Lu Yang | Beneficial interest; Settlor of a discretionary trust | 10,586,582 (L) | 10.07% | Corporate Governance and Compliance The company previously failed to comply with relevant Listing Rules due to director resignations but has since regained compliance through new appointments. The company has adopted and complies with the Corporate Governance Code and Model Code. The Audit Committee has reviewed the interim financial statements, and the Board does not recommend an interim dividend - The company previously failed to comply with Listing Rules 3.10(1), 3.10(2), 3.21, and 3.27A due to director resignations but has regained compliance through new appointments[131] - The company has adopted and applied all applicable code provisions of the Corporate Governance Code set out in Appendix C1 of the Listing Rules[141] - The Audit Committee, composed of three independent non-executive directors, has reviewed the Group's unaudited condensed consolidated financial statements for the six months ended June 30, 2025[143] - The Board does not recommend the payment of any interim dividend for the reporting period[144] Non-Compliance with Listing Rules The company previously failed to comply with Listing Rules 3.10(1), 3.10(2), 3.21, and 3.27A due to the resignations of Ms. Sheng Muxian and Mr. Huang Mincong. However, following new director appointments in February 2025, the company has regained compliance with the relevant provisions - The company previously failed to comply with Listing Rules 3.10(1), 3.10(2), 3.21, and 3.27A due to director resignations[131] - Through the appointments of Ms. Huang Mengying, Mr. Wang Yushan, and Dr. Yu Changhai, the company has regained compliance with the relevant Listing Rules[131] Compliance with Corporate Governance Code and Model Code The company has adopted and applied all applicable code provisions of the Corporate Governance Code in Appendix C1 of the Listing Rules and has adopted its own code of conduct for securities transactions, with terms no less exacting than the Model Code. All directors have confirmed compliance with the Model Code throughout the reporting period - The company has adopted and applied all applicable code provisions of the Corporate Governance Code set out in Appendix C1 of the Listing Rules[141] - The company has adopted its own code of conduct for securities transactions, with terms no less exacting than the Model Code, and all directors have confirmed compliance[142] Audit Committee The Audit Committee comprises three independent non-executive directors, with Mr. Wang Yushan as Chairman. The committee has reviewed the Group's unaudited condensed consolidated financial statements for the six months ended June 30, 2025, and the accounting principles and policies adopted - The Audit Committee comprises three independent non-executive directors: Mr. Wang Yushan (Chairman), Ms. Huang Mengying, and Dr. Yu Changhai[143] - The committee has reviewed the Group's unaudited condensed consolidated financial statements for the six months ended June 30, 2025, and the accounting principles and policies[143] Financial and Operational Disclosures This section discloses the use of proceeds from share subscriptions, primarily for general corporate and working capital purposes. The company was not involved in any material litigation or arbitration and did not undertake significant acquisitions or disposals. No significant events affecting the company occurred after the reporting period - Net proceeds of approximately $7.5 million from the subscription of 17,527,696 new shares are intended for general working capital purposes, expected to be fully utilized by mid-2026[140] Use of Net Proceeds from Subscription (As at June 30, 2025) | Use | Percentage of Use | Net Proceeds (million USD) | Utilized as at December 31, 2024 (million USD) | Utilized during 2025 Reporting Period (million USD) | Unutilized as at June 30, 2025 (million USD) | Estimated Timeline for Utilization of Net Proceeds from Subscription | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | For general corporate and working capital purposes | 100% | 7.5 | – | 0.7 | 6.8 | By mid-2026 | - For the six months ended June 30, 2025, the company was not involved in any material litigation or arbitration[138] - No significant events affecting the company occurred from June 30, 2025, up to the date of this interim report[147] Use of Proceeds from Subscription of Shares On October 2, 2024, the company entered into a subscription agreement with Dr. Pan Honghui to subscribe for 17,527,696 new shares at HK$3.36 per share, yielding net proceeds of approximately $7.5 million, all allocated for general working capital and expected to be fully utilized by mid-2026 - Net proceeds of approximately $7.5 million from the subscription are entirely for general corporate and working capital purposes[140] - As at June 30, 2025, $0.7 million has been utilized, with $6.8 million remaining, expected to be fully utilized by mid-2026[140] Material Litigation The company faces claims from two registered shareholders, Mike Ghias and Asghar Ghias, regarding restrictive legends on shares and refusal to transfer shares. Court proceedings are in early stages, and management deems it premature to assess the probability of success or the extent of liability, thus no provision has been made - Two shareholders filed claims concerning the company's imposition of restrictive legends on shares and refusal to transfer shares[242] - Court proceedings are in early stages, and management believes it is premature to assess the probability of success or the extent of liability, thus no provision has been made[242] Related Party Transactions and Interim Dividend Details of significant related party transactions conducted by the Group in the ordinary course of business are disclosed, with no connected transactions as defined by Chapter 14A of the Listing Rules. The Board does not recommend the payment of any interim dividend for the reporting period - Significant related party transactions were conducted by the Group in the ordinary course of business, with no connected transactions as defined by Chapter 14A of the Listing Rules[145] - The Board does not recommend the payment of any interim dividend for the reporting period[144] Significant Events After Reporting Period No significant events affecting the company occurred from June 30, 2025, up to the date of this interim report - No significant events affecting the company occurred from June 30, 2025, up to the date of this interim report[147] Condensed Consolidated Statement of Profit or Loss and Other Comprehensive Income This section presents the condensed consolidated statement of profit or loss and other comprehensive income, highlighting key financial performance indicators for the period Key Profit or Loss Items For the six months ended June 30, 2025, the company recorded a loss for the period of $3,388 thousand, a significant reduction from $43,493 thousand in the prior year, primarily benefiting from substantial decreases in administrative and R&D expenses, and improved fair value changes in financial assets and liabilities Condensed Consolidated Statement of Profit or Loss and Other Comprehensive Income Summary (Six Months Ended June 30) | Indicator | 2025 (thousand USD) | 2024 (thousand USD) | | :--- | :--- | :--- | | Other income | 124 | 984 | | Other gains and losses | 768 | (23) | | Fair value change of financial assets at fair value through profit or loss | – | (18,108) | | Fair value change of financial liabilities at fair value through profit or loss | 1,724 | (1,389) | | Administrative expenses | (2,553) | (10,160) | | R&D expenses | (3,045) | (14,251) | | Finance costs | (402) | (539) | | Loss for the period | (3,388) | (43,493) | Total Comprehensive Expense The total comprehensive expense for the period was $3,410 thousand, a significant decrease from $43,887 thousand in the prior year, primarily reflecting the narrowed loss for the period Total Comprehensive Expense for the Period (Six Months Ended June 30) | Indicator | 2025 (thousand USD) | 2024 (thousand USD) | | :--- | :--- | :--- | | Total comprehensive expense for the period | (3,410) | (43,887) | Loss Per Share For the six months ended June 30, 2025, basic and diluted loss per share was $0.04, a significant improvement from $0.54 in the prior year Loss Per Share (Six Months Ended June 30) | Indicator | 2025 (USD) | 2024 (USD) | | :--- | :--- | :--- | | Basic and diluted loss per share | (0.04) | (0.54) | Condensed Consolidated Statement of Financial Position This section presents the condensed consolidated statement of financial position, outlining the Group's assets, liabilities, and equity as at the reporting date Assets As at June 30, 2025, the Group's total non-current assets were $7,413 thousand, and total current assets were $13,891 thousand. Cash and cash equivalents amounted to $6,872 thousand Assets Summary (As at June 30, 2025) | Indicator | June 30, 2025 (thousand USD) | December 31, 2024 (thousand USD) | | :--- | :--- | :--- | | Non-current assets | 7,413 | 8,870 | | Current assets | 13,891 | 19,459 | | - Cash and cash equivalents | 6,872 | 11,769 | | - Prepayments, deposits and other receivables | 7,019 | 7,690 | Liabilities As at June 30, 2025, the Group's total current liabilities were $33,944 thousand, and total non-current liabilities were $6,459 thousand. Net current liabilities amounted to $20,053 thousand, and net liabilities were $19,099 thousand Liabilities Summary (As at June 30, 2025) | Indicator | June 30, 2025 (thousand USD) | December 31, 2024 (thousand USD) | | :--- | :--- | :--- | | Current liabilities | 33,944 | 37,226 | | - Financial liabilities at fair value through profit or loss | 22,024 | 23,748 | | - Trade and other payables | 10,174 | 11,603 | | Non-current liabilities | 6,459 | 7,107 | | Net current liabilities | (20,053) | (17,767) | | Net liabilities | (19,099) | (16,004) | Capital and Reserves As at June 30, 2025, the deficit attributable to owners of the company was $5,118 thousand, non-controlling interests were $13,981 thousand, and total deficit was $19,099 thousand Capital and Reserves Summary (As at June 30, 2025) | Indicator | June 30, 2025 (thousand USD) | December 31, 2024 (thousand USD) | | :--- | :--- | :--- | | Share capital | 105 | 105 | | Deficit attributable to owners of the Company | (5,118) | (1,680) | | Non-controlling interests | (13,981) | (14,324) | | Total deficit | (19,099) | (16,004) | Condensed Consolidated Statement of Changes in Equity This section presents the condensed consolidated statement of changes in equity, detailing movements in share capital and reserves for the period Changes in Share Capital and Reserves For the six months ended June 30, 2025, the loss for the period attributable to owners of the company was $3,698 thousand, leading to an increase in accumulated losses. Exchange differences arising from the translation of overseas operations resulted in a $20 thousand decrease in the exchange reserve Condensed Consolidated Statement of Changes in Equity Summary (Six Months Ended June 30, 2025) | Indicator | As at January 1, 2025 (thousand USD) | Loss/(Profit) for the period (thousand USD) | Exchange differences arising from translation of overseas operations (thousand USD) | Share-based payments recognized (thousand USD) | Share options lapsed/forfeited (thousand USD) | As at June 30, 2025 (thousand USD) | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Share capital | 105 | – | – | – | – | 105 | | Share premium | 522,517 | – | – | – | – | 522,517 | | Exchange reserve | (3,620) | – | (20) | – | – | (3,640) | | Share option reserve | 15,897 | – | – | 239 | (63) | 16,073 | | Share award reserve | 16 | – | – | 41 | – | 57 | | Accumulated losses | (524,022) | (3,698) | – | – | 63 | (527,657) | | Subtotal attributable to owners of the Company | (1,680) | (3,698) | (20) | 280 | – | (5,118) | | Non-controlling interests | (14,324) | 310 | (2) | 35 | – | (13,981) | | Total | (16,004) | (3,388) | (22) | 315 | – | (19,099) | Impact of Share-based Payments Total share-based payments recognized during the period amounted to $315 thousand, with $280 thousand attributable to owners of the company and $35 thousand to non-controlling interests. Lapsed/forfeited share options resulted in a $63 thousand decrease in share option reserve and a $63 thousand increase in accumulated losses - Total share-based payments recognized during the period amounted to 315 thousand USD[154] - Lapsed/forfeited share options resulted in a 63 thousand USD decrease in share option reserve and a 63 thousand USD increase in accumulated losses[154] Condensed Consolidated Statement of Cash Flows This section presents the condensed consolidated statement of cash flows, detailing cash movements from operating, investing, and financing activities Operating Cash Flow For the six months ended June 30, 2025, net cash used in operating activities was $4,893 thousand, a significant reduction from $15,365 thousand in the prior year, reflecting the company's efforts to control operating cash outflows Operating Cash Flow (Six Months Ended June 30) | Indicator | 2025 (thousand USD) | 2024 (thousand USD) | | :--- | :--- | :--- | | Net cash used in operating activities | (4,893) | (15,365) | Investing Cash Flow Net cash generated from investing activities was $4 thousand, a significant decrease from $201 thousand in the prior year, primarily due to reduced proceeds from the disposal of property, plant, and equipment Investing Cash Flow (Six Months Ended June 30) | Indicator | 2025 (thousand USD) | 2024 (thousand USD) | | :--- | :--- | :--- | | Net cash generated from investing activities | 4 | 201 | | - Proceeds from disposal of property, plant and equipment | 47 | 90 | Financing Cash Flow Net cash generated from financing activities was $20 thousand, an improvement from a net cash outflow of $696 thousand in the prior year, mainly due to reduced interest paid on lease liabilities and repayment of lease liabilities Financing Cash Flow (Six Months Ended June 30) | Indicator | 2025 (thousand USD) | 2024 (thousand USD) | | :--- | :--- | :--- | | Net cash generated from (used in) financing activities | 20 | (696) | | - Interest paid on lease liabilities | (87) | (539) | | - Repayment of lease liabilities | (126) | (575) | Notes to the Condensed Consolidated Financial Statements This section provides detailed notes to the condensed consolidated financial statements, covering general information, accounting policies, segment information, and specific items in the profit or loss and balance sheets General Information and Basis of Preparation Sirnaomics Ltd. is a public company incorporated in the Cayman Islands, engaged in the development and commercialization of RNAi technology and various therapeutics. The condensed consolidated financial statements are prepared in accordance with IAS 34 and on a going concern basis, despite significant uncertainties including net loss, operating cash outflows, and net current liabilities, with its ability to continue as a going concern dependent on successful financing and restructuring plans - The company is an investment holding company, and its subsidiaries are clinical-stage biotechnology companies engaged in the development and commercialization of RNAi technology and various therapeutics[156] - For the six months ended June 30, 2025, the Group incurred a net loss of 3,388 thousand USD and net operating cash outflows of 4,893 thousand USD, with net current liabilities of 20,053 thousand USD and net liabilities of 19,099 thousand USD[157] - The Group's ability to continue as a going concern largely depends on its capacity to maintain minimum operating cash outflows and sufficient financing resources to meet its financial obligations, actively seeking external financing through equity and debt, exploring business development opportunities, and implementing restructuring plans[157] Accounting Policies and Application The condensed consolidated financial statements are prepared on a historical cost basis, and the accounting policies and methods of computation adopted are consistent with the 2024 annual consolidated financial statements, except for the application of amendments to IFRS accounting standards. The company has not early adopted new and revised IFRS accounting standards issued but not yet effective - The condensed consolidated financial statements are prepared on a historical cost basis, except for certain financial instruments measured at fair value[160] - The Group has not early adopted new and revised IFRS accounting standards issued but not yet effective[161] Revenue and Segment Information The Group generated no revenue during the period. The company's executive directors focus on reviewing the Group's overall performance and financial position, resulting in a single operating segment. The Group's operations and non-current assets are primarily located in the U.S. and mainland China - The Group generated no revenue during the period[162] - The Group has only a single operating segment, and no further analysis of this single segment is presented[163] Non-Current Assets by Geographical Location (Excluding Financial Instruments) | Region | June 30, 2025 (thousand USD) | December 31, 2024 (thousand USD) | | :--- | :--- | :--- | | United States | 4,006 | 5,089 | | China | 2,860 | 3,228 | | Hong Kong | 21 | 34 | | Total | 6,887 | 8,351 | Notes to the Statement of Profit or Loss This section provides detailed explanations for changes in various income and expense items in the statement of profit or loss, including other income, other gains and losses, finance costs, income tax expense, composition of loss for the period, and dividend policy - The loss for the period is primarily attributable to reduced fair value loss on financial assets at fair value through profit or loss, decreased R&D expenses, lower administrative expenses, and reduced fair value loss on financial liabilities at fair value through profit or loss[57] Other Income For the six months ended June 30, 2025, other income decreased by 87% to $0.1 million from $1.0 million in the prior year, primarily due to reductions in consulting income and government grants Other Income Composition (Six Months Ended June 30) | Item | 2025 (thousand USD) | 2024 (thousand USD) | | :--- | :--- | :--- | | Government grants | 64 | 227 | | Rental income | 14 | – | | Interest income from bank balances | 8 | 36 | | Consulting income | 3 | 683 | | Others | 35 | 38 | | Total | 124 | 984 | - Other income decreased by 0.9 million USD or 87%, primarily due to a 0.7 million USD reduction in consulting income and a 0.2 million USD reduction in government grants[46] Other Gains and Losses The Group's other gains and losses shifted from a loss of $23 thousand in the prior year to a gain of $0.8 million, primarily due to a $0.7 million gain from lease modification and increased gains from the disposal of property, plant, and equipment Other Gains and Losses Composition (Six Months Ended June 30) | Item | 2025 (thousand USD) | 2024 (thousand USD) | | :--- | :--- | :--- | | Net exchange loss | (3) | (1) | | Gain (loss) on disposal of property, plant and equipment | 18 | (63) | | Gain arising from lease termination | – | 41 | | Gain arising from lease modification | 746 | – | | Others | 7 | – | | Total | 768 | (23) | - The change is primarily due to a 0.7 million USD gain from lease modification for the six months ended June 30, 2025[48] Finance Costs The Group's finance costs primarily include interest on lease liabilities and bank borrowings. For the six months ended June 30, 2025, finance costs were $402 thousand, a 25.4% decrease from $539 thousand in the prior year, mainly due to reduced interest on lease liabilities Finance Costs Composition (Six Months Ended June 30) | Item | 2025 (thousand USD) | 2024 (thousand USD) | | :--- | :--- | :--- | | Interest on lease liabilities | 392 | 539 | | Interest on bank borrowings | 10 | – | | Total | 402 | 539 | - Interest on lease liabilities decreased by 0.1 million USD or 27% to 0.4 million USD[55] Income Tax Expense No Hong Kong profits tax, U.S. corporate income tax and state tax, or PRC corporate income tax was provided for the six months ended June 30, 2025, as no taxable profits were generated by the respective group entities. Some Chinese subsidiaries enjoy preferential tax rates as high-tech enterprises - No Hong Kong profits tax, U.S. corporate income tax and state tax, or PRC corporate income tax was provided as no taxable profits were generated by the respective group entities[56][170] - Guangzhou Sirnaomics and Suzhou Sirnaomics are recognized as 'High and New Technology Enterprises', enjoying a preferential corporate income tax rate of 15%[169][170] Composition of Loss for the Period The loss for the period decreased from $43.5 million in the prior year to $3.4 million, primarily attributable to reduced fair value loss on financial assets, decreased R&D expenses, lower administrative expenses, and reduced fair value loss on financial liabilities. Total depreciation and amortization expenses were $948 thousand, and total staff costs were $2,710 thousand Loss for the Period Composition Summary (Six Months Ended June 30) | Item | 2025 (thousand USD) | 2024 (thousand USD) | | :--- | :--- | :--- | | Outsourcing service fees included in R&D expenses | 270 | 3,565 | | Amortization of intangible assets | 42 | 42 | | Depreciation of property, plant and equipment | 825 | 3,173 | | Depreciation of right-of-use assets | 81 | 621 | | Staff costs (including directors' emoluments) | 2,710 | 8,459 | - The decrease in loss for the period is primarily attributable to reduced fair value loss on financial assets at fair value through profit or loss, decreased R&D expenses, lower administrative expenses, and reduced fair value loss on financial liabilities at fair value through profit or loss[57] Dividends No dividends were paid or proposed to ordinary shareholders of the company during this interim period. The company's directors decided not to pay dividends for this interim period - No dividends were paid or proposed to ordinary shareholders of the Company during the interim period[172] Loss Per Share For the six months ended June 30, 2025, basic and diluted loss per share attributable to owners of the company was $0.04, a significant improvement from $0.54 in the prior year. Potential ordinary shares with anti-dilutive effects were not included in the calculation of diluted loss per share Loss Per Share Calculation (Six Months Ended June 30) | Indicator | 2025 (thousand USD) | 2024 (thousand USD) | | :--- | :--- | :--- | | Loss for the period attributable to owners of the Company for basic and diluted loss per share calculation | (3,698) | (41,065) | | Weighted average number of ordinary shares for basic and diluted loss per share calculation | 93,694,108 | 76,018,628 | | Basic and diluted loss per share (USD) | (0.04) | (0.54) | - The calculation of diluted loss per share did not include potentially dilutive ordinary shares from various preferred shares and outstanding share options, as their inclusion would have an anti-dilutive effect[173] Notes to the Statement of Financial Position This section details various assets and liabilities in the statement of financial position, including property, plant and equipment, right-of-use assets, financial assets at fair value through profit or loss, prepayments, cash and cash equivalents, trade and other payables, contract liabilities, financial liabilities at fair value through profit or loss, and share capital movements and composition - As at June 30, 2025, the Group's net liabilities increased from 16.0 million USD as at December 31, 2024, to 19.1 million USD[62] Property, Plant and Equipment As at June 30, 2025, the carrying value of property, plant and equipment was $6,075 thousand, with additions of approximately $24 thousand during the period, primarily for laboratory equipment. Some assets were pledged as security for lease liabilities Property, Plant and Equipment Carrying Value (As at June 30, 2025) | Item | June 30, 2025 (thousand USD) | December 31, 2024 (thousand USD) | | :--- | :--- | :--- | | Leasehold improvements | 2,726 | 2,943 | | Furniture and fixtures | 455 | 506 | | Laboratory equipment | 2,662 | 3,137 | | Motor vehicles | 35 | 75 | | Equipment and computers | 125 | 160 | | Construction in progress | 72 | 72 | | Total | 6,075 | 6,893 | - As at June 30, 2025, the Group acquired property, plant and equipment of approximately 24 thousand USD, primarily comprising laboratory equipment[174] - As at June 30, 2025, property, plant and equipment with a carrying value of 756 thousand USD were pledged as security for lease liabilities[175] Right-of-Use Assets As at June 30, 2025, the carrying value of right-of-use assets was $122 thousand. The Group leases various offices and equipment for its operations, with lease contracts typically entered into for fixed terms of one to ten years Right-of-Use Assets Carrying Value (As at June 30, 2025) | Item | June 30, 2025 (thousand USD) | December 31, 2024 (thousand USD) | | :--- | :--- | :--- | | Leased properties | 122 | 728 | - The Group leases various offices and equipment for its operations, with lease contracts typically entered into for fixed terms of one to ten years[176] Financial Assets at Fair Value Through Profit or Loss The Group previously subscribed for shares in a segregated portfolio of TradArt Flagship Investment SPC, but due to the potential default of a private bond issuer, it recorded a significant fair value loss of $18.2 million in 2024. As at June 30, 2025, and December 31, 2024, the Group held no financial assets at fair value through profit or loss - Hong Kong Sirnaomics, a wholly-owned subsidiary, subscribed for shares in a segregated portfolio of TradArt Flagship Investment SPC, with a total subscription amount of 20 million USD[177] - Due to the potential default of a private bond issuer invested by the fund, the Group recorded a fair value loss of 18,178 thousand USD on financial assets at fair value through profit or loss for the year ended December 31, 2024[179] - As at June 30, 2025, and December 31, 2024, the Group had no financial assets at fair value through profit or loss[180] Prepayments, Deposits and Other Receivables As at June 30, 2025, total prepayments, deposits, and other receivables amounted to $7,545 thousand, with a current portion of $7,019 thousand and a non-current portion of $526 thousand. These primarily include prepayments to outsourcing service providers and lease deposits Prepayments, Deposits and Other Receivables Composition (As at June 30, 2025) | Item | June 30, 2025 (thousand USD) | December 31, 2024 (thousand USD) | | :--- | :--- | :--- | | Prepayments to outsourcing service providers | 6,072 | 6,676 | | Lease deposits | 607 | 737 | | Other receivables | 812 | 727 | | Total | 7,545 | 8,209 | | Current | 7,019 | 7,690 | | Non-current | 526 | 519 | Cash and Cash Equivalents As at June 30, 2025, cash and cash equivalents amounted to $6,872 thousand, primarily denominated in USD, RMB, and HKD, bearing market interest rates ranging from 0.001% to 3.8% - As at June 30, 2025, cash and cash equivalents amounted to 6,872 thousand USD[151][183] - Cash and cash equivalents are primarily denominated in USD, RMB, and HKD, bearing market interest rates ranging from 0.001% to 3.8%[183] Trade and Other Payables As at June 30, 2025, total trade and other payables amounted to $10,174 thousand, a decrease from $11,603 thousand as at December 31, 2024. These primarily include trade payables, accrued outsourcing R&D expenses, and accrued other operating expenses Trade and Other Payables Composition (As at June 30, 2025) | Item | June 30, 2025 (thousand USD) | December 31, 2024 (thousand USD) | | :--- | :--- | :--- | | Trade payables | 3,779 | 4,599 | | Accrued outsourcing R&D expenses | 2,958 | 3,010 | | Accrued other operating expenses | 2,976 | 3,451 | | Accrued staff costs | 437 | 492 | | Payables for acquisition of property, plant and equipment | 24 | 51 | | Total | 10,174 | 11,603 | Trade Payables Ageing Analysis (As at June 30, 2025) | Ageing | June 30, 2025 (thousand USD) | December 31, 2024 (thousand USD) | | :--- | :--- | :--- | | 0 to 30 days | 42 | 475 | | 31 to 60 days | 25 | 403 | | 61 to 90 days | 22 | 180 | | Over 90 days | 3,690 | 3,541 | | Total | 3,779 | 4,599 | Contract Liabilities The Group entered into a license agreement with Yunnan Walvax Biotechnology Co., Ltd., receiving an upfront payment of approximately $698 thousand, recognized as contract liabilities. These contract liabilities are expected to be settled within the normal operating cycle and are therefore classified as current liabilities - The Group entered into a license agreement with Yunnan Walvax Biotechnology Co, Ltd, receiving an upfront payment of approximately 698 thousand USD, recognized as contract liabilities[185] - The contract liabilities are expected to be settled within the normal operating cycle and are therefore classified as current liabilities[186] Financial Liabilities at Fair Value Through Profit or Loss Seed Series Preferred Shares and Series A Preferred Shares issued by RNAimmune are classified as financial liabilities at fair value through profit or loss. As at June 30, 2025, their fair value was $22,024 thousand, a decrease from $23,748 thousand as at December 31, 2024. These preferred shares carry voting rights, dividend rights, and liquidation preferences, and are convertible into ordinary shares at the option of the holder or mandatorily RNAimmune Issued Preferred Shares (As at June 30, 2025) | Preferred Share | Year of Issue | Number of Investors | Total Preferred Shares Issued | Subscription Price (USD) | Total Consideration (thousand USD) | | :--- | :--- | :--- | :--- | :--- | :--- | | Seed Series Preferred Shares | 2021 | 7 | 7,936,509 | 1.26 | 10,000 | | Series A Preferred Shares | 2022 | 8 | 7,553,390 | 3.09 | 23,340 | | Total | | | 15,489,899 | | 33,340 | - Both Seed Series Preferred Shares and Series A Preferred Shares issued by RNAimmune are accounted for as financial liabilities at fair value through profit or loss[197] - Preferred shareholders possess voting rights, dividend rights, and liquidation preferences, with options for voluntary or mandatory conversion into ordinary shares[190][191][192][193][195] Share Capital As at June 30, 2025, the company's authorized share capital was $230,000 thousand, and issued and fully paid share capital was $105,166 thousand, consistent with January