Core Insights - MIRXES-B (02629) reported a mid-year revenue of $10.5 million for 2025, reflecting a year-on-year increase of 9.4% [1] - The company recorded a loss attributable to equity shareholders of approximately $28.35 million, which represents a 36.22% reduction compared to the previous year; the loss per share was $0.185 [1] - The increase in revenue is primarily attributed to the growth in earnings from the early detection and precision multi-omics divisions, specifically from GASTROClear and LUNGClear, which offset a $2.6 million revenue decline in the infectious disease division due to the termination of Fortitude product sales [1]

[Financial Highlights](index=1&type=section&id=Financial%20Highlights) [Interim Results Overview](index=1&type=section&id=Interim%20Results%20Overview) H1 2025 revenue grew **9.4%** to **$10.5 million**, gross profit up **51.1%** to **67.6%** margin, and loss narrowed **36.2%** to **$28.4 million** Key Financial Data Comparison for H1 2025 | Metric | 2025 H1 (million USD) | 2024 H1 (million USD) | Y-o-Y Change (%) | | :--- | :--- | :--- | :--- | | Revenue | 10.5 | 9.6 | 9.4% | | Early Detection & Precision Multi-omics Revenue | 10.5 | 7.0 | 50.0% | | Gross Profit | 7.1 | 4.7 | 51.1% | | Early Detection & Precision Multi-omics Gross Profit | 7.1 | 3.5 | 102.9% | | Loss Attributable to Equity Holders | (28.4) | (44.5) | -36.2% | [Consolidated Financial Statements](index=2&type=section&id=Consolidated%20Financial%20Statements) [Consolidated Statement of Profit or Loss and Other Comprehensive Income](index=2&type=section&id=Consolidated%20Statement%20of%20Profit%20or%20Loss%20and%20Other%20Comprehensive%20Income) For H1 2025, revenue reached **$10.5 million**, gross profit **$7.1 million**, operating loss narrowed, and loss attributable to equity holders decreased to **$28.4 million** Summary of Consolidated Statement of Profit or Loss and Other Comprehensive Income (for the six months ended June 30) | Metric | 2025 (USD) | 2024 (USD) | | :--- | :--- | :--- | | Revenue | 10,471,494 | 9,566,753 | | Cost of Sales | (3,368,970) | (4,901,164) | | Gross Profit | 7,102,524 | 4,665,589 | | Other Income and Other Gains / (Losses) | 8,766,264 | (3,279,511) | | Selling and Distribution Expenses | (6,287,446) | (7,044,074) | | Research and Development Expenses | (9,225,967) | (10,693,149) | | General and Administrative Expenses | (20,233,209) | (21,217,439) | | Results from Operating Activities | (19,956,308) | (37,568,584) | | Loss Before Tax | (28,254,881) | (44,387,160) | | Loss for the Period | (28,228,236) | (44,325,936) | | Loss Attributable to Equity Holders of the Company | (28,352,272) | (44,451,768) | | Basic and Diluted Loss Per Share | (0.185) | (0.370) | [Consolidated Statement of Financial Position](index=3&type=section&id=Consolidated%20Statement%20of%20Financial%20Position) As of June 30, 2025, total assets increased to **$163.2 million**, net current assets turned positive to **$96.6 million**, and total equity shifted from deficit to **$114.5 million** due to convertible redeemable preferred shares conversion Summary of Consolidated Statement of Financial Position (as of June 30) | Metric | June 30, 2025 (USD) | December 31, 2024 (USD) | | :--- | :--- | :--- | | Total Assets | 163,211,156 | 71,354,352 | | Total Non-current Assets | 33,485,946 | 36,557,943 | | Total Current Assets | 129,725,210 | 34,796,409 | | Total Liabilities | 48,684,033 | 269,595,191 | | Total Current Liabilities | 33,137,108 | 48,108,811 | | Total Non-current Liabilities | 15,546,925 | 221,486,380 | | Net Current Assets / (Liabilities) | 96,588,102 | (13,312,402) | | Total Equity / (Deficiency) | 114,527,123 | (198,240,839) | [Basis of Preparation](index=5&type=section&id=Basis%20of%20Preparation) This interim financial information is prepared under HKEX Listing Rules and IAS 34, using consistent accounting policies with the 2024 annual financial statements, including condensed consolidated financial statements and explanatory notes - Interim financial reports are prepared in accordance with the HKEX Listing Rules and International Accounting Standard 34, adopting the same accounting policies as the 2024 annual financial statements[10](index=10&type=chunk) - The report includes condensed consolidated financial statements and selected explanatory notes, aiming to explain significant changes in financial position and performance since December 31, 2024[11](index=11&type=chunk) [Changes in Accounting Policies](index=6&type=section&id=Changes%20in%20Accounting%20Policies) Revisions and new standards of IFRS effective in the current accounting period have not materially impacted the Group's current or prior period results and financial position - Multiple amendments and new standards issued by the IASB have not had a material impact on the Group's current or prior period results and financial position[12](index=12&type=chunk) [Business Overview](index=5&type=section&id=Business%20Overview) [Company Profile](index=5&type=section&id=Company%20Profile) Mirxes Holding Company Limited, incorporated in the Cayman Islands on November 17, 2020, and listed on the HKEX Main Board on May 23, 2025, specializes in developing and commercializing precise, non-invasive, affordable, blood-based miRNA test kit products for early cancer and other disease detection - The company was incorporated in the Cayman Islands on November 17, 2020, and listed on the Main Board of the Hong Kong Stock Exchange on May 23, 2025[8](index=8&type=chunk) - The Group primarily engages in the development and commercialization of precise, non-invasive, affordable, blood-based miRNA test kit products for early detection of cancer and other diseases[8](index=8&type=chunk) [Product Pipeline](index=18&type=section&id=Product%20Pipeline) The company boasts a diverse miRNA diagnostic pipeline for gastric, lung, colorectal, liver, breast, and multi-cancer detection, alongside pulmonary hypertension and heart failure, with core product GASTROClearTM commercialized in Singapore and granted FDA Breakthrough Device designation - As of June 30, 2025, the company has one core product (GASTROClearTM), two other commercialized products (LUNGClearTM and FortitudeTM), and six preclinical-stage candidate products[40](index=40&type=chunk) - GASTROClearTM is the world's first and only approved molecular diagnostic IVD product for gastric cancer screening, successfully commercialized in Singapore and granted FDA Breakthrough Device designation[43](index=43&type=chunk) - Various candidate products including LUNGClearTM, CRC-1, LV-1, BC-1, CADENCE, PHinder, and HF-1 are in different development stages, covering lung cancer, colorectal cancer, liver cancer, breast cancer, multi-cancer detection, pulmonary hypertension, and heart failure[44](index=44&type=chunk)[45](index=45&type=chunk)[46](index=46&type=chunk)[47](index=47&type=chunk)[48](index=48&type=chunk)[49](index=49&type=chunk)[50](index=50&type=chunk) [Core Product: GASTROClearTM](index=18&type=section&id=Core%20Product%3A%20GASTROClearTM) GASTROClearTM is the world's first and only approved molecular diagnostic IVD for gastric cancer screening, successfully commercialized in Singapore and granted FDA Breakthrough Device designation - GASTROClearTM is the world's first and only approved molecular diagnostic IVD product for gastric cancer screening, comprising 12 miRNA biomarkers[40](index=40&type=chunk)[43](index=43&type=chunk) - It obtained Singapore HSA Class C IVD certification and successful commercialization in May 2019, CE-IVD certification in November 2017, and US FDA Breakthrough Device designation in May 2023[43](index=43&type=chunk) - The product serves as a supplementary test to the gold standard for gastric cancer screening, and its development experience was a valuable reference for drafting miRNA molecular diagnostic industry standards, including Singapore Standard 656[43](index=43&type=chunk) [Other Candidate Products](index=20&type=section&id=Other%20Candidate%20Products) The company's pipeline includes LUNGClearTM commercialized as LDT in Southeast Asia and Japan, CRC-1 prototyping for IVD registration in Singapore and China, and early-stage development for LV-1, BC-1, CADENCE, PHinder, and HF-1 - LUNGClearTM (lung cancer screening) has been commercialized as an LDT service in Southeast Asia since December 2022 and in Japan since January 2023, aiming to enhance early lung cancer detection and reduce LDCT scan radiation[44](index=44&type=chunk) - CRC-1 (colorectal cancer screening) is expected to complete prototyping in H2 2025, with plans for IVD registration in Singapore and China, and clinical trials anticipated to start in 2026[45](index=45&type=chunk) - LV-1 (liver cancer screening), BC-1 (

新加坡微小核糖核酸(miRNA)技术公司MIRXES-B(2629.HK)今日盘中一度涨8.1%至47.8港元，股价创上市新高，市值约132亿港元。该股于今年5月23日登陆 港交所，上市迄今不到3个月，现价较发行价23.3港元已累涨105%。 MIRXES-B公告，公司间接全资附属公司MiRXESPTE. LTD.近期已与PT DIASTIKA BIOTEKINDO(一间于印尼证券交易所上市的公司)订立一份谅解备忘 录，据此，双方同意在印尼进行用于高发病率及高死亡率癌症早期检测及诊断的分子诊断检测及相关仪器的注册及商业化方面进行合作。谅解备忘录期限自 签署日期起计为期12个月。董事会相信订立谅解备忘录乃集团推动全球化策略并将业务扩张至高潜力新兴市场的关键举措。(格隆汇) ...

Core Viewpoint - MIRXES-B (02629) has seen a significant increase in stock price, reaching a new high of 47.8 HKD, driven by a strategic partnership with PT DIASTIKA BIOTEKINDO for cancer diagnostics in Indonesia [1][2] Group 1: Partnership and Market Expansion - The company has signed a memorandum of understanding with PT DIASTIKA BIOTEKINDO to collaborate on molecular diagnostic testing and related instruments for early detection and diagnosis of high-incidence and high-mortality cancers in Indonesia [1][2] - This partnership allows the company to leverage PT DIASTIKA BIOTEKINDO's existing channels to enter the Indonesian market with blood-based microRNA or multi-omics cancer detection devices [2] - The collaboration aims to utilize local policies in Indonesia, such as tax incentives for local content, and regulatory flexibility under ASEAN medical device frameworks to facilitate market entry [2] Group 2: Regional and Global Strategy - Indonesia is positioned as a pilot region for the company's operations, with plans to replicate the business model in Southeast Asia, the Middle East, North Africa, and other regions that share similar cancer profiles and healthcare structures [2]

Core Viewpoint - MIRXES-B (02629) has seen a significant increase in stock price, rising over 8% to reach a new high of 47.8 HKD, following the announcement of a memorandum of understanding with PT DIASTIKA BIOTEKINDO for collaboration in the Indonesian market [1][2] Group 1 - The company’s indirect wholly-owned subsidiary, MiRXES PTE. LTD., has entered into a memorandum of understanding with PT DIASTIKA BIOTEKINDO to collaborate on molecular diagnostic testing and related instruments for early detection and diagnosis of high-incidence and high-mortality cancers in Indonesia [1][2] - The memorandum is valid for 12 months from the date of signing [1] - Through this partnership, the company aims to leverage PT DIASTIKA BIOTEKINDO's existing channels to deploy blood-based microRNA or multi-omics cancer detection devices in the Indonesian market [2] Group 2 - The collaboration will allow the company to benefit from Indonesia's localization policies, such as tax incentives for local content rates of 40% [2] - The partnership is expected to provide regulatory flexibility under the ASEAN-centered medical device framework [2] - Indonesia is viewed as a pilot region for the company to replicate its business model in Southeast Asia, the Middle East, North Africa, and other regions with similar cancer profiles and healthcare structures [2]

Core Viewpoint - MIRXES-B has seen a significant increase in stock price, reaching a new high following the announcement of a collaboration with PT DIASTIKA BIOTEKINDO for cancer diagnostics in Indonesia [1][2] Group 1: Company Developments - On August 15, MIRXES-B announced a memorandum of understanding with PT DIASTIKA BIOTEKINDO to collaborate on molecular diagnostic testing and related instruments for early detection and diagnosis of high-incidence and high-mortality cancers in Indonesia [1] - The memorandum is valid for 12 months from the date of signing [1] Group 2: Market Expansion Strategy - Through the partnership with PT DIASTIKA BIOTEKINDO, the company aims to enter the Indonesian market by deploying blood-based microRNA or multi-omics cancer detection devices for prevalent cancers such as gastric and lung cancer [2] - The collaboration will leverage local policies in Indonesia, such as tax incentives for local content, and regulatory flexibility under ASEAN-centered medical device frameworks [2] - Indonesia is viewed as a pilot region for expanding operations to Southeast Asia, the Middle East, North Africa, and other areas with similar cancer profiles and healthcare structures [2]

Group 1 - MIRXES-B (02629) has shown strong performance in the Hong Kong biotech sector, reaching a historical high of 44.98 HKD, representing a cumulative increase of over 93% since its IPO price of 23.3 HKD [1][32] - The stock has a market capitalization of 12.22 billion HKD and a trading volume of 1.16 million shares as of August 15 [1] - The stock is expected to be included in the Hong Kong Stock Connect, which has historically led to significant price increases for newly listed companies [3][4] Group 2 - MIRXES-B has a fully circulated structure, which differentiates it from traditional stocks that face lock-up periods and potential selling pressure after listing [6][7] - The company has a strong market position with its GASTROClear™ product, the only approved molecular diagnostic IVD product for gastric cancer screening globally [24][30] - The market for cancer screening in selected regions is projected to grow from 50.4 billion USD in 2023 to 82.8 billion USD by 2033, with a compound annual growth rate of 11.3% [25] Group 3 - The company has established significant technical barriers, including a sensitivity of 87% for miRNA detection, which is superior to traditional tumor markers [24][31] - The penetration rate for gastric cancer screening in high-risk populations in China has increased from 21.6% in 2019 to 27.8% in 2023, with expectations to reach 67.0% by 2033 [28] - Despite current financial performance needing improvement, the rapid development of precision medicine and the company's technical advantages suggest significant long-term potential [32]

Core Viewpoint - MiRXES-B (02629) has entered into a memorandum of understanding with PT DIASTIKA BIOTEKINDO to collaborate on the registration and commercialization of molecular diagnostic tests and related instruments for early detection and diagnosis of high-incidence and high-mortality cancers in Indonesia [1] Group 1 - The memorandum is valid for 12 months from the date of signing [1] - The collaboration allows MiRXES to leverage PT DIASTIKA BIOTEKINDO's existing channels to enter the Indonesian market with blood-based microRNA or multi-omics cancer detection devices for prevalent cancers such as gastric and lung cancer [1] - The partnership aims to utilize local policies in Indonesia, such as tax incentives for a localization rate of 40%, and regulatory flexibility under ASEAN-centered medical device frameworks [1] Group 2 - Indonesia is viewed as a pilot region for the business, with plans to replicate operations in Southeast Asia, the Middle East, North Africa, and other regions that have similar cancer profiles and healthcare structures [1]

Group 1 - The company MiRXES-B (02629) has signed a memorandum of understanding with PT DIASTIKA BIOTEKINDO for collaboration in molecular diagnostic testing and related instruments for early detection and diagnosis of high-incidence and high-mortality cancers in Indonesia [1] - The memorandum is valid for 12 months from the date of signing [1] - The collaboration allows the company to leverage PT DIASTIKA BIOTEKINDO's existing channels to enter the Indonesian market with blood-based microRNA or multi-omics testing devices for high-incidence cancers such as gastric and lung cancer [1] Group 2 - The partnership enables the company to benefit from local policies in Indonesia, such as tax incentives for localization rates of 40% [1] - The collaboration aims to achieve regulatory flexibility under the ASEAN-centered medical device framework [1] - Indonesia is positioned as a pilot region for the company to replicate its business model in Southeast Asia, the Middle East, North Africa, and other regions with similar cancer profiles and healthcare structures [1]

Core Viewpoint - Company MiRXES-B has signed a memorandum of understanding with PT DIASTIKA BIOTEKINDO to collaborate on the registration and commercialization of molecular diagnostic tests for early detection and diagnosis of high-incidence and high-mortality cancers in Indonesia [1][2] Group 1: Collaboration Details - The memorandum is valid for 12 months and includes activities such as sales and distribution of new blood-based microRNA and multi-omics cancer early detection products in Indonesia [1] - The collaboration will involve joint development and clinical validation of projects for the registration of diagnostic devices, as well as training activities for Indonesian scientists and laboratory users [1] - The partnership will explore local manufacturing opportunities [1] Group 2: Market Potential and Strategy - PT DIASTIKA BIOTEKINDO operates a network of over 300 hospitals in Indonesia, providing immediate scale benefits for medical services, with 70% of these hospitals located in Java, serving 57% of the Indonesian population [2] - The collaboration allows the company to leverage existing distribution channels to enter the Indonesian market with blood-based cancer detection devices [2] - The partnership aims to utilize Indonesia's localization policies for tax incentives and regulatory flexibility, with plans to replicate the business model in Southeast Asia, the Middle East, North Africa, and other regions with similar cancer profiles and healthcare structures [2]