e-Therapeutics Plc

LONDON, Oct. 31, 2024 (GLOBE NEWSWIRE) -- e-therapeutics plc, a company integrating computational power and biological data to discover life-transforming RNAi medicines, today announced business updates, including its unaudited interim results for the six months to 31st July 2024. Ali Mortazavi, CEO, said: “We continue to make strong and rapid progress towards becoming a clinical-stage biotech company, as we advance our pipeline of novel GalOmic therapies, aiming to file our first IND submission in 2025. I am also excited about the ongoing evolution of HepNet. Our investment in AWS infrastructure demonstrates our commitment to integrating cutting-edge technologies across our platform. To further these efforts, we are thrilled to welcome Dr Lee Clewley as our Vice President of Applied AI and to announce the promotion of Dr Natalie Pursell to Vice President of Early-stage Development. With a powerful AI-driven platform and a growing GalOmic pipeline, we continue to be well-equipped to transform the landscape of RNAi therapeutics as we advance towards clinical trials.” GalOmic Pipeline Progress ETX-312 for the treatment of Metabolic Dysfunction-Associated Steatohepatitis (MASH): ETX-312 continues to progress through IND-enabling studies with an IND submission anticipated during 2025.ETX-148 for the treatment of Bleeding Disorders: ETX-148 IND-enabling studies initiated, with an IND submission anticipated during 2026.ETX-407 for the treatment of Dry Age-Related Macular Degeneration: ETX-407 continues to progress through the initial phase of IND-enabling studies, following a stage-gated approach to ensure the efficient use of capital.ETX-258 for the treatment of Heart Failure: This program has completed preclinical proof-of-concept studies, with selected data due to be presented at the upcoming American Heart Association Conference.ETX-394 for the treatment of MASH: Our second MASH program continues to advance through preclinical proof-of-concept studies. ETX-394 targets different disease biology to ETX-312, silencing another novel and differentiated target gene. HepNet Platform Updates Infrastructure Development: We are working with Amazon Web Services (AWS) to accelerate advancement of our Generative AI capabilities, leveraging AWS’ global leadership in AI and cloud infrastructure to enhance the design and scalability of our systems with cutting-edge large-language model (LLM) technologies via AWS Bedrock.Application of Latest Artificial Intelligence: We continue to leverage the latest developments in AI to enhance existing processes, including our target-indication assessment workflow that enables us to nominate new programs with confidence in biology, developability, and commercial viability. Additional Corporate Updates Expanding our Leadership Team Dr Natalie Pursell was promoted to VP, Early-stage Development. Natalie has served as Head of Preclinical Development at ETX since April 2023, using her extensive knowledge of preclinical research and oligonucleotide therapeutics to drive the progress of our GalOmic pipeline. Prior to this, she held leadership positions at RNA biotech companies such as Dicerna Pharmaceuticals and Moment Biosciences.Addition of Dr Lee Clewley to ETX as VP, Head of Applied AI and Informatics. Lee specialises in integrating AI into medicine discovery and delivery processes. Most recently, Lee was Head of Applied AI at GSK, where he led the development of a number of innovative projects designed to accelerate biopharma pipelines. Strengthening the Board: Jeremy Punnett was appointed to the Board of Directors in July 2024. Jeremy is a fund manager at M&G Investment Management Ltd and has been involved in numerous private and public investment transactions, including M&G’s most recent investment in ETX. Financial Highlights Cash Position: Cash and cash equivalents were £41.0 million as of 31 July 2024, including a fundraise of £28.9 million gross in June 2024 (31 January 2024: £20.7 million).Operating Loss: Operating loss was £7.5 million as of 31 July 2024 (H1 2023/24 loss: £7.0 million).Research and Development Expenses: R&D expenditure increased to £5.6 million for H1 2024/25 (H1 2023/24: £5.3 million), reflecting investment in industry-leading talent and continued advancement of our pipeline.General and Administrative Expenses: General and administrative costs rose to £2.0 million (H1 2023/24: £1.8 million) due to increased spend on human resources to continue the growth of our expert team, alongside further consultancy costs to support operations and progression of our pipeline towards the clinic.Headcount: Headcount (excluding Non-Executive Directors) was 39 as of 31 July 2024 (31 January 2024: 38). About e-therapeutics plc e-therapeutics plc ("ETX") uniquely combines computation and RNAi to discover and develop life-transforming medicines. ETX's proprietary RNAi chemistry platform, GalOmic™, enables generation of specific, potent, and durable siRNA therapeutics for effective silencing of novel gene targets in hepatocytes. The cutting-edge HepNet™ computational platform allows ETX to discover better medicines faster through generation of novel insights and increased automation across all stages of drug development. HepNet™ encompasses an extensive hepatocyte-specific knowledgebase and a suite of advanced AI-driven approaches which enable identification of novel gene targets, rapid target-indication assessment, and predictive in silico siRNA design. The Company has specialist expertise and a robust position in applying computation to biology. Its computational approaches have been extensively validated through generation of data from pipeline programs and successful drug discovery collaborations with biopharma companies, such as Novo Nordisk, Galapagos NV, and iTeos Therapeutics. Leveraging the combined capabilities of HepNet™ and GalOmic™, ETX is progressing a therapeutic pipeline of highly differentiated RNAi candidates across a variety of therapeutic areas with high unmet need. The Company has generated positive proof-of-concept data on preclinical assets in metabolic dysfunction-associated steatohepatitis (MASH), dry age-related macular degeneration (dry AMD), haemophilia, heart failure, and cardiometabolic disease, further validating its computationally enhanced approach to research and development. ETX is currently progressing its GalOmic™ therapies towards the clinic with its most developed assets, ETX-312 for MASH, ETX-148 for bleeding disorders, and ETX-407 for dry AMD, at the IND-enabling stage. Press Contactpress@etherapeutics.co.uk Investor Relations Contactinvestorrelations@etherapeutics.co.uk Unaudited Interim Results for the Six Months to 31st July 2024 INCOME STATEMENT FOR THE PERIOD ENDED 31 JULY 2024 6 months ended31 July 20246 monthsended 31 July 2023Year ended 31 January 2024 (unaudited)(unaudited)(audited) £’000£’000£’000Revenue-160318Cost of sales---Gross profit-160318Research and development expenditure(5,554)(5,324)(10,247)Administrative expenses(1,966)(1,806)(3,865)Operating loss(7,520)(6,970)(13,794)Interest income277343740Interest expense(28)(4)(27)Loss before tax(7,271)(6,631)(13,081)Taxation1,0091,0371,915Loss for the period/year attributable to equity holders of the Company(6,262)(5,594)(11,166)Loss per share: basic and diluted(0.89)p(0.97)p(1.91)p STATEMENT OF COMPREHENSIVE INCOME FOR THE SIX MONTHS ENDED 31 JULY 2024 6 months ended31 July 20246 months ended31 July 2023Year ended31 January 2024 (unaudited)(unaudited)(audited) £’000£’000£’000Loss for the period(6,262)(5,594)(11,166)Other comprehensive income---Total comprehensive income for the period/year attributable to equityholders of the Company(6,262)(5,594)(11,166) STATEMENT OF CHANGES IN EQUITY FOR THE PERIOD ENDED 31 JULY 2024 SharecapitalSharepremiumRetainedearningsTotal £’000£’000£’000£’000As at 31 January 2023582112,613(80,151)33,044Total comprehensive income for the period Loss for the period--(5,594)(5,594)Total comprehensive income for the period--(5,594)(5,594)Transactions with owners, recorded directly in equity Issue of ordinary shares121-22Equity-settled share-based payment transactions--5959Total contributions by and distribution to owners1215981As at 31 July 2023583112,634(85,686)27,531Total comprehensive income for the period Loss for the period--(5,572)(5,572)Total comprehensive income for the period--(5,572)(5,572)Transactions with owners, recorded directly in equity Issue of ordinary shares114-15Equity-settled share-based payment transactions--1919Total contributions by and distribution to owners1141934As at 31 January 2024584112,648(91,239)21,993Total comprehensive income for the period Loss for the period--(6,262)(6,262)Total comprehensive income for the period--(6,262)(6,262)Transactions with owners, recorded directly in equity Issue of ordinary shares19328,714-28,907Equity-settled share-based paymenttransactions--2525Total contributions by and distribution to owners19328,7142528,932As at 31 July 2024777141,362(97,476)44,663 STATEMENT OF FINANCIAL POSITION AS AT 31 JULY 2024 31 July 202431 July 202331 January2024 Note (unaudited)(unaudited)(audited) £’000£’000£’000Non-current assets Intangible assets 658301407Property, plant and equipment 1,103175988 1,7614761,395Current assets Tax receivable 2,9442,5371,935Trade and other receivables 512302470Prepayments 419647504Cash and cash equivalents 41,04324,84520,665 44,91828,33123,574Total assets 46,67928,80724,969Current liabilities Trade and other payables 1,4951,1862,266Lease Liability 42490393Contract liabilities --- 1,9191,2762,659Non-current liabilities Lease Liability 97-317Total liabilities 2,0161,2762,976 Net assets 44,66327,53121,993Equity Share capital2777583584Share premium 141,362112,634112,648Retained earnings (97,476)(85,686)(91,239)Total equity attributable to equityholders of the Company 44,66327,53121,993 CASH FLOW STATEMENT FOR THE PERIOD ENDED 31 JULY 20246 months ended31 July 20246 months ended31 July 2023Year ended31 January2024 (unaudited)(unaudited)(audited) £’000£’000£’000Loss for the period/year(6,262)(5,594)(11,166)Adjustments for: Depreciation, amortisation and impairment266271535Loss on disposal of fixed assets--1Interest income(277)(343)(740)Interest expense28427Equity-settled share-based payment expenses255978Taxation(1,009)(1,037)(1,935)Operating cash flows before movements in working capital(7,229)(6,640)(13,200)(Increase)/Decrease in trade and other receivables43(137)(162)Increase/(Decrease) in trade and other payables(771)(110)965Tax received--1,500Net cash from operating activities(7,957)(6,887)(10,897)Interest received277343740Interest paid(28)(4)(27)Acquisition of property, plant and equipment(374)(5)(247)Acquisition of other intangible assets(259)(103)(234)Movement in short term investments---Net cash from investing activities(384)231232Net proceeds from issue of share capital28,9072237Repayment of lease liability(188)(210)(396)Net cash from financing activities28,719(188)(359)Net decrease in cash and cash equivalents20,378(6,844)(11,024)Cash and cash equivalents at the beginning of the period/year20,66531,68931,689Cash and cash equivalents at the end of the period/year41,04324,84520,665 Notes 1. Basis of Preparation These unaudited interim financial statements do not comprise statutory accounts as defined within section 434 of the Companies Act 2006. The Company is a public unquoted limited company; and is incorporated and domiciled in the United Kingdom. The address of its registered office is 4 Kingdom Street, Paddington, London, W2 6BD, UK. Statutory accounts for the year ended 31 January 2024 were approved by the Board of Directors on 5 June 2024 and delivered to the Registrar of Companies. The report of the Auditor on the accounts was unqualified, did not contain an emphasis of matter paragraph and did not contain any statement under section 498 of the Companies Act 2006. While this interim statement, which is neither audited nor reviewed, has been prepared in accordance with the recognition and measurement criteria of international accounting standards in conformity with the requirements of the Companies Act 2006 this announcement does not in itself contain sufficient information to comply with IFRS. It does not include all the information required for the full annual financial statements and should be read in conjunction with the financial statements as at, and for the year ended, 31 January 2024. It does not comply with International Accounting Standard ("IAS") 34 'Interim Financial Reporting'. The accounting policies applied in preparing these interim financial statements are the same as those applied in the preparation of the annual financial statements for the year ended 31 January 2024 (as defined therein) other than standards, amendments and interpretations which became effective after 1 February 2024. New standards, amendments and interpretations not adopted in the current financial year have not been disclosed as they are not expected to have a material impact on the Company’s financial statements. 2. Share Capital 31 July 2024 31 July 202331 January 2024 (unaudited)(unaudited)(audited)In issue - fully paid Ordinary shares of £0.001 each (number) 777,074,147582,694,162584,335,487Allotted, called up and fully paid Ordinary shares of £0.001 each (£'000)777583584 During the six-month period to 31 July 2024, 192,666,667 new ordinary shares of 0.1p each were issued following an equity fundraise of £28.9 million by way of two direct subscription of funds, managed by M&G Investment Management Limited and Ora Ventures Limited; £19.65 million and £9.25 million raised respectively. In addition, 71,993 new ordinary shares of 0.1p each were issued at a price of 9.95p each in lieu of fees payable to a non-executive director in accordance with his service agreement.

英国伦敦证交所似乎正在成为Biotech融资的禁区，放在以前，许多英国当地的Biotech会倾向于前往伦敦证交所的AIM（另类投资市场）板块上市。 1995年成立的AIM是个类似国内“新三板”的板块，上市条件非常宽松，外加有来自离岸金融中心的优势（许多上市公司在英吉利海峡群岛或英属维尔京群岛注册），因此在一段时间内也成为了许多当地Biotech挂牌的地方。 但在近期，许多当地Biotech企业不再能从AIM获得公共资金，这促使一些企业向美国市场寻求现金来扩大业务规模，或者干脆私有化退出市场。当地媒体城市晨报指出，AIM现在已经淹没在私有化收购浪潮中，过去一年中这种私有化事件增长了75%，达到12年来的最高水平。 Redx Pharma Redx Pharma可以说是近年来非常倒霉的一家英国Biotech，这家公司最开始于2015年上市于AIM，而且所开发的管线完全有能力大卖，但因为机缘巧合错过了： Redx Pharma是最开始开发BTK抑制剂匹妥布替尼的，后来匹妥布替尼仅以4000万美元被Loxo Oncology低价收购。而Loxo Oncology被礼来收购后，礼来却将匹妥布替尼作为了“重磅炸弹”开发，销售额预测可达30亿美元，可以说Redx Pharma白白错失了“泼天富贵”。非常可惜。 该公司另外的失利来自于核心管线，去年3月porcupine抑制剂RXC004胆道癌临床失败，放弃单药应用，RXC004失败的原因被认为可能是质量窗口太小，拿得出手的管线仅剩下ROCK2抑制剂RXC007和2020年独家授权给阿斯利康的porcupine抑制剂RXC006，用于治疗纤维化疾病。 第二重要的核心管线失利，Redx Pharma也在英国市场上失去了公共资金支持，股价大跌。为了起码能推动RXC007的临床，Redx Pharma与美国公司Jounce Therapeutics在纳斯达克反向合并上市，身为壳的Jounce Therapeutics彻底放弃了自身管线而寻求出售。然而5月的时候，神秘搅局者收购了Jounce Therapeutics，这导致合并报团取暖都做不到。 祸不单行的是，今年Q1的时候，阿斯利康退货了RXC006，Redx Pharma在AIM的股价也随着坏消息而一路下跌。为了生存，该公司还将KRAS G12C抑制剂卖给了Jazz。 很显然，Redx认为AIM市场的流动性限制正在削弱其估值。因此Redx Pharma就从AIM退市。董事会认为，作为一家私营公司，私有化可以接触到更广泛的专业投资者。后续交易就放在了JP Jenkins上。 ReNeuron ReNeuron最初是一家干细胞治疗公司，2022年年初，该公司突然改变了战略开发方向，停止了治疗色素性视网膜炎的干细胞疗法，以将其资源集中在其外泌体平台和相关合作上。 这一决定其实并不意外，2019年这一疗法披露临床时的数据就不怎么好看，22年年初的决定算是比较正确的。 不过，22年初的战略方向更改并不能挽回22年年底的颓势，该公司在22年12月宣布融资失败，裁员40%，来应对现金流压力。这次削减让公司的现金流赛道延长到了今年。 而到了今年，现金流压力也终于给到。 公司管理层目前正在与ReNeuron的债权人商谈，以确定该企业的偿付能力。一旦相关洽谈结束，公司管理层将与董事会一起决定下一步措施。大概率会退出AIM市场，并私有化。 e-therapeutics e-therapeutics是一家小核酸药物的AI发现公司，持有RNAi化学开发平台GalOmic和HepNet计算平台，目前处于IND阶段的管线是：用于MASH的ETX-312，用于干性AMD的ETX-407，目前管线相对处于早期。 虽然没有什么负面消息，但e-therapeutics离开AIM时颇有怨言，CEO当时就指出，英国投资者的风险偏好意味着“ETX等公司在AIM市场的受众有限。” 总结 除了上述提及的退市公司意外，其他的离场者还有Oxford Cannabinoid Technologies和Destiny Pharma等等。 城市晨报指出，现金从专注于英国的股票基金中流出，仅2023年就损失了140亿英镑。这拖累了较小的公司，引起了踩踏事件，更令人担忧的是，如果没有足够的资本流入市场，未来进入AIM市场的资本只会越来越少，一些公司股价也会越来越低。 城市晨报认为，问题可能在于运营模式，AIM似乎仍然在用30年前的上市模式，上市花费过高，上市将花费约50万英镑，RNS公告费、法律费用和其他费用每年增加约20万英镑。 鉴于在AIM上市的约400家公司市值低于5000万英镑，这对英国的小企业来说是一个高昂的代价。 Biotech出现退市潮毫不让人意外。

“In-silico Drug Discovery Market” in terms of revenue was estimated to be worth $10.9 Bn in 2023 and is poised to reach $40.3 Bn by 2031, growing at a CAGR of 18.05% from 2024 to 2031 according to a new report by InsightAce Analytic. Market Analysis: One of the key elements anticipated to boost market expansion and demand is the increase in the amount of drug discovery data. Throughout the projection period, the market is also anticipated to increase as a result of the acceleration of growth in the biomarker identification field and the emphasis on lowering readmission and medical mistake rates. In addition, two important aspects that are anticipated to drive market expansion are the affordability and widespread use of in-silico drug designing services. Download Free Report Sample Pages: Latest Drivers Restraint and Opportunities Market Snapshot: Key factors influencing the in-silico drug discovery market are: Increasing Focus On Reducing Drug Errors Increasing Use Of Cloud-Based Software In Drug Discovery Rapid Technical Advancements In The Computational Biology Sector The following are the primary obstacles to the in-silico drug discovery market’s expansion: Lack Of Awareness About Safety And Health High Expense Of Techniques And Approaches High Levels Of Investment Are Required To Construct The Infrastructure For Healthcare Future expansion opportunities for the in-silico drug discovery market include: Growing Use Of Modern Biomarker Identification Tools Increasing Government Expenditures On R&D Growing Alliances And Partnerships Between Top Academic Institutions And Businesses Involved In Biotechnology And Pharmaceuticals Key Industry Insights & Findings from the Report: The industry is being propelled by technological advancements in computational biology, a growing emphasis on reducing prescription errors, and the expanding utilization of cloud-based technologies in the field of drug discovery. The globe in-silico drug discovery industry is driven by the growth of novel pharmacological compounds and the swift progression of computational biology technology. In 2023, North America controlled the market and contributed to the global revenue share. The largest share of the in-silico drug discovery market was occupied by preclinical experiments. An increasing number of entities are conducting preclinical trials for a variety of reasons, including the demand for more effective medications, the increasing complexity of diseases, and regulatory constraints. List of Prominent Players in the In-silico Drug Discovery Market: Aragen Life Sciences Pvt. Ltd. Curia Global, Inc. Certara, USA. Charles River Chemical Computing Group ULC. Collaborative Drug Discovery Inc. Dassault Systemes e-therapeutics plc. Evotec Insilico Medicine Ligand Pharmaceuticals Incorporated Numerate, Inc. PerkinElmer Inc. Schrödinger, Inc. Selvita Simulations Plus Tracxn Technologies WuXi AppTec Others Recent Developments: January 2022: Insilico Medicine formed a partnership with Fosun Pharma, a Chinese healthcare provider. To generate a new therapeutic portfolio, Insilico's AI-driven, end-to-end drug discovery platforms will be integrated with the clinical development and marketing expertise of Fosun Pharma. April 2021: The E.U. funded the Italian startup InSilicoTrials Technologies' 3 Horizon 2020 project, which aims to use in silico trials to support the development of cutting-edge medical technologies. Future market expansion for computer simulation trials for medical devices is anticipated to benefit from such initiatives. October 2020: The cloud-based software platform for enhancing and automating the biological processes of the enzyme-linked immunosorbent test (ELISA) has been launched by Synthace Ltd. Researchers are now able to create and run automated ELISA protocols with flexibility thanks to the Software Antha. In-silico Drug Discovery Market Dynamics: Market Drivers: Growing Usage of Cloud-Based Software The growing use of cloud technologies is driving the in-silico drug discovery sector. Pharmaceutical researchers can grow their computing environment as needed owing to cloud computing, which gives them access to nearly infinite processing resources. Organizations can more easily adapt solutions to meet their requirements. For instance, B.T.'s Cloud Compute life sciences platform can offer particular pharmaceutical applications from discovery to commercial operations, ensuring that the necessary applications function across pipelines rather than requiring all pipeline teams to use the same application. By allowing drug developers to examine past data as part of their clinical research operations, these tools boost overall productivity and lower the risk of clinical failure. Challenges: Limited Time For Analysis The market for in-silico drug discovery is only constrained by its brief duration. This approach has analysis periods ranging from tens to hundreds of nanoseconds, and it is computationally demanding depending on the size of the stimulated systems. This is problematic because the time interval, which can be anywhere from milliseconds to seconds, is often too brief to detect protein folding. This may lead to an inadequate sampling of protein conformations as a result. North America is Expected to Grow with the Highest CAGR During the Forecast Period In North America, the in-silico drug discovery market is likely to register a significant revenue share and develop at a rapid CAGR over the forecast period. This is explained by the critical need for therapies for uncommon illnesses like Lou Gehrig's disease and cystic fibrosis. Furthermore, U.S. biopharmaceutical businesses are spending more on research and development. U.S. investments in R&D and medicine reached over $250 billion in 2020. The growth of the industry can also be attributed to a more advanced network between manufacturers and service providers than in any other area. Additionally, the U.S. FDA's assistance has cleared up a number of concerns regarding the co-development process and contributed to the creation of a flexible regulatory pathway. The market is also being driven by the existence of strong vendors, technological advancements, an increase in the number of patients with a range of infectious and chronic diseases, and a growing government focus on enhancing the healthcare system. Segmentation of In-silico Drug Discovery Market- By Product Software Software-as-a-Service (SaaS) Consultancy-as-a-Service By Workflow Discovery Target Identification Bioinformatics Reverse Docking Protein Structure Prediction Target Validation Lead Discovery Library Design Pharmacophore Preclinical Tests Clinical Trials By Technology Artificial Intelligence Graphics Processing Unit (GPU) Other Technologies In-Silico Fishing RNN for Drug Design By Software Type Molecular modelling and de novo drug design software Pharmacophore Modelling software By End User Contract Research Organizations Pharmaceutical and Biopharmaceutical Companies Academic and Research Institutes Others By Region- North America- The US Canada Mexico Europe- Germany The UK France Italy Spain Rest of Europe Asia-Pacific- China Japan India South Korea South East Asia Rest of Asia Pacific Latin America- Brazil Argentina Rest of Latin America Middle East & Africa- GCC Countries South Africa Rest of Middle East and Africa Talk with Experts Panel on the In-silico Drug Discovery Market Report @ Call: North America +1 551 226 6109 Email: diana.dsouza@insightaceanalytics.com