e-therapeutics Announces Business Updates and Interim Results

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.

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Unaudited Interim Results for the Six Months to 31st July 2024

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

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.