Interim results for the six months ended 30 June 2022

Continued operational progress and strengthened financial position provides capital for key value inflection points and continued investment in leading technology platform

• Full data expected in Q1 2023 for BEN-2293 Phase IIa clinical study; a potential treatment for atopic dermatitis and a topical, best-in-class PanTrk inhibitor
• Collaboration extended with AstraZeneca to four disease areas, now with a total of three novel targets selected into their drug development portfolio
• Expect CTA by late 2022 for BEN-8744; an oral PDE10 inhibitor and first-in-class treatment for ulcerative colitis
• Continuous advancement of the BenevolentAI Platform™, enhancing  prediction quality and optimising tools for the discovery of novel targets across multiple modalities
• Cash and cash equivalents of £165.3 million providing sufficient capital to Q4 2024 for key value inflection points without including any future capital from licensing or collaboration agreements

London, UK, 27 September 2022: BenevolentAI (Euronext Amsterdam: BAI), a leading, clinical-stage AI-enabled drug discovery and development company, announces its unaudited interim results for the six months ended 30 June 2022.

Joanna Shields, Chief Executive Officer of BenevolentAI, said: “We are pleased with our performance for the first six months of 2022 as we continue to build both internal and external validation of the Benevolent Platform™, our AI-enabled drug discovery platform. We progressed our in-house pipeline to 13 named platform-generated drug programmes and over 10 exploratory stage programmes and consistently delivered in our collaboration with AstraZeneca, who expanded the collaboration into two new disease areas and selected an additional target during the period. In May, we also gained further clinical validation of our approach after the FDA issued a full approval of baricitinib, the COVID-19 treatment first identified by BenevolentAI.”

“The capital raised from the business combination and listing in April this year puts us in a solid financial position to progress our development portfolio through near and medium-term key value inflection points and allows us to increase investment in our differentiated technology. As we look to the future, BenevolentAI’s scalable platform and industry-leading novel target identification capabilities have the potential to transform drug discovery by radically improving our understanding of disease biology and ultimately increasing the probability of clinical success.”

Operational highlights (including post-period)

• Continued development of in-house pipeline across several disease areas with all programmes generated by the Benevolent Platform™, validating its disease-agnostic capabilities.

Clinical programme

• BEN-2293 – topical best-in-class PanTrk inhibitor for atopic dermatitis (AD); data expected in Q1 2023 and on track to complete Phase IIa clinical study by end-2022
• Aim to deliver one to two CTA/IND drug candidates per year

Pre-clinical programmes

• BEN-8744 – oral peripherally-restricted PDE10 inhibitor and first-in-class treatment for ulcerative colitis (UC); CTA expected by late 2022 and a Phase I study anticipated to start in early 2023
• BEN-9160 – oral best-in-class asset for amyotrophic lateral sclerosis (ALS); IND enabling studies are expected to start Q1 2023 pending read-out of the in-vivo efficacy model
• BEN-28010 – oral best-in-class centrally penetrant asset for glioblastoma multiforme (GBM); nominated as a clinical candidate with preparation for IND enabling studies ongoing

Drug discovery and target identification (ID) 

• Working to transition at least one further project into lead optimisation in Q4 2022, with two projects already advanced in H1 2022
• Initiated two new drug discovery programmes in H1 2022 with a further two-to-three anticipated in Q4 2022
• Going forward, intend to focus internal Target ID capabilities on three specific therapy areas: immunology, oncology and neurology
• Strategy enables the Company to build focused expertise to successfully develop assets and, in the future, potentially commercialise with or without a partner

• Consistent delivery in commercial Target ID collaboration with AstraZeneca (AZ) providing ongoing Platform validation:
• Collaboration initiated in 2019 to support novel target identification utilising AI and machine learning for two indications: chronic kidney disease (CKD) and idiopathic pulmonary fibrosis (IPF) with one target selected and validated in-house by AZ for each indication in 2021
• A three-year collaboration extension announced in January 2022, adding two new disease areas: systemic lupus erythematosus (SLE) and heart failure (HF)
• Second novel target selected for IPF in May, taking the total number of novel targets selected to three overall
• Collaboration provided upfront license fees with the potential for future development milestones and sales-based royalty revenues on any successfully commercialised asset

• Full FDA approval of COVID-19 treatment first identified by BenevolentAI providing clinical and regulatory validation

• In May 2022, the US Food and Drug Administration (FDA) granted full approval for baricitinib (approved for rheumatoid arthritis and marketed by Eli Lilly) to treat COVID-19 in hospitalised adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO), clinically validating BenevolentAI’s approach
• BenevolentAI first identified baricitinib as a repurposed drug candidate in 2020 using the Benevolent Platform™. Baricitinib delivered a 38% reduction in mortality in hospitalised patients, rising to 46% for those on supplemental oxygen, in Eli Lilly’s COV-BARRIER trial
• As previously disclosed, Eli Lilly subsequently invested in BenevolentAI in 2020

• Non-commercial collaborations

• Initiated phase two of AI research partnership with the Stanford University-based Helix Group in the first half of 2022 to discover more effective methods to extract knowledge from biological and clinical information, discovering and adjudicating contradictions in scientific literature
• Initiated AI research collaboration with the Drugs for Neglected Disease initiative (DNDi) in April to identify potential biological targets and therapies that could be repurposed for dengue to prevent disease progression. Targets have since been provided to the DNDi for experimental validation

Continuous enhancement of the Benevolent Platform™

• Continued growth of data within Knowledge Graph primarily due to an increase in patient-level data (omics) and enhanced natural language processing (NLP) recall (46% of which is proprietary to BenevolentAI)
• Evolution of data representation and introduction of large language models (LLMs) improve quality of reasoning on scientific literature for better understanding of human disease aiming for higher quality target predictions
• Extensions made to the existing Benevolent Platform^TM to optimise the discovery of novel targets best prosecuted by alternative modalities (e.g., monoclonal antibodies). Expected to lead to a biologic entrant into the pipeline, further diversifying the portfolio

Corporate highlights

• Strengthened Board of Directors and Leadership
• Promoted Dr. Daniel Neil to Chief Technology Officer, and appointed Nicholas Keher as Chief Financial Officer and Dr. Nicola Richmond, GSK veteran, as Vice President of Artificial Intelligence
• Dr. Olivier Brandicourt, former CEO of Sanofi, Jean Raby, former CEO of Natixis Investment Managers, and Dr. Susan Liautaud, Stanford University Ethics Expert, appointed as Non-Executive Directors
• Kenneth Mulvany, Founder and Non-Executive Director, stepped down from the Board and Michael Brennan, Co-Founder and Non-Executive Director, will step down on 30 September 2022
• Continued to expand expertise across the business, including in drug discovery and development, with a focus on enhanced clinical capabilities

Financial highlights

• Revenue of £4.8 million (H1 2021: £1.7 million) driven by extended AstraZeneca collaboration
• Drug Discovery R&D expenditure of £19.3 million) (H1 2021: £13.0 million) reflecting continued investment in pipeline and Phase I/II activities on BEN-2293
• Operating loss of £55.3 million (H1 2021: £46.5 million) in line with internal expectations
• £177.9 million gross proceeds from the successful business combination and listing on Euronext Amsterdam completed April 2022

Analyst and Investor briefing 

BenevolentAI's executive leadership team will be hosting a briefing for analysts and investors at 14:00 BST / 09:00 EST on 27 September 2022 at the offices of FTI Consulting (200 Aldersgate, Aldersgate Street, London, EC1A 4HD, United Kingdom). The presentation will also be accessible via webcast with a recording made available on the Company's website shortly afterwards. To register your interest in attending either in person or virtually, please contact FTI Consulting at BenevolentAI@fticonsulting.com or +44 (0) 20 3727 1000.

At the event, BenevolentAI's management team will lead sessions about the Company's approach and technology and its positioning within the wider AI drug discovery market, as well as talking about the Company's pipeline and business model. The event will also include an overview of BenevolentAI's interim results for the period ended 30 June 2022. Presentations will be given by BenevolentAI's executive leadership team in addition to Professor Tom MacDonald of Immunology at Barts and the London School of Medicine and Dentistry, Queen Mary, University of London.

No additional, material new information will be disclosed during the analyst and investor briefing.