BenevolentAI 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–(BUSINESS WIRE)–Regulatory News:

BenevolentAI (Euronext Amsterdam: BAI) (“BenevolentAI” or the “Company” or the ”Group”), 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™ 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

		Six months ended 30 June
		2022		2021
		£’000		£’000		% Change
Revenue		4,843		1,664		191%
Normalised research and development spend		(36,553)		(25,980)		41%
Normalised administrative expenses		(23,642)		(22,259)		6%
Normalised operating loss		(55,280)		(46,502)		19%
Normalised basic and diluted EPS, expressed in pence		(47.4p)		(45.8p)		3%
Reported operating loss		(134,547)		(46,502)		189%
Reported basic and diluted EPS, expressed in pence		(123.9p)		(45.8p)		171%
Cash and cash equivalents		165,338		40,553		308%

Analyst and Investor briefing

BenevolentAI’s executive leadership team will be hosting a briefing for analysts and investors at 14:00 BST / 09:00 EDT 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 [email protected] 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.

About BenevolentAI

BenevolentAI (AMS: BAI) is a leading, clinical-stage AI-enabled drug discovery and development company listed on the Euronext Amsterdam stock exchange. Through the combined capabilities of its AI platform, scientific expertise, and wet-lab facilities, BenevolentAI is well-positioned to deliver novel drug candidates with a higher probability of clinical success than those developed using traditional methods. The Benevolent Platform™ powers a growing in-house pipeline of 13 named drug programmes and over 10 exploratory programmes, and it maintains successful collaborations with AstraZeneca, as well as leading research and charitable institutions. BenevolentAI is headquartered in London, with a research facility in Cambridge (UK) and a further office in New York.

Forward-looking Statements

This release may contain forward-looking statements. Forward-looking statements are statements that are not historical facts and may be identified by words such as “plans”, “targets”, “aims”, “believes”, “expects”, “anticipates”, “intends”, “estimates”, “will”, “may”, “should” and similar expressions. Forward-looking statements include statements regarding objectives, goals, strategies, outlook and growth prospects; future plans, events or performance and potential for future growth; economic outlook and industry trends; developments in BenevolentAI’s markets; the impact of regulatory initiatives; and/or the strength of BenevolentAI’s competitors. These forward-looking statements reflect, at the time made, BenevolentAI’s beliefs, intentions and current targets/aims. Forward-looking statements involve risks and uncertainties because they relate to events and depend on circumstances that may or may not occur in the future. The forward-looking statements in this release are based upon various assumptions based on, without limitation, management’s examination of historical operating trends, data contained in BenevolentAI’s records, and third-party data. Although BenevolentAI believes these assumptions were reasonable when made, these assumptions are inherently subject to significant known and unknown risks, uncertainties, contingencies and other important factors which are difficult or impossible to predict and are beyond BenevolentAI’s control. Forward-looking statements are not guarantees of future performance, and such risks, uncertainties, contingencies and other important factors could cause the actual outcomes and the results of operations, financial condition and liquidity of BenevolentAI or the industry to differ materially from those results expressed or implied by such forward-looking statements. The forward-looking statements speak only as of the date of this release. No representation or warranty is made that any of these forward-looking statements or forecasts will come to pass or that any forecast result will be achieved.

OPERATING REVIEW

We are pleased to present our first set of financial results following our business combination and listing on Euronext Amsterdam in April 2022, including an update on the operational progress achieved by BenevolentAI during the Period.

BenevolentAI is a leading, clinical-stage AI-enabled drug discovery company with a track record of producing scientifically-validated drug discoveries by delivering novel drug candidates with a higher probability of clinical success than those developed using traditional industry methods.

We combine advanced AI and machine learning (ML) with cutting-edge science to decipher complex disease biology. Our differentiated approach through the Benevolent Platform™ empowers creativity and innovation in drug discovery and development. This approach has generated a growing in-house pipeline of 13 named drug programmes and over 10 exploratory programmes while supporting successful commercial collaborations with AstraZeneca and leading global research and charitable institutions.

The Benevolent Platform™ is a validated AI-enabled hypothesis-driven platform that powers high-confidence drug discovery. It is disease and modality-agnostic and capable of rapidly generating novel targets at scale. Our corporate strategy to date has been to leverage the Benevolent Platform™ to identify novel drug targets across a range of different therapeutic areas with the aim to reduce time and cost and improve the probability of clinical success compared to industry standards.

Following a strategic review completed during the period by the Board, the Company will now look to focus its in-house pipeline on three specific therapy areas: immunology, oncology and neurology. This focused approach to our strategy will allow us to take forward assets where we have the right capabilities to successfully develop and, in the future, potentially commercialise with or without a partner. Subsequently, at an appropriate time, we will look to out-licence assets in therapeutic areas requiring larger and more complex clinical trials or in areas where we do not have the optimal internal capabilities to develop further.

Over the period, we have invested in expanding our expertise by increasing headcount to over 350. Anticipated hiring will be weighted towards drug discovery and development, with a particular focus on enhanced clinical capability.

The following highlights the progress across our lead in-house clinical and preclinical pipeline assets and the continuous enhancement of the Benevolent Platform™.

BEN-2293 – topical best-in-class PanTrk inhibitor in development to relieve inflammation and rapidly resolve itch in patients with atopic dermatitis (AD): Phase IIa data expected in 2023

BEN-2293 is a drug candidate being explored as a treatment for mild and moderate atopic dermatitis, with the potential to be explored within severe atopic dermatitis. The molecule is an inhibitor of three tropomyosin receptor kinases (“Trk”), TrkA, TrkB and TrkC.

The Company is currently progressing a Phase Ib/IIa double-blind, placebo-controlled, first-in-human, two-part clinical study to investigate the safety, tolerability, PK and efficacy of repeat topical dosing of BEN2293 in 90 patients with mild to moderate AD. The Phase Ib portion of the study in 32 patients was successfully completed in December 2021. The Phase IIa portion in 90 patients is set to complete by end-2022 with data expected in Q1 2023. Efficacy measures incorporated in the study included changes to the eczema area severity index (EASI), affected body surface area (BSA), a validated investigator global assessment (vIGA-AD), a NRS itch scale, time to itch reduction and quality of life questionnaires.

The Benevolent Platform™ identified the role of the Trk receptors as mediators of both itch and inflammation in atopic dermatitis. Applying expertise in molecular design, we were able to design potent and selective inhibitors specifically of the three Trk receptors with high selectivity. We believe that BEN-2293 has the potential to demonstrate efficacy against both itch and inflammation with fewer side effects than steroid creams and various inhibitor treatments that are currently the dominant forms of treatment for this chronic condition.

If BEN-2293 successfully completes this clinical trial, our intention is to partner this asset with a pharmaceutical company that has a focus in dermatology for continued clinical development and, if approved, commercialisation. The addressable market for atopic dermatitis is forecast to exceed $14bn¹ in the seven major markets by 2028.

BenevolentAI has filed for formulation and composition of matter patents covering BEN-2293.

BEN-8744 is an orally administered, peripherally-restricted, PDE10 inhibitor under development as a first-in-class treatment for refractory ulcerative colitis (UC)

IND-enabling studies are ongoing, and a Clinical Trial Application (CTA) is scheduled to be filed by late 2022, with the Phase I trial anticipated to start in early 2023.

The Benevolent Platform™ identified PDE10 as an entirely novel target for the treatment of UC – there was no previously known link between PDE10 and UC or other related inflammatory conditions. The target was experimentally validated in ex vivo UC colon samples from patients with active UC, allowing BenevolentAI to demonstrate efficacious target enzyme inhibition. Accordingly, we will look to demonstrate that BEN-8744 is effective in the treatment of moderate-to-severe cases of UC and with fewer side effects than the anti-TNF and JAK inhibitors that are currently the dominant form of treatment for this disease.

Our aim is to progress BEN-8744 through clinical trials and retain commercial rights to this asset in-house. The combination of high and growing disease prevalence, improved diagnosis, high treatments rates and the existence of numerous drugs in the development pipeline, together with the need for better treatments, is driving a market that is forecast to exceed US$7.8 billion by 2026².

BenevolentAI has filed for second medical use and composition of matters patents in respect of BEN-8744.

BEN-9160 is an orally administered, brain-penetrant asset we are developing as a best-in-class treatment for amyotrophic lateral sclerosis

BEN-9160 is a c-Abl inhibitor. Preclinical safety, drug metabolism and pharmacokinetics (“DMPK”) studies were completed in 2022. IND-enabling studies are expected to start Q1 2023, pending read out of an in-vivo efficacy model. Subject to positive data the asset will then be ready for Phase I studies in 2024.

The Benevolent Platform™ identified the c-Abl enzyme as a target for the treatment of ALS. C-Abl inhibitors had previously been studied primarily in the context of cancer treatments, but in vitro ALS models indicate that BEN-9160 also has the potential to be significantly neuroprotective, and we hope to demonstrate the drug candidate’s efficacy in delaying the progression of ALS in our planned clinical development programme.

BenevolentAI has filed for composition of matter patents covering BEN-9160.

BEN-28010 is an orally administered asset we are developing as a best-in-class treatment for glioblastoma multiforme

This asset was declared a clinical candidate, post period, in July 2022 with preparation for IND-enabling studies ongoing. Subject to positive data the asset will then be ready for Phase I studies in 2024.

BenevolentAI has filed a number of patents covering BEN-28010.

Earlier stage pipeline assets

Across the rest of the pipeline we continue to see good progress, with two assets progressing into lead optimisation in the period and a further two assets expected to enter lead optimisation in the second half of 2022. We have also started two new drug programs in the period, with a further two-to-four expected to enter our pipeline in the second half of 2022 and with all targets generated from the Benevolent Platform™.

Continuous enhancement of the Benevolent Platform™

The Benevolent Platform™ powers a growing pipeline of in-house assets and collaborations. The platform is an AI-enabled, hypothesis-driven drug discovery methodology that draws on a multi-modal biomedical knowledge base and enables scientists to explore underlying disease mechanisms and objectively identify potential novel drug targets.

The platform improves predictions by running repeatable, reproducible processes at scale and continuously learns from insights generated from experimental data generated from the Company’s wet-laboratory facilities and AI models. The impact this continuous learning loop has on our platform increases over time, enabling the company to further enhance target identification and accelerate end-to-end drug discovery.

The BenevolentAI Data Foundations sits at the core of our Platform and drug discovery programmes and is built on the foundations of all publicly relevant biomedical data mined from structured sources and language data, including scientific and patent literature, regulatory documents and primary human data, as well as third-party proprietary data and our in-house experimental data. The Knowledge Graph is constantly enriched to supply a comprehensive representation of biomedical data. Our exploratory tools and predictive models empower scientists to explore relationships in the graph between biological entities and disease networks.

We continue to grow and enrich our Data Foundations with new and generated insights primarily due to an increase in patient-level data (‘omics) and enhanced natural language processing (NLP) recall. This led to an increase of over 250% in relationship volume in the Knowledge Graph from June 2021 to August 2022 (46% of which is proprietary to BenevolentAI) albeit we expect this growth rate to moderate in future years. The Knowledge Graph continues to evolve, and a new version was launched during the period to enhance the recall of facts from scientific literature, supporting more nuance and specificity in our biological relationships.

Beyond our data representation, our AI tools for scientists and predictive algorithms have improved at pace. Extensions and enhancements to our existing suite of tools have been completed that allow for novel targets best prosecuted by alternative modalities for example, monoclonal antibodies.

Contacts

Enquiries:
BenevolentAI:
Nick Keher, Chief Financial Officer

+44(0) 203 781 9360

Media:
Rajin Kang – VP Communications

[email protected]
+44(0) 203 781 9360

Investors:
Fleur Wood – VP Investor Relations

[email protected]
[email protected]
+44(0) 203 781 9360

FTI Consulting:
Ben Atwell/Simon Conway/Victoria Foster Mitchell

+44 203 727 1000

[email protected]

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