Oxford Biodyn Regulatory News (OBD)

30 May 2023

Oxford BioDynamics Plc

("OBD" or the "Company" and, together with its subsidiaries, the "Group")

INTERIM RESULTS FOR THE SIX-MONTH PERIOD ENDED 31 MARCH 2023

Positive momentum on EpiSwitch CiRT, progressing at pace on Prostate Screening EpiSwitch

Oxford BioDynamics Plc (AIM: OBD), a biotechnology company developing precision medicine tests based on the EpiSwitch® 3D genomics platform, today announces its interim results for the six-month period to 31 March 2023.

CORPORATE AND OPERATIONAL HIGHLIGHTS

FINANCIAL HIGHLIGHTS

POST-PERIOD END HIGHLIGHTS

Commenting on the results, Dr Jon Burrows, Chief Executive Officer of Oxford BioDynamics, said:

"The first half of our financial year saw excellent progress across the business. There was sustained growth in orders of EpiSwitch CiRT tests, which has continued post-period end. Overwhelming demand for the PSE blood test after announcement of its high accuracy performance led the Group to accelerate its development.

As OBD continues to lead the way and demonstrate to the market the power of applying 3D genomics to precision medicine and clinical testing, it is good to see and hear that there is a growing understanding and appreciation of the innovative solutions developed using our proprietary EpiSwitch® platform.

We continue to focus commercially on growing CiRT sales and establishing the revenue engine while working diligently to launch the PSE clinical test before the end of 2023."

The information contained within this announcement is deemed to constitute inside information as stipulated under the Market Abuse Regulations (EU) No. 596/2014 which is part of domestic UK law pursuant to the Market Abuse (Amendment) (EU Exit) Regulations (SI 2019/310) ("UK MAR"). Upon the publication of this announcement, this inside information (as defined in UK MAR) is now considered to be in the public domain.

Investor presentation

The Company's management will conduct a presentation to investors via the Yellowstone Advisory webinar platform at 2pm BST on 30 May 2023. The presentation is open to existing and potential shareholders. Questions may be submitted by emailing info@yellowstoneadvisory.com.

To register, please visit: https://us02web.zoom.us/webinar/register/3216841534960/WN_XzaMPjm_TE6YFtNcxVxC1g

For further information please contact:

Notes for Editors

About Oxford BioDynamics Plc

Oxford BioDynamics Plc (AIM: OBD) is a global biotechnology company, advancing personalized healthcare by developing and commercializing precision medicine tests for life-changing diseases.

Its flagship product is EpiSwitch® CiRT (Checkpoint Inhibitor Response Test) for cancer, a predictive immune response profile for immuno-oncology (IO) checkpoint inhibitor treatments, launched in February 2022.

OBD's next commercial product will be the Prostate Screening EpiSwitch® (PSE) blood test, due to be launched in Q4 2023.

In March 2021, the Company launched its first commercial prognostic test, EpiSwitch® CST (Covid Severity Test) and the first commercially available microarray kit for high-resolution 3D genome profiling and biomarker discovery, EpiSwitch® Explorer Array Kit, which is available for purchase by the life science research community.

The Company has developed a proprietary 3D genomic biomarker platform, EpiSwitch®, which can build molecular diagnostic classifiers for prediction of response to therapy, patient prognosis, disease diagnosis and subtyping, and residual disease monitoring in a wide range of indications.

Oxford BioDynamics has participated in more than 40 partnerships with big pharma and leading institutions including Pfizer, EMD Serono, Genentech, Roche, Biogen, Mayo Clinic, Massachusetts General Hospital and Mitsubishi Tanabe Pharma.

The Company has created a valuable technology portfolio, including biomarker arrays, molecular diagnostic tests, bioinformatic tools for 3D genomics and an expertly curated 3D genome knowledgebase comprising hundreds of millions of data points from over 10,000 samples in more than 30 human diseases.

OBD is headquartered in Oxford, UK and is listed on AIM of the London Stock Exchange. It also has a commercial office in Gaithersburg, MD, USA and a reference laboratory in Penang, Malaysia.

For more information, please visit the Company's website, www.oxfordbiodynamics.com, or follow on Twitter or LinkedIn.

About EpiSwitch®

The 3D configuration of the genome plays a crucial role in gene regulation. By mapping this architecture and identifying abnormal configurations, EpiSwitch® can be used to diagnose patients or determine how individuals might respond to a disease or treatment.

Built on over 10 years of research, EpiSwitch® is Oxford Biodynamics' award-winning, proprietary platform that enables screening, evaluation, validation and monitoring of 3D genomic biomarkers. The technology is fully developed, based on testing of over 10,000 samples in 30 disease areas, and reduced to practice.

In addition to stratifying patients with respect to anticipated clinical outcome, EpiSwitch® data offer insights into systems biology and the physiological manifestation of disease that are beyond the scope of other molecular modalities. The technology has performed well in academic medical research settings and has been validated through its integration in biomarker discovery and clinical development with big pharma.

A copy of this announcement is available on the Company's website at www.oxfordbiodynamics.com.

This announcement includes "forward-looking statements" which include all statements other than statements of historical facts, including, without limitation, those regarding the Group's financial position, business strategy, plans and objectives of management for future operations, and any statements preceded by, followed by or that include forward-looking terminology such as the words "targets", "believes", "estimates", "expects", "aims", "intends", "will", "can", "may", "anticipates", "would", "should", "could" or similar expressions or the negative thereof. Such forward-looking statements involve known and unknown risks, uncertainties and other important factors beyond the Group's control that could cause the actual results, performance or achievements of the Group to be materially different from future results, performance or achievements expressed or implied by such forward-looking statements. Such forward-looking statements are based on numerous assumptions regarding the Group's present and future business strategies and the environment in which the Group will operate in the future. These forward-looking statements speak only as at the date of this announcement. The Group expressly disclaims any obligation or undertaking to disseminate any updates or revisions to any forward-looking statements contained in this announcement to reflect any change in the Group's expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based. As a result of these factors, readers are cautioned not to rely on any forward-looking statement.

CHIEF EXECUTIVE OFFICER'S REVIEW

Introduction

The first half of the year saw continued growth in orders of OBD's EpiSwitch® CiRT test by early-adopter physicians and a high level of interest in our forthcoming Prostate Screen EpiSwitch (PSE) test. During the period, we took steps to expedite the final development and launch of this next commercial product, while continuing to build commercial sales of CiRT alongside work for pharma customers and grant-funded and internal R&D activity.

EpiSwitch CiRT

The mechanism of action of immune checkpoint inhibitor (ICI) therapies is to release the brakes holding the immune system back and stimulate it so that it can attack a patient's cancer cells. EpiSwitch CiRT, the Group's flagship product, is a first-of-its kind blood test which predicts an individual patient's response to treatment with immune checkpoint inhibitors (ICIs) [1].

The test was initially launched in the US in February 2022. During the period, in November 2022, we hit the key milestone of 100 CiRT tests ordered, around nine months after launch. The next 100 tests were ordered in about half that time and we recently processed the 300th order less than three months later, in mid-May 2023. The period ended with a total of 24 US oncologists 'on the books', 20 of whom had placed orders for CiRT tests since the beginning of 2023 and we have continued to grow our physician base post-period end.

As planned, we have added to our sales and market access team during and after the period, recruiting experienced professionals who are familiar with US oncology practices and the specific challenges they face when deciding treatment pathways for patients. In our FY22 results, we highlighted the importance of learning from the oncologists who are using CiRT for refining our staff training and collateral. Building on our interactions with oncologists, OBD's team have become expert at introducing and explaining the CiRT test and its benefits to patients, physicians and payors alike. More recently, we have begun to facilitate several local advisory boards at which physicians hear not only from the OBD team, but also fellow doctors about their experiences of using the test.

A unique CPT-PLA code for EpiSwitch CiRT has been available for use in the US since the beginning of the period, allowing for reimbursement from US insurers. Reimbursements from US payors under the unique code have typically been in the range anticipated by the Group: the average amount paid for reimbursed tests to date is between $2,000 and $2,500, against a list price of $5,500. Some payors are now routinely providing reimbursement within as little as 2-3 weeks of claims being submitted. Average turn-around time for CiRT (measured from sample receipt to provision of a final test report) remained between three and four days throughout the period.

Post-period end, in May 2023, the Group announced the publication in the high-impact peer-reviewed journal Cancers of a paper describing the development and validation of the CiRT test and, crucially, its expanded validation to the top five (by annual sales) of the most widely used ICI drugs [2]. The study's extended validation results came from a total of 280 patient samples in more than 14 cancer indications.

Second PACT Award, to investigate Hyper-Progressive Disease

Post-period end, in May 2023, the Company was granted a second Partnership for Accelerating Cancer Therapies (PACT) Award [3]. The prestigious PACT Awards are executed by the Foundation for the National Institutes of Health (FNIH), a US not-for-profit organization managing the pre-competitive collaboration between the National Institutes of Health (NIH), National Cancer Institute (NCI), the US Food and Drug Administration (US-FDA) and 12 leading pharma companies.

The Award, worth $963,000 over one year, will help fund the reduction to practice of an EpiSwitch prognostic blood test for immune oncology (IO)-triggered Hyper-Progressive Disease (HPD). HPD is a serious condition observed in a subset of cancer patients with a specific immune profile, who react to treatment with ICIs with accelerated tumour growth, resulting in significantly reduced overall survival. The work enabled by this award will build on the results of a prototype Hyper-ICI Response Test (HiRT) to develop a blood test to identify patients at risk of HPD well before ICI therapy is started. Early accurate prognosis of HPD has long been an unmet clinical need.

The Company's first PACT award, announced in August 2021, funded extended application of the EpiSwitch platform used in the development of CiRT to the analysis of primary and acquired resistance to ICI therapy, drawing on over 186 patient samples from several trials [4]. Recognition by the PACT consortium for a second time is a source of significant pride for the Group. On the announcement of the latest award, Dr Stacey Adam, Associate Vice President, Science Partnerships at FNIH commented on OBD's previous performance: "Oxford BioDynamics has demonstrated its expertise in end-to-end biomarker development with its first PACT award. Today, the PACT partners are pleased to show their support once again, this time to enable a non-invasive and more accurate risk assessment of patients having a hyper-progressive disease profile when being considered for immunotherapy."

Prostate Screening EpiSwitch (PSE)

We plan to launch the PSE test during the final quarter of 2023 [5]. PSE is a simple blood test that combines the widely used prostate specific antigen (PSA) test with an EpiSwitch prostate cancer classifier developed by OBD. In peer-reviewed work, published in the journal Cancers in February 2023, PSE demonstrated compelling results of 93% positive predictive value, 95% negative predictive value and overall accuracy of 94% [6].

Positive results from PSA tests are known to be unreliable, with a positive predictive value of 25% (meaning 3 in 4 men with a raised PSA level will not have cancer) and can lead to many men being referred for expensive follow-on screening, including invasive biopsies that often lead to complications. OBD's PSE test will offer a rapid, accurate, minimally invasive test with significant potential as a screening diagnostic and large addressable markets. In the UK there are approximately 11 million men between the ages of 50 and 80, while in the US the number is closer to 50 million.

OBD will offer the PSE test from its own clinical laboratories in the US and UK. To that end, post-period end, the Group's US subsidiary leased and moved into 7,800 sq ft of laboratory space in Frederick, MD, USA. In due course, this lab will be accredited under the Clinical Laboratory Improvements Act (CLIA) by the Maryland Department of Health. A UK clinical lab meeting the requirements of ISO 15189 (the international quality standard for medical laboratories) is also under development, in the Group's existing UK HQ.

We are delivering on these plans at pace, with an anticipation that is clearly shared by the many physicians who have already requested the PSE test for their patients. With several US-based laboratory staff already recruited, we remain on track to complete equipment installation, technology transfer and test validation in time for the planned launch in Q4 2023.

EpiSwitch in ALS

Amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's disease in the US or motor neurone disease (MND) in the UK, is a fatal disorder that attacks nerve cells that control voluntary muscle movements, like chewing, walking, and breathing, usually leading to death from respiratory failure in 3-5 years.

In December 2022 we announced that Dr James Berry, Director, NCRI, Massachusetts General Hospital (MGH) had shared interim analysis from the Mitsubishi Tanabe Pharma America (MTPA)-sponsored REFINE-ALS biomarker trial in which an assay developed using OBD's EpiSwitch platform is being assessed alongside other biomarker modalities [7].

The EpiSwitch assay used in the trial provides both diagnostic information (whether the patient has ALS) and prognostic stratification (whether the patient will have fast or slow progressing disease). The initial assessment shared by Dr Berry showed that the EpiSwitch assay used in the trial was better than other biomarker modalities at stratifying patients, at baseline, into those with fast or slow progressing ALS.

OBD's EpiSwitch assay has the potential to enable doctors to confirm diagnosis of ALS (and discount other conditions that are often misdiagnosed as ALS) more quickly than is typically possible using the currently used battery of diagnostic tests. Baseline prognostic stratification of ALS patients with fast-progressing disease, combined with early, accurate diagnosis could have significant benefits to patients with this devastating illness.

The potential for OBD's EpiSwitch assay to play a pivotal role in the diagnosis and treatment pathway decisions of ALS patients was highlighted at the recent 2nd Annual ALS Drug Development Summit in Boston, MA, USA at which OBD was Lead Partner (May 2023). OBD's Chief Scientific Officer Dr Alexandre Akoulitchev gave a plenary talk entitled "Liquid Biopsy with 3D Genomic Biomarkers as a Clinical Tool for Diagnosis, Prognosis & Disease Understanding in ALS" that generated significant interest from conference attendees representing pharma, academia and ALS patient advocacy groups.

EpiSwitch Explorer Array Kit

Launched in 2021, OBD's EpiSwitch Explorer Array Kit allows the academic and life science research community to apply the Group's 3D genomics technology to their own areas of research. The kits include EpiSwitch whole genome microarray slides custom-made by Agilent Technologies (NYSE:A) as well as OBD's proprietary reagents for sample preparation and access to first tier analysis software developed in-house by the OBD team.

The Explorer Array Kit allows interrogation of just under 1 million of the most critical interactions between 3D anchor sites (OBD's proprietary "EpiSwitch loci") on the human genome. Results obtained using the kit offer powerful new information to researchers, including confirmation or clarification of their hypotheses. For example, interactions between 3D anchor sites whose presence or absence discriminate between groups with different phenotypes are often found to be at sites located close to genes that are known to play a role in the condition being investigated, but whose contribution is poorly understood.

Feedback from prestigious academic purchasers of the Explorer Array Kit, including scientists from The Francis Crick Institute and the University of Oxford Department of Biochemistry, has been positive, with a number of repeat orders after the period. Results from academic life-science research based on EpiSwitch Explorer Arrays have already been presented at national and international scientific peer group meetings.

Team growth

During and after the period, we have recruited to key positions to support the Group's commercial strategy, including US-based sales and clinical operation roles, and operations, data science and support roles in the UK. The period also saw a managed evolution of the Group's staffing structure, with a rebalancing of roles and lines of responsibility so that it continues to facilitate the achievement of the Group's objectives as efficiently as possible.

Development pipeline

OBD has an extensive pipeline of deployable molecular diagnostic and prognostic tests, across diverse indications. Alongside work on prostate cancer, patient response to immuno-oncology and ALS, the Group's scientists were engaged in successful internal research in several other indications, including neurodegenerative and metabolic diseases and canine oncology, throughout the period. We have previously identified canine oncology and colorectal cancer as offering likely opportunities for future commercialization, after the planned launch of PSE.

Funding to support growth

During the period, in October 2022, we successfully raised gross equity proceeds of approximately £9.3m from new and existing shareholders, at a 33% premium to the then share price. The funds raised were allocated to the provision of working capital to accelerate the commercialization of the EpiSwitch product line, initially focusing on EpiSwitch CiRT, including spend on expanded teams and activity to support sales and marketing of the test. This funding has also enabled us to accelerate our work to bring PSE to the market.

Summary

I am extremely pleased with the progress our Anglo-American OBD team has made during and after the first half of the year. As pioneers of the 3D genomics marketplace, it is encouraging to see an increase in appreciation and understanding of our technology and capabilities as we continue to build the Company as a commercial-stage business. I am particularly appreciative of the continued support from our core investors that enabled us to raise capital at a premium during the period despite difficult market conditions.

The EpiSwitch platform and the extensive EpiSwitch KnowledgeBase™ generated and continually augmented by it, underpin OBD's ability to bring powerful clinical testing solutions that provide acknowledged patient benefit to market for precision medicine. Our pipeline of deployable tests includes significant opportunities for commercialization and partnering. The market is only just beginning to appreciate the enormous long-term potential of the EpiSwitch platform and EpiSwitch KnowledgeBase™ to generate benefits for all healthcare stakeholders.

We are focused on two main objectives through the remainder of our financial year and through to the end of calendar 2023. On CiRT, we continue to concentrate our efforts on sustaining growth in orders and reimbursements for the test and establishing a sustainable revenue engine from the product. For PSE, we are on track to stand up our clinical labs and launch this important and highly sought after test by the end of the calendar year.

In last year's interims statement, I referred to moving forward with excitement and determination and our conviction in the long-term potential of OBD to benefit healthcare has been strengthened as we review a successful period for the Group's products and technology and plan for hard work and further success over the rest of the year.

Dr Jon Burrows

Chief Executive Officer

FINANCIAL REVIEW

Overview

Key activities during the period have included supporting EpiSwitch CiRT, product development work for the forthcoming PSE test and internal and commercial research. Revenue and other operating income were both increased relative to the prior period. Income arising from reimbursement by US healthcare payors for the Group's EpiSwitch CiRT test was recognized for the first time during the period. As expected, the Group's operating cost base also increased compared to the prior period, partly because of activity to support growing adoption of CiRT. The October 2022 fundraising provided the Group with additional cash resources to support its near-term activities.

Financial Performance

Revenue for the period (£220k, H1 2022: £85k) includes amounts in respect of sales of EpiSwitch CiRT tests and EpiSwitch Explorer Array Kits and from contracts with pharma and other commercial customers. As indicated in the Group's latest annual report, revenue arising from reimbursement for the Group's proprietary tests by US insurers is recognised on receipt. Revenue for reimbursed tests is therefore delayed relative to test processing and there is no accounts receivable balance recognized in respect of reimbursed tests prior to receipt.

The reimbursement claims process is a complex one that is carefully managed by the Group's clinical operations team, alongside staff from our partner laboratory. This includes, for example, delaying submission of claims for certain groups of patients until appropriate coverage policies are in place, in order to avoid rejection of claims by payors wherever possible.

As noted above, to date, reimbursements for EpiSwitch CiRT have been received at an average of between $2,000 and $2,500 per reimbursed test, which is within the range originally expected by the Group.

Cost of sales of EpiSwitch CiRT tests, represents a minimum sum payable to the Group's partner lab on the processing of each test, and additional amounts that become due and are recognized only when reimbursement is received from payors.

Other operating income of £200k (H1 2022: £170k) arose from the Group's first PACT Award, referred to in the Chief Executive Officer's review above. The two-year $910,000 PACT Award has funded extended application of the technology used in the development of EpiSwitch CiRT to the analysis of primary and acquired resistance to ICI in several trials. The Group's second PACT Award, supporting the development of prognostic biomarkers for hyper-progressive disease, was announced post-period end in May 2023, and will provide $963,000 in funding over a 12-month period. OBD is also one of 26 participants in the EU-funded HIPPOCRATES (Health initiatives in psoriasis and psoriatic arthritis consortium European states) consortium that was awarded a total of €21 million over 5 years in 2021.

Operating costs have increased overall compared to previous periods (£5.1m, H1 2022: £4.4m), reflecting increased activity across the business, and increases in salaries and most external costs.

R&D costs excluding staff costs were £284k (H1 2022: £191k, H2 2022: £335k). The majority of these costs are incurred in the Group's UK laboratories and include lab consumables, equipment maintenance and other laboratory services. These costs vary depending on the nature and volume of work that is undertaken.

Staff costs increased to £2.6m (H1 2022: £2.1m, H2 2022: £2.4m) driven by inflationary salary increases awarded in January 2023, to help retain skilled, trained staff in a competitive market. Also, although overall average staffing numbers have remained relatively constant since October 2021, the proportion of Group staff employed in more senior roles and based in the US have both increased, which has increased the average per-employee cost.

General and administrative costs also increased in the period to £1.47m (H1 2022: £1.23m). Employee-related expenses increased by £130k, reflecting the increased number of staff engaged in sales support activity that requires travel to meet with customers and some increased travel post-COVID by UK- and US-based staff engaged in business development. Facilities-related costs increased by £60k, predominantly because of increased utilities costs, whilst marketing costs increased by £60k, reflecting costs associated with newly designed and improved Group websites as well as inflationary increases in other costs. IT and communications costs increased by £45k, driven by higher levels of spend on IT security and the Group's clinical order management system being operational for the whole period. The cost of other supplies and services, including professional fees, were £60k lower, mainly reflecting lower legal costs, offset by higher costs of audit and accounting advisory services.

Financial position

Cash and fixed term deposits at 31 March 2023 were £3.62m (31 March 2022: £4.59m, 30 September 2022: £1.0m), reflecting the funds raised in October 2022 offset by increased operating cash outflows.

There was lower expenditure on intangible assets and property plant and equipment than in the equivalent period in the prior year and no new property leases were entered into during the period. Together with depreciation and amortization, this led to a slight decrease in total non-current assets, to £8.19m (31 March 2022: £8.84m, 30 September 2022: £8.58m).

Current assets excluding cash and fixed term deposits increased to £2.47m (31 March 2022: £1.21m, 30 September 2022: £1.77m), mainly because approximately £0.90m in UK R&D Tax Credits remained outstanding at the end of the period (received in April 2023).

Current liabilities were similar to one year ago at £2.10m (31 March 2022: £2.07m, 30 September 2022: £2.91m). The balance outstanding at the 30 September 2022 year end was increased because of higher accruals for staff bonus payments, which are typically paid early in the calendar year, as well as the timing of payment of a number of relatively high value invoices.

Non-current liabilities decreased to £5.47m (31 March 2022: £6.19m, 30 September 2022: £5.85m), driven mainly by payments of rent on the Group's existing property leases during the period.

Cash flow

Net cash used in operating activities increased during the period to £5.22m (H1 2022: £2.30m). In addition to the increased operating loss for the period, operating cash outflow was affected by movements in working capital which had a negative impact on cash of £1.25m relative to the prior period. The Group also received £0.9m in UK R&D Tax Credits post-period end in April 2023, rather than during the period as was the case in the prior period.

Investing cash outflows were reduced, with lower cash payments in respect of asset additions than in the prior period (£0.26m, H1 2022: £0.60m).

Payments in respect of leases (including both capital and interest elements) were unchanged from the prior period (£0.45m, H1 2022: £0.45m). Net cash receipts from the issue of equity were £8.54m as a result of the successful placing, open offer and subscription during the period.

Outlook

The first half of the year included encouraging growth in product orders and the receipt of the first US reimbursements in respect of EpiSwitch CiRT tests, as well as enthusiastic reaction to the Group's PSE test and plans for its launch by the end of 2023. The milestone of 300 EpiSwitch CiRT tests processed, reached post-period in May 2023, demonstrated continued positive momentum.

The Group's financial performance and cashflow for the period reflected the increased cost base necessary to secure these positive commercial developments against modest revenue. Whilst the Group entered the second half of the year with £3.62m in cash and term deposits and received £0.9m of tax refunds shortly after the period end, total cash and fixed-term deposits remain relatively low compared to the Group's monthly cost base.

As was the case at the previous period end and year end, the Group will need to generate increased revenue and/or additional funding during the remainder of the calendar year. At the date of this report, a number of factors make it difficult to predict anticipated product and other commercial revenue and associated cash receipts. Accordingly, as explained in more detail in Note 2 to the interim financial statements, the Board has concluded (as it did in the annual reports for the years ended 30 September 2021 and 30 September 2022) that there continues to be a material uncertainty which may cast significant doubt on the Group's ability to continue as a going concern.

As the financial year progresses, the OBD team remains focused and driven to achieve further commercial success, growing sales of CiRT and preparing for the launch of PSE.

Paul Stockdale

Chief Financial Officer

References

[1] Oxford BioDynamics Plc. (2022). EpiSwitch CiRT. https://www.mycirt.com

[2] Hunter, E., et al. (2023). Development and validation of blood‐based predictive biomarkers for response to PD‐1/PD-L1 checkpoint inhibitors: evidence of a universal systemic core of 3D immunogenetic profiling across multiple oncological indications, Cancers 15(10), 2696. https://www.mdpi.com/2072-6694/15/10/2696

[3] Oxford BioDynamics Plc. (2023). Oxford Biodynamics granted US Foundation of NIH PACT Award for prognosis of cancer patients with IO-triggered Hyper-Progressive Disease. https://otp.tools.investis.com/clients/uk/oxford_biodynamics_plc/rns/regulatory-story.aspx?cid=2040&newsid=1684666

[4] Oxford BioDynamics Plc. (2021). Oxford BioDynamics awarded US FNIH Grant to apply EpiSwitch® Immune Health test for improved prediction of patient response to Immune Checkpoint Inhibitor (ICI) cancer therapies. https://otp.tools.investis.com/clients/uk/oxford_biodynamics_plc/rns/regulatory-story.aspx?cid=2040&newsid=1503717

[5] Oxford BioDynamics Plc. (2023). Business update - plan to launch Prostate Screening EpiSwitch® test by end of 2023; sales progress for flagship EpiSwitch® CiRT. https://otp.tools.investis.com/clients/uk/oxford_biodynamics_plc/rns/regulatory-story.aspx?cid=2040&newsid=1679474

[6]  Pchejetski, D., et al. (2023). Circulating Chromosome Conformation Signatures Significantly Enhance PSA Positive Predicting Value and Overall Accuracy for Prostate Cancer Detection. Cancers, 15(3), 821. http://dx.doi.org/10.3390/cancers15030821

[7] Oxford BioDynamics Plc. (2022). Initial assessment of EpiSwitch® assay in ALS trial. https://otp.tools.investis.com/clients/uk/oxford_biodynamics_plc/rns/regulatory-story.aspx?cid=2040&newsid=1652438

Consolidated income statement

Consolidated statement of comprehensive income

Consolidated statement of financial position

Consolidated statement of changes in equity

Consolidated statement of cash flows

Notes

1. General information

The interim financial information was authorized for issue by the Board of Directors on 29 May 2023. The information for the period ended 31 March 2023 has not been audited and does not constitute statutory accounts as defined in section 434 of the Companies Act 2006 and should therefore be read in conjunction with the audited financial statements of the Company and its subsidiaries as at and for the year ended 30 September 2022, which were prepared in accordance with UK-adopted international accounting standards and have been delivered to the Registrar of Companies. The Report of the Auditor on the financial statements was unqualified, did not contain an emphasis of matter paragraph and did not contain any statement under section 498 of the Companies Act 2006. This interim information does not comply with IAS 34 Interim Financial Reporting, as is permissible under the rules of AIM.

2. Basis of accounting

Basis of preparation

These interim consolidated financial statements have been prepared under the historical cost convention, except for, where applicable, the revaluation of financial liabilities at fair value through profit or loss, and in accordance with the recognition and measurement principles of UK-adopted international accounting standards.

Reporting currency

The consolidated financial statements are presented in pounds sterling (GBP), which is also the Company's functional currency.

Going concern

In assessing the appropriateness of adopting the going concern assumption, as noted in the annual report and accounts for the year ended 30 September 2022, the Group has prepared a detailed budget for the year ending 30 September 2023 ("the budget") and a further forecast ("the forecast") for the period to 30 September 2024. The budget and forecast include:

Combined revenue and other operating income during the period ended 31 March 2023 was increased compared to the equivalent period in the previous year, but was significantly exceeded by the Group's operating costs. The Group was able to maintain its cash reserves during the period, including through the raising of £9.3m (before fees) by way of a placing, subscription and open offer for new ordinary shares in October 2022. The Group also sought to continue to control costs and cash outflow as much as possible, whilst still supporting product and sales development and business development activity with pharma.

In preparing the budget and forecast, the Directors also note the existence of several factors that increase the difficulty inherent in predicting the Group's performance, including its cash generation. These include:

To date, cash balances have remained broadly in line with budgeted amounts. However, in the event that sufficient product and new project revenue and/or operating income is not generated, the Group would need to obtain additional funding during the remainder of 2023 in order to continue as a going concern.

The Group successfully raised £9.3m, at a premium of 33% to the Company's then share price during the period in October 2022. However, as at the date of publication of this report, there is no guarantee that it will be able to access further cash resources from investors. This issue may be compounded if the Company's share price were to fall from its current level.

The Directors do not believe that any of the factors above is unusual or unexpected for the Group at this point in the execution of its strategy. However, shareholders should be aware that there is uncertainty around its ability to generate sufficient revenues and the timing of receipts from customers, as well as the ability of the Group to raise sufficient finance to meet its expected costs. These conditions present a material uncertainty which may cast significant doubt on the Group and Parent Company's ability to continue as a going concern and, therefore, it may be unable to realize its assets and discharge its liabilities in the normal course of business.

Accounting policies

The interim financial statements have been prepared in accordance with the accounting policies set out in the Annual Report and Accounts for the year ended 30 September 2022, which is available on the Company's website.

Accounting judgements and estimates

There have been no significant changes to critical accounting judgements or accounting estimates of amounts reported in prior financial periods.

Prior period adjustment in respect of warrant liability

On 11 November 2021, the Company issued 7,791,803 warrants to subscribe for new ordinary shares (the "Warrants"). The Warrants are classified as liabilities in the balance sheet. The fair value of the Warrants is estimated at least on every reporting date. The estimates of the fair value of the Warrants as at the date of their issue on 11 November 2021 and as at 31 March 2022 have been corrected in comparative figures for the six months ended and as at 31 March 2022 in this report. These corrections impact the allocation of the amounts raised in October 2021 between equity and the liability associated with the Warrants, the fair value of the Warrants as at 31 March 2022 and the non-cash fair value gain on financial liabilities designated as FVTPL in the consolidated income statement for the six months ended 31 March 2022. No correction is required to the amounts included in the Annual Report and Accounts for the year ended 30 September 2022.

Impact of restatement on prior period:

The impact of the restatement on the consolidated statement of changes in equity is shown on the statement itself.

3. Revenue

All revenue is derived from the Group's principal activities, namely sales of proprietary products and biomarker research and development. An analysis of the Group's revenue by segment, geography and pattern of revenue recognition is as follows:

4. Business segments

Products and services from which reportable segments derive their revenues

Information reported to the Group's Chief Executive (who has been determined to be the Group's Chief Operating Decision Maker) for the purposes of resource allocation and assessment of segment performance is focused on costs incurred to support the Group's main activities. The Group is currently determined to have one reportable segment under IFRS 8, that of sales and proprietary products and biomarker research and development. This assessment will be kept under review as the Group's activity expands.

The Group's costs and non-current assets (other than investments accounted for using the equity method), analysed by geographical location were as follows:

Information about major customers

The Group's revenues for the periods covered by this report are derived from a small number of customers, several of which represent more than 10% of the revenue for the period. These are summarized below:

5. Staff costs

The average number of persons, including executive directors, employed by the Group during the period was as follows:

6. Loss per share

From continuing operations

The calculation of the basic and diluted earnings per share is based on the following data:

*Potential ordinary shares are not treated as dilutive as the Group is loss-making and the potential ordinary shares do not increase the loss per share from continuing operations.

7. Intangible fixed assets