Oncimmune Regulatory News (ONC)

8 July 2022

RNS

This announcement contains inside information

for the purposes of the UK Market Abuse Regulation

Oncimmune Holdings plc

("Oncimmune" or the "Company")

Board Changes and Trading Update

Alistair Macdonald to chair Board

Oncimmune Holdings plc (AIM: ONC.L), a leading global immunodiagnostics group, today announces the appointment of Alistair Macdonald as Non-executive Chair, effective immediately. Alistair succeeds Meinhard Schmidt as Chair of the Board, who has retired from the Board.

Appointment of Alistair Macdonald to Chair

Alistair brings a wealth of knowledge in the pharma services sector, developed through his 25-year career in life sciences, culminating in his role as CEO of leading, integrated CRO Syneos Health Inc. (Nasdaq: SYNH; market cap c.US$6.6bn) ("Syneos"), which he held for 6 years, before which he was CEO of INC Research which merged with inVentiv Health to become Syneos in 2017. During his time with INC and then Syneos, revenue grew from $20m to over $5.0bn. Prior to becoming a CEO, Alistair led multiple functions including Global Business Development and Marketing, Alliances Development and Delivery, Global Oncology, and Clinical Development Services. Over the last 25 years, he has held management positions in the pharmaceutical industry across manufacturing, consultancy, business and corporate development, data management and clinical operations.

Alistair retired as CEO of Syneos Health in April 2022, a company that he led post-merger through further substantial organic as well as inorganic growth. Alistair led the merger that formed Syneos, which brought together approximately 24,000 employees serving customers in 110 countries with innovative, end-to-end solutions to accelerate their clinical development and commercialisation timelines. Until recently, Alistair has also served as Chair of ACRO, the Association of Clinical Research Organisations, having been on its board for approximately seven years.

Recent and Current Trading

Biodesix, Inc. (Nasdaq: BDSX) ("Biodesix"), who is the US distributor of our EarlyCDT Lung product, recently announced that WPS Government Health Administrators, the Medicare Administrative Contractor with jurisdiction for Biodesix's Kansas laboratory, has provided a coverage determination for the NodifyCDT® lung nodule test (the marketing name for EarlyCDT Lung in the US) at an in-market selling price which is 10 times the current price. This is a significant milestone and will assist access and availability to the NodifyCDT® lung nodule test for US patients with lung nodules. Medicare coverage will also ensure physicians have access to the NodifyCDT® lung nodule test which is expected in turn to drive faster and wider adoption of the NodifyCDT® lung nodule test across the US. Oncimmune receives royalties on every in-market sale of a NodifyCDT® lung nodule test as well as revenue from the supply of the test to Biodesix.

Biodesix has also recently announced that Royal Philips ("Philips") is to incorporate the results from tests performed on the NodifyCDT® lung nodule into the Philips Lung Cancer Orchestrator lung cancer patient management system. This important commercial agreement is expected to drive an increase in NodifyCDT® lung nodule test volumes and act as a force multiplier to raise the profile of the NodifyCDT® lung nodule test markedly across the US.

In parallel with these positive Biodesix commercial developments, we recently restructured the EarlyCDT Lung product business of its cost base to further support the commercialisation of the EarlyCDT Lung product and to ensure that the business is immediately EBITDA profitable before the potential upside from higher commercial sales.

On the pharma services side of our business, both our pipeline of potential contracts and the level of active engagement with our commercial team for our ImmunoINSIGHTS service offering by existing and new potential clients continues to build, which the Board considers is an encouraging indicator for the continued growth of this business. However, the current global economic and geopolitical conditions have well reported as adversely affecting the biotech sector, in particular. As a consequence this is impacting decision-making and causing a slowdown in signing new ImmunoINSIGHTS contracts.

The Board is also alert to acquisition opportunities and partnerships to broaden the Company's offering and drive revenue growth from large pharma clients in particular. The appointment of Alistair with his extensive experience in growing pharma services business will we believe be invaluable to the execution of our acquisition strategy.

As previously stated, Oncimmune has changed its financial year end from 31 May to 31 August, to align the ImmunoINSIGHTS service business better with the procurement cycles of clients and for the financial year to more closely reflect contract awards within the same period. The Company intends to release unaudited interim results for the 12 months ending 31 May 2022 by 31 August 2022 and to publish its audited accounts for the 15-month period to 31 August 2022 by 31 January 2023.

Alistair Macdonald, Oncimmune's incoming Chair, said: "Oncimmune has successfully delivered on its strategy to transform the business from one wholly focussed on a single asset diagnostic to an emerging pharma services business; the foundation stone is now laid for growth. I am excited to bring my knowledge of growing pharma services businesses to help Oncimmune's experienced senior management team to develop the Company into a leading, global provider of services to the pharmaceutical sector."

Meinhard Schmidt, Oncimmune's outgoing Chair, said: "I joined Oncimmune in 2015 to help guide the Company through its IPO and to support Adam and the wider senior management team to deliver on the Company's three-year strategy and capitalise on Oncimmune's world-leading autoantibody technology. Having successfully completed that strategy, through which the focus of the business has fundamentally changed, I am delighted to be handing over the reins to Alistair with his wealth of experience in growing pharma services business."

Dr Adam M Hill, CEO of Oncimmune said: "Having re-directed our proprietary technology platform towards best-in-class autoantibody profiling services for the pharmaceutical sector, it is gratifying to welcome Alistair with his track record of successfully growing services companies in this sector. Autoantibodies are increasingly recognised as an important part of the toolkit for understanding the effect of and predicted response to immune modulating therapies. Together with Alistair, I look forward to evaluating acquisition opportunities with the potential to add capabilities and accelerate growth."

Additional disclosures relating to the appointment of Alistair Macdonald to the Oncimmune Board are included below.

The Directors of the Company named below take responsibility for this announcement.

For further information:

Oncimmune Holdings plc

Dr Adam M Hill, Chief Executive Officer

Matthew Hall, Chief Financial Officer

contact@oncimmune.co.uk

Singer Capital Markets (Nominated Adviser and Joint Broker)

Aubrey Powell, Harry Gooden, George Tzimas, James Fischer

+44 (0)20 7496 3000

WG Partners (Joint Broker)

David Wilson, Nigel Barnes, Erland Sternby

+44 (0)20 3705 9321

Media enquiries:

John Goold

IR@oncimmune.com

About Oncimmune

ImmunoINSIGHTS Service Business

Oncimmune is a leading immunodiagnostics developer, primarily focused on the growing fields of immuno-oncology, autoimmune disease and infectious diseases. The ImmunoINSIGHTS service business leverages Oncimmune's technology platform and methodologies across multiple diseases, to offer life-science organizations actionable insights for therapies across the development and product lifecycle. Our core immune-profiling technology is underpinned by our library of over eight thousand immunogenic proteins, one of the largest of its kind. This helps identify trial participants and patients into clinically relevant subgroups, enabling development of targeted and more effective treatments.

Oncimmune's ImmunoINSIGHTS service business is based at the Company's discovery research centre in Dortmund, Germany. The business platform enables life science organizations to optimize drug development and delivery, leading to more effectively targeted and safer treatments for patients.

The ImmunoINSIGHTS development team is based in the US and Europe and Oncimmune is seeking to replicate the Dortmund facility in the US in the medium term.

EarlyCDT Product Business

Oncimmune's immunodiagnostic technology, EarlyCDT, can detect and help identify cancer on average four years earlier than standard clinical diagnosis. Our lead diagnostic test, EarlyCDT Lung, targets a vast market estimated to grow to £3.8bn by 2024. With over 200,000 tests already performed for patients worldwide and its use being supported by peer reviewed data in over 12,000 patients, we are poised to become an integral component of future lung cancer detection programs, globally.

Oncimmune's diagnostic products business is located at its laboratory facility in Nottingham, UK.

For more information, visit www.oncimmune.com

Additional Disclosures relating to the appointment of Alistair Macdonald

Alistair John Macdonald (aged 52) has held the following directorships or partnerships in the past five years:

Current directorships and partnerships:

· Medicines Discovery Catapult

· 3, Royal Crescent Bath (Properties) Limited

Previous directorships and partnerships held in the past five years:

Subsidiaries of INC Research/Syneos Health:

· Syneos Health UK Limited

· Syneos Health, Inc.

· Syneos Health, LLC

· Synteract HCR Limited

· Synteract HCR Holdings Corporation

· Syneos Health Branches Limited

· Syneos Health Clinical Development Services Limited

· Sharpview Ophthalmology Limited

· Association of Clinical Research Organizations

· Kendle India Private Limited

· Syneos Health South Africa (Pty) Limited

· INC Research GmbH

· INC Research Netherlands B.V.

· INC Research NV

· INC Research Spain, S.A.

· INC Research Sweden A.B.

· Kendle Americas Investment Inc.

· Kendle Americas Management Inc.

· Kendle Data & Technologies (India) Private Limited

· Kendle NC LLC

· SHCR Holdings Corporation

· Syneos Health Clinical K.K.

· Syneos Health Romania S.R.L.

· INC Research Branches Limited-Sofia Branch

· Syneos Health Investment, LLC

· INC Research Austria GmbH

· Syneos Health CZ s.r.o.

· Syneos Health Hungary Korlátolt Felelősségű Társaság

Other directorships/partnerships:

· Association of Clinical Research Organizations

Alistair Macdonald does not currently hold any ordinary shares in the Company.

There are no additional disclosures required under Rule 17 and Schedule 2(g) of the AIM Rules for Companies.