Physiomics Regulatory News (PYC)

10 March 2020

Physiomics plc

("Physiomics") or (the "Company")

NIHR i4i award

Physiomics plc (AIM: PYC), the oncology consultancy using mathematical models and its Virtual Tumour™ technology to support the development of cancer treatment regimens and personalised medicine solutions, is pleased to announce that it has been awarded a "Connect" award by the National Institute for Health Research ("NIHR") Invention for Innovation ("i4i") programme in respect of the Company's continued development of its tool for use in personalised treatment of cancer.

The title of the award project is "Further development of and evidence generation for a precision dosing tool for optimising chemotherapy dosing in advanced prostate cancer (NIHR201282)". The award, which is funded by the UK Department of Health & Social Care, will provide 100% reimbursement of project costs of up to £150,000, over an anticipated 12-month period, starting in April 2020, with no matched funding required from Physiomics.

The project will build on the Company's successful work to date in developing its personalised oncology tool, that has been funded mainly through Innovate UK grants in 2017 and 2018. In particular, the 2018 Innovate UK grant enabled the Company to develop a demonstrator version of a decision support tool to help clinicians treating late-stage prostate cancer to optimise the dosing of docetaxel, a commonly used chemotherapy.

Personalised treatment of prostate cancer - progress to date

Prostate cancer represents around 13% of all new cancers, with around 50,000 new cases diagnosed each year in the UK and 170,000 in the USA. Of these, 20-30% of patients present with late stage metastatic disease, where 5-year survival is below 30%. In these patients, docetaxel is commonly used as a first line chemotherapy. Variations between individuals in blood levels of the drug have been observed within a 2-3-fold range for the same administered dose level(1), potentially leading to a significant number of patients being either under or over-dosed. Exposure-controlled dosing, relying on pharmacokinetic or proxy biomarker measurements, has been shown to significantly improve patient survival(2) and toxicity(3) in chemotherapy. However, such precision-dosing techniques typically require costly additional tests, which restrict their use in clinical practice in the UK, although they may be becoming more prevalent in the USA.

Supported by previous grant funding, Physiomics has developed, and demonstrated to leading clinicians, a prototype precision dosing tool for docetaxel in prostate cancer, which aims to significantly improve patient outcomes at a low cost compared with novel pharmaceuticals, without disrupting the current clinical treatment pathway. The tool incorporates information that is already available to clinicians as part of current clinical practice in the UK, supplemented by additional blood tests that are relatively cheap and universally available. It is intended that the tool will provide guidance to the clinician as to the likely level of toxicity, and potentially efficacy, associated with the current actual and possible alternative doses of docetaxel.

The NIHR i4i award

The i4i award funding will enable the Company to undertake an observational trial that will be run by the Portsmouth Technology Trials Unit ("PTTU"), which is a collaboration between Portsmouth Hospitals NHS Trust and the University of Portsmouth, specialising in clinical trials in new healthcare technologies. The trial will not directly involve the use of the tool itself, but will focus on collecting key patient data that will enable Physiomics to further explore and validate the value of the tool, as well as begin to build a case for possible future regulatory approval of the tool.

The award funding will also be used to better understand the intellectual property, trademark and copyright landscape relating to software of this nature, and to fund Physiomics' time spent in analysing the trial data.

Looking ahead - Personalised Medicine

The Company continues to assess the opportunities for further grant funding and, while there is no guarantee of further funding from the i4i programme, the Company notes that i4i Connect awards aim to help SMEs get to a point where they can apply for further funding, in particular for an i4i Product Development Award.

As we highlighted in our annual report for the year ending 30 Jun 2019, we have also been in discussions with a number of companies in the personalised oncology space regarding potential collaboration. These discussions remain at an early stage and we will keep shareholders updated on any developments, as and when appropriate.

Physiomics will also continue to explore the possibility of seeking regulatory approval of its tool as a medical device in Europe and beyond, as well as consider other cancer types and drugs where the tool may be applicable.

Dr Jim Millen, CEO of Physiomics, said: "We're very pleased to have been selected for this important award, especially in light of the level of competition. According to public i4i committee minutes, it received 126 first round applications, of which 11 have been selected for funding after a robust scrutiny from a multidisciplinary committee, including members of the public.

We believe this award provides further evidence of the broad support that our focus on personalisation of cancer treatment appears to be generating and we look forward to continuing to move the technology forwards, to the point where it can be used to support real-world decision making."

(1) McLeod, H.L et al, 1998. Evaluation of the linearity of docetaxel pharmacokinetics. Cancer chemotherapy and pharmacology, 42(2), pp.155-159.

(2) Fang, Luo, et al. Pharmacokinetically guided algorithm of 5-fluorouracil dosing, a reliable strategy of precision chemotherapy for solid tumors: a meta-analysis. Scientific reports 6 (2016): 25913.

(3) Hénin, Emilie, et al. Revisiting dosing regimen using PK/PD modeling: the MODEL1 phase I/II trial of docetaxel plus epirubicin in metastatic breast cancer patients. Breast cancer research and treatment 156.2 (2016): 331-341.

The information contained within this announcement is deemed to constitute inside information as stipulated under the Market Abuse Regulations (EU) No. 596/2014.

Enquiries:

Physiomics plc

Dr Jim Millen, CEO

+44 (0)1865 784 980

Strand Hanson Ltd (NOMAD)

Richard Tulloch & James Dance

+44 (0)20 7409 3494

Hybridan LLP (Broker)

Claire Louise Noyce

+44 (0)20 3764 2341

Notes to Editor

About Physiomics

Physiomics® is an oncology consultancy which uses mathematical PKPD models as well as its proprietary Virtual Tumour™ technology to predict the effects of cancer drugs and treatments and improve the success rate of drug discovery and development projects. The predictive capability of Virtual Tumour has been confirmed by 55 projects, involving over 25 targets and 60 drugs, and has worked with clients such as Merck KGaA, Merck & Co, Bayer and Lilly.

Based in Oxford UK, the Company works with clients worldwide to support their pre-clinical and clinical oncology development programs. Its team of scientists and computer modelling experts provide bespoke solutions encompassing data, analytics and insight.

Physiomics senior management has academic and commercial expertise, including over 90 years collectively of working in oncology and/or computational biology and over 100 publications in peer reviewed journals.

For more information please visit:

www.physiomics-plc.com

www.twitter.com/Physiomics

www.linkedin.com/company/physiomics-plc/

About The National Institute for Health Research (NIHR)

The National Institute for Health Research (NIHR) is funded by the Department of Health to improve the health and wealth of the nation through research. The NIHR is the research arm of the NHS. Since its establishment in April 2006, the NIHR has transformed research in the NHS. It has increased the volume of applied health research for the benefit of patients and the public, driven faster translation of basic science discoveries into tangible benefits for patients and the economy, and developed and supported the people who conduct and contribute to applied health research. The NIHR plays a key role in the Government's strategy for economic growth, attracting investment by the life-sciences industries through its world-class infrastructure for health research. Together, the NIHR people, programmes, centres of excellence and systems represent the most integrated health research system in the world. For further information, visit the NIHR website (www.nihr.ac.uk).