Big Picture – A Deep Dive Examination of the ValiRx Plc
ValiRx Plc Snapshot
ValiRx is a biotechnology oncology focused company specialising in developing novel treatments for cancer and associated biomarkers. It aims to make a significant contribution in “precision” medicine and science, namely to engineer a breakthrough into human health and well-being, through the early detection of cancer and its therapeutic intervention.
The Company’s business model focuses on out-licensing therapeutic candidates early in the development process. By aiming for early-stage value creation, the company reduces risk considerably while increasing the potential for realising value. The group is already in licensing discussions with major players in the oncology field.
ValiRx’s four therapeutics drugs in development, which each have the potential for meeting hitherto unmet medical needs by existing methods, have worldwide patent filings and agreed commercial rights. They originate or derive from Word class institutions, such as Cancer Research UK and Imperial College.
Until recently, cancer treatments relied on non-specific agents, such as chemotherapy. With the development of target-based agents, primed to attack cancer cells only, less toxic and more effective treatments are now possible. New drugs in this group—such as those in ValiRx’s pipeline—promise to greatly improve outcomes for cancer patients.
The Company listed on the Alternative Investment Market (“AIM”) of the London Stock Exchange in October 2006 and trades under the ticker symbol: VAL.
ValiRx operates through the following divisional companies:
The Company’s leading anti-cancer therapeutic VAL201 is currently in clinical trials for the treatment of prostate cancer and potentially other indications of hormone induced unregulated growth including endometriosis. The Phase I/II trial has been initiated and VAL201 was safe and well tolerated at the doses tested. Progressing through the dose escalation and expansion stages, the study is then designed to investigate further details of these aspects as well as efficacy. Particular emphasis will be placed on evaluating the pharmacokinetics, pharmacodynamics and early assessment of anti-tumour activity in response to VAL201, using a variety of measurements including ValiRx’s biomarkers, with biomarkers being key indicators in personal medicine.
VAL201 selectively prevents tumour growth by specifically inhibiting the proliferation of tumour cells. As a result, tumour growth is suppressed and metastasis is significantly reduced. The approach is a targeted therapeutic with pre-clinical results that indicate that due to the specific nature of this treatment, this therapy is likely to be less toxic than many other therapeutic options. The VAL201 target is also associated with other cancers and there is significant potential for VAL201 to be used as a treatment for other hormone-induced cancers, such as breast and ovarian and also endometriosis.
Endometriosis is a gynaecological medical condition in which cells from the lining of the uterus (endometrium) appear and flourish outside the uterine cavity lined by endometrial cells, which are under the influence of female hormones. These endometrial-like cells in areas outside the uterus (endometriosis) are influenced by hormonal changes and respond in a way that is similar to the cells found inside the uterus and symptoms often worsen with the menstrual cycle. The treatments chosen will depend on symptoms, age, and lifestyle plans. VAL201 has been shown though to reduce abnormal endometrial growth, whilst leaving other hormone-induced activities working normally. ValiRx’s initial in-vitro results show a reduction in endometrial lesion size directly related to dose and two generations of offspring produced by treated animals. This strongly suggests that the peptide does not affect fertility the same way other treatments do.
Lung Cancer and others
VAL401 is the reformulation of a generic drug that has over 20 years of clinical use for treatment of a chronic non-oncology disease in an oral capsule. The re-formulation allows the drug to access previously unexploited anti-cancer activity. VAL401 is progressing satisfactorily through its remaining preclinical development and towards clinical Phase II trials for the treatment of lung cancer and other oncology indications. Progress into clinical trials will comprise a shorter than usual route to Market Authorisation by use of prior clinical data gathered on the original generic drug. Preclinical efficacy data has been collected in both non-small cell lung and prostate cancers. Preclinical toxicology has revealed no side effects beyond those expected from the parent drug, with preclinical pharmacokinetc data allowing bridging from VAL401 to the historical full clinical data package on the parent. Formulation stability tests are currently underway to complete the CMC package.
During 20 years of prior clinical use, the active drug has been safely administered long term (chronic use of over 2 year’s duration) with good compliance.
Other possible indications include prostate and pancreatic cancer.
VAL101 (GeneICE, VAL101 & TRAC)
GeneICE “rebellious gene” technology continues to show good progress in the pre-clinical phase – the programme currently benefits from a second Eurostars grant for up to €1.6 million.
Rebellious genes are genes that are overexpressed or are erroneously expressed when they should not be, e.g. in cancers, inflammatory conditions, Alzheimer’s and autoimmune diseases. ValiRx’s proprietary GeneICE technology enables the selective silencing of specific genes by targeted histone deacetylation leading to chromatin condensation. This prevents access and silences gene expression. In nature histone deacetylation of a particular gene is brought about by recruitment of a histone deacetylase complex (HDAC) to the gene. GeneICE constructs mimic this natural mechanism by delivery to the nucleus of a dual-module construct comprising: the binding of GeneICE construct to its target gene leads to deacetylation of the histones associated with the gene, localised chromatin condensation and gene silencing.
VAL101 is a novel therapeutic based on the Company’s proprietary GeneICE (Gene Inactivation by chromatin engineering) platform. It acts to target and switch “OFF” the gene that expresses Bcl-2, a protein that is implicated in about half of all carcinomas. Pre-clinical studies have established VAL101’s efficacy in prostate, ovarian and pancreatic cancers and it may also have anti-tumour activity against orphan oncologic indications. ValiRx’s GeneICE technology enables the selective silencing or the shutting down of particular rebellious genes, thereby halting and reversing tumour growth.
NAV3 (BioMarkers and Diagnostics)
Biomarker development programme, to support clinical and pre-clinical development, is continuing to produce results with the recent acquisition of complimentary TRAC technology. The programme is supported extensively by Finnish government regional funding.
The use of biomarkers with oncology therapeutics is one of the fastest growing areas of cancer research, as not only can the biomarkers identify patients who are more likely to respond to a particular drug therapy, but they can also indicate tumour progression.
ValiRx’s biomarker subsidiary, ValiFinn in Finland provides the Group with exposure to the Biomarker market, a key and increasingly exciting field within its industry, but also to a revenue stream, derived from the provision of contract services to the pharmaceutical industry.
ValiFinn has built on its specialist biomarker expertise to develop its own companion diagnostic biomarkers to complement ValiRx’s therapeutics, its existing intellectual property and its companion diagnostic activities, as well as marketing that expertise for the development programmes of other companies. Its services for consumers include biomarker measurements for health monitoring.
ValiFinn conducts the management of certain aspects of VAL201 late preclinical work and will assist in the regulatory work pertaining to the clinical trials and will manage certain aspects of the clinical work regarding hormone induced refractory cancer.
ValiRx’s proprietary novel NAV3 Cancer Screening Test enables the detection of cancer cells in tissue samples, whether they are primary tumours, metastases or pre-malignant cell, at a stage when tumour development is only about to start. The test is based on the detection of specific changes in the NAV3 gene and the system of tests can be applied to a range of cancers.
Transcript Analysis with the Aid of Affinity Capture’ or TRAC technology enables the efficient screening of a large number of drug candidates for a wide range of genetic safety and efficacy markers. The technology platform already has an established customer base and it has been generating revenue since 2012. Going forward, ValiRx will look to leverage upon TRAC’s market presence and grow the sales of this diagnostic business. The Company believes that together with clinical validation, revenues from TRAC will grow, which will support both the biomarker and therapeutic development businesses. ValiFinn, which is itself already generating revenues, is well placed to further develop as a service/licensing business.
Mr Oliver de Giorgio-Miller - Chairman
Oliver has a wealth of experience in the management and commercial advancement of life science companies. He has worked for over 30 years with several global pharmaceutical and medical device companies including Schering AG, Hoffman la Roche, Intavent-Orthofix and Photo Therapeutics, a Cancer Research UK company and he has extensive experience advising a number of other early stage biopharmaceutical and medical device companies.
Dr Satu Vainikka - Chief Executive Officer
Satu has many years experience of the biotechnology industry, including extensive first hand experience of equity financing, business management and developing life science technology into commercial enterprises. Prior to her current role as CEO of Valirx, she was a founder, director and CEO of Cronos Therapeutics Limited.
In her past roles, Dr Vainikka has developed and exited successful business models, negotiated corporate and academic transactions, and raised funding for a number of companies. (Member of Remuneration Committee) Dr Satu Vainikka has gained the following qualifications and awards:
MBA at Imperial College Business School 2000.
PHD in signal transduction in oncology, University of Helsinki 1996.
Prestigious “embo” fellowship for Postdoctoral research, at the imperial cancer research (Now CRC).
Dr George Morris - Chief Operations Officer
George has over 25 years’ experience in biological and medical research, and financial services. In the past he has worked for Guy‘s hospital medical school department of medicine, King’s college and University College London. As a Research Scientist, he is an author of numerous books and articles on refereed papers, approximately 70 abstracts, short reports and posters, and an inventor of multiple patents.
George was a founding member of the expert advisory panel, the ‘Biotechnology and Finance Forum’, set up jointly between the European Commission and the European Association of Securities Dealers. George involved in a number of conferences and workshops with the EU research and agricultural directorates and is an ‘expert’ to the Commission, and has been invited into several policy discussion groups.
George has worked with a variety of commercial, governmental organisations and financial institutions in the US, Europe and Australia and many consultancy projects covering various biotechnology and financial activities. He is regularly asked to chair or participate in conferences in his areas of experience, including acting as a ‘Venture Academy’ mentor. Has undertaken numerous continuing professional development courses covering finance and general management as well as in specific areas related to science & technology, statistics.
Mr Gerry Desler - Chief Financial Officer
Gerry is a chartered accountant, who qualified in 1968 with a City firm, before becoming a partner in 1970. Between 1985 to 1990 he was the Senior Partner. During his time in the City, he has specialised in consultancy work, much of it involving funding and venture capital.
He was involved in one of the first joint ventures in what was then the People’s Republic of China in 1980. Gerry was previously the Finance Director of Premier Management Holdings plc, an AIM listed company and is on the board of a number of private companies. Gerry also holds positions as Company Secretary at Prospex Oil and Gas Plc both Aim listed companies. (Member of Audit Committee)
Mr Kevin Alexander - Non-Executive Director
Kevin is a qualified solicitor in England and an attorney in New York and he was a partner at major law firms in both London and the United States for over 25 years. Since leaving the law he has been involved in forming and managing various businesses, both private and public. Kevin is a director of Valirx Plc, and joined the board in September 2006. He has an MA in law from Cambridge University.
For information on the Executive Committee, please click here
For information on the Management team, please click here
ValiRx plc is a company incorporated in the United Kingdom under the Companies Act 1985, its principle place of business is in the United Kingdom.
The Total Number of shares with nominal value 0.1p in issue is 133,356,114.
The information below was last updated on 04 May 2017.
The percentage of securities not in public hands is approximately 1.4%.
The shareholders who hold more than 3% are as follows:
The Directors’ holding are as follows:
16 Upper Woburn Place
London, WC1H 0BS
Tel: +44 (0)203 0084416
Fax: +44 (0)203 0084415
Email: [email protected]
Registered Office Address
16 Upper Woburn Place
London, WC1H 0BS
Beaufort Securities Limited, 63 St Mary Axe, London, EC3A 8AA. http://www.beaufortsecurities.com
Cairn Financial Advisers LLP, Cheyne House, Crown Court, 62-63 Cheapside, London, EC2V 6AX. www.cairnfin.com
Capita Asset Services, The Registry, 34 Beckenham Road, Beckenham, BR3 4TU. www.capitaassetservices.com
Bircham Dyson Bell, 50 Broadway, London, SW1H 0BL, UK
Adler Shine, Aston House, Cornwall Avenue, Finchley, N3 1LF
The Royal Bank of Scotland, Argylle House, 246 Regent Street, London, W1B 3PB