« BackCytox Limited

One Line Pitch: Cytox is a company developing products for Alzheimer’s disease (AD) diagnosis and treatment, based on the cell cycle theory of the pathogenesis of AD. We are in the second year of a two year programme to validate our biomarkers and targets. We will provide assay products and services to the pharmaceutical industry for use in clinical and pre-clinical development, followed longer-term by an FDA AD-dementia diagnostic and new AD therapeutics.

Business Summary:

Cytox is a company developing products for Alzheimer’s disease (AD) diagnosis and treatment, based on the cell cycle theory of the pathogenesis of AD. We are in the second year of a two year programme to validate our biomarkers and targets. We will provide assay products and services to the pharmaceutical industry for use in clinical and pre-clinical development, followed longer-term by an FDA AD-dementia diagnostic and new AD therapeutics.

Management:

The cell cycle theory of AD is based on original work by Dr. Nagy. Dr Hawkins has been CEO and Chairman of five biotech companies in diagnostics and therapeutics. Richard Hadden spent five years as co-lead of the Healthcare team at NESTA. Dr. Tankosic has spent twenty years in development and strategy in neuroscience-based product development. Paul Davies built the bus dev function for Pharmagene, an supplier of novel assays for drug development.

Customer Problem:

There are no validated biomarkers with high predictive specificity and sensitivity for sporadic AD in the early stages of the disease. This prevents effective treatment and drug development.

Product/Services:

We provide biomarker assay services to AD drug developers. Our assays improve understanding of clinical trial outcome, by enabling companies to profile patients better. Using our biomarkers, our customers will be able to: assign patients accurately to disease groups and sub-groups, e.g. AD / control and predict which patients respond to their drug (patient-drug selection) and how (pharmacodynamics). Our diagnostic test will enable early treatment

Target Market:

There are 7m patients in Europe with AD dementia and a further 10m with mild cognitive impairment (of whom c15% convert each year to AD dementia). There are 3.1m AD dementia patients in North America. The global population of 26m will rise to 106m by 2050. Each US AD patient costs c. $21k in healthcare. There are 70+ companies developing 110 drugs for AD in the clinical phase. We estimate the near-term market for AD clinical trials at $3.8Bn.

Customers:

Potential customers include nearly every major drug development companies, e.g. Merck, Pfizer, Eli Lily, and the major clinical diagnostic players, e.g. Roche, J&J.

Sales/Marketing Strategy:

We will target companies with AD drugs entering or leaving Phase II development, with a proposal of a companion diagnostic proof-of-principle study based on our biomarkers. Our aim is to develop a strategic relationship with a major drug development company, from a small number of proof-of-principle studies.

Business Model:

We aim to provide our assays commercially in proof-of-principle studies with major drug and diagnostic co's, and license them as long-term development partners for our companion & clinical diagnostics.

Competitors:

There are various imaging techniques and biomarkers in development for AD. All contenders need to displace the existing method of neuropsychiatric evaluation. Our nearest competitor is Satoris, a Stanford spin-out ($5m raised Jan 2008) validating a panel of biomarkers for AD, which have been identified based on pure statistical correlation. There are no competing biomarkers based on a unifying patho-mechanism, such as the cell cycle theory of AD

Competitive Advantage:

We have a family of diagnostic patents (Europe, USA, Japan) and a family of therapeutic patents (Europe, USA), licensed from Oxford. We also have proprietary data and access to the OPTIMA longitudinal AD study.

What other information do you think we should know?:

We are looking to raise major US VC money in 2009 and move the company to the US. We attended Angelfair last year as floor delegates. The interest from several investors in 2007, e.g. the Merrill Lynch sponsors on behalf of their private clients, encouraged us to consider pitching this year, as part of the top-up of our 2008 angel round. We have just raised $1.1m from our existing UK investors for 2008.