COGSTATE LTD — Regulatory Filings 2013

Sep 25, 2013

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ASX Announcement

26 September 2013

Growing recognition of Cogstate test as a central tool to measuring cognitive decline in world-leading studies

Medical technology company Cogstate continues to strengthen its position as an essential partner for measuring cognition in important studies around the world, with results from a schizophrenia study using Cogstate's test published in a major scientific journal.

In a peer reviewed paper published in the European Neuropsychopharmacology journal coauthored by Cogstate Chief Science Officer Dr Paul Maruff, it was reported that Lurasidone, an atypical antipsychotic drug, improved cognitive function of schizophrenia patients, as measured by the Cogstate tests, significantly more than the control group.

Cognitive impairment is a fundamental element of schizophrenia. For patients dealing with the everyday struggles of this disease, any improvement in their cognitive functioning is highly compelling in the absence of a cure for the disease.

The study involved 486 test patients diagnosed with schizophrenia who received six weeks of treatment once-daily with Lurasidone. The Cogstate computerised cognitive battery of tests were given to the patients before treatment to establish a base line and then again at week six, 19 and 32 to determine whether the drug helped the patients’ cognitive functioning including processing speed, attention, visual learning, working memory, and social cognition at a statistically significant level. The results concluded that Lurasidone (at 160mg/d) improved the cognition functioning of the patients at the six week, three month and six month milestones.

“We have seen already that the Cogstate schizophrenia test battery is sensitive to cognitive improvement in chronic schizophrenia,” said Dr. Maruff. “The really exciting thing about the results from this study is that they show now that the Cogstate battery is also sensitive to cognitive improvement in schizophrenia with acute exacerbation of psychosis.”

“This growing body of positive data suggest that cognitive impairment at all stages of the schizophrenia can be ameliorated and that this improvement can be detected using cognitive outcome measures with optimal sensitivity, like the Cogstate battery.”

Mr Brad O’Connor, Chief Executive Officer of Cogstate added:“Our involvement in this study is further evidence of the growing validation of the Cogstate test to measure cognitive decline in these important trials and the essential role Cogstate’s experts such as Paul are playing.”

Alzheimer’s disease trial receives funding boost

In a further validation for the Company, the Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU) trial was awarded US$1.5 million in funding from the National Institutes of Health (NIH) to support its Alzheimer’s disease prevention trial, which is using the Cogstate test as the tool to measure cognitive function.

This four-year trial, a multi-site international effort, will test three anti-amyloid-beta interventions: gantenerumab, solanezumab and a third, as yet undetermined, drug. This trial is supported by the Alzheimer's Association[®,] , Roche, Lilly, Avid Radiopharmaceuticals and Cogstate.

The funding, which could increase to US$6 million over the duration of the study, is part of a broader US$45 million funding initiative by the NIH towards new research into Alzheimer’s Disease and Prevention, was announced recently.

“The magnitude of funding awarded by the NIH to both DIAN-TU and other studies, underlines the importance, at an international public policy level, to support further research into early intervention and new treatments for Alzheimer’s disease. We are pleased to see some of these funds dedicated to a study as groundbreaking as the DIAN-TU trial,” said Mr O’Connor.

“Cogstate’s involvement in the DIAN-TU study and in the Lurasidone schizophrenia trial builds on the multiple validation points of the ability of the Cogstate technology to detect subtle changes in cognition that are clinically meaningful.”

A copy of the European Neuropsychopharmacology paper is available http://www.europeanneuropsychopharmacology.com/article/S0924-977X(13)00216-2/abstract and the NIH release can be accessed here: http://www.nih.gov/news/health/sep2013/nia-18.htm

ENDS

For further information contact:

Brad O’Connor

Cogstate Chief Executive Officer +61 3 9664 1300 or 0411 888 347 boconnor@cogstate.com

Investor Relations and Media: Australia Rebecca Wilson +61 3 9866 4722 rwilson@buchanwe.com.au

US Lauren Glaser +1 646 378 2972 LGlaser@troutgroup.com

Ben Oliver (Media) +61 3 9866 4722 boliver@buchanwe.com.au

About Cogstate

Cogstate Ltd (ASX: CGS) is a multi-faceted cognitive assessment and training company, focused on the development and commercialisation of rapid, computerised tests of cognition (brain function). It has three distinct business units:

Clinical Trials: In the clinical drug trial market, Cogstate technology and associated services are used by pharmaceutical and biotechnology companies to quantify the effect of drugs or other interventions on human subjects participating in clinical trials. Since sales into the clinical trials market began in 2004, Cogstate has secured agreements with top pharmaceutical companies including Pfizer, AstraZeneca, Bristol-Myers Squibb, GlaxoSmithKline, Johnson & Johnson, Novartis, Lundbeck, Dainippon Sumitomo, Targacept, Otsuka, and Servier.

Axon Sports: The mission of Axon Sports is to “protect and train the athletic brain”. Axon’s focus is to research, develop and deliver cutting edge tools to assess, monitor and improve the athletic brain.

Axon has been developing sport specific training products, initially focussed on American football and baseball, and the resulting technologies have now been launched within a small number of elite US college programs. In addition, the first of Axon’s consumer iPad apps was launched in 2012.

In the area of sports related concussion, Cogstate’s technology has been used by a number of highly regarded institutions and sporting organisations around the world for almost 10 years. That technology is now marketed to consumers as Axon Sports. Current users of Cogstate/Axon Sports in Australia include the AFL and NRL, whilst in the USA elite programs such as the NBA, WNBA, NHL as well as college programs such as University of Notre Dame, University of Michigan and University of Connecticut all use the Axon Sports system.

Healthcare: In the primary care or general practice setting, the Cogstate’s COGNIGRAM ™ assesses cognition in patients and the reports generated on the basis of this assessment can allow physicians to identify subtle changes that could be indicative of the early stage of a neurodegenerative disease, such as Alzheimer’s disease. Cogstate intends to develop COGNIGRAM ™ to monitor changes in cognitive function following concussion or after treatment with drugs or other types of interventions. In June 2012, Cogstate entered into an agreement with Merck Canada Inc. providing it with the exclusive right to market and promote COGNIGRAM ™ in Canada.