CGS – Cogstate Limited
2. Earlier today, Eisai Co., Ltd , a company incorporated in Japan and listed on the Tokyo Stock Exchange, announced that its confirmatory phase 3 Clarity AD study of experimental therapy, Lecanemab, met primary endpoint, showing a statistically significant reduction of clinical decline in a global clinical study of 1,795 participants with early Alzheimer’s disease. This development relates to an arrangement between Eisai and Biogen Inc. in relation to the development of Lecanemab pursuant to a co-commercialisation and co-promotion agreement between those parties. Cogstate is not a party to those arrangements and does not have access to, nor is it otherwise aware of, any information in relation to this development other than as publicly released by Eisai and Biogen.
On 26 October 2020, Cogstate announced that it had entered into an agreement with Eisai to grant Eisai rights to exclusively develop and distribute Cogstate digital cognitive assessment technologies in healthcare and other markets worldwide. The agreement specifically excluded the Clinical Trials market, in which Cogstate continues to market its offering independently.
In respect of Cogstate’s business in Clinical Trials, when commenting on its FY23 outlook on 30 August 2022, the Company noted that the release of positive phase 3 clinical trial data from Eisai (and others) may be expected to lead to a general increase in research and development expenditure in respect of Alzheimer’s disease, which may provide additional sales opportunities for Cogstate in its Clinical Trials business and may also impact Cogstate’s Healthcare business. Cogstate has also consistently stated that the upside revenue opportunity for the Healthcare business, beyond the contracted minimum payments from Eisai, is expected to be dependent upon the release, reimbursement, and availability of proven Alzheimer’s therapeutics.
Since executing the agreement in October 2020, Eisai (which is also a substantial holder in the Company) and Cogstate have progressed commercial plans for launching digital brain health assessment solutions using Cogstate technologies, including both a direct-to-consumer self-check as well as a medical device, CognigramTM, to aid healthcare professionals in clinical diagnosis decisions. It may be expected that such digital cognitive assessments could play an important role in supporting the type of large-scale cognitive assessment that will be necessary in the launch of disease modifying therapies for Alzheimer’s disease.
Save for the announcement by Eisai and Biogen earlier today, which has been reported in the Reuters article referred to in the ASX Letter, the Company is not aware of any other explanation for the recent trading in its securities.
3. in Compliance
