Report from second quarter 2012

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The interim report for the second quarter 2012 was approved by the Board of Directors on 28 August 2012. Please find the interim report and presentation attached.

Highlights from the report:

Paul de Potocki announced as new CEO, assumes his position September 17th

Paul de Potocki was appointed as new CEO June 26 and assumes his position 17 September and succeeds Henrik Lund who has been interim CEO since April 17 when Erik Christensen resigned.

DiaGenic awarded international prize for best scientific article in 2011 by the Journal of Alzheimer's Disease

The world's leading journal in Alzheimer's disease, the Journal of Alzheimer's Disease (JAD), awarded DiaGenic the price for best scientific publication in 2011 on the 2nd of May.

DiaGenic allocated NOK 7.8 million from the Norwegian Research Council

In May DiaGenic was granted up to NOK 7.8 million from Norwegian Research Council to continue the development of DiaGenic tests for early detection of Alzheimer's disease.

Licensing activities and research collaboration with pharma

Licensing activities and partnering discussions with leading diagnostic companies and pharmaceutical companies continued in the 2nd quarter. New improved accuracy of DiaGenics diagnostic tests that was announced after the quarter has provided additional momentum in these interactions.

Alzheimer's disease - Clinical phase ongoing for development of a genetic test for PET amyloid imaging with GE

The 7th of June the first patient with MCI (mild cognitive impairment) was recruited in the collaborative project between GE Healthcare and DiaGenic. There has been good progress in the project, with just 2 months between contract signing and first patient in.

Patent – trademarks: approval of key trademarks for the products ADtect®, BCtect®, PDtect® and MCItect®

Financials

Total operating costs for the second quarter in 2012 amounted to NOK 12.7 million compared with NOK 9.8 million in the corresponding period in 2011. Comprehensive income totalled NOK -12.5 million for the second quarter in 2012 compared with NOK -8.1 million in the corresponding period in 2011. The company’s cash and cash equivalents totalled NOK 38.9 million at 30 June 2012.

Post quarter highlights

Alzheimer diagnostic tests ADtect and MCItect - accuracies above 80% using fewer genes

A critical milestone was achieved on the 18 July with the presentation of research results showing test accuracies above 80% using a limited number of genes both for ADtect and MCItect presented at the Alzheimer's Association International Conference. The results indicate a significant improvement in diagnostic test accuracy for a new version of the CE marked ADtect® test showing an accuracy of 82% for the detection of Alzheimer's disease in the dementia stage. In addition the results show 81% accuracy of a new 25 gene signature for detecting MCI converting to AD dementia within 2 years (MCItect®).

Patent
New family 3 patent in Japan for the diagnosis of breast cancer granted.

Outlook

Diagenic´s goals for the next 12 months include:

  • Initiation of clinical trials in the US to prepare for FDA submission of MCItect
  • CE marking of MCItect and new ADtect in Europe
  • Partner agreements with leading pharmaceutical companies with ongoing clinical programs in Alzheimer's disease.
  • Presentation of results from Parkinson LRRK2 study
  • Presentation of interim results from the ongoing PET study with GE Healthcare for amyloid IVD development.
  • Explore financing opportunities of the company through proceeds from up-front payments on out licensing or through other options such as loans, equity and R&D grants

  Attachments: The interim report and presentation

Contact:

Henrik Lund, CEO

Telephone: 47 90971219

e-mail: henrik.lund@diagenic.com

About DiaGenic ASA

DiaGenic seeks to create value for patients, partners, and investors by developing innovative and more patient friendly methods for early detection of diseases utilizing DiaGenic’s unique concept. The concept implies that a disease evokes systemic responses in the blood unique for the disease, and which can be measured by using blood samples.

DiaGenic is a world leader in identifying these gene expression signatures in peripheral blood and is focused on the development of biomarkers in the field of Alzheimer’s disease and Parkinson’s disease. DiaGenic’s Alzheimer’s disease development program includes the CE marked diagnostic test ADtect®, for detection of mild to moderate Alzheimer’s disease, and MCItect®which is under development for identifying patients with very early stages of Alzheimer’s disease (prodromal AD).

DiaGenic’s concept is protected through an extensive patent portfolio. DiaGenic promotes its products and services towards leading pharmaceutical, imaging and diagnostic companies. DiaGenic is located in Norway and listed on the Oslo Stock Exchange. For more information please visit: www.diagenic.com