Report from third quarter 2013

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MCItect® enters optimization study following failure in validation trial, AMYtect™ study progresses to data analysis. Organizational downsizing and cost reductions initiated

The interim report for the third quarter 2013 was approved by the Board of Directors on 12 November 2013. Please find the interim report and presentation attached.

Highlights from the report:

  • On July 29th, DiaGenic reported that the validation study for MCItect®, a blood based diagnostic test for Alzheimer’s disease in the pre-dementia stage, had failed to reach the target results. Consequently, DiaGenic decided not to pursue CE-marking of this version of MCItect®
  • A study to develop and verify an optimized MCItect® biomarker test, based on a larger and ethnically more diverse patient population, was initiated
  • The clinical and laboratory analysis phases of the AMYtect™ study were completed
  • The Board and management decided to implement a program to reduce operational expenses. As part of this program 6.5 positions were terminated end of August, the cost savings of which will take effect as from December 2013
  • Q3 2013 pre-tax earnings were NOK –9.3 million compared with NOK –8.6 million in Q3 2012, in line with estimates

Significant events after the end of the period:

  • On 10 October 2013 DiaGenic announced the results from a calibration study for an optimized MCItect® test based on a larger study population. In a patient population of 157 patients diagnosed with amnestic mild cognitive impairment, MCItect® demonstrated a total prediction accuracy of 75% in detecting patients converting to Alzheimer’s disease dementia within two years
  • On 23 October 2013 DiaGenic received a request for the convening of an extraordinary general meeting from shareholders Corona Maritime AS and Tycoon Industrier AS, pursuant to section 5-7 (2) of the Norwegian Public Companies Act. It is requested that election of the board of directors is addressed. The date and time for the extraordinary general meeting is set to 22 November 2013 at 10 hours (CET)
  • On 28 October DiaGenic announced that its management and board of directors will seek to restructure the company, or divest all or selected company assets. As a consequence, the Board decided to give notice of termination to the staff; a process which was fully executed end of October. Work to finalize ongoing projects and third party collaborations will continue during the November to January period
  • On 29 October DiaGenic reported intermediate results from an exploratory study that examines the correlation between gene expression in blood and brain amyloid PET imaging. In an initial patient population of 100 patients, a correlation between brain amyloid load as measured by brain PET imaging and gene expression in peripheral blood was established. Additional data analyses and preferably additional patients are required to determine the degree of correlation and test accuracy

Outlook

DiaGenic´s goals for the next 6 months include:

DiaGenic´s goals for the next 6 months include:

  • Complete the AMYtect™ study for a novel blood-based test correlating with brain PET imaging
  • Restructure the company and/or divest all or selected company assets

 Attachments: The interim report and presentation

Contact:

Paul de Potocki, Chief Executive Officer

Telephone: 47 2324 8950

e-mail: paul.depotocki@diagenic.com

Ruben Ekbråten, Chief Financial Officer

Telephone: 47 2324 8950

e-mail: ruben.ekbraten@diagenic.com

About DiaGenic ASA

DiaGenic is an innovative Norwegian diagnostic company that seeks to create value for patients, partners and investors by developing innovative and patient friendly in vitro diagnostic (IVD) products for early detection of diseases. The company’s proprietary concept implies that a disease evokes systemic responses in the blood unique for the disease, and which can be measured by using a blood sample. DiaGenic is a world leader in identifying gene expression signatures in blood and is focused on the development of IVD biomarker products in the field of Alzheimer’s disease. The company protects its technology through an extensive patent portfolio. DiaGenic is listed on the Oslo Stock Exchange. For more information please visit: www.diagenic.com