Report from first quarter 2013

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Private placement raising NOK 30 million completed, full focus on Alzheimer’s disease product portfolio development

The interim report for the first quarter 2013 was approved by the Board of Directors on 14 May 2013. Please find the interim report and presentation attached.

Highlights from the report:

  • On 7 March 2013 DiaGenic raised NOK 30 million in gross proceeds through a private placement of 50 million new shares at a price of NOK 0.60 per share. Registration of the private placement took place after the end of the quarter and the cash balance at the end of March was NOK 9.5 million
  • Q1 2013 pre-tax earnings were NOK -9.7 million compared with NOK -9.0 million in Q1 2012, in line with estimates
  • Technical verification studies and calibration trials for MCItect® and ADtect® have progressed according to plans. Patient recruitment for AMYtect™ study is on track
  • In February, the FDA issued new draft industry guidelines regarding drug development for Alzheimer’s disease (AD). The FDA emphasizes the value of identifying and studying patients with early stage Alzheimer's disease, and highlights the need for biomarkers to identify AD patients in the mild cognitive impairment (MCI) pre-dementia stage of the disease
  • DiaGenic’s study on the ‘Prediction of MCI due to AD in an amnestic MCI population’ was accepted for publication in the Journal of Alzheimer’s Disease
  • DiaGenic signed an agreement with a major U.S. university that provides access to additional U.S. patient samples and clinical data enabling validation of DiaGenic’s MCItect® product
  • As a consequence of the strategic decision to focus on product development targeting Alzheimer’s disease, DiaGenic has terminated certain research activities and related employment positions outside of this focus. These measures will reduce the Company’s cost base by approximately NOK 3 million in 2013

Significant events after the end of the period:

  • On 2 April 2013 the Extraordinary General Meeting of DiaGenic resolved the private placement of 50 million new shares at a price of NOK 0.60 per share and the subsequent offering for the shareholders that did not participate in the private placement, at equal terms. A total of 4,575,078 new shares have been issued in the subsequent offering which brings total share capital up to NOK 40,799,365 divided into 81,598,730 shares

Outlook

DiaGenic´s goals for the next 6 months include:

DiaGenic´s goals for the next 6 months include:

  • To deliver on the near-term milestones related to product development:
    • CE marking of new ADtect® and MCItect® in Europe
    • Present interim results for a blood-based test correlating with brain PET imaging
    • Conduct a pre-submission meeting with the FDA to confirm the requirements for U.S. regulatory clearance of MCItect®
  • Proactively and in parallel evaluate alternatives for strategic development providing optimal shareholder value, including strategic collaborations, asset sale or trade sale
  • To enter into additional collaborative agreements related to Alzheimer's disease with major pharmaceutical companies

 Attachments: The interim report and presentation

Contact:

Paul de Potocki, Chief Executive Officer

Telephone: 47 2324 8950

e-mail: paul.depotocki@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