Report from second quarter 2011

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Important milestones achieved

Read Out of the MCI study ongoing

The interim report for the second quarter 2011 was approved by the Board of Directors on 18 August 2011. Please find the interim report and presentation attached.

Highlights from the report:

  • Pfizer collaboration proceeds according to plan, all laboratory and bioinformatic analysis finalized
    • Finalized study report to Pfizer post quarter
  • Discussions with pharma and imaging companies advancing
    • Confirmation of strong IP within Alzheimers by third parties
  • Dr Magnus Sjögren recruited as CMO from UCB Pharma

DiaGenic’s collaboration with Pfizer is the first collaboration between a diagnostics company and the market leader for Alzheimer’s therapeutics that aims to identify blood based diagnostic tools that can detect early Alzheimer’s disease, before the disease is clinically overt, or accessible to other either more invasive and costly or less precise diagnostic exploration. The first clinical program with Pfizer is now in final data read out phase. The two diagnostic tests being developed jointly with Pfizer are one progression test that aim to uniquely identify which patients with mild cognitive impairment that will develop Alzheimer’s disease within the next few years and a second test that aims to demonstrate further disease progression. Both tests will be suitable for patient inclusion into clinical trials for the pre dementia stage of AD and for monitoring treatment effects of new drugs. The Pfizer project advanced according to expected timelines and DiaGenic finalized all laboratory analysis in the quarter. After the quarter DiaGenic finalized the bioinformatic work described in the agreement and a comprehensive study report will be reviewed and concluded independently by Pfizer before scientific results are presented in the coming months.

In parallel with the Pfizer study and as previously stated, we have continued promoting our capabilities, core assets and diagnostic tests to multiple large pharma companies who are engaged in the AD field. The feedback on our unique concept and value proposition is very encouraging. Positive R&D findings from the non-exclusive Pfizer collaboration will enable new momentum to the Pfizer collaboration as well as adding important weight to securing additional revenue generating pharma collaboration with identified partners.

We have also advanced our dialogues with producers of amyloid PET tracers on R&D collabo­rations; these have resulted in joint development of study protocols, clinical site reviews and funding scenarios. These dialogues also address use of blood based biomarkers together with high cost PET imaging as part of a multimodal approach of future AD management.

Operating revenue were NOK 1,151 thousand in the second quarter 2011 and NOK 2,759 thousand in first half of 2011, compared with NOK 8 thousand in the corresponding periods in 2010. Total operating costs for the second quarter in 2011 amounted to NOK 9.8 million and NOK 21.0 million for the first half of 2011, compared with NOK 10.5 million and NOK 22.5 million in the corresponding periods in 2010. Comprehensive income totalled NOK -8.1 million for the second quarter in 2011 and NOK -17.1 million in the first half of 2011, compared with NOK -10.5 million and NOK -22.4 in the corresponding periods in 2010. The company’s cash and cash equivalents totalled NOK 76.1 million at 30 June 2011.

Outlook

  • Successfully leverage on and expand the Pfizer collaboration further
  • Communicate the results from the Pfizer study in the coming months
  • Execute on the companion diagnostics initiative, closing R&D and licensing agreements with pharmaceutical and imaging companies operating in the CNS field

 Attachments: The interim report and presentation

 

 

 

 

About DiaGenic ASA

DiaGenic is an innovative Norwegian biotechnology company that seeks to create value for patients, partners, and investors by developing new and more patient friendly methods for early detection of diseases. DiaGenic is currently a world leader in analyzing gene expression signatures related to disease in easily available clinical samples such as peripheral blood. This unique method is based on the principle that even when a disease is localized at a specific part of the body, secondary responses, which are also characteristic of the disease, can be measured in other parts of the body. DiaGenic has developed and CE marked two blood based diagnostic tests, BCtect® for early breast cancer detection and ADtect® for early detection of Alzheimer’s Disease. The company protects its technology through an extensive patent portfolio. DiaGenic promotes its products towards leading pharmaceutical and imaging companies, and towards clinicians. DiaGenic is listed on the Oslo Stock Exchange. For more information visit www.diagenic.com

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