Report from first quarter 2012
The interim report for the first quarter 2012 was approved by the Board of Directors on 8 May 2012. Please find the interim report and presentation attached.
Highlights from the report:
DiaGenic and GE Healthcare enter into R&D agreement to collaborate on Amyloid-PET imaging and gene signatures in Alzheimer’s disease – First in class study comparing gene signature and brain PET imaging.
A target of 300 individuals will be recruited to the study. A majority will undergo GE Healthcare 18F-Flutemetamol amyloid-PET imaging. All subjects will be analyzed with exploratory gene expression analyses. Collaboration with University of Lund, and co-funded by Innovation Norway providing 2 million NOK. Important step change in Alzheimer market with FDA approval of first 18 F-PET ligand (AMYVID®; Eli Lilly) for detecting amyloid in the brain April 4th. Market expected to hit 1.5 bn USD. GE Healthcare has completed a phase 3 program developing 18F Flutemetamol PET ligand and expects a FDA submission in late 2012.
Increased out-licensing interactions in US (with Ferghana Partners) and collaborative interest for DiaGenic’s Alzheimer’s products from large pharma
A series of face-to-face meetings between potential partners and DiaGenic supported by transaction Partner Ferghana, has been logged in US in Q1. These partners represent service providers (typically laboratory chains) or technology providers (platform providers). Additional interest from large pharma players with ongoing AD clinical programs.
European multicenter study in Parkinson’s disease show high accuracy (88%) in early diagnosis.
The trial includes 79 PD patients, 109 matched controls and utilized a 700 probes approach. Patients were recruited from DiaGenic’s biobank of 900 PD patients from Norway, Sweden, Germany and Italy. Dialogues with partners providing imaging diagnostics have been initiated. Imaging in the diagnosis of Parkinson’s disease is standard procedure. Several million tests performed annually - early diagnosis is however insufficient with existing procedures. To date, there are few alternatives and DiaGenic give priority to provide an innovative improvement to the diagnosis of PD. DiaGenic’s gene expression signature is encouraging and may act as a co-diagnostic to imaging.
Breast cancer patents filed in 2004 and in 2005 progress from Notice of Allowance to Approval.
Operating revenue were NOK 23 thousand in the first quarter 2012 compared with NOK 1.6 million for the corresponding period in 2011. Total operating costs for the first quarter in 2012 amounted to NOK 9.4 million compared with NOK 11.2 million in the corresponding period in 2011. Comprehensive income totalled NOK -9 million for the first quarter in 2012, improved by NOK 0.1 million from the corresponding period in 2011. The company’s cash and cash equivalents totalled NOK 48.1 million at 31 March 2012.
Post quarter highlights
Erik Christensen resigned as Chief Executive Officer on April 17th and will continue to support DiaGenic as a consultant. Henrik Lund appointed interim Chief Executive Officer. Recruitment of New Chief Executive Officer is initiated.
The world’s leading Alzheimer’s disease magazine, Journal of Alzheimer`s Disease (JAD) awards DiaGenic for best scientific publication in 2011. The publication describes the performance of ADtect®.
Data collection and genetic analysis in unique study on familial Parkinson’s disease aiming at identifying pre-symptomatic gene signature in mutation carriers (LRRK2) completed
DiaGenic has been granted world-wide trademarks for its key brands ADtect®, BCtect®, PDtect® and MCItect®
Post quarter outlook
- CEO recruitment
- Study start of 18F PET study with GE Healthcare and first patient scanned with amyloid PET
- Partnering discussion with large pharma players with ongoing AD clinical programs.
- US out-licensing activities of DiaGenic’s products with Ferghana Partners
- Results from Parkinson’s disease LRRK2 study
Attachments: The interim report and presentation
Henrik Lund, CEO
Telephone: 47 90971219
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