Report from third quarter 2012
The interim report for the third quarter 2012 was approved by the Board of Directors on 23 October 2012. Please find the interim report and presentation attached.
Highlights from the report:
- Paul de Potocki starts as new CEO on September 17th
- Patrik Dahlén assumes the role as Deputy Chairman of the Board
- New ADtect® and MCItect® exceed 80% test accuracy – a significant breakthrough for DiaGenic’s technology and product development
- A U.S. regulatory consultancy firm has been contracted, and preparations for a clinical study to generate MCI patient data required for an FDA filing are ongoing
- Comprehensive evaluation of company strategy and financing alternatives for implementation
- Q3 2012 pre-tax earnings of NOK -8.6 million compared with NOK -9 million in Q3 2011. Cash balance of NOK 28 million at the end of the quarter
Significant events after the end of the period:
- DiaGenic signs contract with Harvard Medical School, enabling studies on MCI in the U.S.
- DiaGenic finalizes contract negotiations with a European group for validation of gene signature for MCI in the EU
- DiaGenic gene signature detects Parkinson Disease in patients with familial (LRRK2) Parkinson Disease with 75% accuracy
Focus going forward
DiaGenic will increase its focus on the large unmet needs related to Alzheimer’s Disease. The company believes that the most attractive option to create shareholder value is to pursue a strategy to develop an FDA approved product while maintaining ownership to the company’s intellectual property.
The interest in DiaGenic from key industry stakeholders has remained strong. We will continue to pursue non-exclusive partnerships and collaborative development deals with industry partners, while maintaining control of our intellectual property and technology platform related to Alzheimer’s Disease. As a consequence, DiaGenic does not expect partnering deals to provide significant income in the short term. However, such partnerships could be of great strategic importance in the development and commercialization of DiaGenic’s products going forward.
DiaGenic is currently assessing in more detail the process and timelines to achieve FDA cleared products. As part of the assessment of implementing a product and disease focused company strategy, DiaGenic is evaluating its capital need and financing alternatives. DNB Markets has been retained as advisor to support the company in this work.
Outlook
DiaGenic´s goals for the next 12 months include:
- Assessment of capital need and securing of financing for the implementation of a product development and disease focused strategy
- Patient recruitment for clinical trials in the U.S. to prepare for FDA approval of MCItect®
- CE marking of new ADtect® and MCItect® in Europe
- Entering into additional third party collaborative agreements related to Alzheimer's disease
- Presentation of results from the ongoing clinical study with GE Healthcare to identify gene signatures and an IVD test correlating with brain PET imaging
Attachments: The interim report and presentation
Contact:
Paul de Potocki, Chief Executive Officer and President
Telephone: +47 4047 3060
e-mail: paul.depotocki@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