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Overview

BioLineRx is a publicly-traded (NASDAQ/TASE: BLRX), clinical-stage biopharmaceutical company based in Jerusalem, Israel, dedicated to identifying, in-licensing and developing promising therapeutic candidates. The Company in-licenses novel compounds primarily from academic institutions and biotech companies based in Israel, develops them through pre-clinical and/or clinical stages, and then partners with pharmaceutical companies for advanced clinical development and/or commercialization.

BioLineRx's close ties with universities, research institutes, academic institutions, technology transfer offices and biotechnology companies, both in Israel and globally, enable access to promising projects at an early stage. The first stage involves a stringent selection process. BioLineRx's scientists specialize in evaluating potential drug candidates from both scientific and marketing perspectives. After acquiring the most promising projects, the Company then performs feasibility assessment studies and development through pre-clinical and clinical stages. Supported and assisted by a distinguished panel of scientific advisers, the Company's scientists and experts in pharmacy and regulation, clinical trials and IP work together to advance BioLineRx’s pipeline usually through Phase II proof of concept in humans. And finally, the Company partners with medium size and large pharmaceutical companies to complete the clinical development and bring the product to market.
 
BioLineRx's pipeline currently consists of six clinical stage therapeutic candidates:

BL-1040, a medical device developed for the prevention of cardiac remodeling in acute myocardial infarction patients, which was out-licensed to Bellerophon Therapeutics (f/k/a Ikaria) (in pivotal CE Mark registration trial);

BL-8040, for acute myeloid leukemia (AML) and other hematological cancers (in midst of Phase II trial for AML and Phase I trial for stem-cell mobilization);

BL-7010a novel, non-absorbable, high molecular weight polymer intended for the treatment of celiac disease (Phase I/II trial successfully completed);

BL-5010a novel formulation for the non-surgical removal of skin lesions (Phase I/II trial successfully completed), which was out-licensed to Omega Pharma in the territories of Europe, Australia and additional selected countries;

BL-7040a novel, orally available synthetic oligonucleotide for the treatment of inflammatory bowel disease (Phase IIa trial successfully completed);

BL-8020, an orally available interferon-free treatment for Hepatitis C (HCV) and other viral indications (in Phase I/II development), which has been partnered with Genoscience and Panmed.

Additional compounds are currently in the pipeline at various stages of pre-clinical development.

In addition to the above compounds, BioLineRx also has a multi-year a strategic collaboration with Novartis for the co-development of selected Israeli-sourced novel drug candidates. The companies intend to co-develop a number of pre-clinical and early clinical therapeutic projects through clinical proof-of-concept for potential future licensing by Novartis.