BioLineRx Reports Third Quarter 2014 Financial Results
JERUSALEM--(BUSINESS WIRE)--Nov. 10, 2014--
"BL-8040 is currently advancing towards completing the dose escalation stage of the ongoing Phase 2 trial for the treatment of AML. We recently announced the addition of higher dosing cohorts due to encouraging efficacy and excellent safety results from all doses tested to date. Under the amended trial protocol, we expect to complete the dose escalation early next year and anticipate reporting final Phase 2 data in the second half of 2015. Additionally, we initiated patient dosing in a second indication for our BL-8040 platform - a Phase 1 trial for stem cell mobilization for which we expect final results in late 2014 or early 2015. Finally, we announced compelling preclinical results from a combination study of BL-8040 and the investigational FLT3 inhibitor AC220, in which BL-8040 demonstrated profound synergy in minimizing residual disease in this particularly difficult-to-treat form of AML, potentially opening a future avenue of BL-8040 development. We look forward to updating the market on our continued progress, including new clinical studies that we plan to start in 2015."
"We also announced final results from our Phase 1/2 safety study of BL-7010, our novel, non-absorbable, orally available, co-polymer intended for the treatment of celiac disease. Consistent with the interim results announced in
"For our lead partnered asset, BL-1040, a novel resorbable polymer solution for the prevention of ventricular remodeling following an acute myocardial infarction (AMI), we announced an update from the ongoing pivotal CE Mark registration PRESERVATION I trial. Our out-licensing partner Bellerophon has enrolled over 280 patients into the study, out of a total of approximately 300 patients. Based on this enrollment update, we continue to expect Bellerophon to complete enrollment by the end of the year, and complete the study in mid-2015."
Financial Results for Quarter and Nine Months Ended
Research and development expenses for the three months ended
Sales and marketing expenses for the three months ended
General and administrative expenses for the three months ended
The Company's operating loss for the three months ended
The Company's net non-operating income amounted to
The Company's net financial income amounted to
The Company's net loss for the three months ended
The Company held
Net cash used in operating activities was
Net cash used in investing activities for the nine months ended
Net cash provided by financing activities for the nine months ended
Conference Call and Webcast Information
BioLineRx will hold a conference call to discuss its third quarter 2014 results today,
BioLineRx is a publicly-traded, clinical-stage biopharmaceutical company 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 current portfolio consists of a variety of clinical and pre-clinical projects, including: BL-1040 for prevention of pathological cardiac remodeling following a myocardial infarction, which has been out-licensed to Bellerophon BCM (f/k/a Ikaria) and is in the midst of a pivotal CE-Mark registration trial scheduled for completion in mid-2015; BL-8040, a cancer therapy platform, which is in the midst of a Phase 2 study for acute myeloid leukemia (AML) as well as a Phase 1 study for stem cell mobilization; and BL-7010 for celiac disease, which has completed a Phase 1/2 study.
For more information on BioLineRx, please visit www.biolinerx.com or download the investor relations mobile device app, which allows users access to the Company's SEC documents, press releases, and events. BioLineRx's IR app is available on the iTunes App Store as well as the Google Play Store.
Various statements in this release concerning BioLineRx's future expectations constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include words such as "may," "expects," "anticipates," "believes," and "intends," and describe opinions about future events. These forward-looking statements involve known and unknown risks and uncertainties that may cause the actual results, performance or achievements of BioLineRx to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Some of these risks are: changes in relationships with collaborators; the impact of competitive products and technological changes; risks relating to the development of new products; and the ability to implement technological improvements. These and other factors are more fully discussed in the "Risk Factors" section of BioLineRx's most recent annual report on Form 20-F filed with the
Tiberend Strategic Advisors, Inc.
Joshua Drumm, Ph.D.