Release Details

TEL AVIV, Israel, May 17, 2016 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ/TASE: BLRX), a clinical-stage biopharmaceutical company dedicated to identifying, in-licensing and developing promising therapeutic candidates, today reports its financial results for the first quarter ended March 31, 2016.

Highlights and achievements during the first quarter of 2016, and to date: 

• Signing of immuno-oncology collaboration with Merck for BL-8040 Phase 2a study in      pancreatic cancer
• Successful top-line results from Phase 2a study for BL-8040 in r/r AML
• Continued ramp-up of Phase 2b study for BL-8040 as consolidation treatment for AML patients following standard induction treatment
• Initiation of Phase 2 study for BL-8040 in allogeneic stem-cell transplantation
• Receipt of medical device classification for BL-7010 for celiac disease in Europe
• BL-5010 for non-surgical removal of skin lesions receives CE mark and begins initial product launch in Europe

Expected upcoming significant milestones for the remainder of 2016:

• Initiation of Phase 2a study for BL-8040 in combination with KEYTRUDA®, in patients with metastatic pancreatic cancer, expected mid-year
• Full set of data from Phase 2a study for BL-8040 in r/r AML to be provided at an upcoming US-based scientific conference
• Partial results from Phase 2 study for BL-8040 in stem-cell mobilization for allogeneic transplantation expected by end of 2016
• Initiation of efficacy study in gluten sensitivity for BL-7010
• Roll-out of BL-5010 product launch by Omega to additional countries and selection of 2^nd OTC indication for development

Kinneret Savitsky, Ph.D., CEO of BioLineRx, remarked, "During the first quarter of 2016, we made significant progress in advancing BL-8040, our lead oncology platform. We announced successful results in our Phase 2a study for relapsed and refractory AML and we continue to push forward in our Phase 2b trial in an earlier treatment line for AML - as a consolidation treatment following standard induction treatment. We also announced our entering into the exciting field of immuno-oncology, through our collaboration with Merck on a Phase 2a study to investigate BL-8040 in combination with KEYTRUDA® for the treatment of pancreatic cancer. In addition, we are progressing with our strategic collaboration with Novartis for the co-development of selected Israeli-sourced novel drug candidates. Novartis has flagged several pre-clinical projects, which we intend to bring into our pipeline over the next few months.  With $45 million of cash on our balance sheet as of the end of the first quarter, we are well positioned to carry out our strategic and operational plans through the end of 2018, and look forward to achieving our expected milestones during the second half of 2016."

Financial Results for First Quarter Ended March 31, 2016

Research and development expenses for the three months ended March 31, 2016 were $2.5 million, a decrease of $0.7 million, or 20.9%, compared to $3.2 million for the three months ended March 31, 2015. The decrease resulted primarily from the conclusion of one of the clinical trials for BL-8040 in 2015, and the wind-down of a second clinical trial for BL-8040 during the 2016 period.

Sales and marketing expenses for the three months ended March 31, 2016 were $0.2 million, substantially similar to the comparable period in 2015.

General and administrative expenses for the three months ended March 31, 2016 were $1.0 million, an increase of $0.1 million, or 15.5%, compared to $0.9 million for the three months ended March 31, 2015. The small increase was the cumulative effect of an increase in several categories of expenses, none of which individually was material.

The Company's operating loss for the three months ended March 31, 2016 amounted to $3.8 million, compared with an operating loss of $4.3 million for the corresponding 2015 period.

Non-operating income (expenses) for the three months ended March 31, 2016 and 2015 were not material, and primarily relate to fair-value adjustments of warrant liabilities on the Company's balance sheet.

Financial income (expenses), net for the three months ended March 31, 2016 and 2015 were not material, and primarily relate to investment income earned on bank deposits, as well as banking fees. 

The Company's net loss for the three months ended March 31, 2016 amounted to $3.5 million, compared with a net loss of $4.3 million for the corresponding 2015 period.

The Company held $45.0 million in cash, cash equivalents and short-term bank deposits as of March 31, 2016

Net cash used in operating activities was $4.2 million for the three months ended March 31, 2016, compared with net cash used in operating activities of $3.5 million for the 2015 period. The $0.7 million increase in net cash used in operating activities was primarily the result of a decrease in trade payables and accruals.

Net cash provided by investing activities for the three months ended March 31, 2016 was $1.7 million, compared to net cash used in investing activities of $20.7 million for the corresponding 2015 period. The changes in cash flows from investing activities relate primarily to investments in, and maturities of, short-term bank deposits and other investments during the respective periods.

Net cash provided by financing activities for the three months ended March 31, 2016 was $1.6 million, compared to net cash provided by financing activities of $26.5 million for the corresponding 2015 period. The decrease in cash flows from financing activities reflects the underwritten public offering completed by the Company in March 2015.

Conference Call and Webcast Information

BioLineRx will hold a conference call to discuss its first-quarter end March 31, 2016 results today, May 17, 2016, at 10:00 a.m. EDT. To access the conference call, please dial 1-888-407-2553 from the US, or +972-3-918-0644 internationally. The call will also be available via live webcast through BioLineRx's website. A replay of the conference call will be available approximately two hours after completion of the live conference call. To access the replay, please dial 1-888-295-2634 from the US or +972-3-925-5945 internationally. The replay will be available through May 20, 2016.

(Tables follow)

About BioLineRx

BioLineRx is a 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 leading therapeutic candidates are: BL-8040, a cancer therapy platform, which has successfully completed a Phase 2a study for relapsed/refractory AML, is in the midst of a Phase 2b study as an AML consolidation treatment, and has recently initiated a Phase 2 study in stem cell mobilization for allogeneic transplantation; and BL-7010 for celiac disease and gluten sensitivity, which has successfully completed a Phase 1/2 study. In addition, BioLineRx has a strategic collaboration with Novartis for the co-development of selected Israeli-sourced novel drug candidates, and has recently signed a collaboration agreement with MSD (known as Merck in the US and Canada) to run a Phase 2a study in pancreatic cancer using the combination of BL-8040 and Merck's KEYTRUDA^®.

For additional information on BioLineRx, please visit the Company's website at www.biolinerx.com, where you can review the Company's SEC filings, press releases, announcements and events. BioLineRx industry updates are also regularly updated on Facebook, Twitter, and LinkedIn.

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 Securities and Exchange Commission on March 10, 2016. In addition, any forward-looking statements represent BioLineRx's views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. BioLineRx does not assume any obligation to update any forward-looking statements unless required by law.

 

Contact:
PCG Advisory
Vivian Cervantes
Investor Relations
212-554-5482  
vivian@pcgadvisory.com

or

Tsipi Haitovsky
Public Relations
+972-52-598-9892  
tsipihai5@gmail.com

 

 

 

 

 

 

 

 

 

 

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SOURCE BioLineRx Ltd