Press Release

TEL AVIV, Israel, Nov. 11, 2019 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a clinical-stage biopharmaceutical company focused on oncology, today reports its financial results for the quarter ended September 30, 2019 and provides a corporate update.  

Highlights and achievements during the third quarter 2019 and subsequent period:

• Continued to advance its COMBAT/KEYNOTE-202 Phase 2a trial in collaboration with Merck, evaluating BL-8040 in combination with pembrolizumab and chemotherapy in metastatic pancreatic cancer;
• Obtained initial safety data from Part 1 of Phase 1/2a trial of AGI-134 and initiated patient dosing in Part 2, the monotherapy basket arm;
• Presented positive triple-combination preclinical data from the evaluation of BL-8040 in combination with an anti PD-1 and chemotherapy in pancreatic cancer, which support BL-8040's mechanism of action and provide a very strong rationale for the triple-combination clinical study, at the Society for Immunotherapy of Cancer Annual Meeting (SITC);
• Presented encouraging results from an MD Anderson investigator-sponsored, dual-combination study of BL-8040 in combination with KEYTRUDA in metastatic pancreatic cancer patients at SITC;
• Invited to deliver an oral presentation highlighting new clinical data from the triple-combination COMBAT/KEYNOTE-202 Phase 2a study at the European Society of Medical Oncology Immuno-Oncology Congress in December.

"We are quickly approaching a potentially transformational milestone for our Company with the anticipated release of results by the end of the year from the triple combination arm of our ongoing COMBAT/KEYNOTE-202 study of BL-8040, KEYTRUDA^® and chemotherapy in metastatic pancreatic cancer," stated Philip Serlin, Chief Executive Officer of BioLineRx. "Recent preclinical results from the triple combination of BL-8040, an anti PD-1 and chemotherapy, together with clinical results from two separate dual combination studies of BL-8040 and KEYTRUDA^®, give us a high degree of conviction in BL-8040's ability to modify the tumor microenvironment, thereby inducing infiltration of T-cells into the core and periphery of metastatic lesions. Based on our data to date, we believe we can potentially introduce a promising new treatment option not only for metastatic pancreatic cancer, but other difficult-to-treat solid tumor indications as well, where current standards of care are inadequate. At the same time, our trials of BL-8040 in AML and stem cell mobilization are progressing, with key data readouts expected next year."   

"Regarding our second clinical candidate, the universal anti-cancer vaccine AGI-134, we successfully completed Part 1 of the ongoing Phase 1/2a clinical trial in a range of solid tumor types, and quickly initiated dosing in Part 2. We look forward to initial results by year-end 2020," Mr. Serlin concluded.   

Upcoming Milestones

2019

• Response results from the Phase 2a triple combination COMBAT/KEYNOTE-202 pancreatic cancer trial of BL-8040, KEYTRUDA and chemotherapy under the collaboration with Merck;
• Oral presentation with additional data from the Phase 2a triple combination COMBAT/KEYNOTE-202 pancreatic cancer trial at the European Society of Medical Oncology Immuno-Oncology Congress in December 

2020

• Progression-free survival and overall survival data from the COMBAT/KEYNOTE-202 Phase 2a triple combination study in mid-2020;
• Interim results from the Phase 2b AML consolidation study during the first half of 2020;
• Top-line results from Phase 3 GENESIS registrational study in stem cell mobilization in the second half of 2020;
• Initial results from Part 2 of Phase 1/2a trial of AGI-134 by year-end 2020.

Financial Results for the Third Quarter Ended September 30, 2019 

Research and development expenses for the three months ended September 30, 2019 were $5.6 million, an increase of $0.6 million, or 11%, compared to $5.0 million for the three months ended September 30, 2018. The increase resulted primarily from higher expenses associated with the BL-8040 GENESIS and COMBAT/KEYNOTE-202 clinical trials. Research and development expenses for the nine months ended September 30, 2019 were $15.3 million, an increase of $0.7 million, or 5%, compared to $14.6 million for the nine months ended September 30, 2018. The increase resulted primarily from higher expenses associated with the BL-8040 GENESIS and COMBAT/KEYNOTE-202 clinical trials, offset by a decrease in expenses related to BL-1230, a project which was terminated.

Sales and marketing expenses for the three months ended September 30, 2019 were $0.2 million, a decrease of $0.1 million, or 31%, compared to $0.3 million for the three months ended September 30, 2018. The decrease resulted primarily from a decrease in payroll and related expenses. Sales and marketing expenses for the nine months ended September 30, 2019 were $0.7 million, a decrease of $0.4 million, or 40%, compared to $1.1 million for the nine months ended September 30, 2018. The decrease resulted primarily from a decrease in payroll and related expenses, including a one-time compensation payment in the 2018 period.

General and administrative expenses for the three months ended September 30, 2019 were $0.9 million, similar to the comparable period in 2018. General and administrative expenses for the nine months ended September 30, 2019 were $2.8 million, similar to the comparable period in 2018.

The Company's operating loss for the three months ended September 30, 2019 was $6.6 million, compared to $6.2 million for the three months ended September 30, 2018. The Company's operating loss for the nine months ended September 30, 2019 was $18.7 million, compared to $18.6 million for the comparable period in 2018.  

Non-operating income for the three and nine months ended September 30, 2019 primarily relate to fair-value adjustments of warrant liabilities on the Company's balance sheet, offset by warrant offering expenses. Non-operating income (expense) for the three and nine months ended September 30, 2018 primarily relate to fair-value adjustments of warrant liabilities on the Company's balance sheet, as well as a capital gain from realization of the investment in iPharma.

Net financial expenses amounted to $0.4 million for the three months ended September 30, 2019 compared to net financial income of $0.1 million for the three months ended September 30, 2018. Net financial expenses for the 2019 period primarily relate to interest paid on loans, offset by investment income earned on bank deposits. Net financial income for the 2018 period primarily relates to investment income earned on bank deposits. Net financial expenses amounted to $0.9 million for the nine months ended September 30, 2019 compared to net financial income of $0.4 million for the nine months ended September 30, 2018. Net financial expenses for the 2019 period primarily relate to interest paid on loans, offset by investment income earned on bank deposits. Net financial income for the 2018 period primarily relates to investment income earned on bank deposits, offset by losses recorded on foreign currency hedging transactions.

The Company's net loss for the three months ended September 30, 2019 amounted to $3.9 million, compared with a net loss of $6.3 million for the comparable period in 2018. The Company's net loss for the nine months ended September 30, 2019 amounted to $15.6 million, compared with a net loss of $17.3 million for the comparable period in 2018.

The Company held $30.1 million in cash, cash equivalents and short-term bank deposits as of September 30, 2019.

Net cash used in operating activities was $17.2 million for the nine months ended September 30, 2019, compared with net cash used in operating activities of $19.0 million for the nine months ended September 30, 2018. The $1.8 million decrease in net cash used in operating activities during the nine-month period in 2019, compared to the nine-month period in 2018, was primarily the result of changes in operating asset and liability items in the two periods., i.e., a decrease in prepaid expenses and other receivables in 2019 versus an increase in 2018, as well as an increase in accounts payable and accruals in 2019 versus a decrease in 2018.

Net cash provided by investing activities was $2.1 million for the nine months ended September 30, 2019, compared to net cash provided by investing activities of $16.0 million for the nine months ended September 30, 2018. The changes in cash flows from investing activities relate primarily to investments in, and maturities of, short-term bank deposits and the realization of the investment in iPharma in 2018.

Net cash provided by financing activities was $16.6 million for the nine months ended September 30, 2019, compared to net cash provided by financing activities of $2.8 million for the nine months ended September 30, 2018. The increase in cash flows from financing activities reflects the underwritten public offering completed in February 2019.

Conference Call and Webcast Information

BioLineRx will hold a conference call today, November 11, 2019 at 10:00 a.m. EST. To access the conference call, please dial +1-888-407-2553 from the U.S. or +972-3-918-0644 internationally. The call will also be available via webcast and can be accessed through the Investor Relations page of BioLineRx's website. Please allow extra time prior to the call to visit the site and download any necessary software to listen to the live broadcast.

A replay of the conference call will be available approximately two hours after completion of the live conference call on the Investor Relations page of BioLineRx's website. A dial-in replay of the call will be available until November 13, 2019; please dial +1-888-782-4291 from the U.S. or +972-3-925-5904 internationally.

(Tables follow)

About BioLineRx

BioLineRx is a clinical-stage biopharmaceutical company focused on multiple oncology indications. The Company's lead program, BL-8040, is a cancer therapy platform currently being evaluated in a Phase 2a study in pancreatic cancer in combination with KEYTRUDA^® and chemotherapy under a collaboration agreement with MSD. BL-8040 is also being evaluated in a Phase 2b study in consolidation AML and a Phase 3 study in stem cell mobilization for autologous bone-marrow transplantation. In addition, the Company has an ongoing collaboration agreement with Genentech, a member of the Roche Group, evaluating BL-8040 in combination with Genentech's atezolizumab in two Phase 1b/2 solid tumor studies.

BioLineRx is developing a second oncology program, AGI-134, an immunotherapy treatment for multiple solid tumors that is currently being evaluated in a Phase 1/2a study.

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 28, 2019. 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:
Tim McCarthy  
LifeSci Advisors, LLC   
+1-212-915-2564    
tim@lifesciadvisors.com

or

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

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SOURCE BioLineRx Ltd.