On November 23, 2020 BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a late clinical-stage biopharmaceutical company focused on oncology, reported its financial results for the quarter ended September 30, 2020 and provides a corporate update (Press release, BioLineRx, NOV 23, 2020, View Source [SID1234571554]).

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Significant events and achievements during the third quarter 2020 and subsequent period:

Reported positive results from a pre-planned interim analysis of GENESIS Phase 3 trial of motixafortide for stem cell mobilization (SCM) in multiple myeloma patients. The Data Monitoring Committee (DMC) found statistically significant evidence favoring treatment with motixafortide in the primary endpoint, and subsequently issued a recommendation to cease patient enrollment immediately. In accordance with the DMC’s recommendation, study enrollment was completed at 122 patients (instead of 177 as originally planned). SCM is the Company’s most efficient path to registration;
Announced initiation of Phase 2 investigator-initiated study of motixafortide in combination with LIBTAYO and chemotherapy in first-line PDAC. The study is being run by Columbia University;
Announced initiation of investigator-initiated Phase 1b study, led by Wolfson Medical Center in Holon, Israel, to evaluate motixafortide in patients hospitalized with acute respiratory distress syndrome (ARDS) secondary to COVID-19 and other respiratory viral infections;
Renewed study enrollment in Part of Phase 1/2a trial for AGI-134, which had been temporarily suspended in the second quarter of 2020 due to clinical operating risks associated with the COVID-19 pandemic;
Conducted interim analysis for Phase 2b BLAST study in consolidation AML; analysis did not demonstrate statistically significant effect in primary endpoint; DMC recommended not to continue the study.
"The past several months have been very exciting for BioLineRx, highlighted by the very positive result of the interim analysis of our Phase 3 GENESIS study in stem cell mobilization" stated Philip Serlin, Chief Executive Officer of BioLineRx. "A statistically significant benefit in the primary endpoint was observed by combining motixafortide with the standard of care, G-CSF, leading the DMC to recommend that we cease study enrollment at 122 patients, instead of the 177 originally planned. We look forward to publishing final results of the study in the first half of next year, as we continue to advance motixafortide toward registration.

"With regard to the Phase 2b BLAST study in consolidation AML, based on the results of the interim analysis, the DMC recommended not to continue the study. Although we are disappointed by this outcome, particularly following the positive results that we previously observed in our Phase 1/2a study of motixafortide with cytarabine in relapsed/refractory AML, we continue to believe in the relevance of CXCR4 as a viable target in other AML treatment lines, such as rr/AML and induction treatment. We will decide on next steps in AML once we’ve had a chance to review and analyze the unblinded data, including detailed biomarker and subpopulation data, from this study. I would also like to express our gratitude to the University of Halle, as study sponsor, and Dr. Carsten Müller-Tidow, as principal study investigator, as well as the other investigators and the patients who made this important trial possible.

"Finally, in the coming weeks, we plan to announce full results, including progression free survival (PFS) and overall survival (OS) data, on all study patients from the triple combination arm of our Phase 2a COMBAT/KEYNOTE-202 study in second-line PDAC. We previously shared preliminary positive overall response rate and disease control rate data, on approximately half of the patients enrolled in this study arm, at last year’s ESMO (Free ESMO Whitepaper) IO conference, and we remain optimistic that the combination of motixafortide and KEYTRUDA, together with chemotherapy, will prove beneficial to survival as well.

"The significant and growing body of data that we are compiling on motixafortide, including the strikingly positive results of the interim analysis in the GENESIS phase 3 study reported last month, reassure us about the unique characteristics of motixafortide as the best-in-class CXCR4 antagonist, and confirm our belief that this promising compound can potentially serve as the backbone of combination therapies to treat a broad range of solid tumor and hematological cancers," Mr. Serlin concluded.

Upcoming Expected Milestones

Overall final results, including PFS and OS data, from the COMBAT/KEYNOTE-202 Phase 2a triple combination study in second-line PDAC by the end of 2020;
Final results from the Phase 3 GENESIS trial in SCM in the first half of 2021;
Preliminary results of the Phase 1b study in ARDS in the first half of 2021;
Initial results from Part 2 of the Phase 1/2a trial of AGI-134 in solid tumors in the second half of 2021;
Data from the Columbia University-initiated study of motixafortide in combination with LIBTAYO and chemotherapy in first-line PDAC in mid-2022;
Financial Results for the Quarter Ended September 30, 2020

Research and development expenses for the three months ended September 30, 2020 were $3.5 million, a decrease of $2.1 million compared to $5.6 million for the comparable period in 2019. The decrease resulted primarily from termination of the BATTLE clinical study for motixafortide in 2019 and from lower expenses associated with the AGI-134 study, as well as a decrease in payroll and related expenses due to a Company-wide salary reduction related to the COVID-19 pandemic carried out in the second and third quarters of 2020. Research and development expenses for the nine months ended September 30, 2020 were $13.5 million, a decrease of $1.7 million, compared to $15.2 million for the nine months ended September 30, 2019. The decrease resulted primarily from lower expenses associated with the motixafortide COMBAT clinical trial and the AGI-134 study, as well as a decrease in payroll and related expenses due to a Company-wide salary reduction related to the COVID-19 pandemic mentioned above.

Sales and marketing expenses for three months ended September 30, 2020 were $0.3 million, an increase of $0.1 million compared to $0.2 million for the comparable period in 2019. The increase resulted primarily from consultancy services and market research for motixafortide offset by a decrease in payroll and related expenses related to a reduction in headcount. Sales and marketing expenses for the nine months ended September 30, 2020 were $0.7 million, similar to the comparable period in 2019.

General and administrative expenses for the three months ended September 30, 2020 were $0.9, similar to the comparable period in 2019. General and administrative expenses for the nine months ended September 30, 2020 were $2.8 million, similar to the comparable period in 2019.

The Company’s operating loss for the three months ended September 30, 2020 amounted to $4.6 million, compared to an operating loss of $6.6 million for the comparable period in 2019. The Company’s operating loss for the nine months ended September 30, 2020 was $17.1 million, compared to $18.7 million for the comparable period in 2019.

Non-operating income (expenses) for the three- and nine-month periods ended September 30, 2020 and 2019 primarily relate to fair-value adjustments of warrant liabilities on the Company’s balance sheet, offset by warrant offering expenses and issuance expenses of the Company’s ATM program.

Net financial expenses for the three months ended September 30, 2020 amounted to $0.3 million compared to net financial expenses of $0.4 million for the comparable period in 2019. Net financial expenses for both periods primarily relate to interest paid on loans, offset by investment income earned on bank deposits. Net financial expenses for the nine months ended September 30, 2020 amounted to $0.9 million, similar to the comparable period in 2019. Net financial expenses for both periods primarily relate to interest paid on loans, offset by investment income earned on bank deposits.

The Company’s net loss for the three months ended September 30, 2020 amounted to $4.6 million, compared with a net loss of $3.9 million for the comparable period in 2019. The Company’s net loss for the nine months ended September 30, 2020 amounted to $18.0 million, compared with a net loss of $15.6 million for the comparable period in 2019.

The Company held $20.8 million in cash, cash equivalents and short-term bank deposits as of September 30, 2020.

Net cash used in operating activities was $17.8 million for the nine months ended September 30, 2020, compared with net cash used in operating activities of $17.2 million for the nine months ended September 30, 2019. The $0.6 million increase in net cash used in operating activities during the nine-month period in 2020 was primarily the result of the decrease in accounts payable and accruals in the 2020 period.

Net cash provided by investing activities was $8.1 million for the nine months ended September 30, 2020, compared to net cash provided by investing activities of $2.1 million for the nine months ended September 30, 2019. The changes in cash flows from investing activities relate primarily to investments in, and maturities of, short-term bank deposits.

Net cash provided by financing activities was $10.9 million for the nine months ended September 30, 2020, compared to net cash provided by financing activities of $16.6 million for the nine months ended September 30, 2019. The cash flows in 2020 primarily reflect the May and June financings and the net proceeds from the Company’s ATM program, offset by repayments of the loan from Kreos Capital. The cash flows in 2019 primarily reflect the underwritten public offering of our ADSs in February 2019, as well as net proceeds from the ATM facility.

Conference Call and Webcast Information

BioLineRx will hold a conference call today, November 23, 2020 at 10:00 a.m. EST. To access the conference call, please dial +1-866-744-5399 from the US or +972-3-918-0664 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 25, 2020; please dial +1-877-456-0009 from the US or +972-3-925-5929 internationally.