On August 6, 2020 BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a late clinical-stage biopharmaceutical company focused on oncology, reported its financial results for the quarter ended June 30, 2020 and provides a corporate update (Press release, BioLineRx, AUG 6, 2020, View Source [SID1234563138]).

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Highlights and achievements during the second quarter 2020 and subsequent period:

Continued to advance clinical programs, with three key data readouts in pancreatic cancer, stem cell mobilization and AML expected between now and year-end;

Announced publication in the peer-reviewed journal Nature Medicine of previously disclosed biomarker and clinical data from the COMBAT/KEYNOTE-202 trial in pancreatic cancer, showing encouraging clinical activity, as well as proof-of-mechanism;

Strengthened balance sheet with $13.4 million in gross proceeds from two registered direct offerings.

"We continue to eagerly await important survival data from the triple combination arm of our COMBAT/KEYNOTE-202 clinical trial of motixafortide in combination with KEYTRUDA and chemotherapy in metastatic pancreatic cancer," stated Philip Serlin, Chief Executive Officer of BioLineRx. "The compelling data on 22 patients that we reported in December give us conviction that this combination has the potential to be a real breakthrough in one of the most difficult to treat cancers. As this is an event-driven trial, we are obviously very pleased that there are still patients on study, although we now anticipate a modest delay of a few months in announcing the data from our original expectation.

"Turning to stem cell mobilization, this continues to be our most efficient path to registration. Given a significantly lower patient dropout rate than we had anticipated in our Phase 3 GENESIS trial, we now plan to conduct an interim analysis in the second half of this year. If the primary endpoint is met, we plan to immediately announce cessation of recruitment, without the need to enroll the full planned sample size. In order to maintain study blinding for all study endpoints, including those related to engraftment for a period of 100 days subsequent to transplantation, we expect to announce top-line results in the first half of 2021. At the same time, our Phase 2b BLAST consolidation study in AML is progressing, and we anticipate results from a planned interim analysis in the second half of this year.

"As we indicated last quarter, development of our second clinical candidate, AGI-134, has been impacted by COVID-19, as enrollment in the Phase 1/2a trial has been temporarily suspended. We have, however, recently begun activities to restart study recruitment and we expect data from that study in the second half of next year.

"The COVID-19 pandemic has caused significant disruptions in drug development timelines across the industry. We are pleased that we expect to report on three important and potentially value-creating data readouts by the end of the year, and with the additional $13.4 million that we raised during the second quarter, we have the resources to reach these important milestones. We believe the broad clinical utility of motixafortide across a wide range of cancer indications that we have observed in data generated to date highlight its potential as a promising new treatment option, and we look forward to reporting these data as they become available," concluded Mr. Serlin.

Upcoming Expected 2020 and 2021 Milestones

Overall results, including progression free survival (PFS) and overall survival (OS) data, from the COMBAT/KEYNOTE-202 Phase 2a triple combination study in the second half of this year;

Newly planned interim analysis of the Phase 3 GENESIS registrational study in stem cell mobilization in the second half of this year. If the primary endpoint is reached, recruitment would be stopped immediately (and announced); topline data are expected in the first half of 2021;

Interim analysis from the BLAST Phase 2b AML consolidation study during the second half of 2020, unchanged from prior guidance;

Initial results from Part 2 of Phase 1/2a trial of AGI-134 in the second half of 2021.

Financial Results for the Second Quarter Ended June 30, 2020

Research and development expenses for the three months ended June 30, 2020 were $4.6 million, a decrease of $0.7 million, or 12.5%, compared to $5.3 million for the three months ended June 30, 2019. The decrease resulted primarily 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 quarter of 2020. Research and development expenses for the six months ended June 30, 2020 were $10.1 million, an increase of $0.4 million, or 3.8%, compared to $9.7 million for the six months ended June 30, 2019. The increase resulted primarily from higher expenses associated with the motixafortide COMBAT and GENESIS clinical trials, offset by a decrease in expenses associated with the AGI-134 study.

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Sales and marketing expenses for the three months ended June 30, 2020 were $0.2 million, similar to the comparable period in 2019. Sales and marketing expenses for the six months ended June 30, 2020 were $0.4 million, a decrease of $0.1 million, or 25.9%, compared to $0.5 million for the six months ended June 30, 2019. The decrease resulted primarily from a decrease in payroll and related expenses related to a decrease in share-based compensation from the 2019 period.

General and administrative expenses for the three months ended June 30, 2020 were $0.7 million, a decrease of $0.2 million, or 21.6% compared to $0.9 million for the three months ended June 30, 2019. The decrease resulted primarily from 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 quarter of 2020, as well as a decrease in professional fees. General and administrative expenses for the six months ended June 30, 2020 were $2.0 million, an increase of $0.1 million, or 5.7%, compared to $1.9 million for the six months ended June 30, 2019. The increase resulted primarily from an increase in share-based compensation.

The Company’s operating loss for the three months ended June 30, 2020 amounted to $5.6 million, compared to an operating loss of $6.5 million for the three months ended June 30, 2019. The Company’s operating loss for the six months ended June 30, 2020 was $12.4 million, compared to $12.1 million for the comparable period in 2019.

Non-operating income (expenses) for the three and six months ended June 30, 2020 and for the three and six months ended June 30, 2019 primarily relate to fair-value adjustments of warrant liabilities on the Company’s balance sheet, offset by warrant offering expenses.

Net financial expenses for the three months ended June 30, 2020 amounted to $0.4 million compared to net financial expenses of $0.3 million for the three months ended June 30, 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 six months ended June 30, 2020 amounted to $0.6 million compared to net financial expenses of $0.5 million for the six months ended June 30, 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 June 30, 2020 amounted to $6.8 million, compared with a net loss of $5.5 million for the comparable period in 2019. The Company’s net loss for the six months ended June 30, 2020 amounted to $13.4 million, compared with a net loss of $11.6 million for the comparable period in 2019.

The Company held $27.3 million in cash, cash equivalents and short-term bank deposits as of June 30, 2020.

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Net cash used in operating activities was $12.3 million for the six months ended June 30, 2020, compared with net cash used in operating activities of $11.1 million for the six months ended June 30, 2019. The $1.2 million increase in net cash used in operating activities during the six-month period in 2020 was primarily the result of changes in operating asset and liability items in two periods, i.e., an increase in prepaid expenses and other receivables in 2020 versus a decrease in 2019, as well as a larger decrease in accounts payable and accruals in 2020 versus 2019.

Net cash provided by investing activities was $0.6 million for the six months ended June 30, 2020, compared to net cash used in investing activities of $3.1 for the six months ended June 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 $12.0 for the six months ended June 30, 2020, compared to net cash provided by financing activities of $15.7 million for the six months ended June 30, 2019. The cash flows in 2020 primarily reflect the May and June financings, and the net proceeds from the ATM facility, offset by repayments of the loan from Kreos Capital. The cash flows in 2019 primarily reflect the underwritten public offering completed in February 2019, as well as net proceeds from the ATM facility.

Conference Call and Webcast Information

BioLineRx will hold a conference call today, August 6, 2020 at 10:00 a.m. EDT. To access the conference call, please dial +1-888-668-9141 from the US or +972-3-918-0610 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 August 8, 2020; please dial +1-888-782-4291 from the US or +972-3-925-5921 internationally.