On May 20, 2020 BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a late clinical-stage biopharmaceutical company focused on oncology, reported its financial results for the quarter ended March 31, 2020 and provides a corporate update (Press release, BioLineRx, MAY 20, 2020, View Source [SID1234558307]).

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

Completed recruitment of the triple combination arm of the COMBAT/KEYNOTE-202 study;

Continued to advance the COMBAT/KEYNOTE-202 study toward progression free survival (PFS) and overall survival (OS) data in mid-2020;

Received Orphan Drug Designation for motixafortide (BL-8040) for the Treatment of Pancreatic Cancer in Europe;

Announced Notice of Allowance from USPTO for a broad patent covering motixafortide in combination with anti-PD-1 for the treatment of any and all types of cancer.

"The ongoing COVID-19 pandemic has caused an unprecedented disruption in business activities and continues to impact drug development timelines around the world," stated Philip Serlin, Chief Executive Officer of BioLineRx. "During this crisis, we have remained in close contact with our principal investigators, and we remain on track to report important survival data from the triple combination arm of our ongoing Phase 2a COMBAT/KEYNOTE-202 study in advanced second-line pancreatic cancer mid-year, consistent with our prior guidance. The compelling and sustained preliminary response data on 22 evaluable patients that we reported in December give us hope that the combination of motixafortide, KEYTRUDA and chemotherapy could represent a significant breakthrough in one of the most difficult to treat cancers.

"We also continue to expect results from our ongoing BLAST Phase 2b study of motixafortide in consolidation therapy for AML patients and our GENESIS Phase 3 trial in stem cell mobilization for autologous transplantation in multiple myeloma patients by the end of this year.

"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 now expect data from that study in the second half of next year.

"We have taken swift actions in response to the pandemic to conserve cash and ensure that we can successfully navigate through this unprecedented time. But we remain as enthusiastic as ever about the broad therapeutic potential of motixafortide to treat a broad range of cancers, and we look forward to three important data readouts this year," Mr. Serlin concluded.

Upcoming 2020 and 2021 Milestones

Progression-free survival and overall survival data from the triple combination arm of the COMBAT/KEYNOTE-202 Phase 2a study in mid-2020;

Interim results from the BLAST Phase 2b AML consolidation study in the second half of 2020;

Results from the GENESIS Phase 3 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, which were initially expected by year-end 2020, are now anticipated in the second half of 2021 due to a temporary suspension of recruitment caused by the COVID-19 pandemic.

Financial Results for the Quarter Ended March 31, 2020

Research and development expenses for the quarter ended March 31, 2020 were $5.4 million, an increase of $1.0 million, or 23.5%, compared to $4.4 million for the comparable period in 2019. The increase resulted primarily from higher expenses associated with the motixafortide COMBAT clinical trial as well as an increase in share-based compensation.

Sales and marketing expenses for the quarter ended March 31, 2020 were $0.2 million, a decrease of $0.1 million, or 31.6%, compared to $0.3 million for the comparable period in 2019. The decrease resulted primarily from a decrease in payroll and related expenses.

General and administrative expenses for the quarter ended March 31, 2020 were $1.2 million, an increase of $0.3 million, or 33.7%, compared to $0.9 million for the comparable period in 2019. The increase resulted primarily from an increase in share-based compensation.

The Company’s operating loss for the quarter ended March 31, 2020 amounted to $6.8 million, compared to an operating loss of $5.6 million for the comparable period in 2019.

Non-operating income amounted to $0.5 million for the quarter ended March 31, 2020, compared to non-operating expense of $0.3 million for the comparable period in 2019. Non-operating income for the three months ended March 31, 2020 primarily relates to fair-value adjustments of warrant liabilities on the Company’s balance sheet. Non-operating expenses for the three months ended March 31, 2019 primarily relate to warrant offering expenses offset by fair-value adjustments of warrant liabilities on the Company’s balance sheet.

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Net financial expenses amounted to $0.3 million for the quarter ended March 31, 2020, compared to net financial expenses of $0.2 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.

The Company’s net loss for the quarter ended March 31, 2020 amounted to $6.6 million, compared with a net loss of $6.2 million for the comparable period in 2019.

The Company held $21.2 million in cash, cash equivalents and short-term bank deposits as of March 31, 2020.

Net cash used in operating activities was $6.7 million for the quarter ended March 31, 2020, compared with net cash used in operating activities of $4.6 million for the comparable period in 2019. The $2.1 million increase in net cash used in operating activities during the three-month period in 2020, compared to the three-month period in 2019, was primarily the result of changes in operating asset and liability items in the two periods, i.e., an increase in prepaid expenses and other receivables in 2020 versus a decrease in 2019, as well as higher decrease in accounts payable and accruals in 2020 versus 2019.

Net cash provided by investing activities was $6.2 million for the quarter ended March 31, 2020, compared to net cash used in investing activities of $9.3 million for the comparable period in 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 $0.4 million for the quarter ended March 31, 2020, compared to net cash provided by financing activities of $14.9 million for the comparable period in 2019. The decrease 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, May 20, 2020 at 10:00 a.m. EDT. To access the conference call, please dial +1-888-668-9141 from the US or +972-3-918-0609 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 May 22, 2020; please dial +1-888-782-4291 from the US or +972-3-925-5928 internationally.