PR Newswire | Aug 6, 2020 07:01AM EDT

Update

08/06 06:00 CDT

BioLineRx Reports Second Quarter 2020 Financial Results and Provides Corporate Update- On track to report three significant data readouts in next few months -- Completes successful financings, raising gross proceeds of $13.4 million; sufficient to reach multiple important milestones -- Management to hold conference call today, August 6, at 10:00 am EDT - TEL AVIV, Israel, Aug. 6, 2020

TEL AVIV, Israel, Aug. 6, 2020 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a late clinical-stage biopharmaceutical company focused on oncology, today reports its financial results for the quarter ended June 30, 2020 and provides a corporate update.

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.

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 payrolland 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 ?nancial 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.

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.

(Tables follow)

AboutBioLineRx

BioLineRx Ltd. (NASDAQ/TASE: BLRX) is a late clinical-stage biopharmaceutical company focused on oncology. The Company's business model is to in-license novel compounds, develop them through clinical stages, and then partner with pharmaceutical companies for further clinical development and/or commercialization.

The Company's lead program, motixafortide (BL-8040), is a cancer therapy platform currently being evaluated in a Phase 2a study for the treatment of pancreatic cancer in combination with KEYTRUDA(r) and chemotherapy under a collaboration agreement with MSD. Motixafortide 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.

BioLineRx is developing a second oncology program, AGI-134, an immunotherapy treatment for multiple solid tumors that is currently being investigated 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 12, 2020. 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 McCarthyLifeSci Advisors, LLC+1-212-915-2564tim@lifesciadvisors.com

BioLineRx Ltd.

CONDENSED CONSOLIDATED INTERIM STATEMENTS OF FINANCIAL POSITION (UNAUDITED)

December 31, June 30,

2019 2020

in USD thousands

Assets

CURRENT ASSETS

Cash and cash equivalents 5,297 5,523

Short-term bank deposits 22,192 21,779

Prepaid expenses 108 426

Other receivables 613 441

Total current assets 28,210 28,169

NON-CURRENT ASSETS

Property and equipment, net 1,816 1,580

Right-of-use assets, net 1,650 1,490

Intangible assets, net 21,891 21,750

Total non-current assets 25,357 24,820

Total assets 53,567 52,989

Liabilities and equity

CURRENT LIABILITIES

Current maturities of long-term loans 2,692 2,867

Accounts payable and accruals:

Trade 7,794 7,396

Other 1,280 1,260

Lease liabilities 202 200

Total current liabilities 11,968 11,723

NON-CURRENT LIABILITIES

Warrants 658 6,077

Long-term loans, net of current maturities 5,799 4,329

Lease liabilities 1,762 1,630

Total non-current liabilities 8,219 12,036

COMMITMENTS AND CONTINGENT LIABILITIES

Total liabilities 20,187 23,759

EQUITY

Ordinary shares 4,692 8,281

Share premium 265,938 271,107

Capital reserve 12,132 12,639

Other comprehensive loss (1,416) (1,416)

Accumulated deficit (247,966) (261,381)

Total equity 33,380 29,230

Total liabilities and equity 53,567 52,989

BioLineRx Ltd.

CONDENSED CONSOLIDATED INTERIM STATEMENTS OF COMPREHENSIVE LOSS (UNAUDITED)

Three months ended June Six months ended June 30, 30,

2019 2020 2019 2020

in USD thousands in USD thousands

RESEARCH AND DEVELOPMENT (5,302) (4,640) (9,694) (10,062)EXPENSES

SALES AND MARKETING EXPENSES (226) (182) (482) (357)

GENERAL AND ADMINISTRATIVE (949) (744) (1,879) (1,987)EXPENSES

OPERATING LOSS (6,477) (5,566) (12,055) (12,406)

NON-OPERATING INCOME 1,261 (843) 921 (374)(EXPENSES), NET

FINANCIAL INCOME 171 35 381 175

FINANCIAL EXPENSES (440) (396) (887) (810)

NET LOSS AND COMPREHENSIVE LOSS (5,485) (6,770) (11,640) (13,415)

in USD in USD

LOSS PER ORDINARY SHARE - BASIC (0.04) (0.03) (0.08) (0.07)AND DILUTED

WEIGHTED AVERAGE NUMBER OFSHARES USED IN CALCULATION OF 145,461,598 220,317,889 139,270,178 198,277,447LOSS PER ORDINARY SHARE

BioLineRx Ltd.

CONDENSED INTERIM STATEMENTS OF CHANGES IN EQUITY (UNAUDITED)

Ordinary shares Share Capital Other Comprehensive Accumulated Total premium reserve loss deficit

in USD thousands

BALANCE AT JANUARY 1, 2019 3,110 250,192 11,955 (1,416) (222,520) 41,321

CHANGES FOR SIX MONTHSENDED JUNE 30, 2019:

Issuance of share capital, 890 10,437 - - - 11,327net

Employee stock options 1 27 (27) - - 1exercised

Employee stock options - 866 (866) - - -forfeited and expired

Share-based - - 773 - - 773compensation

Comprehensive loss for the - - - - (11,640) (11,640)period

BALANCE AT JUNE 30, 2019 4,001 261,522 11,835 (1,416) (234,160) 41,782

Ordinary shares Share Capital Other Comprehensive Accumulated Total premium reserve loss deficit

in USD thousands

BALANCE AT JANUARY 1, 2020 4,692 265,938 12,132 (1,416) (247,966) 33,380

CHANGES FOR SIX MONTHSENDED JUNE 30, 2020:

Issuance of share capital, 3,581 4,754 - - - 8,335net

Employee stock options 8 224 (224) - - 8exercised

Employee stock options - 191 (191) - - -forfeited and expired

Share-based - - 922 - - 922compensation

Comprehensive loss for the - - - - (13,415) (13,415)period

BALANCE AT JUNE 30, 2020 8,281 271,107 12,639 (1,416) (261,381) 29,230

BioLineRx Ltd.

CONDENSED INTERIM STATEMENTS OF CHANGES IN EQUITY (UNAUDITED)

Ordinary Share Capital Other Accumulated shares premium reserve Comprehensive deficit Total loss

in USD thousands

BALANCE AT APRIL 1, 2019 3,928 259,860 12,191 (1,416) (228,675) 45,888

CHANGES FOR THREE MONTHSENDED JUNE 30, 2019:

Issuance of share capital, 73 817 - - - 890net

Employee stock options - 9 (9) - - -exercised

Employee stock options - 836 (836) - - -forfeited and expired

Share-based - - 489 - - 489compensation

Comprehensive loss for the - - - - (5,485) (5,485)period

BALANCE AT JUNE 30, 2019 4,001 261,522 11,835 (1,416) (234,160) 41,782

Ordinary Share Capital Other Accumulated shares premium reserve Comprehensive deficit loss

Total

in USD thousands

BALANCE AT APRIL 1, 2020 4,907 267,140 12,488 (1,416) (254,611) 28,508

CHANGES FOR THREE MONTHSENDED JUNE 30, 2020:

Issuance of share capital, 3,373 3,859 - - - 7,232net

Employee stock options 1 20 (20) - - 1exercised

Employee stock options - 88 (88) - - -forfeited and expired

Share-based - - 259 - - 259compensation

Comprehensive loss for the - - - - (6,770) (6,770)period

BALANCE AT JUNE 30, 2020 8,281 271,107 12,639 (1,416) (261,381) 29,230

BioLineRx Ltd.

CONDENSED CONSOLIDATED INTERIM CASH FLOW STATEMENTS (UNAUDITED)

Six months ended June 30,

2019 2020

in USD thousands

CASH FLOWS - OPERATING ACTIVITIES

Comprehensive loss for the period (11,640) (13,415)

Adjustments required to reflect net cash used inoperating activities 573 1,112

(see appendix below)

Net cash used in operating activities (11,067) (12,303)

CASH FLOWS - INVESTING ACTIVITIES

Investments in short-term deposits (27,510) (23,751)

Maturities of short-term deposits 24,441 24,335

Purchase of property and equipment (53) (1)

Net cash provided by (used in) investing activities (3,122) 583

CASH FLOWS - FINANCING ACTIVITIES

Issuance of share capital and warrants, net of issuance 15,879 13,411costs

Employee stock options exercised 1 8

Repayments of loans (47) (1,331)

Repayments of lease liabilities (110) (121)

Net cash provided by financing activities 15,723 11,967

INCREASE IN CASH AND CASH EQUIVALENTS 1,534 247

CASH AND CASH EQUIVALENTS - BEGINNING 3,404 5,297 OF PERIOD

EXCHANGE DIFFERENCES ON CASH AND CASH EQUIVALENTS 34 (21)

CASH AND CASH EQUIVALENTS - END OF PERIOD 4,972 5,523

BioLineRx Ltd.

APPENDIX TO CONDENSED CONSOLIDATED INTERIM CASH FLOW STATEMENTS (UNAUDITED)

Six months ended June 30,

2019 2020

in USD thousands

Adjustments required to reflect net cash used inoperating activities:

Income and expenses not involving cash flows:

Depreciation and amortization 439 533

Long-term prepaid expenses (4) -

Exchange differences on cash and cash equivalents (34) 21

Fair value adjustments of warrants (1,354) (250)

Share-based compensation 773 922

Warrant issuance costs 417 593

Interest and exchange differences on short-term deposits (440) (171)

Interest on loans 292 36

Exchange differences on lease liability - (8)

89 1,676

Changes in operating asset and liability items:

Decrease (increase( in prepaid expenses and other 848 (146)receivables

Decrease in accounts payable and accruals (364) (418)

484 (564)

573 1,112

Supplemental information on interest received in cash 442 300

Supplemental information on interest paid in cash 477 534

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SOURCE BioLineRx Ltd.